24.9.2010

Official Journal of the European Union

C 258/32

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010

[Decisions taken pursuant to Article 34 of Directive 2001/83/CE (1) or Article 38 of Directive 2001/82/CE (2)]

(2010/C 258/02)

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	MemberState concerned	Date of notification
2.6.2010	Clopidogrel Orion	See annex I	See annex I	3.6.2010
10.6.2010	Colistin sulfate	See annex II	See annex II	11.6.2010
19.4.2010	Diovan (1219)	See annex III	See annex III	20.4.2010
15.3.2010	Lescol	See annex IV	See annex IV	17.3.2010
19.4.2010	Diovan (1220)	See annex V	See annex V	20.4.2010
10.6.2010	Losec and associated names	See annex VI	See annex VI	14.6.2010
15.4.2010	Protium and associated names	See annex VII	See annex VII	16.4.2010
26.3.2010	Cevazuril 50 mg/ml oral suspension for piglets	See annex VIII	See annex VIII	30.3.2010
30.3.2010	Pantoprazole Bluefish	See annex IX	See annex IX	31.3.2010
30.3.2010	Pantoprazole Olinka (1169)	See annex X	See annex X	31.3.2010
30.3.2010	Pantoprazole Olinka (1170)	See annex XI	See annex XI	31.3.2010
26.5.2010	Valproate-ratiopharm chrono 300/500 mg Retardtabletten	See annex XII	See annex XII	27.5.2010
4.6.2010	Clopidogrel Teva and associated names	See annex XIII	See annex XIII	7.6.2010
14.6.2010	Doxycycline hyclate	See annex XIV	See annex XIV	15.6.2010
10.6.2010	Opgenra	Howmedica International S. de R. L., RaheenBusinessPark, Limerick, Ireland	This Decision is addressed to the Member States	14.6.2010
10.5.2010	Tysabri	Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland	This Decision is addressed to the Member States	11.5.2010
10.5.2010	Ranexa	Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg	This Decision is addressed to the Member States	12.5.2010
11.3.2010	Revolade	GlaxoSmithKline Trading Services Limited, 6900 CorkAirportBusinessPark, Kinsale Road, Cork, Ireland	This Decision is addressed to the Member States	12.3.2010
11.3.2010	Stelara	Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse - België	This Decision is addressed to the Member States	12.3.2010

— Refusal of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	MemberState concerned	Date of notification
27.4.2010	Vasotop	See annex XV	See annex XV	28.4.2010

— Suspension of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	MemberState concerned	Date of notification
3.3.2010	Sibutramine	See annex XVI	See annex XVI	4.3.2010
14.6.2010	Dextropropoxyphene	See annex XVII	See annex XVII	15.6.2010

— Revocation of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	MemberState concerned	Date of notification
14.6.2010	Dextropropoxyphene	See annex XVIII	See annex XVIII	15.6.2010
14.6.2010	benfluorex	See annex XIX	See annex XIX	15.6.2010

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

MemberState EU/EEA	Applicant	(Invented) Name	Strength	Pharmaceutical Form	Route of administration
Czech Republic	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Denmark	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Finland	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Germany	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Latvia	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Lithuania	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Norway	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Slovak Republic	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use
Sweden	Orion Corporation Orionintie 1, FI-02200 Espoo Finland	Clopidogrel Orion	75 mg	Film-coated tablet	Oral use

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member state/EEA	Applicant/Marketing Authorisation Holder	Product name	INN	Strength	Pharmaceutical form	Animal species	Frequency and route of administration	Recommended dose	Withdrawal period(s)
Austria	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	Colivet 2 000 000 IU/ml, Konzentrat für eine orale Lösung für Schweine und Geflügel	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Pigs Poultry	For three consecutive days in drinking water	Pigs: 100 000 IU/kg bw/day in two equally divided doses per day Poultry: 75 000 IU/kg bw/day	Pigs: meat: 1 day Broilers and laying hens: 1 day Other poultry: 7 days Eggs: Zero days
Belgium	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Calves, Lambs: meat and offals 7 days. Pigs: meat and offals 1 day. Broiler and laying, hens: 1 day. Eggs: Zero days. Other Poultry: meat and offals - 7 days. Eggs: Zero days
Bulgaria	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	Colivet oral solution	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poutry	Orally: 3 days	Pigs: 100 000 IU/kg b.w./day Poultry: 75 000 IU/kg/b.w./day	Meat: 1 days Eggs: Zero days
Bulgaria	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Calves, Lambs: meat and offals 7 days. Pigs: meat and offals 1 day. Broiler and laying, hens: 1 day. Eggs: Zero days. Other poultry: meat and offals: 7 days. Eggs: Zero days
Cyprus	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	COLIVET 2 000 000 IU/ml	Colistin sulfate	2 MIU/ml	Oral Solution	Pigs Birds	Pigs: 100 000 IU/kg/day Poultry: 75 000 IU/kg/day	Pigs: 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days Poultry: 37,5 ml of product per tonne of body weight per day for 3 consecutive days.	Meat and offal: Pigs: 1 day Broilers and laying hens: 1 day Other poultry: 7 days Eggs: Zero days
Czech Republic	Ceva Animal Health Slovakia s.r.o. Račianska 77 831 02 Bratislava SLOVAK REPUBLIC	Colivet Sol.	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Chicken (broilers)	Daily.Orally	Broilers: 75 000 IU colistin per kg of bodyweight (i.e. 0,37 ml of product per 10 kg of bodyweight per day for 3-5 days via drinking water) Pigs: 50 000 IU colistin per kg of bodyweight per 12 hrs (i.e. 0,25 ml of product per 10 kg of bodyweight per 12 hrs for 3-5 days via drinking water or milk replacement).	Meat and offal: Pigs and chicken broilers: 2 days. Do not use in laying hens producing eggs for human consumption.
Denmark	Ceva Animal Health A/S Andkærvej 19 7100 Vejle DENMARK	Colivet	Colistin sulfate	2 MIU/ml	Oral Solution	Pigs	Daily.Orally	100 000 IU colistin / kg body weight daily for 3-5 days.	1 day
Denmark	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat and offal: 7 days Eggs: Zero days
France	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	COLISTINE CEVA 2 MUI/ml concentré pour solution buvable pour porcins et volailles	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poultry	3 days	Pigs: 100 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days. Poultry: 75 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 37,5 ml of product per tonne of body weight per day for 3 consecutive days.	Meat and offals: Pigs: 1 day Chickens and egg laying hens: 1 day Other poultry: 7 days Eggs: Zero days
France	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	COLIVET SOLUTION	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals: Calves and lambs: 7 days Porcine: 1 day Chicken and egg-laying hens: 1 day Other birds: 7 days Eggs: Zero days
France	Coophavet S.A.S Saint Herblion, B.P. 70089 44153 Ancenis Cedex FRANCE	COFACOLI SOLUTION	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals: 7 days. Eggs: Zero days
France	Franvet Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCE	MILICOLI	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals:Porcine, calves, chicken: 1 day Lamb and poultry other than chicken: 7 days Eggs: Zero days
France	Laboratoires Biové 3 rue de Lorraine 62510 Arques FRANCE	ACTI COLI 2 MUI/ML	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals: Pigs: 0 days Chicken: 1 day Other poultry: 7 days Calves: 2 days Lamb: 7 days Eggs: Zero days
France	Laprovet 2 Chemin de la Milletière B.P. 67562 37075 Tours Cedex 2 FRANCE	COLISTINE SOLUTION E.A.F.	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals: 7 days. Eggs: Zero days
France	Sogeval Zone Industrielle des Touches 200, avenue de Mayenne B.P. 2227 53022 Laval Cedex 9 FRANCE	SOGECOLI 2 millions UI/ml solution buvable	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals: Pigs: 0 day Chicken: 1 day Other poultry: 7 days. Calves: 2 days. Lamb: 7 days Eggs: Zero days
France	Virbac S.A. 1ere Avenue 2065 M LID B.P. 27 06516 Carros Cedex FRANCE	COLISTINE SULFATE 2 MUI/ml buvable virbac	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	3 days	Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day	Meat and offals: 7 days. Eggs: Zero days
Germany	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	Coliplus	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat and offal: 7 days Eggs: Zero days
Greece	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	Colivet	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Pigs Poultry	Drinking water/per day	Pigs: 100 000 IU/Kg BW x 3 days Poultry:75 000 IU/Kg BW X 3 days	Pigs: 1 day Broilers and laying hens: 1 day Other poultry: 7 days Eggs: Zero days
Greece	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLISTIN 2 000 000 IU/ML/DIVASA-FARMANIC	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat and offal: 7 days Eggs: Zero days
Hungary	Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat and offal: 7 days Eggs: Zero days.
Hungary	Coophavet S.A.S Saint Herblion, B.P. 70089 44153 Ancenis Cedex FRANCE	Cofacoli oral solution	Colistin sulfate	2 MIU/ml	Oral solution	Cattle (suckling calf) Pig Chicken	Calf, Pig: 0,25 ml product/10 kg bw twice daily for 3-4 days Chicken, Laying hen: 37,5 ml product/ton of living weight dissolved in drinking water for 3 days.	Calf, Pig: 50 000 IU/kg bw Broiler chicken, laying hen: 75 000 IU/kg bw/day.	Calf: 3 days Pig: 2 days Chicken and laying hen: 2 days Eggs: Zero days.
Ireland	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	COLISCOUR 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Pigs Poultry	Daily for three consecutive days. Administration is by the oral route via drinking water.	Pigs: 100 000 IU of colistin per kg body weight per day i.e. 0,50 ml of product per 10 kg of body weight per day Poultry: 75 000 IU of colistin per kg body weight per day i.e. 37,5 ml of product per tonne of body weight per day	Pigs: Meat and offal: 1 day Broilers and laying hens: Meat and offal: 1 day Other poultry: Meat and offal: 7 days. Eggs: Zero days.
Italy	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Calves, Lambs: Meat and offals: 7 days. Pigs: Meat and offals: 1 day. Broiler and laying, hens: 1 day. Eggs: Zero days. Other Poultry: meat and offals: 7 days. Eggs: Zero days
Latvia	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	Colivet oral solution	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poultry	Oral use. Administration vis drinking water or milk or direct application by mouth. Twice a day for 3 to 5 consecutive days.	Chicken: 75 000 IU colistin per kg per day (0,37 ml of Colivet per 10 kg twice a day) Pig: 50 000 IU of colistin per kg twice a day(0,25 ml Colivet per 10 kg twice a day).	Edible tissues: 1 day Eggs: 1 day
Lithuania	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	COLIVET SOLUTION, geriamasis tirpalas	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poultry	With drinking water or milk powder. Orally via drinking water.	Pigs: 50 000 IU/kg of body weight, i.e. 0,25 ml Colivet Solution per 10 kg of body weight twice daily for 3-5 consecutive days. Poultry: 75 000 IU/kg of body weight per day, i.e. approximately 0,37 ml of Colivet Solution per 10 kg of body weight per day for 3-5 consecutive days.	Meat: 1 day. Poultry: meat and eggs: 1 day
Lithuania	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	Colistop, geriamasis tirpalas	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poultry (broilers chickens)	For oral administration, usually via drinking water. For 3 consecutive days.	Pigs: 102500 IU/kg BW every 12 hours, for 3 days (equivalent to 0,5 ml of Colistop Solution/10 kg BW every 12 hours, for 3 consecutive days). Broilers chickens: 123 000 IU/kg BW/day, for 3 days (equivalent to 0,06 ml of Colistop Solution/kg BW/day, for 3 consecutive days)	Fattening pigs: 2 days. Broilers chickens: 7 days
Lithuania	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Calves, Lambs: Meat and offals: 7 days. Pigs: Meat and offals: 1 day. Broiler and laying, hens: 1 day. Eggs: Zero days. Other Poultry: Meat and offals: 7 days. Eggs: Zero days
Poland	Ceva Santé Animale Zone Industrielle La Ballastiere B.P. 126 33500 Libourne FRANCE	Colivet solution	Colistin sulfate	2 MIU/ml	oral solution	Pig Chickens	Administration via drinking water or milk. For 3-5 days	Chickens: 75 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,37 ml of product/10 kg b.w.twice daily for 3 - 5 days Pigs: 50 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,25 ml of product/10 kg b.w. twice daily for 3 - 5 days.	Meat and offal: 1 day Eggs: 1 day
Poland	DIVASA - FARMAVIC, S.A. Ctra. Sant Hipòlit, km 71 08503 GURB - VIC (Barcelona) Spain	Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens	Colistin (as colistin sulfate)	2 MIU/ml	Concentrate for oral solution for use in drinking water	Cattle (calves), sheep (lambs), swine and chickens	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat and offal: 7 days Eggs: Zero days Not permitted for use in animals producing milk for human consumption
Portugal	Ceva Saúde Animal - Produtos Farmacêuticos e Farmacológicos, Lda Rua Doutor António Loureiro Borges, 9/9A - 9°A Miraflores 1495-131 Algés PORTUGAL	Colivet 2 000 000 UI/ml, concentrate for oral solution for pigs and birds	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Pigs Domestic birds	3 days	Swine: 100 000 UI/kg BW/day Birds: 75 000 UI/kg BW/day	Meat and offal: Pigs: 1 day Broilers and laying hens: 1 day, Other birds: 7 days, Eggs: Zero days
Portugal	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Calves, Lambs: Meat and offals: 7 days. Pigs: Meat and offals: 1 day. Broiler and laying, hens: 1 day. Eggs: Zero days. Other Poultry: Meat and offals: 7 days. Eggs: Zero days
Romania	CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus SPAIN	ENTEROBAS SOLUCION	Colistin sulfate	2 MIU/ml	oral solution	Calves Pigs Poultry	Oral administration (drinking water or as milk replacer) treatment: 4-5 days	Calves and Pigs: 100 000 UI/kg b.w/day equivalent to 0,5 ml/10 kg b.w./day Poultry: 100 000 UI/kg b.w./day equivalent to 0,5 ml/litre drinking water/day	Meat: calves - 2 days Pigs: 5 days Poultry: 3 days Eggs: do not use in animals from which eggs are produced for human consumption
Romania	CEVA SANTE ANIMALE ROMANIA SRL 5 Chindiei, sector 4 040185 Bucharest ROMANIA	COLIVET SOLUTION	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poultry	Oral administration (drinking water) treatment: 3 consecutive days	Pigs: 100 000 I.U. of colistin (as sulfate) /1kg b.w. in two equally divided doses/day, i.e. 0,5 ml of product per 10 kg of body weight in two equally divided doses/day Poultry: 75 000 I.U. of colistin (as sulfate) /1kg b.w. per day, i.e. 37,5 ml of product per 1 tone of body weight/day	Meat and offal: pigs 1 day Broilers and layers: 1 day Eggs: Zero days
Romania	Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat and offal: 7 day Eggs: Zero days
Romania	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS SOLUTION	Colistin sulfate	2 MIU/ml	Oral solution	Pigs, Broilers	Oral administration (drinking water) treatment: 3 days	Poultry: 0,03 ml/kg b.w/day Pigs: 0,5 ml/10 kg b.w. every 12 hours	Meat: 9 days
Romania	Franvet Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCE	MILICOLI	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Pigs Poultry	Oral administration (drinking water or milk replacer) treatment: 3 - 4 days	Calves, Pigs and Lambs: 50 000 I.U./kg b.w. or 0,25 ml of product/10 kg b.w Poultry: 75 000 I.U./kg/day or 0,25 ml/1 litre water	Meat and offal: 7 days Eggs: Zero days
Romania	S.C. CRIDA PHARM S.R.L. Str. Stadionului nr. 1 Oltenita ROMANIA	COLICRID	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Poultry	Oral administration (drinking water) treatment: 3 - 5 days	Pigs: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day Poultry: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day	Meat: pigs: 7 days Poultry: 3 days
Romania	Sogeval Zone Industrielle des Touches 200, avenue de Mayenne B.P. 2227 53022 Laval Cedex 9 FRANCE	SOGECOLI	Colistin sulfate	2 MIU/ml	Oral solution	Calves Lambs Poultry	Oral administration treatment: 3 - 4 days	Calves, Lamb: 50 000 I.U./kg b.w. or 0,25 ml/10 kg b.w. twice a day, morning and evening Poultry: 75 000 I.U./ kg b.w. daily or 0,25 ml/1 litre water	Meat: 7 days
Slovak Republic	Ceva Animal Health Slovakia, spol. s.r.o. Račianska 77 831 02 Bratislava SLOVAK REPUBLIC	COLIVET sol. ad us.vet.	Colistin sulfate	2 MIU/ml	Oral solution	Pigs, Chickens	3 - 5 days in drinking water, milk or direct administration	Pigs: 50 000 IU colistine sulfate/kg b.w. (0,25 ml product/10 kg b.w.) (2 times). Chickens: 75 000 IU colistine sulfate/kg b.w. (0,37 ml product/10 kg b.w.	Meat: 1 day. Eggs: 1 day.
Slovak Republic	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml koncentrát na perorálny roztok na použitie v pitnej vode pre hovädzí dobytok, ovce, ošípané a kurčatá	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Calves, Lambs: Meat and offals: 7 days. Pigs: Meat and offals: 1 day. Broiler and laying, hens: 1 day. Eggs: Zero days. Other Poultry: Meat and offals: Zero days.
Spain	CEVA SALUD ANIMAL, S.A. Carabela La Niña no 12 5a planta 08017 Barcelona SPAIN	COLIVET 2 000 000 UI/ML	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Birds	3 days. Orally	Pigs: 100 000 UI/Kgbw Birds: 75 000 UI/Kg bw	1 day
Spain	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS SOLUCION	Colistin sulfate	2 MIU/ml	Oral solution	Pigs Birds (Chicken)	3 days. Orally	Pigs: 102 500 UI/Kg bw/12 hours Birds: 123 000 UI/Kg bw/12 hours	Pigs: 2 days Birds: 7 days
Spain	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLISTINA DIVASA 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat: 7 days Eggs: Zero days
The Netherlands	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat: 7 days Eggs: Zero days.
United Kingdom	Ceva Animal Health Ltd 90 The Broadway Chesham Buckinghamshire HP5 1EG UNITED KINGDOM	Colibird	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Poultry	For three consecutive days in drinking water	75 000 IU/kg bw/day	Meat: 7 days. Eggs: Zero days.
United Kingdom	Ceva Animal Health Ltd 90 The Broadway Chesham Buckinghamshire HP5 1EG UNITED KINGDOM	Coliscour, oral solution of colistin sulphate 2 MIU/ml	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Pigs	Twice daily for five consecutive days (via drinking water or direct oral administration)	50 000 IU/kg bw given twice daily	Meat and offal: 1 day
United Kingdom	Divasa-FarmavicS.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN	Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens	Colistin sulfate	2 MIU/ml	Concentrate for oral solution	Calves Lambs Pigs Poultry	Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.	Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days. Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.	Meat: 7 days Eggs: Zero days.

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA	Marketing Authorisation Holder	Invented name	Strength	Pharmaceutical Form	Route of administration
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 40 mg Filmtabletten	40 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 40 mg Filmtabletten	40 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 80 mg Filmtabletten	80 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 80 mg Filmtabletten	80 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 160 mg Filmtabletten	160 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 160 mg Filmtabletten	160 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 320 mg Filmtabletten	320 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 320 mg Filmtabletten	320 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 40 mg	40 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 80 mg	80 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 160 mg	160 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 320 mg	320 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Czech Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 (Tel +420-2–2577 51 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Czech Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 (Tel +420-2–2577 51 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan	40 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan	80 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan	160 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan	320 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
France	Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON France (Tel: +33-1–5547 60 00)	Tareg 40 mg	40 mg	film-coated tablets	Oral Use
France	Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON France (Tel: +33-1–5547 60 00)	Tareg 80 mg	80 mg	film-coated tablets	Oral Use
France	Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON France (Tel: +33-1–5547 60 00)	Tareg 160 mg	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 40 mg	40 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 40 mg	40 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 80 mg	80 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 80 mg	80 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 160 mg protect	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 160 mg	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 160 mg	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 320 mg forte	320 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 320 mg	320 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 320 mg	320 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 40 mg	40 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 80 mg	80 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 160 mg	160 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 320 mg	320 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 40 mg	40 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 40 mg	40 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 80 mg	80 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 80 mg	80 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 160 mg	160 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 160 mg	160 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 320 mg	320 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 320 mg	320 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 80 mg plėvele dengtos tabletės	80 mg	film-coated tablets	Oral Use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 160 mg plėvele dengtos tabletės	160 mg	film-coated tablets	Oral Use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 320 mg plėvele dengtos tabletės	320 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6824 DP Arnhem (Tel: + 31-26-378 21 00)	Diovan 40	40 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6800 LZ Arnhem (Tel: + 31-26-378 21 00)	Diovan 80	80 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6824 DP Arnhem (Tel: + 31-26-378 21 00)	Diovan 160	160 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6824 DP Arnhem (Tel: + 31-26-378 21 00)	Diovan 320	320 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	40 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	80 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	160 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	320 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	40 mg	film-coated tablets	Oral Use
Portugal	Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Tareg	40 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	80 mg	film-coated tablets	Oral Use
Portugal	Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Tareg	80 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	160 mg	film-coated tablets	Oral Use
Portugal	Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Tareg	160 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	320 mg	film-coated tablets	Oral Use
Romania	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 40 mg, film coated tablets	40 mg	film-coated tablets	Oral Use
Romania	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 80 mg, film coated tablets	80 mg	film-coated tablets	Oral Use
Romania	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 160 mg, film coated tablets	160 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 40 mg filmsko obložene tablete	40 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 80 mg filmsko obložene tablete	80 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 160 mg filmsko obložene tablete	160 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 320 mg filmsko obložene tablete	320 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován Cardio 40 mg comprimidos recubiertos con película	40 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress Cardio 40 mg comprimidos recubiertos con película	40 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten Cardio 40 mg comprimidos recubiertos con película	40 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován 80 mg comprimidos recubiertos con película	80 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress 80 mg comprimidos recubiertos con película	80 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten 80 mg comprimidos recubiertos con película	80 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován 160 mg comprimidos recubiertos con película	160 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress 160 mg comprimidos recubiertos con película	160 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten 160 mg comprimidos recubiertos con película	160 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován 320 mg comprimidos recubiertos con película	320 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress 320 mg comprimidos recubiertos con película	320 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten 320 mg comprimidos recubiertos con película	320 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	40 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	40 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	40 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	80 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	80 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	80 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	160 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	160 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	160 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	320 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	320 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	320 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA	Marketing Authorisation Holder	Invented name	Strength	Pharmaceutical Form	Route of administration
Austria	Novartis Pharma GmbH, Brunner Strasse 59 1235 Wien, Austria	Lescol 20 mg - Kapseln	20 mg	Capsule, hard	Oral use
Austria	Novartis Pharma GmbH, Brunner Strasse 59 1235 Wien, Austria	Lescol 40 mg - Kapseln	40 mg	Capsule, hard	Oral use
Austria	Novartis Pharma GmbH, Brunner Strasse 59 1235 Wien, Austria	Fluvastatin ‘Novartis’ 20 mg-Kapseln	20 mg	Capsule, hard	Oral use
Austria	Novartis Pharma GmbH, Brunner Strasse 59 1235 Wien, Austria	Fluvastatin ‘Novartis’ 40 mg-Kapseln	40 mg	Capsule, hard	Oral use
Austria	Novartis Pharma GmbH, Brunner Strasse 59 1235 Wien, Austria	Lescol MR 80 mg – Filmtabletten	80 mg	Film-coated tablet	Oral use
Austria	Novartis Pharma GmbH, Brunner Strasse 59 1235 Wien, Austria	Fluvastatin ‘Novartis’ MR 80 mg – Filmtabletten	80 mg	Film-coated tablet	Oral use
Belgium	Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde, Belgium	Lescol 20 mg, hard capsules	20 mg	Capsule, hard	Oral use
Belgium	Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde, Belgium	Lescol 40, hard capsules	40 mg	Capsule, hard	Oral use
Belgium	Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde, Belgium	Lescol Exel 80 mg prolonged-release tablet	80 mg	Prolonged-release tablet	Oral use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg, Germany	Lescol caps. 40 mg	40 mg	Capsule, hard	Oral use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg, Germany	Lescol XL prolonged release tablet 80 mg	80 mg	Prolonged-release tablet	Oral use
Cyprus	Demetriades & Papaellinas Ltd., Kasou 21, 1086 Nicosia, Cyprus	Lescol Capsule, 20mg	20 mg	Capsule, hard	Oral use
Cyprus	Demetriades & Papaellinas Ltd., Kasou 21, 1086 Nicosia, Cyprus	Lescol Capsule, 40mg	40 mg	Capsule, hard	Oral use
Cyprus	Demetriades & Papaellinas Ltd., Kasou 21, 1086 Nicosia, Cyprus	Lescol XL Prolonged release tablet 80mg	80 mg	Film-coated tablet	Oral use
Czech Republic	Novartis, s.r.o. Na Pankráci 1724/129 140 00 Praha 4 - Nusle, Czech Republic	Lescol 20 mg	20 mg	Capsule, hard	Oral use
Czech Republic	Novartis, s.r.o. Na Pankráci 1724/129 140 00 Praha 4 - Nusle, Czech Republic	Lescol 40 mg	40 mg	Capsule, hard	Oral use
Czech Republic	Novartis, s.r.o. Na Pankráci 1724/129 140 00 Praha 4 - Nusle, Czech Republic	Lescol XL	80 mg	Film-coated tablet	Oral use
Denmark	Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark	Lescol	20 mg	Capsule, hard	Oral use
Denmark	Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark	Lescol	40 mg	Capsule, hard	Oral use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 2100 Kopenhagen Ø, Denmark	Lescol Depot	80 mg	Prolonged-release tablet	Oral use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland	Lescol 40 mg	40 mg	Capsule	Oral use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland	Lescol XL	80 mg	Prolonged-release tablet	Oral use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FI–02130 Espoo Finland	Lescol 20 mg	20 mg	Capsule, hard	Oral use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FI–02130 Espoo Finland	Lescol 40 mg	40 mg	Capsule, hard	Oral use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FI–02130 Espoo Finland	Lescol Depot 80 mg	80 mg	Prolonged-release tablet	Oral use
France	Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex, France	LESCOL 20 mg	20 mg	Capsule, hard	Oral use
France	Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex, France	LESCOL 40 mg	40 mg	Capsule, hard	Oral use
France	Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne, France	Fractal 20 mg	20 mg	Capsule, hard	Oral use
France	Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne, France	Fractal 40 mg	40 mg	Capsule, hard	Oral use
France	Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex, France	Lescol LP 80 mg	80 mg	Film-coated, modified-release tablet	Oral use
France	Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne France	Fractal LP 80 mg	80 mg	Film-coated, modified-release tablet	Oral use
Germany	Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany	Locol 20 mg Hartkapsel	20 mg	Capsules, hard	Oral use
Germany	Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany	Locol 40 mg Hartkapsel	40 mg	Capsules, hard	Oral use
Germany	Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany	Cranoc 20 mg Hartkapsel	20 mg	Capsules, hard	Oral use
Germany	Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany	Cranoc 40 mg Hartkapsel	40 mg	Capsules, hard	Oral use
Germany	Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany	Locol 80 mg Retardtabletten	80 mg	Prolonged-release tablet	Oral use
Germany	Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany	Cranoc 80mg Retardtabletten	80 mg	Prolonged-release tablet	Oral use
Germany	Grünwalder Gesundheitsproducte GmbH Ruhlandstrasse 5, 83646 Bad Töltz, Germany	Fluvastatin-Novartis 80 mg	80 mg	Prolonged-release tablet	Oral use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km), Metamorphosis GR-144 51 Athens Greece	Lescol® Capsule, hard 20mg	20 mg	Capsule, hard	Oral use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens, Greece	Lescol® Capsule, hard 40mg	40 mg	Capsule, hard	Oral use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens, Greece	Lescol®XL Prolonged-release tablet 80mg	80 mg	Prolonged release tablet	Oral use
Hungary	Novartis Hungária Kft. Pharma Bartók Béla út 43-47, 5th Floor, 1114 Budapest, Hungary	Lescol 40 mg hard caps	40 mg	Capsule, hard	Oral use
Hungary	Novartis Hungária Kft. Pharma Bartók Béla út 43-47, 5th Floor, 1114 Budapest, Hungary	Lescol XL 80 mg retard tablet	80 mg	Prolonged-release tablet	Oral use
Iceland	Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark	Lescol 20 mg hard caps	20 mg	Capsule, hard	Oral use
Iceland	Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark	Lescol 40 mg hard caps	40 mg	Capsule, hard	Oral use
Iceland	Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark	Lescol Depot 80 mg	80 mg	Prolonged-release tablet	Oral use
Ireland	Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom	Lescol 20mg Capsules	20 mg	Capsule, hard	Oral use
Ireland	Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom	Lescol 40mg Capsules	40 mg	Capsule, hard	Oral use
Ireland	Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom	Lescol XL 80mg prolonged release tablets	80 mg	Prolonged release tablet	Oral use
Italy	Novartis Farma S.p.A. Largo Boccioni, 1, 21040 Origgio (VA), Italy	Lescol	20 mg	Capsule, hard	Oral use
Italy	Novartis Farma S.p.A. Largo Boccioni, 1, 21040 Origgio (VA), Italy	Lescol	40 mg	Capsule, hard	Oral use
Italy	ITALFARMACO S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy	Lipaxan	20 mg	Capsule, hard	Oral use
Italy	ITALFARMACO S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy	Lipaxan	40 mg	Capsule, hard	Oral use
Italy	UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy	Primesin	20 mg	Capsule, hard	Oral use
Italy	UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy	Primesin	40 mg	Capsule, hard	Oral use
Italy	SANDOZ S.p.A Address: Largo Umberto Boccioni 1 I–21040 Origgio / VA Italy	FLUVASTATINA Sandoz	20 mg	Capsule, hard	Oral use
Italy	SANDOZ S.p.A Address: Largo Umberto Boccioni 1 I–21040 Origgio / VA Italy	FLUVASTATINA Sandoz 40 mg hard capsules	40 mg	Capsule, hard	Oral use
Italy	Novartis Farma S.p.A. Largo Boccioni, 1, 21040 Origgio (VA), Italy	Lescol 80 mg	80 mg	Prolonged-release tablet	Oral use
Italy	ITALFARMACO S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy	Lipaxan 80 mg	80 mg	Prolonged-release tablet	Oral use
Italy	UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy	Primesin 80 mg	80 mg	Prolonged-release tablet	Oral use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland	Lescol XL 80 mg	80 mg	Prolonged-release tablet	Oral use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo, Finland	Lescol XL	80 mg	Prolonged-release tablet	Oral use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg, Germany	Locol 20 mg hard caps	20 mg	Capsules, hard	Oral use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg, Germany	Locol 40 mg hard caps	40 mg	Capsules, hard	Oral use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg, Germany	Locol 80 mg Retard tablet	80 mg	Prolonged-release tablet	Oral use
Malta	Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom	Lescol	20 mg	Capsule, hard	Oral use
Malta	Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom	Lescol	40 mg	Capsule, hard	Oral use
Malta	Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom	Lescol XL	80 mg	Film-coated tablet	Oral use
Norway	Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway	LESCOL	20 mg	Capsule, hard	Oral use
Norway	Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway	LESCOL	40 mg	Capsule, hard	Oral use
Norway	Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway	LESCOL DEPOT 80 mg	80 mg	Prolonged-release tablet	Oral use
Netherlands	Novartis Pharma B.V. P.O. Box 241 6800 LZ Arnhem The Netherlands	Lescol 20 mg, capsules	20 mg	Capsule, hard	Oral use
Netherlands	Novartis Pharma B.V. Raapopseweg 1, 6824 DP Arnhem, The Netherlands	Lescol 40 mg, capsules	40 mg	Capsule, hard	Oral use
Netherlands	Novartis Pharma B.V. Raapopseweg 1, 6824 DP Arnhem, The Netherlands	Lescol XL 80, tablet	80 mg	Film-coated tablet	Oral use
Poland	Novartis Pharma GmbH Roonstrasse 25, D–90429Nürnberg, Germany	Lescol	20 mg	Capsule, hard	Oral use
Poland	Novartis Pharma GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	Lescol	40 mg	Capsule, hard	Oral use
Poland	Novartis Pharma GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	Lescol XL	80 mg	Prolonged-release tablet	Oral use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra, Portugal	Lescol	20 mg	Capsule, hard	Oral use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra, Portugal	Lescol	40 mg	Capsule, hard	Oral use
Portugal	Bialport – Produtos Farmacêuticos, S.A. À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado Portugal	Cardiol 20	20 mg	Capsule, hard	Oral use
Portugal	Bialport – Produtos Farmacêuticos, S.A. À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado Portugal	Cardiol 40	40 mg	Capsule, hard	Oral use
Portugal	Laboratório Normal - Produtos Farmacêuticos, S.A. Rua do Centro empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal	Canef	20 mg	Capsule, hard	Oral use
Portugal	Laboratório Normal - Produtos Farmacêuticos, S.A. Rua do Centro empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal	Canef	40 mg	Capsule, hard	Oral use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra, Portugal	Lescol XL	80 mg	Prolonged-release tablet	Oral use
Portugal	Bialport – Produtos Farmacêuticos, S.A. À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado Portugal	Cardiol XL	80 mg	Prolonged-release tablet	Oral use
Portugal	Laboratório Normal - Produtos Farmacêuticos, S.A. Rua do Centro empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal	Canef 80 mg	80 mg	Prolonged-release tablet	Oral use
Romania	NOVARTIS PHARMA GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	LESCOL 20 mg	20 mg	Capsule, hard	Oral use
Romania	NOVARTIS PHARMA GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	LESCOL 40 mg	40 mg	Capsule, hard	Oral use
Romania	NOVARTIS PHARMA GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	LESCOL XL	80 mg	Prolonged-release tablet	Oral use
Slovak Republic	Novartis, s.r.o. U Nákladového nádraží 10, 13000 Prague 3, Czech Republic	Lescol 20 mg	20 mg	Capsule, hard	Oral use
Slovak Republic	Novartis, s.r.o. U Nákladového nádraží 10, 13000 Prague 3, Czech Republic	Lescol 40 mg	40 mg	Capsule, hard	Oral use
Slovak Republic	Novartis, s.r.o. U Nákladového nádraží 10, 13000 Prague 3, Czech Republic	Lescol XL 80 mg	80 mg	Prolonged-release tablet	Oral use
Slovenia	Novartis Pharma GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	Lescol 40 mg trde kapsule	40 mg	Capsule, hard	Oral use
Slovenia	Novartis Pharma GmbH Roonstrasse 25, D–90429 Nürnberg, Germany	Lescol XL 80 mg tablete s podaljšanim sproščanjem	80 mg	Prolonged-release tablet	Oral use
Spain	Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona, Spain	Lescol 20 mg caps	20 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona, Spain	Lescol 40 mg caps	40 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona, Spain	Liposit 20 mg caps	20 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona, Spain	Liposit 40 mg caps	40 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona, Spain	Vaditon 20 mg caps	20 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona, Spain	Vaditon 40 mg caps	40 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica, S.A. Av. Diagonal, 507 08029 Barcelona, Spain	Digaril 20 mg caps	20 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica, S.A. Av. Diagonal, 507 08029 Barcelona, Spain	Digaril 40 mg caps	40 mg	Capsule, hard	Oral use
Spain	GRÜNENTHAL PHARMA, S.A. Doctor Zamenhof no 36 28027 Madrid, Spain	Lymetel 20 mg caps	20 mg	Capsule, hard	Oral use
Spain	GRÜNENTHAL PHARMA, S.A. Doctor Zamenhof no 36 28027 Madrid, Spain	Lymetel 40 mg caps	40 mg	Capsule, hard	Oral use
Spain	Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona, Spain	Lescol prolib 80 mg	80 mg	Prolonged-release tablet	Oral use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain	Liposit Prolib 80	80 mg	Prolonged-release tablet	Oral use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain	Vaditon Prolib 80 mg	80 mg	Prolonged-release tablet	Oral use
Spain	Novartis Farmacéutica, S.A. Av. Diagonal, 507 08029 Barcelona Spain	Digaril Prolib 80 mg	80 mg	Prolonged-release tablet	Oral use
Spain	Laboratorios Andrómaco, S.A. Doctor Zamenhof no 36 28027 Madrid Spain	Lymetel Prolib 80 mg	80 mg	Prolonged-release tablet	Oral use
Sweden	Novartis Sverige AB Box 1150, 18311 Täby, Sweden	Lescol	20 mg	Capsule, hard	Oral use
Sweden	Novartis Sverige AB Box 1150, 18311 Täby, Sweden	Lescol	40 mg	Capsule, hard	Oral use
Sweden	Novartis Sverige AB Box 1150, 18311 Täby, Sweden	Lescol Depot	80 mg	Prolonged-release tablet	Oral use
United Kingdom	Novartis Pharmaceuticals UK Ltd (Trading as Sandoz Pharmaceuticals) FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom	LESCOL CAPSULES 20MG	20 mg	Capsule, hard	Oral use
United Kingdom	Novartis Pharmaceuticals UK Ltd (Trading as Sandoz Pharmaceuticals) FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom	LESCOL CAPSULES 40MG	40 mg	Capsule, hard	Oral use
United Kingdom	Novartis Pharmaceuticals UK Ltd (Trading as Sandoz Pharmaceuticals) FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom	LESCOLXL 80 mg Prolonged Release Tablets	80 mg	Prolonged-release tablet	Oral use

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA	Marketing Authorisation Holder	Invented name	Strength	Pharmaceutical Form	Route of administration
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 40 mg Filmtabletten	40 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 40 mg Filmtabletten	40 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 80 mg Filmtabletten	80 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 80 mg Filmtabletten	80 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 160 mg Filmtabletten	160 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 160 mg Filmtabletten	160 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Diovan 320 mg Filmtabletten	320 mg	film-coated tablets	Oral Use
Austria	Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A–1020 Wien (Tel: + 43-1–8665 70)	Angiosan 320 mg Filmtabletten	320 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 40 mg	40 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 80 mg	80 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 160 mg	160 mg	film-coated tablets	Oral Use
Belgium	N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B–1800 Vilvoorde (Tel: +32-2-246 16 11)	Diovane 320 mg	320 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Bulgaria	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Cyprus	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Czech Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 (Tel +420-2–2577 51 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Czech Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 (Tel +420-2–2577 51 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Denmark	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø (Tel: +45-39-16 84 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan	40 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan	80 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan	160 mg	film-coated tablets	Oral Use
Estonia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan	320 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Finland	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo (Tel: + 358-9–6133 22 11)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
France	Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON (Tel: +33-1–5547 60 00)	Tareg 40 mg	40 mg	film-coated tablets	Oral Use
France	Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON (Tel: +33-1–5547 60 00)	Tareg 80 mg	80 mg	film-coated tablets	Oral Use
France	Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray 92500 RUEIL-MALMAISON (Tel: +33-1–5547 60 00)	Tareg 160 mg	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 40 mg	40 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 40 mg	40 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 80 mg	80 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 80 mg	80 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 160 mg protect	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 160 mg	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 160 mg	160 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Diovan 320 mg forte	320 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Cordinate 320 mg	320 mg	film-coated tablets	Oral Use
Germany	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg (Tel: +49-911-273-0)	Provas 320 mg	320 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 40 mg	40 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 80 mg	80 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 160 mg	160 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Greece	Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens (Tel: +30-210-281 17 12)	Dalzad 320 mg	320 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Hungary	Novartis Hungaria Kft. Bartók Béla út 43-47 H–1114 Budapest (Tel: +36-1-457 65 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø Denmark (Tel: +45-39-16 84 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø Denmark (Tel: +45-39-16 84 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø Denmark (Tel: +45-39-16 84 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Iceland	Novartis Healthcare A/S Lyngbyvej 172 DK–2100 København Ø Denmark (Tel: +45-39-16 84 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Ireland	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 40 mg	40 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 40 mg	40 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 80 mg	80 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 80 mg	80 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 160 mg	160 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 160 mg	160 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Tareg 320 mg	320 mg	film-coated tablets	Oral Use
Italy	Novartis Farma S.p.A. Largo Umberto Boccioni 1 I–21040 Origgio (Tel: + 39-02–96542214)	Rixil 320 mg	320 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Latvia	Novartis Finland OY Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 80 mg plėvele dengtos tabletės	80 mg	film-coated tablets	Oral Use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 160 mg plėvele dengtos tabletės	160 mg	film-coated tablets	Oral Use
Lithuania	Novartis Finland Oy Metsänneidonkuja 10 FIN–02130 Espoo Finland (Tel: + 358-9–6133 22 11)	Diovan 320 mg plėvele dengtos tabletės	320 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Luxembourg	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Malta	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR United Kingdom (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6824 DP Arnhem (Tel: + 31-26-378 21 00)	Diovan 40	40 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6800 LZ Arnhem (Tel: + 31-26-378 21 00)	Diovan 80	80 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6824 DP Arnhem (Tel: + 31-26-378 21 00)	Diovan 160	160 mg	film-coated tablets	Oral Use
Netherlands	Novartis Pharma B.V. Postbus 241 NL–6824 DP Arnhem (Tel: + 31-26-378 21 00)	Diovan 320	320 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Norway	Novartis Norge AS Brynsalléen 4 Postboks 237 Økern NO–0510 Oslo (Tel: +47–2305 20 00)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	40 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	80 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	160 mg	film-coated tablets	Oral Use
Poland	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan	320 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	40 mg	film-coated tablets	Oral Use
Portugal	Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Tareg	40 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	80 mg	film-coated tablets	Oral Use
Portugal	Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Tareg	80 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	160 mg	film-coated tablets	Oral Use
Portugal	Laboratório Normal-Produtos Farmacêuticos, Lda Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Tareg	160 mg	film-coated tablets	Oral Use
Portugal	Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P–2710-444 Sintra (Tel: +351 21000 86 00)	Diovan	320 mg	film-coated tablets	Oral Use
Romania	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 40 mg, film coated tablets	40 mg	film-coated tablets	Oral Use
Romania	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 80 mg, film coated tablets	80 mg	film-coated tablets	Oral Use
Romania	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 160 mg, film coated tablets	160 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
Slovak Republic	NOVARTIS s.r.o. Pharma Nagano III. U Nákladového nádraží 10 130 00 Praha 3 Czech Republic (Tel +420-2–2577 51 11)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 40 mg filmsko obložene tablete	40 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 80 mg filmsko obložene tablete	80 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 160 mg filmsko obložene tablete	160 mg	film-coated tablets	Oral Use
Slovenia	Novartis Pharma GmbH Roonstrasse 25 D–90429 Nürnberg Germany (Tel: +49-911-273-0)	Diovan 320 mg filmsko obložene tablete	320 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován Cardio 40 mg comprimidos recubiertos con película	40 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress Cardio 40 mg comprimidos recubiertos con película	40 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten Cardio 40 mg comprimidos recubiertos con película	40 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován 80 mg comprimidos recubiertos con película	80 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress 80 mg comprimidos recubiertos con película	80 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten 80 mg comprimidos recubiertos con película	80 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován 160 mg comprimidos recubiertos con película	160 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress 160 mg comprimidos recubiertos con película	160 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten 160 mg comprimidos recubiertos con película	160 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Diován 320 mg comprimidos recubiertos con película	320 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Kalpress 320 mg comprimidos recubiertos con película	320 mg	film-coated tablets	Oral Use
Spain	Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona (Tel: +34-93-306 42 00)	Miten 320 mg comprimidos recubiertos con película	320 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	40 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	40 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	40 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	80 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	80 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	80 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	160 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	160 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	160 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Diovan	320 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Angiosan	320 mg	film-coated tablets	Oral Use
Sweden	Novartis Sverige AB Kemistvägen 1B P.O. Box 1150 SE-183 11 Täby (Tel: + 46-8-732 32 00)	Valsartan Novartis	320 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR (Tel: +44–1276-69 22 55)	Diovan 40 mg	40 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR (Tel: +44–1276-69 22 55)	Diovan 80 mg	80 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR (Tel: +44–1276-69 22 55)	Diovan 160 mg	160 mg	film-coated tablets	Oral Use
United Kingdom	Novartis Pharmaceuticals UK Ltd FrimleyBusinessPark Frimley, Camberley Surrey GU16 7SR (Tel: +44–1276-69 22 55)	Diovan 320 mg	320 mg	film-coated tablets	Oral Use

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA	Marketing Authorisation Holder	(Invented) name	Strength	Pharmaceutical Form	Route of administration	Content (concentration)
Austria	AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien Austria	Losec 10mg – Kapseln	10 mg	capsule, hard	Oral use
Austria	AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien Austria	Losec 20mg – Kapseln	20 mg	capsule, hard	Oral use
Austria	AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien Austria	Losec 40 mg -Trockenstechampulle mit Lösungsmittel	40 mg	Powder for solution for injection	Intravenous use	40 mg
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec 40mg Forte, harde maagsapresistente capsules	40 mg	Hard Gastroresistant capsules	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec 40 mg, poeder voor oplossing voor intraveneuze infusie	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec-Mups 10mg, 10 mg, maagsapresistente tabletten	10 mg	Gastroresistant tablets	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec-Mups 20mg, 20 mg, maagsapresistente tabletten	20 mg	Gastroresistant tablets	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec-Mups 40mg, 40 mg, maagsapresistente tabletten	40 mg	Gastroresistant tablets	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel Belgium	Omeprazole AstraZeneca 20mg, harde maagsapresistente capsules	20 mg	Hard Gastroresistant capsules	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel Belgium	Omeprazole AstraZeneca 40mg Forte, harde maagsapresistente capsules	40 mg	Hard Gastroresistant capsules	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Omeprazole AstraZeneca 40mg, poeder voor oplossing voor intraveneuze infusie	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Logastric 10mg, maagsapresistente capsules	10 mg	Hard Gastroresistant capsules	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Logastric 20mg, maagsapresistente capsules	20 mg	Hard Gastroresistant capsules	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Logastric 40mg Forte, maagsapresistente capsules	40 mg	Hard Gastroresistant capsules	Oral use
Belgium	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Logastric-Mups 40mg, 40 mg, maagsapresistente tabletten	40 mg	Gastroresistant tablets	Oral use
Cyprus	AstraZeneca AB, 151 85 Södertälje Sweden	Losec Mups	10mg	Gastro-resistant tablets	Oral use
Cyprus	AstraZeneca AB, 151 85 Södertälje Sweden	Losec Mups	20mg	Gastro-resistant tablets	Oral use
Czech Republic	AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom	LOSEC 20 mg	20 mg	Gastro-resistant capsule, hard	Oral use
Czech Republic	AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom	LOSEC 40 mg	40 mg	Powder for solution for infusion	Intravenous use
Denmark	AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark	Losec	10 mg	Gastroresistant tablets	Oral use
Denmark	AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark	Losec	20 mg	Gastroresistant tablets	Oral use
Denmark	AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark	Losec	40 mg	Gastroresistant tablets	Oral use
Denmark	AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark	Losec	40 mg/ml	Powder and Solvens for solution for injection	Intravenous use	40 mg
Denmark	AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark	Losec	40 mg/ml	Powder for solution for infusion	Intravenous use	40 mg
Estonia	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec MUPS	20 mg	Gastroresistant tablets	Oral use
Estonia	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 40 MG	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Finland	AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland	Losec Mups 10 mg enterotabletti	10 mg	Gastroresistant tablet	Oral use
Finland	AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland	Losec Mups 20 mg enterotabletti	20 mg	Gastroresistant tablet	Oral use
Finland	AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland	Losec Mups 40 mg enterotabletti	40 mg	Gastroresistant tablet	Oral use
France	AstraZeneca 1, Place Renault 92844 RUEIL-MALMAISON Cedex France	MOPRAL® 20 mg microgranules gastrorésistants en gélule	20 mg	Capsules	Oral use
France	AstraZeneca 1, Place Renault 92844 RUEIL-MALMAISON Cedex France	MOPRAL® 10 mg microgranules gastrorésistants en gélule	10 mg	Capsules	Oral use
France	AstraZeneca 1, Place Renault 92844 RUEIL-MALMAISON Cedex France	ZOLTUM® 20 mg microgranules gastrorésistants en gélule	20 mg	Capsules	Oral use
France	AstraZeneca 1, Place Renault 92844 RUEIL-MALMAISON Cedex France	ZOLTUM® 10 mg microgranules gastrorésistants en gélule	10 mg	Capsules	Oral use
France	AstraZeneca 1, Place Renault 92844 RUEIL-MALMAISON Cedex France	MOPRAL 40 mg, lyophilisat pour perfusion (IV).	40 mg	Lyophylizat for perfusion	Intravenous use	40 mg
Germany	AstraZeneca GmbH 22876 Wedel Germany	Antra pro infusione	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Germany	AstraZeneca GmbH 22876 Wedel Germany	Antra MUPS 10 mg	10 mg	Gastro-resistant tablets	Oral use
Germany	AstraZeneca GmbH 22876 Wedel Germany	Antra MUPS 20 mg	20 mg	Gastro-resistant tablets	Oral use
Germany	AstraZeneca GmbH 22876 Wedel Germany	Antra MUPS 40 mg	40 mg	Gastro-resistant tablets	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec®, Γαστροανθεκτικό καψάκιο σκληρό 10 mg/CAP	10 mg	Gastro-resistant capsules, hard	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec®, Γαστροανθεκτικό καψάκιο σκληρό 20 mg/CAP	20 mg	Gastro-resistant capsules, hard	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec®, Γαστροανθεκτικό καψάκιο σκληρό 40 mg/CAP	40 mg	Gastro-resistant capsules, hard	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec MUPS®, Γαστροανθεκτικό δισκίο 10 mg/TAB	10 mg	Gastro-resistant tablets	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec MUPS®, Γαστροανθεκτικό δισκίο 20 mg/TAB	20 m	Gastro-resistant tablets	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec MUPS®, Γαστροανθεκτικό δισκίο 40 mg/TAB	40 mg	Gastro-resistant tablets	Oral use
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec®, Ενέσιμο λυόφιλο 40 mg/VIAL	40 mg	Powder and solvent for solution for injection	Intravenous use	40 mg
Greece	AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece	Losec®, Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40 mg/VIAL	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Hungary	AstraZeneca Kft. H-2045 Törökbálint, Park u. 3. Hungary	Losec 10 mg kapszula	10 mg	Capsule, hard	Oral use
Hungary	AstraZeneca Kft. H-2045 Törökbálint, Park u. 3. Hungary	Losec 20 mg kapszulaz	20 mg	Capsule, hard	Oral use
Hungary	AstraZeneca Kft. H-2045 Törökbálint, Park u. 3. Hungary	Losec 40 mg por infúzióhoz	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Iceland	AstraZeneca A/S Roskildevej 22 DK-2620 Albertslund Denmark	Losec	10 mg	Gastroresistant tablets	Oral use
Iceland	AstraZeneca A/S Roskildevej 22 DK-2620 Albertslund Denmark	Losec	20 mg	Gastroresistant tablets	Oral use
Iceland	AstraZeneca A/S Roskildevej 22 DK-2620 Albertslund Denmark	Losec	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Ireland	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec MUPS Tablets 10mg	10mg	Gastro-resistant, film-coated tablet	Oral use
Ireland	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec MUPS Tablets 20mg	20mg	Gastro-resistant, film-coated tablet	Oral use
Ireland	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec MUPS Tablets 40mg	40mg	Gastro-resistant, film-coated tablet	Oral use
Ireland	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec Losec 40mg Powder for Solution for Infusion	40mg	Powder for solution for infusion	Intravenous use	40 mg
Ireland	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec IV 40mg Powder and Solvent for Solution for Injection	40mg	Powder and solvent for solution for injection	Intravenous use	40 mg
Italy	AstraZeneca S.p.A. Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy	Antra 10 mg capsule rigide a rilascio modificato	10 mg	Hard modified release capsules	Oral use
Italy	AstraZeneca S.p.A. Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy	Antra 20 mg capsule rigide a rilascio modificato	20 mg	Hard modified release capsules	Oral use
Italy	AstraZeneca S.p.A. Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy	Antra 40 mg capsule rigide a rilascio modificato	40 mg	Hard modified release capsules	Oral use
Italy	AstraZeneca S.p.A. Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy	Antra 40 mg polvere per soluzione per infusione	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Italy	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 10 mg capsule rigide a rilascio modificato	10 mg	Hard modified release capsules	Oral use
Italy	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 20 mg capsule rigide a rilascio modificato	20 mg	Hard modified release capsules	Oral use
Italy	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 40 mg capsule rigide a rilascio modificato	40 mg	Hard modified release capsules	Oral use
Italy	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 40 mg polvere per soluzione per infusione	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Italy	Bracco S.p.A. Via E. Folli 50 20134 Milano Italy	Mepral 10 mg capsule rigide a rilascio modificato	10 mg	Hard modified release capsules	Oral use
Italy	Bracco S.p.A. Via E. Folli 50 20134 Milano Italy	Mepral 20 mg capsule rigide a rilascio modificato	20 mg	Hard modified release capsules	Oral use
Italy	Bracco S.p.A. Via E. Folli 50 20134 Milano Italy	Mepral 40 mg capsule rigide a rilascio modificato	40 mg	Hard modified release capsules	Oral use
Italy	Bracco S.p.A. Via E. Folli 50 20134 Milano Italy	Mepral 40 mg polvere per soluzione per infusione	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Italy	Malesci Istituto Farmacobiologico S.p.A. Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy	Omeprazen 10 mg capsule rigide a rilascio modificato	10 mg	Hard modified release capsules	Oral use
Italy	Malesci Istituto Farmacobiologico S.p.A. Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy	Omeprazen 20 mg capsule rigide a rilascio modificato	20 mg	Hard modified release capsules	Oral use
Italy	Malesci Istituto Farmacobiologico S.p.A. Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy	Omeprazen 40 mg capsule rigide a rilascio modificato	40 mg	Hard modified release capsules	Oral use
Italy	Malesci Istituto Farmacobiologico S.p.A. Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy	Omeprazen 40 mg polvere per soluzione per infusione	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Latvia	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 40 mg pulveris infūziju šķīduma pagatavošanai	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Luxembourg	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec Forte Gelules 40mg	40 mg	Hard gastroresis-tant capsules	Oral use
Luxembourg	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec poudre pour perfusion 40 mg	40 mg	Powder for solution for intravenous infusion	Intravenous use	40 mg
Luxembourg	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec-Mups 10mg	10 mg	Gastroresistant tablets	Oral use
Luxembourg	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec-Mups 20mg	20 mg	Gastroresistant tablets	Oral use
Luxembourg	NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels Belgium	Losec-Mups 40mg	40 mg	Gastroresistant tablets	Oral use
Malta	AstraZeneca AB S-151 85 Södertälje Sweden	Losec MUPS Tablets 10mg	10mg	Gastro-resistant, film-coated tablet	Oral use
Malta	AstraZeneca AB S-151 85 Södertälje Sweden	Losec MUPS Tablets 20mg	20mg	Gastro-resistant, film-coated tablet	Oral use
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec 10	10 mg	Gstroresistant capsules	Oral use
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec 20	20 mg	Gastroresistant capsules	Oral use
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec 40	40 mg	Gastroresistant capsules	Oral use
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec	40 mg	Powder and solvent for solution for injection	Intravenous use	40 mg
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec Infuus	40 mg	Powder for solution for intravenous infusion	Intravenous use	40 mg
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec MUPS 10	10 mg	Gastroresistant tablets	Oral use
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec MUPS 20	20 mg	Gastroresistant tablets	Oral use
Netherlands	AstraZeneca BV Postbus 599 2700 AN, Zoetermeer The Netherlands	Losec MUPS 40	40 mg	Gastroresistant tablets	Oral use
Norway	AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO Norway	Losec® MUPS®	10 mg	Gastroresistant tablets	Oral use
Norway	AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO Norway	Losec® MUPS®	20 mg	Gastroresistant tablets	Oral use
Norway	AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO Norway	Losec®	40mg	Powder for solution for infusion	Intravenous use	40 mg
Poland	AstraZeneca AB S-151 85 Södertälje Sweden	Losec 10	10mg	Capsules	Oral use
Poland	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	20mg	Capsules	Oral use
Poland	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	40mg	Powder for solution for infusion	Intravenous use	40 mg
Portugal	AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, n.o 7, Valejas 2745-663 Barcarena Portugal	Losec	20 mg	Gastroresistant capsules	Oral use
Portugal	AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, n.o 7, Valejas 2745-663 Barcarena Portugal	Losec	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Portugal	AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, n.o 7, Valejas 2745-663 Barcarena Portugal	Losec	40 mg	Powder and solvent for injectable solution	Intravenous use	40 mg
Romania	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec MUPS 10 mg coprimate filmate gastrorezistente	10 mg	Film-coated gastroresistant tablets	Oral use
Romania	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec MUPS 20 mg comprimate filmate gastrorezistene	20mg	Film-coated gastroresistant tablets	Oral use
Romania	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec 40mg liofilizat pentru solutie perfuzabila	40mg	Lyophilisate for solution for infusion	Intravenous use	40 mg
Slovak Republic	AstraZeneca AB, S-151 85 Södertälje Sweden	Losec®	40 mg	Powder for solution for infusion	Intravenous use	40 mg
Spain	Laboratorio Tau, S.A. C/Serrano Galvache, 56 Edificio Roble 28033 Madrid Spain	LOSEC infusión i.v.	40 mg	Powder for infusion	Intravenous use	40 mg
Spain	Laboratorio Tau, S.A. C/Serrano Galvache, 56 Edificio Roble 28033 Madrid Spain	LOSEC cápsulas 20 mg	20 mg	Capsules, hard	Oral use
Sweden	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	10 mg	Gastro-resistant tablets	Oral use
Sweden	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	20 mg	Gastro-resistant tablets	Oral use
Sweden	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	40 mg	Gastro-resistant tablets	Oral use
Sweden	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	40 mg	Powder for solution for injection	Intravenous use	40 mg
Sweden	AstraZeneca AB S-151 85 Södertälje Sweden	Losec	40 mg	Powder for solution for infusion	Intravenous use	40 mg
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec MUPS Tablets 10mg	10mg	Film-coated Tablet	Oral use
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec MUPS Tablets 20mg	20mg	Film-coated Tablet	Oral use
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec MUPS Tablets 40mg	40mg	Film-coated Tablet	Oral use
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec Capsules 10mg	10mg	Hard gelatin capsules	Oral use
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec Capsules 20mg	20mg	Hard gelatin capsules	Oral use
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec Capsules 40mg	40mg	Hard gelatine capsules	Oral use
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec Infusion 40mg	40mg	Powder for solution for infusion	Intravenous use	40 mg
United Kingdom	AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom	Losec IV Injection 40mg	40mg	Powder and solvent for solution for injection	Intravenous use	40 mg

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA	Marketing Authorisation Holder	(Invented) name	Strength	Pharmaceutical Form	Route of administration	Content (concentration)
Austria	Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Austria	Pantoloc 20 mg -Filmtabletten	20 mg	Gastro-resistant tablet	oral use
Austria	Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Austria	Pantoloc 40 mg -Filmtabletten	40 mg	Gastro-resistant tablet	oral use
Austria	Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Austria	Pantoloc 40 mg -Trockenstech- ampulle	40 mg	Powder for solution for injection	intravenous use	40 mg
Austria	Nycomed Austria GmbH St. Peter Strasse 25 4020 Linz Austria	Zurcal 20 mg -Filmtabletten	20 mg	Gastro-resistant tablet	oral use
Austria	Nycomed Austria GmbH St. Peter Strasse 25 4020 Linz Austria	Zurcal 40 mg -Filmtabletten	40 mg	Gastro-resistant tablet	oral use
Austria	Nycomed Austria GmbH St. Peter Strasse 25 4020 Linz Austria	Zurcal 40 mg -Trockenstech- ampulle	40 mg	Powder for solution for injection	intravenous use	40 mg
Belgium	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Pantozol	40 mg	Gastro-resistant tablet	oral use
Belgium	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Pantozol	20 mg	Gastro-resistant tablet	oral use
Belgium	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Pantozol IV	40 mg	Powder for solution for injection	intravenous use	40 mg
Belgium	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Zurcale	40 mg	Gastro-resistant tablet	oral use
Belgium	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Zurcale 20 mg	20 mg	Gastro-resistant tablet	oral use
Belgium	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Zurcale IV	40 mg	Powder for solution for injection	intravenous use	40 mg
Bulgaria	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc	20 mg	Gastro-resistant tablet	oral use
Bulgaria	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc	40 mg	Gastro-resistant tablet	oral use
Cyprus	Mundipharma Pharmaceuticals Ltd. Othellos str. 13 Dhali Industrial Zone 1685 Nicosia Cyprus	Controloc	20 mg	Gastro-resistant tablet	oral use
Cyprus	Mundipharma Pharmaceuticals Ltd. Othellos str. 13 Dhali Industrial Zone 1685 Nicosia Cyprus	Controloc	40 mg	Gastro-resistant tablet	oral use
Cyprus	Mundipharma Pharmaceuticals Ltd. Othellos str. 13 Dhali Industrial Zone 1685 Nicosia Cyprus	Controloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Czech Republic	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc 20 mg	20 mg	Gastro-resistant tablet	oral use
Czech Republic	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc 40 mg	40 mg	Gastro-resistant tablet	oral use
Czech Republic	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Denmark	Nycomed Denmark ApS Langebjerg 1 4000 Roskilde Denmark	Pantoloc	20 mg	Gastro-resistant tablet	oral use
Denmark	Nycomed Denmark ApS Langebjerg 1 4000 Roskilde Denmark	Pantoloc	40 mg	Gastro-resistant tablet	oral use
Denmark	Nycomed Denmark ApS Langebjerg 1 4000 Roskilde Denmark	Pantoloc	40 mg	Powder for solution for injection	intravenous use	40 mg
Estonia	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc 20 mg	20 mg	Gastro-resistant tablet	oral use
Estonia	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc 40 mg	40 mg	Gastro-resistant tablet	oral use
Finland	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Somac 20 mg enterotabletti	20 mg	Gastro-resistant tablet	oral use
Finland	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Somac 40 mg enterotabletti	40 mg	Gastro-resistant tablet	oral use
Finland	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Somac 40 mg injektiokuiva-aine, liuosta varten	40 mg	Powder for solution for injection	intravenous use	40 mg
France	Nycomed France 13, rue Watt 75013 Paris France	Eupantol 20 mg, comprimé gastro- résistant	20 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Eupantol 40 mg, comprimé gastro- résistant	40 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Eupantol 40 mg poudre pour solution injectable IV	40 mg	Powder for solution for injection	intravenous use	40 mg
France	Nycomed France 13, rue Watt 75013 Paris France	Inipomp 20 mg, comprimé gastro- résistant	20 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Inipomp 40 mg, comprimé gastro- résistant	40 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Inipomp 40 mg; poudre pour IV	40 mg	Powder for solution for injection	intravenous use	40 mg
France	Nycomed France 13, rue Watt 75013 Paris France	Pantec 20 mg, comprimé gastro- résistant	20 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Pantec 40 mg, comprimé gastro- résistant	40 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Pantipp 20 mg, comprimé gastro- résistant	20 mg	Gastro-resistant tablet	oral use
France	Nycomed France 13, rue Watt 75013 Paris France	Pantipp 40 mg, comprimé gastro- résistant	40 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantoprazol NYC 20 mg	20 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantoprazol NYC 40 mg	40 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantoloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantoprazol 20 mg Byk	20 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantoprazol-Byk i.v.	40 mg	Powder for solution for injection	intravenous use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantozol 20 mg	20 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantozol 40 mg	40 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantozol i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	PantoLomberg 20 mg	20 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantoprazole Lomberg 20 mg	20 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Rifun 20 mg	20 mg	Gastro-resistant tablet	oral use
Germany	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Rifun 40 mg	40 mg	Gastro-resistant tablet	oral use
Germany	Byk Tosse Arzneimittel GmbH, Moltkestr. 4 78467 Constance Germany	Zurcal S 20 mg magensaftresistente Tabletten	20 mg	Gastro-resistant tablet	oral use
Germany	Byk Tosse Arzneimittel GmbH, Moltkestr. 4 78467 Constance Germany	Zurcal S 40 mg magensaftresistente Tabletten	40 mg	Gastro-resistant tablet	oral use
Greece	Sanofi-Aventis Greece 348, Syngrou Avenue Building A 176 74 Kallithea Greece	Controloc 20 mg	20 mg	Gastro-resistant tablet	oral use
Greece	Sanofi-Aventis Greece 348, Syngrou Avenue Building A 176 74 Kallithea Greece	Controloc	40 mg	Gastro-resistant tablet	oral use
Greece	Sanofi-Aventis Greece 348, Syngrou Avenue Building A 176 74 Kallithea Greece	Controloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Greece	Nycomed Hellas S.A. 196, Kifissias Ave. 152 31 Chalandri Athens Greece	Zurcazol 20 mg	20 mg	Gastro-resistant tablet	oral use
Greece	Nycomed Hellas S.A. 196, Kifissias Ave. 152 31 Chalandri Athens Greece	Zurcazol	40 mg	Gastro-resistant tablet	oral use
Greece	Nycomed Hellas S.A. 196, Kifissias Ave. 152 31 Chalandri Athens Greece	Zurcazol i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Hungary	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc 20 mg	20 mg	Gastro-resistant tablet	oral use
Hungary	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 40 mg	40 mg	Gastro-resistant tablet	oral use
Hungary	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Ireland	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Protium	40 mg	Gastro-resistant tablet	oral use
Ireland	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Protium 20 mg	20 mg	Gastro-resistant tablet	oral use
Ireland	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Protium i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Italy	Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italy	Pantecta	40 mg	Gastro-resistant tablet	oral use
Italy	Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italy	Pantecta	20 mg	Gastro-resistant tablet	oral use
Italy	Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italy	Pantopan	40 mg	Gastro-resistant tablet	oral use
Italy	Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italy	Pantopan	20 mg	Gastro-resistant tablet	oral use
Italy	Nycomed S.p.A. Via Temolo 4 20126 Milan Italy	Pantorc	40 mg	Gastro-resistant tablet	oral use
Italy	Nycomed S.p.A. Via Temolo 4 20126 Milan Italy	Pantorc	20 mg	Gastro-resistant tablet	oral use
Italy	Nycomed S.p.A. Via Temolo 4 20126 Milan Italy	Pantorc.	40 mg	Powder for solution for injection	intravenous use	40 mg
Italy	Recordati Industria Chimica e Farmaceutica S.p.A Via M. Civitali 1 20148 Milan Italy	Peptazol	40 mg	Gastro-resistant tablet	oral use
Italy	Recordati Industria Chimica e Farmaceutica S.p.A Via M. Civitali 1 20148 Milan Italy	Peptazol	20 mg	Gastro-resistant tablet	oral use
Latvia	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 20 mg	20 mg	Gastro-resistant tablet	oral use
Latvia	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 40 mg	40 mg	Gastro-resistant tablet	oral use
Lithuania	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc	20 mg	Gastro-resistant tablet	oral use
Lithuania	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc	40 mg	Gastro-resistant tablet	oral use
Luxembourg	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Panto-Byk-20	20 mg	Gastro-resistant tablet	oral use
Luxembourg	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Panto-Byk-40	40 mg	Gastro-resistant tablet	oral use
Luxembourg	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Panto-Byk-IV	40 mg	Powder for solution for injection	intravenous use	40 mg
Luxembourg	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Pantozol-20	20 mg	Gastro-resistant tablet	oral use
Luxembourg	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Pantozol 40	40 mg	Gastro-resistant tablet	oral use
Luxembourg	Nycomed Belgium SCA/CVA Gentsesteenweg 615 1080 Brussels Belgium	Pantozol-IV	40 mg	Powder for solution for injection	intravenous use	40 mg
Netherlands	Nycomed bv Jupiterstraat 250 2132 HK Hoofddorp Netherlands	Pantozol 20	20 mg	Gastro-resistant tablet	oral use
Netherlands	Nycomed bv Jupiterstraat 250 2132 HK Hoofddorp Netherlands	Pantozol 40	40 mg	Gastro-resistant tablet	oral use
Netherlands	Nycomed bv Jupiterstraat 250 2132 HK Hoofddorp Netherlands	Pantozol i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Netherlands	Nycomed bv Jupiterstraat 250 2132 HK Hoofddorp Netherlands	Pantoprazol Nycomed 40 mg	40 mg	Gastro-resistant tablet	oral use
Norway	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Somac	20 mg	Gastro-resistant tablet	oral use
Norway	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Somac	40 mg	Gastro-resistant tablet	oral use
Norway	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Somac	40 mg	Powder for solution for injection	intravenous use	40 mg
Poland	Nycomed Pharma Sp.z o.o. Al. Jerozolimskie 146A 02-305 Warsaw Poland	Controloc 20	20 mg	Gastro-resistant tablet	oral use
Poland	Nycomed Pharma Sp.z o.o. Al. Jerozolimskie 146A 02-305 Warsaw Poland	Controloc 40	40 mg	Gastro-resistant tablet	oral use
Poland	Nycomed Pharma Sp.z o.o. Al. Jerozolimskie 146A 02-305 Warsaw Poland	Controloc	40 mg	Powder for solution for injection	intravenous use	40 mg
Portugal	Laboratórios Delta, Lda. Rua Direita, 148 Massamá 2745-751 QUELUZ Portugal	Apton 40 mg	40 mg	Gastro-resistant tablet	oral use
Portugal	Laboratórios Delta, Lda. Rua Direita, 148 Massamá 2745-751 QUELUZ Portugal	Apton	20 mg	Gastro-resistant tablet	oral use
Portugal	Nycomed Portugal Produtos Farmaceuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Pantoc 40 mg	40 mg	Gastro-resistant tablet	oral use
Portugal	Nycomed Portugal - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Pantoc	20 mg	Gastro-resistant tablet	oral use
Portugal	Nycomed Portugal - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Pantoc IV	40 mg	Powder for solution for injection	intravenous use	40 mg
Portugal	Nycomed Portugal - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Zurcal	20 mg	Gastro-resistant tablet	oral use
Portugal	Nycomed Portugal Produtos Farmaceuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Zurcal 40 mg	40 mg	Gastro-resistant tablet	oral use
Portugal	Nycomed Portugal - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Pantoprazole ALTANA 20 mg	20 mg	Gastro-resistant tablet	oral use
Portugal	Nycomed Portugal - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D'Arcos 2770-192 Paço D'Arcos Portugal	Pantoprazole ALTANA 40 mg	40 mg	Gastro-resistant tablet	oral use
Romania	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Controloc 20 mg	20 mg	Gastro-resistant tablet	oral use
Romania	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany	Controloc 40 mg	40 mg	Gastro-resistant tablet	oral use
Romania	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany	Controloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Slovak Republic	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 20 mg gastrorezistentné tablety	20 mg	Gastro-resistant tablet	oral use
Slovak Republic	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 40 mg	40 mg	Gastro-resistant tablet	oral use
Slovak Republic	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg
Slovenia	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 20 mg gastrorezistentne tablete	20 mg	Gastro-resistant tablet	oral use
Slovenia	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 40 mg gastrorezistentne tablete	40 mg	Gastro-resistant tablet	oral use
Slovenia	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Controloc 40 mg prašek za raztopino za injiciranje	40 mg	Powder for solution for injection	intravenous use	40 mg
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Anagastra 20 mg Blister	20 mg	Gastro-resistant tablet	oral use
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Anagastra 40 mg blister	40 mg	Gastro-resistant tablet	oral use
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Anagastra 40 mg polvo para solución inyectable I.V.	40 mg	Powder for solution for injection	intravenous use	40 mg
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantecta 20 mg comprimidos gastrorresistentes Blister	20 mg	Gastro-resistant tablet	oral use
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Pantecta 40 mg Blister	40 mg	Gastro-resistant tablet	oral use
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany	Ulcotenal 20 mg comprimidos gastrorresistentes Blister	20 mg	Gastro-resistant tablet	oral use
Spain	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany	Ulcotenal 40 mg Blister	40 mg	Gastro-resistant tablet	oral use
Sweden	Nycomed AB Box 27264 102 53 Stockholm Sweden	Pantoloc	20 mg	Gastro-resistant tablet	oral use
Sweden	Nycomed AB Box 27264 102 53 Stockholm Sweden	Pantoloc	40 mg	Gastro-resistant tablet	oral use
Sweden	Nycomed AB Box 27264 102 53 Stockholm Sweden	Pantoloc	40 mg	Powder for solution for injection	intravenous use	40 mg
United Kingdom	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany	Protium 20 mg	20 mg	Gastro-resistant tablet	oral use
United Kingdom	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany	Protium 40 mg	40 mg	Gastro-resistant tablet	oral use
United Kingdom	Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany	Protium i.v.	40 mg	Powder for solution for injection	intravenous use	40 mg

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State	Applicant/Marketing Authorisation Holder	Invented name	Pharmaceutical form	Strength	Animal species	Frequency and route of administration
Austria	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Belgium	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, orale suspensie voor biggen	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Bulgaria	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	СЕВАЗУРИЛ 50 мг/мл, суспензия за перорално прилагане при прасета	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Cyprus	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Czech Republic	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Perorální suspense pro selata	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Denmark	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	Cevazuril 50mg/ml, oral suspension til spædgrise	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Estonia	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE Bristol UK	CEVAZURIL 50 mg/ml, Suukaudne suspension jaoks põrsad	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
France	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1)	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Germany	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Greece	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Hungary	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, belsőleges szuszpenzió malacoknak	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Ireland	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, oral suspension for piglets	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Italy	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, sospensione orale per suinetti	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Latvia	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Lithuania	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Geriamoji suspensija dèl paršeliai	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Luxembourg	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1)	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Malta	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml Suspensjoni orali għal ħnienes	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
The Netherlands	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, orale suspensie voor biggen	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Poland	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, zawiesina doustna dla prosiąt	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Portugal	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, suspensão oral para leitões	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.
Romania	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Suspensie orală pentru purceii	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.
Slovakia	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Perorálna suspenzia pre prasiatka	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.
Spain	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, Suspensión Oral para lechones	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.
United Kingdom	Ceva Santé Animale Z.I. La Ballastière 33500 Libourne FRANCE	CEVAZURIL 50 mg/ml, oral suspension for piglets	Oral suspension	50 mg toltrazuril/ml	Piglets	Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

(1) Marketing Authorisation granted

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

Member State EU/EEA	Applicant	(Invented) Name	Strength	Pharmaceutical Form	Route of administration
Austria	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazol Bluefish 20 mg/40 mg magensaftresistente Tabletten	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Denmark	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Finland	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish 20 mg/40 mg enterotabletia/entero-tabletter	20 mg and 40 mg	Gastro-resistant tablet	Oral use
France	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish 20 mg/40 mg comprimé gastro- resistant	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Germany	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish 20 mg/40 mg magensaftresistente tabletten	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Hungary	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish 20 mg/40 mg bélben oldódó tabletta	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Ireland	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish 20 mg/40 mg gastro-resistant tablet	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Italy	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazolo Bluefish	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Netherlands	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazol Bluefish 20 mg/40 mg maagsapresistente-tabletten	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Norway	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazol Bluefish enterotabletter	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Poland	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Portugal	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Spain	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish 20 mg/40 mg comprimidos gastro-resistentes	20 mg and 40 mg	Gastro-resistant tablet	Oral use
Sweden	Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden	Pantoprazole Bluefish	20 mg and 40 mg	Gastro-resistant tablet	Oral use

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

Member State EU/EEA	Applicant	(Invented) Name	Strength	Pharmaceutical Form	Route of administration
Czech Republic	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 20 mg Gastro-resistant tablets	20 mg	Gastro-resistant tablet	Oral use
Czech Republic	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 40 mg Gastro-resistant tablets	40 mg	Gastro-resistant tablet	Oral use
Germany	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 20 mg Gastro-resistant tablets	20 mg	Gastro-resistant tablet	Oral use
Germany	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 40 mg Gastro-resistant tablets	40 mg	Gastro-resistant tablet	Oral use
Poland	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole Olinka	20 mg	Gastro-resistant tablet	Oral use
Poland	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole Olinka	40 mg	Gastro-resistant tablet	Oral use
Slovak Republic	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole Olinka 20 mg Gastrorezistentne tablety	20 mg	Gastro-resistant tablet	Oral use
Slovak Republic	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole Olinka 40 mg Gastrorezistentne tablety	40 mg	Gastro-resistant tablet	Oral use
United Kingdom	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 20 mg Gastro-resistant tablets	20 mg	Gastro-resistant tablet	Oral use
United Kingdom	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 40 mg Gastro-resistant tablets	40 mg	Gastro-resistant tablet	Oral use

ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

Member State EU/EEA	Applicant	(Invented) Name	Strength	Pharmaceutical Form	Route of administration
Germany	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 20 mg Volkspharma Gastro-resistant tablets	20 mg	Gastro-resistant tablet	Oral use
Germany	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 40 mg Volkspharma Gastro-resistant tablets	40 mg	Gastro-resistant tablet	Oral use
Poland	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole Phargem	20 mg	Gastro-resistant tablet	Oral use
Poland	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole Phargem	40 mg	Gastro-resistant tablet	Oral use
United Kingdom	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 20 mg Gastro-resistant tablets	20 mg	Gastro-resistant tablet	Oral use
United Kingdom	Olinka (UK) Limited 38/40 Chamberlayne Road London, United Kingdom NW10 3JE	Pantoprazole 40 mg Gastro-resistant tablets	40 mg	Gastro-resistant tablet	Oral use

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)

Member State (EU/EEA)	Marketing Authorisation Holder	Product Name	Strength	Pharmaceutical Form	Route of administration
Czech Republic	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm, Germany	Valproat-Ratiopharm Chrono 300 mg	300 mg	Prolonged-release tablet	Oral use
Czech Republic	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm, Germany	Valproat-Ratiopharm Chrono 500 mg	500 mg	Prolonged-release tablet	Oral use
Germany	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm, Germany	Valproinsäure-ratiopharm chrono 300 mg Retardtabletten	300 mg	Prolonged-release tablet	Oral use
Germany	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm, Germany	Valproinsäure-ratiopharm chrono 500 mg Retardtabletten	500 mg	Prolonged-release tablet	Oral use
Italy	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm, Germany	Acido valproico E sodio Valproato Ratiopharm	300 mg	Prolonged-release tablet	Oral use
Italy	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm, Germany	Acido valproico E sodio Valproato Ratiopharm	500 mg	Prolonged-release tablet	Oral use
Luxembourg	Ratiopharm GmbH Postfach 3380 89070 Ulm, Germany	Valproinsäure Ratiopharm Chrono	300 mg	Prolonged-release tablet	Oral use
Luxembourg	Ratiopharm GmbH Postfach 3380 89070 Ulm Germany	Valproinsäure Ratiopharm Chrono	500 mg	Prolonged-release tablet	Oral use
The Netherlands	Ratiopharm Nederland B.V. Florapark 4 2012HK Haarlem The Netherlands	Natriumvalproaat ratiopharm chrono 300 mg	300 mg	Prolonged-release tablet	Oral use
The Netherlands	Ratiopharm Nederland B.V. Florapark 4 2012HK Haarlem The Netherlands	Natriumvalproaat ratiopharm chrono 500 mg	500 mg	Prolonged-release tablet	Oral use
Poland	Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany	Valpro-ratiopharm Chrono 300 mg	199,8 mg + 87 mg	Prolonged-release tablet	Oral use
Poland	Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany	Valpro-ratiopharm Chrono 500 mg	333 mg + 145 mg	Prolonged-release tablet	Oral use
Portugal	Ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro – Edifício Tejo 6° Piso Carnaxide P-2790-143	Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada	300 mg	Prolonged-release tablet	Oral use
Portugal	Ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro – Edifício Tejo 6° Piso Carnaxide P-2790-143 Portugal	Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada	500 mg	Prolonged-release tablet	Oral use
Slovakia	Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany	Valpro ratiopharm Chrono	500 mg	Prolonged-release tablet	Oral use
United Kingdom	Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany	Valprotek CR 300 mg (prolonged release) tablets	300 mg	Prolonged-release tablet	Oral use
United Kingdom	Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany	Valprotek CR 500 mg (prolonged release) tablets	500 mg	Prolonged-release tablet	Oral use

ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Member State EU/EEA	Applicant company name, address	(Invented) Name	Strength	Pharmaceutical Form	Route of administration
Austria	TEVA Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands	Clopidogrel Teva 75 mg Filmtabletten	75 mg	Film-coated tablet	Oral Use
Belgium	TEVA Pharma B.V. Computerweg10, 3542DR Utrecht The Netherlands	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Bulgaria	TEVA Pharma B.V., Computerweg 10 3542 DR Utrecht The Netherlands	Clopix 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Cyprus	TEVA Pharma BV Computerweg 10, 3542 DR Utrecht The Netherlands	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Czech Republic	Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c, 150 00 Praha 5, Czech Republic	Teclop 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Denmark	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopix	75 mg	Film-coated tablet	Oral Use
Estonia	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel Dr. Reddy's 75 mg	75 mg	Film-coated tablet	Oral Use
Finland	Teva Sweden AB Jarnvägsgatan 11 Box 1070 25110 Helsingborg Sweden	Tevaplat 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
France	TEVA Classics Immeuble Palatin 1 1 cours du Triangle 92836 PARISLA DEFENSE FRANCE	Clopidogrel TEVA CLASSICS 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Germany	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Greece	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Hungary	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	ALVADAVIX 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Ireland	TEVA Generics B.V. Computerweg 10, 3542DR Utrecht The Netherlands	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Italy	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Latvia	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel Dr. Reddy's 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Lithuania	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel Dr. Reddy's 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Luxembourg	Teva Pharma BV Computerweg 10 NL- 3542 DR Utrecht The Netherlands	Clopidophar	75 mg	Film-coated tablet	Oral Use
The Netherlands	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel 75 mg filmomhulde tabletten	75 mg	Film-coated tablet	Oral Use
Norway	Teva Sweden AB Järnvägsgatan 11, Box 1070 251 10 Helsingborg	Tevaplat 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Poland	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands	Clopidogrel Teva Pharma	75 mg	Film-coated tablet	Oral Use
Romania	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	XOVAL 75 mg comprimate filmate	75 mg	Film-coated tablet	Oral Use
Slovak Republic	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Spain	TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania 4oIzq. 28003 MADRID, Spain	Clopidogrel TEVAGEN 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use
Sweden	Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom	Clopidogrel Reddy's	75 mg	Film-coated tablet	Oral Use
United Kingdom	Teva Pharma BV. Computerweg 10, Utrecht NL–3542DR Netherlands	Clopidogrel 75 mg film-coated tablets	75 mg	Film-coated tablet	Oral Use

ANNEX XIV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, INDICATIONS/WITHDRAWAL PERIODS AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member state/EEA

Applicant/Marketing Authorisation Holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period(s)/Indications

Austria

Chevita Tierarzneimittel

Gesellschaft

m.b.H. Kaplanstraße 10 AT

4600 Wels

AUSTRIA

Doxymax 500 mg/g - Pulver zur Herstellung einer Lösung zum Einnehmen für Schweine und Hühner

Doxycycline hyclate

500 mg/g

Oral powder

Pigs,

Chicken (broiler)

Chicken:

3-5 days, oral via drinking water

Chicken: 25mg doxycyclin hyclat/kg BW/day = 1g powder/20 kg/day

Meat and offal: Chicken (Broiler) 5 days,

Eggs: not for use in laying hen

Indications: infection of respiratory tract caused by Mycoplasma spp. (M.gallisepticum, Escherichia coli, Septicamia caused by Pasteurella multocida

Belgium

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % Dopharma

Doxycycline hyclate

500 mg/g

Water soluble powder

Calves, porcine, poultry

Poultry:

50mg/kg/day

3-5 days 500 g/1 000 L drinking water

Meat and offal: 6 days

Indications: infections by micro-organisms in respiratory or gastro-intestinal system

Belgium

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox 50 %

Doxycycline hyclate

500 mg/g

Water soluble powder

Calves, porcine, poultry

Poultry: 50 mg/kg/day

3-5 days 500 g/1 000 L drinking water

Meat and offal: 6 days

Indications: infections by micro-organisms in respiratory or gastro-intestinal system

Belgium

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

500mg/g

Water soluble powder

Porcine, poultry

Poultry:

10-20mg/kg/day

3-4 days 100-200 g/1 000 L drinkwater

Meat and offal:

3 days/10mg/kg

12 days/20mg/kg

Indications: respiratory diseases

Belgium

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 15 % ad. us. vet..

Doxycycline hyclate

150mg/g

Water soluble powder

Porcine, calves, poultry, fancy birds, pigeons

Poultry:

10-20mg/kg/day

3-5 days 500 g/1 000 L drinkwater

Meat and offal:

7 days

Indications: respiratory diseases caused by germs

Belgium

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

Hydrodoxx 500 mg/g water-soluble powder

Doxycycline hyclate

500mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Bulgaria

Farma Sis OOD

4 San Stefano Str.

Dobrich

BULGARIA

Doxinyl

10 % Oral Suspension

Doxycycline hyclate

100mg/ml

Oral Suspension

Poultry

Via drinking water

50 -100 ml Doxinyl 10 % in 100 l drinking water per day

(50-100 mg Doxycycline in 1 l drinking water) 3-5 days

Meat - 5 days

Bulgaria

Farma Sis OOD

4 San Stefano Str.

Dobrich

BULGARIA

Cyvadox 10 %

Doxycycline hyclate

100mg/ml

Oral Suspension

Poultry

Via drinking water

0,5-1 ml in 1 l drinking water per day \3-5 days\ 50-100 mg Doxycycline

Meat - 7 days

Bulgaria

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 %

w.s.p.

Doxycycline hyclate

500mg/g

Water soluble powder

Poultry

Via drinking water

500g Doxycycline 50 % w.s.p. in 100 l drinking water/3-5 days/

Meat - 4 days

Bulgaria

Farmavet OOD

40 Otec Paisij Str.

Shumen

BULGARIA

Doxycycline 20 %

Pulvis solubilis

Doxycycline hyclate

200mg/g

Water soluble powder

Poultry

Via drinking water

50g Doxycycline 20 % in 100l drinking water/3-5 days/

Meat - 7 days

Bulgaria

Interchemie Werken

De Adelaar BV

Hosterweg 26a

5811 Ccastenray

THE NETHERLANDS

Doxy – WS

Doxycycline hyclate

200mg/g

Water soluble powder

Poultry

Via drinking water

1kg Doxy-WS in 2 000-4 000 l drinking water

Meat - 7 days

Bulgaria

Ceva Sante Animale France

La Balastiere

33501 Libourne Cedex

FRANCE

Doxyvit 50 %

WSP

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Via drinking water

2-3g Doxyvit 50 % WSP in 10 l. Drinking water - 5 days/equivalent to 100-150 mg Doxycycline in 1l water

Meat - 7 days

Bulgaria

Ceva Sante Animale France

La Balastiere

33501 Libourne Cedex

FRANCE

Doxyvit 100

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry

Via drinking water

10 mg Doxyvit per kg body weight per day

Meat - 7 days

Bulgaria

Vetpartners OOD

Ivan Asen Str.

4270 Parvomaj

BULGARIA

Polidoxichem 500/WSP

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Via drinking water

50-100 mg Doxycycline in 1l drinking water/3-5 days/ equivalent to 0,1-0,2g Polidoxichem 500 WSP in 1l drinking water per day

Meat - 7 days

Bulgaria

Biovet AD

39 Petar Rakov Str.

4550 Peshtera

BULGARIA

Vibravet 10 %

Water soluble premix

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry

Via drinking water

1g Vibravet 10 % in 1l drinking water /=67-100 mg Doxycycline/per day. 5 days

Meat - 7 days

Cyprus

PREMIER SHUKUROGLOU LTD

HIPRADOXI -S

Doxycycline hyclate

100 mg

Oral solution

Pigs, Chicken (broiler)

By oral route, via drinking water

Broilers: 50-100 mg doxycycline hyclaye/L water for 3-5 days

Broilers: meat: 5 days Pigs: meat:6 days

Czech republic

Industria Italiana Integratori TREI S.p.A.

Viale Corassori 62

41100 Modena

ITALY

DOXIPAN 20

Doxycycline hyclate

20 g/100 g

Powder for oral solution

Chicken-broiler, turkey

Administer orally via drinking water for 5 days.

Broiler:

5-7,5 g of product/10 l drinking water

turkey:

10 – 20 mg doxycycline/kg bodyweight

Chicken broiler: Meat and offal: 5 days.

Turkey: meat and offal: 10 days

Indications:

Chicken broilers: Chronic respiratory diseases and associated infections.

Turkeys: Diseases caused G+ and G- micro-organisms and mycoplasmas, especially respiratory and articular syndrome caused by mycoplasmas and/or staphylococcus.

Czech republic

Pharmagal s.r.o.,

Murgašova 5,

949 01 Nitra,

SLOVAK REPUBLIC

DOXYGAL

Doxycycline hyclate

50 mg/1 g

Powder for oral solution

Poultry

Administer orally via drinking water for 3-5 days.

Therapeutically- preventive: 50 mg doxycycline/1 l drinking water

Therapeutically: 100 mg doxycycline/1 l drinking water

Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Used for the treatment of the secondary bacterial infections following to viral origin diseases. Poultry: CRD (mycoplasmosis), colibacillosis

Czech republic

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

DOXYVIT 40 %

Doxycicline hyclate

40g/100g

Powder for oral solution

Chicken-broiler, turkey

Administer orally via drinking water for 3-5 days.

1.Continuous therapy:

1,0g DOXYVIT 40 % per 3-6 L of drinking water

2.Pulse therapy:

10-20 mg doxycycline / kg b.w., intervals 4-8 hours.

Chicken broiler, turkey: Meat and offal: 4 days. Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications:

Treatment and prevention of respiratory, intestinal and systemic infections caused by microorganisms susceptible to doxycycline in broilers and turkeys. Chronic respiratory disease (Mycoplasma gallisepticum, Escherichia coli) Aerosaculitis (Mycoplasma meleagridis) Infectious synovitis (Mycoplasma synoviae) Fowl cholera (Pasterella multocida) Bordetella turkey infections (Bordetella avium) Infectious coryza (Haemophilus paragallinarum) Colibacillosis (Eschrichia coli) Necrotic enteritidis (Clostridium perfringens) Chlamydiosis (Chlamydia psittaci)

Czech republic

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

KARIDOX 100 mg/ml

Doxycycline hyclate

100 mg/1 ml

Oral solution

Chicken-broiler

Administer orally via drinking water for 3-5 days.

10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/l of drinking water/day).

Chickens(broilers): Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption

Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline.

Czech republic

Tekro, spol. s.r.o.,

Višňová 2/484,

140 00 Praha 4,

CZECH REPUBLIC

MEDITEK DOX 100

Doxycycline hyclate

100g/kg

Powder for oral solution

Broiler

Administer orally via drinking water for 3-5 days.

10 mg Doxycycline hyclate/1kg bodyweight (1,0 kg of product / 1 000 l drinking water)

Chickens (broilers): Meat and offal: 7 days

Indications: Prevention and treatment of infection disease of the respiratory and gastrointestinal tract in pigs and broilers caused by the pathogens susceptible to doxycycline. It is efficient on the several bacteria resistant to first generation tetracyclines.

Czech republic

CHEMO IBERICA, S.A. Gran Via Carlos III, 98 7a Edificio Trade

08028 Barcelona SPAIN

ORIDOX 100 mg/ml, perorální roztok pro podání v pitné vodě pro brojlery a prasata

Doxycycline hyclate

100 mg/1ml

Oral solution

Chicken-broiler

Administer orally via drinking water for 3-5 days.

10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/ldrinking water/day

Chickens (broilers): Meat and offal: 7 days.

Eggs: Not permitted for use in laying hens from which eggs are produced for human consumption

Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline.

Czech republic

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox O.S.P. 5 %

Doxycycline hyclate

0,05 g/1g

Powder for oral solution

Poultry

Administer orally via drinking water for 3-5 days.

Poultry till 2 weeks: 1 g of the product per L of drinking water and day

Poultry over 2 weeks: 2 g of the product per L of drinking water and day

Duration of the treatment: 3 - 5 days.

Chicken (broilers): Meat and offal: 4 days, Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications:

Treatment of respiratory infections caused by the pathogens susceptible to doxycycline and chickens (broilers).

Czech republic

KELA Laboratoria n.v.

Industrial Zone

De Kluis

St. Lenaartseweg 48

2320 Hoogstraten

BELGIUM

Respidox 5 %

Doxycycline hyclate

50 mg / 1 g

Powder for oral solution

Poultry

Administer orally via drinking water for 3 days.

2 g of product/l drinking water

Poultry: Meat and offal: 7 days

Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Treatment of the infections caused by the microrganisms susceptible to doxycycline.

Poultry: CRD, colibacillosis, inflammation of nasal mucosa, synovitis, salmonelosis, fowl cholera, chlamydiosis

Czech republic

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

RONAXAN P.S. 5 %

Doxycycline hyclate

50 mg / 1 g

Powder for oral solution

Chickens

Administer orally via drinking water for 5 days.

10 mg doxycycline / kg bodyweight. / day (i.e.. 1 g of product/5 kg bodyweight.)

Chicken (broilers): Meat and offal: 4 days,

Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Treatment of respiratory infections caused by the pathogens susceptible to doxycycline in chickens (broilers).

Czech republic

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

Doxycycline Calier 500 mg/g

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

6 days

Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Czech republic

Ceva Animal Health Slovakia spol. s.r.o.

Račianska 77

831 02 Bratislava

SLOVENIA

DOXYVIT 100

Doxycycline hydrocloride

100 g/1 000 g

Powder for oral solution

Poultry (chicken, turkey, goose)

Administer orally via drinking water for 5 days.

10 mg doxycycline/kg bodyweight per day, i.e. 0,1 g DOXYVIT 100 / kg bodyweight

Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Treatment and prevention of respiratory, intestinal and systemic infections caused by micro-organisms susceptible to doxycycline in hens, turkeys and gouses: chronical respiratory disease (Mycoplasma gallisepticum, Escherichia coli), aerosaculitis (Mycoplasma meleagridis), synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella mul tocida), bordetela turkey infections (Bordetella avium), infectious coryza (Haemophilus paragallinarum), colibacillosis (Esccherichia coli), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci), prevention in stress conditions (vaccination, changes in housing, transportation)

Denmark

Laborartorios Karizoo

S.A. Pol.Ind. La Borda c/Mas Pujades 11-12

Caldes de Montbui 08140

SPAIN

Karidox

Doxycycline hyclate

10 %

Oral solution

Chickens, swine

Orally (drinking water) for 3 to 5 days

In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day)

Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.

Indications:Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline.

Denmark

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox

Doxycycline hyclate

10 %

Oral solution

Chickens, swine

Orally (drinking water) for 3 to 5 days

In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day)

Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.

Indications: Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline.

Denmark

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Estonia

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-S

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

chicken (broilers)

oral use via drinking water.

50 … 100 mg doxycycline/litre water

Meat and offal:

5 days. Not authorised for use in laying birds producing eggs for human consumption.

Indications: Colibacillosis, C.R.D. and associated infections.

Estonia

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-P

Doxycycline hyclate

100 mg/g

powder for oral solution

chicken (broilers)

oral use via drinking water.

20 mg doxycycline/kg bw/day

Meat and offal:

5 days. Not authorised for use in laying birds producing eggs for human consumption.

Indications: Colibacillosis, C.R.D. and associated infections.

Estonia

Maxx Pharma OÜ

Kaluri tee 5

Haabneeme

74001 Viimsi

Harjumaa

ESTONIA

Doxyprim 40 %

Doxycycline hyclate

400 mg/g

powder for oral solution

chicken, turkeys

oral use via drinking water.

10 … 20 mg/kg bw/day 5 days

Meat and offal:

4 days. Not authorised for use in laying birds producing eggs for human consumption.

Indications: For the treatment of respiratory, intestinal and systemic infections caused by doxycycline-sensitive organisms.

Estonia

Zoovetvaru

uusaru 5

76505 Saue

Harjumaa

ESTONIA

Doxycin

Doxycycline hyclate

200 mg/g

powder for oral solution

chicken (broilers)

for oral administaration, via drinking water.

10 mg doxycycline/kg bw/day 3-5 days

Meat and offal:

6 days. Do not use in laying birds producing eggs for human consumption.

Indications: For the treatment of infections of the respiratory system and alimentary tract caused by microorganisms sensitive to doxycycline, including mycoplasmas, bordeteliosis, chlamydiosis, pasteurellosis anaerobic infections, salmonellosis, staphylococcosis, colibacillosis.

Estonia

Dutch Farm Veterinary Pharmaceuticals B.V.

Veemweg 1

3771 MT Barnevald

THE NETHERLANDS

Dutch Farm Doxycycline 20 % WSP

Doxycycline hyclate

200 mg/g

powder for oral solution

poultry

for oral administration, via drinking water.

15 mg Doxycycline hyclate/kg bw/day 3-5 days.

Meat and offal:

7 days. Do not use in laying birds producing eggs for human consumption.

Indications: For the treatment of infections caused by microorganisms sensitive to doxycycline, especially respiratory infections.

Germany

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

DOXYCYCLINE CALIER 500 mg/g, Pulver zum Eingeben über das Trinkwasser für Huhn und Schwein

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

6 days

Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Germany

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g Pulver zum Eingeben über das Trinkwasser

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Greece

Durden Trading Limited

12, Kennedy Av.

Nicosia

CYPRUS

Stardox

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

20 mg/kg X 4-7 days

Meat and offal:

14 days

Indications: CRD caused by Mycoplasma gallisepticum colibacilosis

Greece

NEW VET A.E

Fleming 15

15123 Marousi Attikis

GREECE

Nexyclin

Doxycycline hyclate

400 mg/g

Powder for oral solution

Chickens(broiler) Turkeys pigs

In drinking water

20 mg/kg

Meat and offal:

4 days

Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli Pasteurella multocida, Chlamydia psittaci

Greece

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

10 mg/kg X 3-5 days

Meat and offal:

9 days

Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum

Greece

Nutri-Biomed Hellas LTD

1, V. Hugo & Chlois

Metamorfosi Attikis

14452 Athens

GREECE

Doxyveto

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

25 mg/kg X 3-5 days

Meat and offal:

9 days

Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum

Greece

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycyclin 50 Dopharma

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Calves pigs

In drinking water

25 mg/kg X 3-5 days

Meat and offal:

9 days

Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum

Greece

Durden Trading Limited

12, Kennedy Av.

Nicosia

CYPRUS

Doxycycline 150/Durden

Doxycycline hydrocloride

150 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

10 mg/kg X 3-5 days

Meat and offal:

4 days

Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum

Greece

AFOI TETOROU ABE

10 km National road Athens-Lamia

14451, Metamorfosi

GREECE

Doxycycline 150/Afoi Tetorou

Doxycycline hydrocloride

150 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

10 mg/kg X 3-5 days

Meat and offal:4 days

Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum

Spain

LAB. DR ESTEVE

Avda Mare de Deu de Montserrat

221 08041 Barcelona

SPAIN

DOX ESTEVE

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry Pigs Bovine

Oral 3-5 days

20 mg / Kg/day

Meat and offal:

9 days

Indications: Infections caused by Mycoplasma spp (Micoplasmosis, CRD) or Pasteurella multocida (Pasteurellosis).

Meat and offal:

Poultry: 5 days

Turkeys: 7 days

colibacilosis, C.R.D., micoplasmosis.

Spain

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

DOXI 100 mg/ml POLVO ORAL

Doxycycline hyclate

10 g/100 g

Water soluble powder

Poultry

Turkeys Pigs

Oral

3-5 days (Poultry and turkeys) 5 days (Pigs)

50 – 100 mg/l drinking water/day (poultry and turkey) 10 mg/kg/day (pigs)

Meat and offal:

Broilers: 5 days Turkeys: 7 days Pigs: 4 days

Spain

FATRO URIACH VETERINARIA, S.L.

Constitucion, 1

08960 Sant Just Desvern

SPAIN

DOXIDOL

Doxycycline hyclate

10 g/100 g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

7.5 – 15 mg/kg/day

Meat and offal:

7 days

Indications: Colibacilosis

CRD

Spain

DIVASA-FARMAVIC, S.A.

CTRA. SANT HIPOLIT, KM. 71

08503 GURB – VIC

SPAIN

DOXIVET 20

Doxycycline hyclate

200 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

10 - 20 mg/Kg/day

Meat and offal:

7 days

Indications: Colibacilosis, CRD, Micoplasmosis

Spain

MEVET, S. A.

POLIGONO INDUSTRIAL EL SEGRE, PARCELA409-410

25191 Lérida

SPAIN

DOXICIVALL POLVO

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

4 days

Indications: Colibacilosis, CRD, Micoplasmosis

Spain

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

HIPRADOXI-S

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

5 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

LAMONS, S.A.

POL.IND. MECANOVA, NAVES 27-28

25191 LLEIDA

SPAIN

DOXICICLINA 10 % LAMONS

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

5 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

HIPRADOXI-P

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/Kg/day

Meat and offal:

5 days

Indications: colibacilosis, C.R.D., and associated infections

Spain

POLICHEM, S.A.

Ctra. Reus-Cambrils, Km. 3

43206 Reus

SPAIN

DOXICHEM

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

SUPER'S DIANA, S.L

Ctra. Barcelona - Ripoll, Km 17

08150 Parets del Valles

SPAIN

DOXBRON

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

COTECNICA -COOPERATIVA TECNICA AGROPECUARIA

Ctra. N II KM 494,5

25250 Bellpuig (Lerida)

SPAIN

DOXICICLINA 500 USO VETERINARIO COTECNICA

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

LAFIDOX POLVO ORAL

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

LABORATORIOS SYVA, S.A.

PARROCO PABLO DIEZ, 49-57

24010 TROBAJO DEL CAMINO

SPAIN

SYVADOX 10 %

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

INVESA INTERNACIONAL, S.A.

Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT

SPAIN

DX-10

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

DOXICICLINA 500 GANADEXIL

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

DIVASA-FARMAVIC, S.A.

CTRA. SANT HIPOLIT, KM. 71

08503 GURB – VIC

SPAIN

DOXIVET 5

Doxycycline hyclate

50 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

INDUSTRIAL VETERINARIA S.A.

Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT

SPAIN

DOXINYL

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

JAER, S.A.

Barcelona, 411

08620 San Vicens del Horts

SPAIN

MASTERMIX DOXICICLINA

Doxycycline hyclate

50 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

KARIDOX

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pig

Oral

3-5 days

10 - 20 mg/Kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

SOLDOXIN

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pig

Oral

3-5 days

10 - 20 mg/Kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

CALIERDOXINA 50 % P O

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

5 days

20 mg/kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

GANAMIX DOXICICLINA 50 % P O

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

5 days

20 mg/kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

HIDRODOX 10 %

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

VIRBAC ESPAÑA, S.A.

Angel Guimera, 179-181

08950 Esplugues de Llobregat

SPAIN

PULMODOX P.O.S.

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

DILUDOX

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

DOXICICLINA CALIER 500 mg/g

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

6 days

Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Spain

LABORATORIOS MAYMO, S.A.

Via Augusta, 302

08017 Barcelona

SPAIN

MAYDOX PS

Doxycycline hydrocloride

50 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

France

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

RONAXAN P.S. 5 %

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkey

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Broilers: 4 days

Indications: Broilers and turkey:

Preventive and treatment of infections in respiratory system

France

FRANVET

ZI d'Etriche-Route d'Avire

BP 103

49500 Segré Cedex

FRANCE

DOXY 5 FRANVET

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkey,

Porcine

Hens

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

PULMODOX P.O.S. 5 %

Doxycycline hyclate

50 mg/g

Water soluble powder

Porcine

Calves

Poultry

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Sogeval Laboratoires

200 route De Mayenne

53022 Laval Cedex FRANCE

DOXYVAL 5 %

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkey

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Laboratoires Biove

3 rue de Lorraine

62510 Arques

FRANCE

ACTI DOXY 5

Doxycycline hyclate

50 mg/g

Water soluble powder

Dindon

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Ceva Sante Animale France

La Balastiere

33501 Libourne Cedex

FRANCE

DOXYVIT

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkeys

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Noe

10 rue Clement Ader

ZA Le Patis

78120 Rambouillet

FRANCE

COMPOMIX V DOXYCYCLINE

Doxycycline hyclate

50 mg/g

Water soluble powder

Dindon

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

SOLDOXIN 100 MG/ML SOLUTION BUVABLE POUR POULES POULETS ET PORCINES

Doxycycline hyclate

100 mg/ml

Oral solution

Porcine

Hens

Broilers

CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day

3 - 5 days

Indications: CHICKENS (BROILERS) Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

France

Laborartorios Karizoo

S.A. Pol.Ind. La Borda c/Mas Pujades 11-12

Caldes de Montbui 08140

SPAIN

DOXYSOL 10 %

Doxycycline hyclate

100 mg/ml

Oral solution

Porcine

Hens

Broilers

CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day

3 - 5 days

Indications: CHICKENS (BROILERS). Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

France

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HYDRODOXX 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcs

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

France

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

DOXYCYCLINE CALIER 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcins

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

6 days

Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Hungary

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

Ronaxan P.S. 5 % oldható por

Doxycycline hyclate

5 g/100 g

Powder for oral solution

Chicken

Chicken younger than 2 weeks: 1 g powder/1 litre of drinking water/day. Chicken older than 2 weeks: 2 g powder/1 litre of drinking water.

10 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment of CRD and Mycoplasma diseases, and other infections

Hungary

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

500 g product dissolved in 1 000 litre of drinking water.

25 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment and control of chicken respiratory diseases

Hungary

Kon-Pharma GmbH.

30625 Hannover

GERMANY

Doxy 50 % por belsőleges oldathoz

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken, turkey

Chicken: 500 mg product dissolved in 1 litre of drinking water. Turkey: 400 mg product/1 litre of drinking water

30 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

Chicken and turkey: 11 days.

Hungary

V.M.D. Állatgyógyászati Kft.

1093 Budapest

HUNGARY

Doxyveto-50

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

Continuous treatment: 0,2 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 8 hours.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

10 days

Indications: For the treatment of CRD and pasteurellosis; synovitis in turkey.

Hungary

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

Doxyril 50 % por belsőleges oldathoz

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

5 g product/100 kg bw/day, dissolved in the drinking water.

25 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

6 days

Indications: For the treatment of CRD, pasteurellosis, colibacillosis, Haemophilus and Clostridium infections

Hungary

Animal-Med Kft.

1029 Budapest

HUNGARY

Anidox 10 % por belsőleges oldathoz

Doxycycline hyclate

100 mg/g

Powder for oral solution

Chicken

1 000 g product dissolved in 1 000 litre of drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

12 days

Indications: For the treatment of mycoplasmosis, pasteurellosis, colibacillosis.

Hungary

Animal-Med Kft.

1029 Budapest

HUNGARY

Anidox 100 % por belsőleges oldathoz

Doxycycline hyclate

1 000 mg/g

Powder for oral solution

Chicken

100 g product dissolved in 1 000 litre of drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

12 days

Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida

Hungary

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

Doxyprim 40 % vízoldékony pulvis

Doxycycline hyclate

400 mg/g

Powder for oral solution

Chicken, turkey

Continuous treatment: 1 g product/3-6 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 4-8 hours.

10-20 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida

Hungary

CHEMIFARMA S.p.A

Via Don Eugenio Servadei 16

47100 Forli

ITALY

Doxifarm 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

40 g product/100 kg bw/100 litre of drinking water.

20 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

5 days

Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection.

Hungary

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

500 g product dissolved in 1 000 litre of drinking water.

25 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment of CRD and other respiratory diseases, caused by: Mycoplasma spp., Pasteurella spp., E. coli, and Chlamydia psittaci.

Hungary

Phylaxia Pharma Zrt.

8000 Székesfehérvár

HUNGARY

Doxyphyl SP

Doxycycline hyclate

300 mg/g

Powder for oral solution

chicken, turkey

40 g product/1 200 kg bw/day, calculated amount of the product should be dissolved in the drinking water consumed during 3 hours.

10 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

chicken: 7 days, turkey: 10 days.

Indications: For the treatment of respiratory infections caused by Mycoplasma spp., E. coli, Haemophilus paragallinarum, Bordetella avium, and ileitis caused by Clostridium perfringens and Cl. colinum.

Hungary

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 % pulvis

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

Dissolved in the drinking water.

10 mg/kg bw and 20 mg/kg bw/day, for 4 days.

Meat and offal:

chicken treated with 10 mg/kg bw: 5 days, chicken treated with 20 mg/kg bw: 12 days.

Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria.

Hungary

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox 100 mg/ml belsőleges oldat

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

Chicken

100 mg/ml oral concentrate dissolving in the drinking water.

10-20 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

7 days

Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria.

Hungary

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 100 mng/ml belsőleges oldat

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

Chicken

100 mg/ml oral concentrate dissolving in the drinking water.

10-20 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

7 days

Indications: For the treatment and prevention of CRD or other Mycoplasma diseases

Hungary

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

Doxycen belsőleges oldat

Doxycycline hyclate

200 mg/ml

Concentrate for oral solution

Chicken

1 ml/20 kg bw/day dissolved in the drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

5 days

Indications: For the treatment of CRD, mycoplasmosis and colibacillosis.

Hungary

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

Doxyvit 100 WSP

Doxycycline hydrocloride

100 mg/g

Powder for oral solution

Chicken, turkey, goose

Continuous treatment: 1 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 6-8 hours.

10 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

Chicken, turkey, goose 7 days

Indications: For the treatment of respiratory and enteric diseases in broiler chickens

Hungary

Industria Italiana Integratori TREI S.p.A.

Viale Corassori 62

41100 Modena

ITALY

Doxipan 20 WSP

Doxycycline hydrocloride

200 mg/g

Powder for oral solution

Chicken

5-7.5 g product dissolving in 10 litre of drinking water.

10-15 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

5 days

Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection.

Hungary

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-S oral solutio

Doxycycline hydrocloride

100 mg/ml

Concentrate for oral solution

Chicken

100 mg/ml oral concentrate dissolving in 1 litre of drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

5 days

Indications: For the treatment and prevention of CRD or other Mycoplasma diseases

Ireland

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

DOXIVEX 10 % Concentrate for oral solution.

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

Chickens (broilers) and Pigs

For oral administration via the drinking water. for 3-5 days

Chickens (broilers): 50 - 100 mg Doxycycline / litre of drinking water / day (equivalent to 0.5 - 1.0 ml DOXIVEX 10 % / litre of drinking water / day) for 3-5 days

Meat & offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption

Indications: Treatment of colibacillosis, chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline

Ireland

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

Aquadoxx 500 mg/g water-soluble powder

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Italy

CEVA VETEM S.P.A.

Via Colleoni n.15

20041 Agrate Brianza (Milano)

ITALY

DOXICICLINA 20 % CEVA VETEM

Doxycycline hyclate

Doxycycline 200 g. per 1 kg. of product

Water soluble powder

broiler, turkey

drinking water

Broiler, Turkey: 1 g / 10 kg b.w per 5 days.

Meat and offal:

broiler: 7 days

turkey: 8 days

Indications: Broiler: Treatment of chronic respiratory disease

Turkey: Treatment of infective synusitis

Italy

CHEMIFARMA S.p.A

Via Don Eugenio Servadei 16

47100 Forli

ITALY

DOXICICLINA 50 % CHEMIFARMA

Doxycycline hyclate

Doxycycline 500 g. per 1 kg. of product

Water soluble powder

broiler, swine

drinking water

Broiler: 20 mg of doxycycline / per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline / per 1 kg b.w per 3 - 5 days

Meat and offal:

broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 5 days

Indications: Broiler: Chronic respiratory disease caused by: Pasteurella soo, Mycoplasma spp, Haemophilus gallinarum, Bordetella avium, ans Clamidia psittaci.

Italy

SINTOFARM S.P.A.

Via Togliatti n.5

42016 Guastalla (Reggio Emilia)

ITALY

DOXIFARM 50 %

Doxycycline hyclate

Doxycycline hyclate 500 mg. (equivalent to 433,3 mg of Doxiclina) per 1 g. of product

Water soluble powder

broiler, swine

drinking water

Broiler: 25 mg of doxycycline hyclate/per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline hyclate/per 1 kg b.w per 5 days

Meat and offal:

broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 4 days

Indications: Broiler: Treatment and control of respiratory disease caused by Mycoplasma spp, Haemophilus paragallinarum, Escherichia coli. Enteritis caused by Clostridium perfringens and Clostridium colinum

Italy

INDUSTRIA ITAILIANA INTEGRATORI TREI SpA

Via Affarosa n.4

42010 Rio Saliceto (Reggio Emilia) ITALY

DOXIPAN 54

Doxycycline hyclate

Doxycycline 500 g. per 1 kg. of product

Water soluble powder

broiler, turkey, swine

drinking water

Broiler: 10 mg of doxycycline / 1 kg b.w. Turkey: 20 mg of doxycycline / 1 kg b.w. Swine: 10 mg of doxycycline / 1 kg b.w per 5 days

Meat and offal:

broiler: 3 days Do not use in hens producing eggs for human consumption. turkey: 10 days swine: 4 days

Indications: Broiler:Chronic respiratory disease. Turkey:Respiratory and joints syndroms caused by Mycoplasms and/or Staphilococcus

Italy

INTERVET ITALIA S.R.L.

Via W. Tobagi n.7

20068 Peschiera Borromeo (Milano)

ITALY

NAXOCET

Doxycycline hyclate

Doxycycline hyclate 500 mg. per 1 g. of product

Water soluble powder

broiler

drinking water

Broiler: 20 mg of doxyclyne hyclate/1 kg b.w. per 5 days.

Meat and offal:

broiler: 8 days Do not use in hens producing eggs for human consumption.

Indications: Chronic respiratory disease caused by Mycoplasma spp.

Lithuania

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

DOXYCYCLINE 50 %, geriamieji milteliai

Doxycycline hyclate

500 mg/g

Oral powder

Calves, pigs and poultry.

4–7 days with drinking water

Poultry: 40 mg per 1 kg of body weight, or 200–400 g per 1 000 litres of drinking water, during 4–7 days.

Meat and offal:

Poultry – 4 days. Do not use in animals producing eggs for human consumption.

Indications: for the treatment of poultry: ornythosis, caused by Clamydia psittaci, colibacteriosis caused by E. coli, CRD caused by Mycoplasma gallisepticum

Lithuania

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

DOXYPRIM 40 % geriamieji milteliai

Doxycycline hyclate

400 mg/g

Oral powder

Chickens, turkeys and pigs.

Should be administered for a period of 5 days in chicken and turkeys together with drinking water.

Chicken and turkeys: 10–20 mg doxycycline hyclate per 1 kg of body weight daily, administrated pulse dosed when the daily requirement is given in limited quantity of water to be consumed by the birds within 4–8 hours or supplied continuously as 67–133 mg ml Doxycycline hyclate per 1 litre of drinking water.

Meat and offal:

Edible tissues of chickens and turkeys – 4 days.

Indications: In chickens and turkeys indications include: chronicle respiratoric diseases (Mycoplasma gallisepticum, E. coli), airsacculitis (Mycoplasma meleagridis), infectious synovitis (Mycoplasma synoviae), colibacillosis (E. coli), fowl cholera (Pasteurella multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci).

Lithuania

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

SOLUDOX 50 %, geriamieji milteliai

Doxycycline hyclate

500 mg/g

Oral powder

Pigs and chickens.

Should be administered orally with drinking water for a period of 4 days.

Chickens: 10* mg doxycycline hyclate per 1 kg of body weight daily for 4 days; 20* mg doxycycline hyclate per 1 kg of body weight daily for 4 days. * The highest dose is recommended in case of infections caused by strains which are moderately susceptible (MIC up to 2 µg/ml), whilst the lowest dosage maybe used for (highly) susceptible strains (MIC up to 0.5–1.0 µg/ml)

Indications: For the treatment of infections caused by micro-organisms susceptible to doxycycline, such as Pasteurella multocida and Ornithobacterium rhinotracheale in chickens.

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline-hyclaat 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Calves, non-egg laying chickens and turkeys.

Non-egg laying chickens and turkeys: oral via drinking water. bodyweight per day for 4-7 days.

Non-egg laying chickens and turkeys: 20 mg doxycycline hyclate per kg

Turkeys - meat: 28 days.

Non-egg laying chickens - meat: 14 days.

Indications: Turkeys:

—	Ornithosis caused by Chlamydia psittaci

—	Colibacillosis caused by E. coli

—	CRD caused by Mycoplasma gallisepticum

Non-egg laying chikens Colibacillosis caused by E. coli

The Netherlands

Dutch Farm Veterinary Pharmaceuticals B.V.

Veemweg 1

3771 MT

Barneveld

THE NETHERLANDS

Doxycycline 20 % W.O.

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate

Powder for oral solution

Non-egg laying chickens

Oral via drinking water. for 3 days

10 mg doxycycline hyclate per kg bodyweight per day for 3 days

Meat: 7 days.

Indication non-egg laying chickens:

—	Polyarthritis caused by Mycoplasma synoviae;

—	CRD, amongst others caused by Mycoplasma gallisepticum;

—	Colibacillosis caused by Escherichia coli

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline-hyclaat 20 %

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Calves, pigs, chickens and turkeys.

Chickens and turkeys: oral via drinking water for 4-7 days.

Chickens and turkeys: 20 mg doxycycline hyclate per kg bodyweight

Turkeys - meat: 28 days.

Chickens - meat: 14 days, eggs: 10 days.

Indication turkeys:

—	Ornithosis caused by Chlamydia psittaci

—	Colibacillosis caused by E. coli

—	CRD caused by Mycoplasma gallisepticumIndication

Indication chickens:

—	Colibacillosis caused by E. coli

—	CRD caused by Mycoplasma gallisepticum

The netherlands

Dutch Farm International B.V.

Nieuw Walden 112

1394 PE

Nederhorst den Berg

THE NETHERLANDS

Doxycycline 20 % W.O.

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens (broilers).

Oral via drinking water.

10 mg doxycycline hyclate per kg bodyweight per day for 3 days.

Meat: 7 days. Do not administer to chickens producing eggs for human consumption. Indication non-egg laying chickens:

—	Polyarthritis caused by Mycoplasma synoviae;

—	CRD, amongst others caused by Mycoplasma gallisepticum;

—	Colibacillosis caused by Escherichia coli.

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline-hyclaat 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Calves, pigs, non-egg laying chickens.

Non-egg laying chickens: oral via drinking water. for 4-5 days.

Non-egg laying chickens: 20 mg doxycycline hyclate per kg bodyweight per day for 4-5 days.

Non-egg laying chickens - meat: 14 days.

Indication non-egg laying chickens:

—	Colibacillosis caused by E. coli

—	CRD caused by Mycoplasma gallisepticum

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % WSP

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: 25 mg doxycycline hyclate per kg bodyweight per day for 3-5 days.

Non-egg laying chickens - meat: 6 days.

Indication non-egg laying chickens:

—	Respiratory infections caused by Mycoplasma spp (M. gallisepticum, M.synoviae en M. meleagridis), E. coli and Haemophilus paragallinarum;

—	Enteritis caused by Clostridium perfringens en Clostridium colinum.

The Netherlands

Interchemie Werken

De Adelaar BV

Hosterweg 26a

5811 Ccastenray

THE NETHERLANDS

Doxy WS

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens (broilers).

Oral via drinking water.

10 mg doxycycline hyclate per kg bodyweight per day for 3 days.

Meat: 7 days.

Indication non-egg laying chickens:

—	Polyarthritis caused by Mycoplasma synoviae;

—	CRD, amongst others caused by Mycoplasma gallisepticum;

—	Colibacillosis caused by Escherichia coli.

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: - Pasteurellosis caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 days.infections caused by Ornithobacterium rhinotracheale (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days

Non-egg laying chickens: - Pasteurellosis – meat: 5 days.- ORT – meat: 12 days.

Do not administer to chickens producing eggs for human consumption

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Doxyfar 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: Pasteurellosis caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 - Respiratory infections caused by Ornithobacterium rhinotracheale (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days

Non-egg laying chickens:

—	Pasteurellosis – meat: 5 days.

—	ORT – meat: 12 days.

Do not administer to chickens producing eggs for human consumption.

The Netherlands

Kepro B.V.

Maagdenburgstraat 38

7421 ZE

Deventer

THE NETHERLANDS

Doxy 200 W.S.P.

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens (broilers).

Oral via drinking water.

10 mg doxycycline hyclate per kg bodyweight per day for 3 days.

Meat: 7 days.

Do not administer to chickens producing eggs for human consumption.

Indication:

—	Polyarthritis caused by Mycoplasma synoviae;

—	CRD, amongst others caused by Mycoplasma gallisepticum;

—	Colibacillosis caused by Escherichia coli.

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 days.

Non-egg laying chickens – meat: 5 days.

Indication: Pasteurellosis caused by Pasteurella multocida

The Netherlands

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 10 % Oral Solution

Doxycycline hyclate

Per ml: 100 mg doxycycline (as hyclate).

Oral solution

Pigs and chickens (broilers).

Chickens (broilers): oral via drinking water.

Chickens (broilers): 10-20 mg doxycycline per kg bodyweight per day for 3-5 days

Chickens (broilers) - meat: 7 days.

Indication: Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

The Netherlands

Huvepharma, Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g

Doxycycline hyclate

Per g: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and chickens (broilers).

Chickens (broilers): oral via drinking water.

Chickens (broilers): 20 mg doxycycline per kg bodyweight per day for 3-5 days

Chickens (broilers) - meat: 6 days.

Do not administer to chickens producing eggs for human consumption.

The Netherlands

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Soldoxin

Doxycycline hyclate

Per ml: 100 mg doxycycline (as hyclate).

Oral solution

Pigs and chickens (broilers).

Chickens (broilers): oral via drinking water.

Chickens (broilers): 10-20 mg doxycycline per kg bodyweight per day for 3-5 days

Chickens (broilers) - meat: 7 days.

Do not administer to chickens producing eggs for human consumption.

Indication: Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Poland

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer THE NETHERLANDS

Doxymed 50

Doxycycline hyclate

500 mg/g

powder for oral solution

chickens

250-500 ml product/1 000 liter of drinking water

25 mg doxycyclini hyclate / kg bw/day for 3-5 days

Meat and offal:

4 days. Not for use in laying hens.

Poland

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

500 mg/g

Oral powder

chickens

2 g product/100 kg bw/day in case of Pasteurellosis or 4 g product / 100 kg bw/day in case of Ornithrobacterium rhinotracheale infection.

10 mg doxycycliny hyclate/kg bw/day in case of Pasteurellosis or 20 mg doxycyclini hyclate/kg bw/day in case of Ornithrobacterium rhinotracheale infection for 3-4 days

Meat and offal:

5 days in case of Pasteurellosis.

12 days in case of Ornithrobacterium rhinotracheale infection.

Not for use in laying hens.

Poland

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-S

Doxycycline hyclate

100 mg/ml

Oral solution

chickens

0,5-1,0 ml product/1 liter of drinking water

50-100 mg doxycyclini hyclate/1 liter of drinking water for 3-5 days

Meat and offal:

5 days. Not for use in laying hens.

Poland

Oropharma n.v.

Dijkstraat 30

9140 Temse

BELGIUM

Ornicure

Doxycycline hyclate

300 mg/4 g

Oral powder

pigeon, parrot

pigeon: 4g prodyct/2 liters of drinking water, parrot: 4 g product/0,5 liter

15 mg/kg bw./ day for 5 days, in case of parrot desease or clinical ornitosis for 3-4 weeks

Not for use in pigeons for human consumption.

Poland

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

Doxiryl 50 %

Doxycycline hyclate

500 mg/g

powder for oral solution

chicken (broiler)

25 mg doxycyclini hyclate / kg bw/day

25 mg doxycyclini hyclate / kg bw/day for 3-5 days

Meat and offal:

4 days. Not for use in laying hens.

Poland

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1 Apartado 60

Riudoms 43330 (Tarragona) SPAIN

Doxivex 10 %

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

chicken (broiler)

05-1,0 ml product/1 liter of drinking water

50-100 mg doxycyclini hyclas/1 liter of drinking water/day for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox

Doxycycline hyclate

100 mg/ml

Oral solution

chicken (broiler)

05-1,0 ml product/1 liter of drinking water

10-20 mg doxycyclini hyclas/kg bw/day for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox

Doxycycline hyclate

100 mg/ml

Oral solution

chicken (broiler)

05-1,0 ml product/1 liter of drinking water

10 -20 mg doxycyclini hyclas/kg bw/day for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

Grójecka 6

05-651 Drwalew

POLAND

Doxymina 20 %

Doxycycline hyclate

200 mg/g

Oral powder

chicken

25-50 g product/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

V.M.D.n.v./ s.a.

Hoge Muew 900

2370 Arendonk

BELGIUM

Doxycycline hyclate 50 %

Doxycycline hyclate

500 mg

powder for oral solution

chicken

25 mg doxycyclini hyclate / kg bw/day

25 mg doxycyclini hyclate / kg bw/day for 3-5 days

Meat and offal:

5 days. Not for use in laying hens.

Poland

INDUSTRIAL VETERINARIA S.A.

Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT SPAIN

Doxinyl

Doxycycline hyclate

100 mg/ml

Oral solution

chicken (broiler)

0,5-1,0 ml product/1 liter of drinking water/day

50-100 mg doxycyclini hyclate/1 liter of drinking water for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Biofaktor Sp. z o.o.(Skierniewice)

Czysta 4

96-100 Skierniewice

POLAND

Doxycyclinum 20 %

Doxycycline hyclate

200 mg/ml

powder for oral solution

chicken, turkey

25-50 g product/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

1 Meat and offal:

4 days. Not for use in laying hens.

Poland

Tarchomińskie Zakłady Farmaceutyczne Polfa S.A.

Fleminga 2

03-176 Warszawa

POLAND

Doxycyclinum wet proszek

Doxycycline hyclate

200 mg/g

powder for oral solution

chicken, turkey,

25-50 g powder/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Sogeval Laboratoires

200 route De Mayenne

53022 Laval Cedex FRANCE

DOXYVAL 20 %

Doxycycline hyclate

20 g/100 g

Oral powder

chicken (broiler)

5 g produkt/100 kg bw/day or 0,5 g/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

Meat and offal:

4 days. Not for use in laying hens.

Poland

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 15 %

Doxycycline hyclate

150 mg/g

Oral powder

chicken, turkey, pigeon, cage bird

10-20 mg doxycyclini hyclas/kg bw/day

10-20 mg/ kg bw/day for 3-5 days. In case of Chlamydia psittaci infection for 30-45 days.

Meat and offal:

7 days. Not for use in laying hens or in pigeons for human consumption.

Portugal

CEVA Saúde Animal –Produtos farmacêuticos e Imunológicos

Lda. Ceva Saúde Animal Lda.

Rua Doutor António

Loureiro Borges 9/9a 9o A Miraflores

1495-131 Algés

PORTUGAL

DOXYPRIM 400 mg / g Pó para Solução Oral para Suínos, Frangos e Perus.

Doxycycline hyclate

Doxycycline hyclate 400 mg / g

Powder for oral solution

Swine, Chicken, Turkey

For oral administration in drinking water

Broilers and Turkeys: 20 mg Doxycycline hyclate/kg bw, for 5 days.

Chicken (Broilers) meat and offal: 5 days; Tukeys meat and offal:6 days;

Not permitted for use in laying birds producing eggs for human consumption

Portugal

DIVASA FARMAVIC DE PORTUGAL

Produtos e Equipamentos Veterinários

Lda. Parque Empresarial de Vialonga

Armazém no 21

Casal do Bagulho

Granja de Alpriate

2625-607 Vialonga

PORTUGAL

DOXYVET-10

Doxycycline hyclate

Doxycycline hyclate 10g; Bromexin Cloridrate 1g

Oral solution

Bovine (Calves), Swine, Broilers, Turkeys, Ovine, Goat (Kid)

For oral administration in drinking water

Broilers and Turkeys: 50-100 mg/liter of water/day, for 3-5 days (Equivalent to 0,5-1 ml of DOXIVET-10 / liter of water/day

Meat and offal:

5 days

Portugal

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

VETADOXI 50

Doxycycline hyclate

Doxycycline hyclate 500 mg/g

Oral powder

Bovine (Calves), Swine and Birds

For oral administration in drinking water, milk or feed

25 mg/Kg bw in birds; 200 g/1 000 L water/day 3-5 days; 500 g/1 000 L drinking water birds

Meat and offal:

5 days; Not permitted for use in laying birds producing eggs for human consumption

Portugal

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

Hidrodox 10 % Concentrado para solução oral para aves (frangos de carne) e suínos

Doxycycline hyclate

Doxycycline (as hyclate) 100 mg

Concentrate for Oral Solution

Chickens (broilers) and swine

For oral administration in drinking water

Broilers: 50 – 100 mg Doxycycline hyclate/L drinking water/day (0,5-1,0 ml of VMP/drinking water/day) 3-5 days.

Birds (Broilers) meat and offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption

Portugal

Univete SA

Rua D. Jerónimo Osório, 5

B 1400-119 Lisboa

PORTUGAL

UNIDOXINA 200 mg/ml solução oral para suínos e aves

Doxycycline hyclate

Doxycycline (as hyclate) 200 mg

Oral solution

Chickens (broilers) and swine

For oral administration in drinking water

Broilers and Turkeys: 20 mg Doxycycline hyclate/kg bw, for 5 days.

Chicken (Broilers) meat and offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption

Romania

DELOS IMPEX' 96 SRL

17, Pictor Ştefan Luchian

sector 2

Bucharest

ROMANIA

Doxidem 20

Doxycycline hyclate

200 mg/ml doxycycline hyclate

Oral solution

Poultry

(not for use in animals from which eggs are produced for human consumption)

Oral

—	75 ml of product/100 litres drinking water/day for 3-5 consecutive days in young poultry up to 4 weeks

—	150 ml of product/100 litres drinking water/day for 3-5 consecutive days in adult poultry

Meat and offal: 28 days

Indications:

Poultry For the treatment of mycoplasmosis, pasteurellosis, colibacillosis, staphylococcosis.

Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli., Haemophillus paragallinarium, Staphylococcus, hepatitis caused by Campylobacter and dermatitis.

Romania

DELOS IMPEX' 96 SRL

17, Pictor Ştefan Luchian

sector 2

Bucharest

ROMANIA

Doxidem 50

Doxycycline hyclate

500 mg/g

doxycycline hyclate

Water soluble powder

Poultry

(not for use in animals from which eggs are produced for human consumption)

Pigs

Oral

(drinking water)

—	20-40 mg of product/kg body weight/day for 5 consecutive days, per os;

—	200-300 g of product/1 000 litres of drinking water for 5 consecutive days

Meat and offal: 28 days

Indications: Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli., Haemophillus paragallinarium, Staphylococcus, hepatitis caused by Campylobacter, dermatitis and other diseases caused by microorganisms sensitives to doxycycline.

Romania

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption)

Calves

Pig

Oral

(drinking water)

40 mg/kg of body weight or 200-400 g/1 000 litres of drinking water for 4-7 days

Meat and offal: Poultry 4 days

Indications:

—	Ornithosis caused by Chlamydia psittaci in turkeys;

—	Colibacillosis caused by E. coli in chickens and turkeys;

—	CRD caused by Mycoplasma gallisepticum in chickens and turkeys;

Romania

FRANVET

ZI d'Etriche-Route d'Avire

BP 103

49500 Segré Cedex

FRANCE

Doxy 5 Franvet

Doxycycline hyclate

50 mg/g doxycycline (as hyclate)

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) Calves Pig

Oral (drinking water or liquid feed)

—	1 g of product/1 litre drinking water/day for 3-5 days in poultry up to 2 weeks

—	2 g of product/1 litre drinking water/day for 3-5 days in poultry over 2 weeks

Meat and offal: Poultry 4 days

Indications: For the prevention and treatment of respiratory infections caused by doxycycline sensitive microorganisms.

Romania

INDUSTRIA ITAILIANA INTEGRATORI TREI SpA

Via Affarosa n.4

42010 Rio Saliceto (Reggio Emilia)

ITALY

Doxipan 20

Doxycycline hyclate

200 mg/g doxycycline hyclate

Water soluble powder

Poultry

pig

Oral (drinking water)

5-7,5 g of product for every 10 litres of drinking water

Meat and offal: Poultry 5 days

Indications: Chronic respiratory disease and associated complications.

Romania

PHYLAXIA PHARMA LTD

1103 Budapest

Gergely u.79

HUNGARY

Doxyphyl SP A.U.V.

Doxycycline hyclate

300 mg/g doxycycline hyclate

Water soluble powder

Poultry (chicken, hens, turkeys) v

Oral (drinking water)

10 mg/kg b.w. for 3-5 days or 100 mg of product/1 litre of drinking water

Chickens, hens: 7 days Turkey: 7 days (not for use in animals from which eggs are produced for human consumption)

Indications: For the prevention and treatment of several bacterial infections.

Romania

LABORATORIOS SYVA S.A.

Avda. Parroco Pablo Diez, 49-57

24010 Leon

SPAIN

Syvadox 10 %

Doxycycline hyclate

100 mg/1 ml doxycycline (as hyclate)

Oral solution

Chickens (not for use in animals from which eggs are produced for human consumption)

Oral (drinking water)

50-100 mg doxycycline/1 litre of drinking water/day (equivalent to 0,5-1,0 ml of product/1litre of drinking water/day for 3-5 days

Chickens 7 days (not for use in animals from which eggs are produced for human consumption)

Indications: Colibacillosis, CRD, mycoplasmosis – caused by previously mentioned germs sensitive to doxycycline.

Romania

VMD

Berendonk 74

2370 Arendonk

BELGIUM

Doxyveto 50S

Doxycycline hyclate

500 mg/g doxycycline (as hyclate)

Water soluble powder

Poultry Swine calves lambs

Oral (drinking water or feed)

20 mg doxycycline/kg b.w. /day in drinking water or 300 g of product/1 000 litres of drinking water or 600 g/1 000 kg of feed for 3-5 days

Poultry 8 days

Indications: CRD (Mycoplasma gallisepticum), Ornithosis (Chlamidia psittaci), Infectious synovitis (Mycoplasma synoviae), Fowl cholera (Pasteurella multocida).

Romania

CHEMIFARMA S.p.A

Via Don Eugenio Servadei 16

47100 Forli

ITALY

Doxiciclina 50 %

Doxycycline hyclate

500 mg/g doxycycline

Water soluble powder

Broiler chickens swine

Oral (per os, drinking water or liquid feed)

40 g of product/100 kg b.w. (20 mg of doxycycline/kg b.w) corresponding to about 15-30 g of product/100 litres of water for 3-5 days.

Broiler chickens 5 days

Indications: Chronic respiratory disease and other respiratory illnesses, specially produced by Pasteurella spp., Mycoplasma spp., Haemophilus gallinarium, Bordetella avium and Chlamidia psittaci.

Romania

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

Doxiprim 40 % Soluble Powder

Doxycycline hyclate

400 mg/g doxycycline hyclate

Water soluble powder

Chickens turkeys (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

20 mg doxycycline hyclate/kg b.w.

Chickens and turkeys 4 days (not for use in animals from which eggs are produced for human consumption)

Indications: treatment of respiratory, intestinal and systemic infections caused by doxycycline sensitive organisms: CRD (Mycoplasma gallisepticum, E. Coli), airsaculitis (Mycoplasma maleagridis), infectious synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella multocida), infectious coryza (Haemophylus paragallinarum), colibacillosis (E. Coli), turkeys bordetellosis (Bordetella avium), necrotic enteritidis (Clostridium perfringens), chlamydiosis (Chlamidia psittaci). Prevention of secundary becterial infections due to stress conditions, vaccination, change of housing, transport.

Romania

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

Doxyril 50 %

Doxycycline hyclate

500 mg/g doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

25 mg doxycycline hyclate/kg b.w. during 3 to 5 consecutive days

Poultry 4 days (not for use in animals from which eggs are produced for human consumption)

Indication: Respiratory tract Infections caused by Mycoplasma spp. (M. gallisepticum, M. synoviae and M. melagridis), E. coli, Haemophylus paragallinarium and Ornithobacterium rhinotracheale. Enteritidis caused by Clostridium perfringens and Clostridium colinum. Septicemia caused by Pasteurella multocida.

Romania

CEVA SANTE ANIMALE ROMANIA SRL

5 Chindiei, sector 4,

Bucharest

ROMANIA

Doxyvit 50 % WSP

Doxycycline hyclate

500 mg/g doxycycline hyclate

Water soluble powder

Poultry (chickens and turkeys) (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

15 mg doxycycline/kg b.w. for 5 consecutive days or 2 g of product/10 litres drinking water and equivalent to 100 mg of doxycycline/litre of drinking water

Poultry (chickens and turkeys) 7 days (not for use in animals from which eggs are produced for human consumption)

Indications: Colibacillosis, CRD and mycoplasmosis, Clostridium perfringens, chlamydiosis, infectious coryza caused by Bordetella avium.

Romania

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 100 mg/ml oral solution for use in drinking water for chickens and pigs

Doxycycline hyclate

100 mg/ml doxycycline (as hyclate)

Oral solution

Poultry (chickens) (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

10-20 mg doxycycline/kg b.w. for 3 - 5 days.

Poultry (chickens) t days (not for use in animals from which eggs are produced for human consumption)

Indications:

Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Romania

S.C. VIM SPECTRUM SRL

409 Sighisoarei

Targu Mures

ROMANIA

Vidoxim 10 % powder for oral solution for pigs and poultry

Doxycycline hyclate

100 mg/g doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

1 000 g of product/1 000 litres drinking water for 5 days

Poultry 10 days (not for use in animals from which eggs are produced for human consumption)

Indications:

Infections caused by Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophylus paragallinarium and Pasteurela multocida.

Romania

S.C. VIM SPECTRUM SRL

409 Sighisoarei

Targu Mures

ROMANIA

Vidoxim 100 % powder for oral solution for pigs and poultry

Doxycycline hyclate

1 000 mg/g doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

100 g of product/1 000 litres drinking water for 5 days

Poultry 10 days (not for use in animals from which eggs are produced for human consumption)

Indications: Infections caused by M. gallisepticum, E. coli, Bordetella avium, Haemophylus paragallinarium and P. multocida.

Romania

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox (Soldoxin) 100 mg/ml oral solution for use in drinking water for chickens and pigs

Doxycycline hyclate

100 mg/ml doxycycline (as hyclate)

Oral solution

Chickens (broilers) (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

10-20 mg doxycycline/kg b.w. for 3 - 5 days.

Poultry (chickens) 7 days (not for use in animals from which eggs are produced for human consumption) Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Romania

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g Water Soluble Powder

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications:

Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Romania

CEVA PHYLAXIA VETERINARY BIOLOGICALS CO. LTD.

1107 Budapesta

Szallas u.5

HUNGARY

Doxivit 100

Doxycycline hydrocloride

100 mg/g doxycycline hydrochloride

Water soluble powder

Poultry (chickens, turkeys and goose) pigs

Oral (drinking water)

10 mg doxycycline hydrochloride/kg b.w. daily for 5 days

Poultry) 7 days (not for use in animals from which eggs are produced for human consumption)

Indications:

CRD (Mycoplasma gallisepticum, E. Coli), infectious coryza (Haemophylus paragallinarum), fowl cholera (Pasteurella multocida), colibacillosis (E. Coli), airsaculitis (Mycoplasma maleagridis), chlamydiosis (Chlamidia psittaci), necrotic enteritis (Clostridium perfringens).

Romania

PHARMATEKA BT

1046 Budapest

Szigyarto u. 10 / 20 Kossuth Str.

Pusztaberki, 2658

HUNGARY

DOXY H 10 %

Doxycycline hydrocloride

100 mg/g doxycycline hydrochloride

Water soluble powder

Poultry

Oral (drinking water)

1 g of product/1 litre of drinking water for 3-5 days

Poultry 10 days (not for use in animals from which eggs are produced for human consumption)

Romania

s.c. romvac company s.a.Şos.

Centurii, nr. 7

Voluntari

ROMANIA

Doxiciclina 10 %

Doxycycline hydrocloride

100 mg/g doxycycline hydrochloride

Water soluble powder

Poultry, including pigeons pigs bovine (calves)

Oral (drinking water)

2 g of product/10 kg b.w./day for 5-8 days

Poultry (chickens) 5 days (not for use in animals from which eggs are produced for human consumption)

Romania

S.C. Crida pharm s.r.l

2 Intrarea Vagonetului

Bl. 101, Ap. 47, sector 6

Bucharest

ROMANIA

Doxicol 60 %

Doxycycline hydrocloride

600 mg/g doxycycline hydrochloride

Water soluble powder

Poultry

pigs

Oral (drinking water or feed)

broiler 0-14 days:

50g/1 000 litres of water; broiler 15 -28 days: 100g/1 000 litres of water;broiler 29 -35 days: 120g/1 000 litres of water;

Poultry 5 days (not for use in animals from which eggs are produced for human consumption)

Indications:

prevention and treatment of colibacillosis, respiratory diseases, mycoplasmosis.

Slovenia

Novartis Veterina d.o.o.

Verovškova 57

1000 Ljubljana

SLOVENIA

DOXYRIL 50 %

Doxycycline hyclate

50 %

(500 mg/g)

powder for oral solution

pigs, poultry

Pigs and poultry: once a day, three to five days consecutively in drinking water

Pigs: 20 mg of doxycycline hycate per 1 kg of BW; Poultry 25 mg of doxycycline hycate per 1 kg of BW

Meat and offal:

poultry: 4 days;

Indications: respiratory infections (M gallisepticum, M, synoviae in M, melagridis), Escherichia coli, Haemophilus paragallinarum, Ornithobacterium rhinotracheale; Enteritis (Clostridium perfringens and Clostridium colinum; Septicemia (Pasteurella multocida)

Slovak republic

Trei Bio pharmaceutical division, Industria Italiana Integratori Trei

Via Affarosa n.4

42010 Rio Saliceto (Reggio Emilia)

ITALY

DOXIPAN 20 plv.sol. ad us.vet.

Doxycycline hyclate

20 g/100 g

Water soluble powder

Calves, pigs, poultry-broilers, turkey

for 5 days in drinking water

Poultry-broilers: 5-7,5 g product/10 litre of drinking water Turkey:10-20 mg active substance/b. w. corresponding to 50-100 g product/100 liter d.w. Calves, pigs: 10 mg active substance/b.w./day corresponding to 0,5 g product/10 kg b.w.

Meat: Broilers 5 days, turkeys 10 days,

Indications: Broilers: chronic respiratory disease and assotiated complications

Turkeys: infections caused by G-positive and G-negative germs, mycoplasmas sensitive to doxycycline especially respiratory and articular syndrom caused by mycoplasma and/or staphylococcus

Slovak republic

DIVASA-FARMAVIC, S.A.

CTRA. SANT HIPOLIT, KM. 71

08503 GURB – VIC

SPAIN

DOXIVET 10 % plv.sol. a.u.v.

Doxycycline hyclate

100 mg/ml

Water soluble powder

Poultry: (chickens and turkeys), bovine and swine

for 4 - 5 days in drinking water

0,5 ml of product/litre of drinking water

Meat: 5 days

Indications: Treatment of CRD, mycoplasmosis, porcine enzootic pneumonia, bronchopneumonias, chlamidiasis, unspecific diarheas.

Slovak republic

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

DOXYRIL 500 mg/g prášok na perorálny roztok ad us.vet.

Doxycycline hyclate

500 mg/g

Water soluble powder

Pigs, broilers

during 3 to 5 consecutive days in drinking water

Pigs: 20 mg doxycycline hyclate/kg b.w. Broilers: 25 mg doxycycline hyclate/kg b.w.

Eddible tissues: broilers 4 days.

Indications: Treatment of infections caused by microorganisms susceptible to doxycycline, particularly: Broilers: respiratory tract infections caused by Mycoplasma spp. (M.gallisepticum, M.synoviae and M.meleagridis), Escherichia coli, Haemophilus paragallinarum and Ornithobacterium rhinotracheale, enteritis caused by Clostridium perfringens and Clostridium colinum, septicemia caused by Pasteurella multocida

Slovak republic

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

DOXYVIT 40 % plv.sol.

Doxycycline hyclate

40 g/100 g

Water soluble powder

Poultry: (chickens and turkeys) and swine

3-5 days in drinking water, poutry in drinking water, pigs: in drinking water, in feed

Chickens and turkeys:10-20 mg active doxycyclini hyclate/kg b.w.)/day, continual treatment: 1 g product/3-6 litre of drinking water, repeated treatment: 25-50 mg product/kg b.w.(10-20 mg doxycycline hyclate/kg b.w.) in drinking water

Meat of chickens and turkey: 4 days,

Indications: Treatment and prophylaxis of respiratory, intestinal and systematic infections caused by doxycycline sensitive organism: Chickens, turkeys: chronic respiratory disease (Mycoplasma gallisepticum, E.coli), airsacculitis (M.meleagridis), infectious synovitis (M.synoviae), fowl cholera (P. multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), collibacilosis (E.coli), necrotic enteritis (Clostridium prefringens), chlamydiiosis (CH. psittaci),

Slovak republic

Tekro, spol. s.r.o.,

Višňová 2/484,

140 00 Praha 4,

CZECH REPUBLIC

Meditek DOX 100 plv.sol. ad us.vet.

Doxycycline hyclate

100 g/1 000 g

Water soluble powder

Broilers, pigs

3-5 days in drinking water

Broilers: 10 mg doxycyclini hyclate/kg b.w (corresponding to 1 kg product/1 000 litre of drinking water)

Meat of broilers and pigs: 7 days.

Indications: Treatment and prevention of respiratory and gastrointestinal diseases caused by organism sensitive to doxycycline: broilers: CRD, mycoplasmosis, aerosaculitis, synovitis, pasteurellosis, infectious cholera, colibacillosis, chlamidiosis, necrotic enteritis

Slovak republic

Pharmagal s.r.o.,

Murgašova 5,

949 01 Nitra,

SLOVAK REPUBLIC

DOXYGAL plv.sol. ad us.vet.

Doxycycline hyclate

5 g/100 g

Water soluble powder

Pigs, poultry, calves, rabbits

Poultry: prevention 5 days, treatment 3 days, in drinking water Pigs, calves, rabbits: 5 days, in drinking water, in feed

Poultry: prevention: 50 mg active substance/1 litre of drinking water (1 g product/1 litre water), treatment: 100 mg active substance/1 litre water (2 g product/1 litre water)

Meat of poultry and rabbits: 7 days

Indications: Poultry: CRD (mycoplasmosis), colibacillosis.

Slovak republic

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

RONAXAN 5 % plv.sol. ad us.vet.

Doxycycline hyclate

5 g/100 g

Water soluble powder

Pigs, poultry, calves

Prevention: 1-3 days, treatment: 3-5 days, in drinking, in feed

10 mg active substance/kg b.w./day (1 g product/5 kg b.w./day) Polutry:

—	less than 2 weeks old: 1 g product/litre of drinking water/day,

—	more than 2 weeks old: 2 g/litre water/day

Meat of poultry 4 days

Indications: Poultry: preventive and curative treatment of respiratory infections,

Slovak republic

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

KARIDOX 100 mg/ml roztok pre podávanie hydine a ošípaným perorálne v pitnej vode

Doxycycline hyclate

100 mg/ml

Water soluble powder

Chicken (broilers), pigs

Broilers: 3-5 days, Pigs: 5 days, in drinking water

Broilers: 10 -20 mg of doxycycline/kg b.w./day, (0,5-1,0 ml of product/litre of drinking water),

Meat and offals: chicken (broilers) 7 days

Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline.

Slovak republic

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

ORIDOX 100 mg/ml roztok pre podávanie hydine a ošípaným perorálne v pitnej vode

Doxycycline hyclate

100 mg/ml

Water soluble powder

Chicken (broilers), pigs

Broilers: 3-5 days, Pigs. 5 days, in drinking water

Broilers: 10 -20 mg of doxycycline/kg b.w./day, (0,5-1,0 ml of product/litre of drinking water),

Meat and offals: chicken (broilers) 7 days,

Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline.

United kingdom

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 100 mg/ml Oral Solution for use in drinking water for Chickens and Pigs

Doxycycline hyclate

100 mg/ml doxycycline (as doxycycline hyclate)

Oral solution

Chickens (broilers) & Pigs

Oral (drinking water)

10-20 mg doxycycline/kg x 3-5 days

Meat & offal:

Chickens (broilers): 7 days

Indications: CHICKENS (BROILERS):

Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

United kingdom

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Soldoxin 100 mg/ml Oral Solution for use in drinking water for chickens and pigs

Doxycycline hyclate

100 mg/ml doxycycline (as doxycycline hyclate)

Oral solution

Chickens (broilers) & Pigs

Oral (drinking water)

10-20 mg doxycycline/kg x 3-5 days

Meat & offal:

Chickens (broilers): 7 days

Indications: CHICKENS (BROILERS):

Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

United kingdom

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g Water Soluble Powder

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

UNITED KINGDOM

VMD NV, HOGE MAUW

900-2370 Arendonk

BELGIUM

Doxyveto 50 s plus

Doxycycline hyclate

50 % w/w doxycycline hyclate

Powder for oral administration

Non-egg laying chickens

Oral (drinking water)

25 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:6 days

Indications: Respiratory infections caused by Mycoplasma spp., E. coli and Haemophilus paragallinarum.

Enteritis caused by Clostridium perfringens and Clostridium colinum

ANNEX XV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION Holder IN THE MEMBER STATES

Member State / EEA	Marketing Authorisation Holder	Invented name	Pharmaceutical form	Strength	Animal species	Frequency and route of administration	Recommended dose
Austria	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Belgium	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Denmark	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Germany	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Greece	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Spain	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Finland	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Ireland	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Luxemburg	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
The Netherlands	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Norway	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment
Portugal	Intervet International B.V. P.O. Box 31 5830 AA Boxmeer The Netherlands	Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs	Tablet	0,625; 1,25 or 2,5 mg of ramipril	Dogs	Daily, oral	0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

ANNEX XVI

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)

Member State EU/EEA	Marketing Authorisation Holder	Invented Name	Strength	Pharmaceutical form	Route of administration
Austria	Abbott GmbH Perfektastraße 84A A–1230 Wien Austria	Reductil 10 mg - Hartkapseln	10 mg	Capsule, hard	oral use
Austria	Abott GmbH Perfektastraße 84A A–1230 Wien Austria	Reductil 15 mg - Hartkapseln	15 mg	Capsule, hard	oral use
Austria	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Sibutramin Teva 10 mg Kapseln	10 mg	Capsule, hard	oral use
Austria	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Sibutramin Teva 15 mg Kapseln	15 mg	Capsule, hard	oral use
Belgium	Abbott SA rue du Bosquet 2 1348 Ottignies/LLN Belgium	Reductil 10 mg	10 mg	Capsule, hard	oral use
Belgium	Abbott SA rue du Bosquet 2 1348 Ottignies/LLN Belgium	Reductil 15 mg	15 mg	Capsule, hard	oral use
Belgium	SandozNV TelecomGardens Medialaan 40 1800 Vilvoorde Belgium	Sibutramin Sandoz 10 mg	10 mg	Capsule, hard	oral use
Belgium	SandozNV TelecomGardens Medialaan 40 1800 Vilvoorde Belgium	Sibutramin Sandoz 15 mg	15 mg	Capsule, hard	oral use
Belgium	Teva pharma belgium Laarstraat 16 2610 Wilrijk Belgium	Sibutramin Teva 10 mg	10 mg	Capsule, hard	oral use
Belgium	Teva pharma belgium Laarstraat 16 2610 Wilrijk Belgium	Sibutramin Teva 15 mg	15 mg	Capsule, hard	oral use
Bulgaria	Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil	10 mg	Capsule, hard	oral use
Bulgaria	Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil	15 mg	Capsule, hard	oral use
Bulgaria	Sandoz d.d., Verovskova 57 SI - 1000 Ljubljana Slovenia	Sibutramin Sandoz	10 mg	Capsule, hard	oral use
Bulgaria	Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia	Sibutramin Sandoz	15 mg	Capsule, hard	oral use
Bulgaria	Zentiva k.s. U kabelovny 130 102 37 Prague 10 Czech Republic	Lindaxa	10 mg	Capsule, hard	oral use
Bulgaria	Zentiva k.s. U kabelovny 130 102 37 Prague 10 Czech Republic	Lindaxa	15 mg	Capsule, hard	oral use
Bulgaria	Teva Pharmaceuticals Bulgaria EOOD 15 N.V. Gogol str. Sredetz district 1124 Sofia Bulgaria	Meissa	10 mg	Capsule, hard	oral use
Bulgaria	Teva Pharmaceuticals Bulgaria EOOD 15 N.V. Gogol str. Sredetz district 1124 Sofia Bulgaria	Meissa	15 mg	Capsule, hard	oral use
Czech Republic	Abbott GmbH & Co.KG Max-Planck-Ring-2 65202 Wiesbaden Germany	MERIDIA 10 MG	10 mg	Capsule, hard	oral use
Czech Republic	Abbott GmbH & Co.KG Max-Planck-Ring-2 65202 Wiesbaden Germany	MERIDIA 15 MG	15 mg	Capsule, hard	oral use
Czech Republic	Zentiva, k.s. U kabelovny 130, 102 37 Prague 10 Czech Republic	LINDAXA 10	10 mg	Capsule, hard	oral use
Czech Republic	Zentiva, k.s. U kabelovny 130, 102 37 Prague 10 Czech Republic	LINDAXA 15	15 mg	Capsule, hard	oral use
Czech Republic	TEVA Pharmaceuticals ČR, s.r.o. Radlická 3185/Ic 150 00 Prague 5 Czech Republic	SIBUTRAMIN-TEVA 10 MG TOBOLKY	10 mg	Capsule, hard	oral use
Czech Republic	TEVA Pharmaceuticals ČR, s.r.o. Radlická 3185/Ic 150 00 Prague 5 Czech Republic	SIBUTRAMIN-TEVA 15 MG TOBOLKY	15 mg	Capsule, hard	oral use
Denmark	Abbott Scandinavia AB Postboks 509 SE-169 29, Solna Sweden	Reductil	10 mg	Capsule, hard	oral use
Denmark	Abbott Scandinavia AB Postboks 509 SE-169 29, Solna Sweden	Reductil	15 mg	Capsule, hard	oral use
Denmark	1A Farma A/S Herstedøstervej 27-29 DK–2620 Albertslund Denmark	Sibutramin ‘1A Farma’	10 mg	Capsule, hard	oral use
Denmark	1A Farma A/S Herstedøstervej 27-29 DK–2620 Albertslund Denmark	Sibutramin ‘1A Farma’	15 mg	Capsule, hard	oral use
Denmark	Sandoz A/S C. F. Tietgens Boulevard 40 DK–5220 Odense SØ Denmark	Sibutramin ‘Sandoz’	10 mg	Capsule, hard	oral use
Denmark	Sandoz A/S C. F. Tietgens Boulevard 40 DK–5220 Odense SØ Denmark	Sibutramin ‘Sandoz’	15 mg	Capsule, hard	oral use
Denmark	Teva Danmark A/S Østergade 38 DK–1100 København K Denmark	Sibutramin ‘Teva’	10 mg	Capsule, hard	oral use
Denmark	Teva Danmark A/S Østergade 38 DK–1100 København K Denmark	Sibutramin ‘Teva’	15 mg	Capsule, hard	oral use
Estonia	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	REDUCTIL	10mg	Capsule, hard	oral use
Estonia	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	REDUCTIL	15mg	Capsule, hard	oral use
Estonia	Sandoz d.d. Verovskova 57 1000 Ljubljana Slovenia	SIBUTRIL	10mg	Capsule, hard	oral use
Estonia	Sandoz d.d. Verovskova 57 1000 Ljubljana Slovenia	SIBUTRIL	15mg	Capsule, hard	oral use
Estonia	Zentiva, k.s. U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic	LINDAXA 10	10mg	Capsule, hard	oral use
Estonia	Zentiva, k.s. U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic	LINDAXA 15	15mg	Capsule, hard	oral use
Estonia	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	SIBUTRAMINE TEVA	10mg	Capsule, hard	oral use
Estonia	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	SIBUTRAMINE TEVA	15mg	Capsule, hard	oral use
Finland	Abbott ScandinaviaAB P.O. Box 509 16929 Solna Sweden	Reductil	10 mg, 15 mg	Capsule, hard	oral use
Finland	Sandoz A/S C.F. Tietgens Boulevard 40 5220 Odense SØ Denmark	Sibutramin Sandoz	10 mg, 15 mg	Capsule, hard	oral use
Finland	Teva Sweden AB Järnvägsgatan 11 Box 1070 25110 Helsingborg Sweden	Sibutramine Teva	10 mg, 15 mg	Capsule, hard	oral use
France	ABBOT France 10, RUE D'ARCUEIL SILIC 233 94528 RUNGIS CEDEX FRANCE	SIBUTRAL 10 mg, gélule	10 mg	capsule	oral use
France	ABBOT France 10, RUE D'ARCUEIL SILIC 233 94528 RUNGIS CEDEX FRANCE	SIBUTRAL 15 mg, gélule	15 mg	capsule	oral use
Germany	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil 10 mg Hartkapseln	10 mg	Capsule, hard	oral use
Germany	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil 15 mg Hartkapseln	15 mg	Capsule, hard	oral use
Germany	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Zelium 10 mg Hartkapseln	10 mg	Capsule, hard	oral use
Germany	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Zelium 15 mg Hartkapseln	15 mg	Capsule, hard	oral use
Germany	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reduxade 10 mg Hartkapseln	10 mg	Capsule, hard	oral use
Germany	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reduxade 15 mg Hartkapseln	15 mg	Capsule, hard	oral use
Germany	1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany	Sibutramin - 1A Pharma 10 mg Hartkapseln	10 mg	Capsule, hard	oral use
Germany	1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany	Sibutramin - 1A Pharma 15 mg Hartkapseln	15 mg	Capsule, hard	oral use
Germany	HEXAL AG Postfach 1263 83602 Holzkirchen Germany	Sibutramin-HEXAL 10 mg Hartkapseln	10 mg	Capsule, hard	oral use
Germany	HEXAL AG Postfach 1263 83602 Holzkirchen Germany	Sibutramin-HEXAL 15 mg Hartkapseln	15 mg	Capsule, hard	oral use
Greece	Abbott Laboratories (Hellas) S.A. 512, Vouliagmenis Avenue GR 17456, Alimos Athens Greece	Reductil	10 mg	Capsule, hard	oral use
Greece	Abbott Laboratories (Hellas) S.A. 512, Vouliagmenis Avenue GR 17456, Alimos Athens Greece	Reductil	15 mg	Capsule, hard	oral use
Greece	Teva Pharmaceuticals Europe B.V. European Headquarters Computerweg 10 3542 DR Utrecht The Netherlands	Sibutramine/Teva	10mg	Capsule, hard	oral use
Greece	Teva Pharmaceuticals Europe B.V. European Headquarters Computerweg 10 3542 DR Utrecht The Netherlands	Sibutramine/Teva	15 mg	Capsule, hard	oral use
Hungary	Zentiva k. s. U Kabelovny 130 102 37 Praha 10 Czech Republic	LINDAXA	10mg	Capsule, hard	oral use
Hungary	Zentiva k. s. U Kabelovny 130 102 37 Praha 10 Czech Republic	LINDAXA	15mg	Capsule, hard	oral use
Hungary	Teva Magyarország zrt. Rákóczi út 70-72. 1074 Budapest Hungary	MINIMECTIL	10mg	Capsule, hard	oral use
Hungary	Teva Magyarország zrt. Rákóczi út 70-72. 1074 Budapest Hungary	MINIMECTIL	15mg	Capsule, hard	oral use
Hungary	Abbott Laboratories Kft. Teve u. 1/a-c 1139 Budapest Hungary	REDUCTIL	10mg	Capsule, hard	oral use
Hungary	Abbott Laboratories Kft. Teve u. 1/a-c 1139 Budapest Hungary	REDUCTIL	15mg	Capsule, hard	oral use
Iceland	Abbott Scandinavia Gårdsvägen 8 Box 5091 SE-169 29 Solna Sweden	Reductil	10 mg	Capsule, hard	oral use
Iceland	Abbott Scandinavia Gårdsvägen 8 Box 5091 SE-169 29 Solna Sweden	Reductil	15 mg	Capsule, hard	oral use
Ireland	Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands	Sibutramine Teva 10 mg Capsules	10 mg	Capsule, hard	oral use
Ireland	Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands	Sibutramine Teva 15 mg Capsules	15 mg	Capsule, hard	oral use
Ireland	Abbot Laboratories Ireland Ltd 4051 Kingswood Drive Citywest Business Campus Dublin 24 Ireland	Reductil 10 mg capsules, hard	10 mg	Capsule, hard	oral use
Ireland	Abbot Laboratories Ireland Ltd 4051 Kingswood Drive Citywest Business Campus Dublin 24 Ireland	Reductil 15 mg capsules, hard	15 mg	Capsule, hard	oral use
Ireland	Rowex Ltd Bantry Co.Cork Ireland	Sitrane 10 mg hard capsules	10 mg	Capsule, hard	oral use
Ireland	Rowex Ltd Bantry Co.Cork Ireland	Sitrane 15 mg hard capsules	15 mg	Capsule, hard	oral use
Italy	ABBOTT srl Via Pontina Km 52 04010 Campoverde di Aprilia Italy	REDUXATE	10 mg	capsule	oral use
Italy	ABBOTT srl Via Pontina Km 52 04010 Campoverde di Aprilia Italy	REDUXATE	15 mg	capsule	oral use
Italy	ABBOTT srl Via Pontina Km 52 04010 Campoverde di Aprilia Italy	ECTIVA	10 mg	capsule	oral use
Italy	ABBOTT srl Via Pontina Km 52 04010 Campoverde di Aprilia Italy	ECTIVA	15 mg	capsule	oral use
Italy	ABBOTT srl Via Pontina Km 52 04010 Campoverde di Aprilia Italy	REDUCTIL	10 mg	capsule	oral use
Italy	ABBOTT srl Via Pontina Km 52 04010 Campoverde di Aprilia Italy	REDUCTIL	15 mg	capsule	oral use
Latvia	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil 15 mg hard capsules	15 mg	Capsule, hard	oral use
Latvia	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil 10 mg hard capsules	10 mg	Capsule, hard	oral use
Latvia	Sandoz d.d. Verovškova 57 1000 Ljubljana Slovenia	Sibutril 15 mg capsules, hard	15 mg	Capsule, hard	oral
Latvia	Sandoz d.d. Verovškova 57 1000 Ljubljana Slovenia	Sibutril 10 mg capsules, hard	10 mg	Capsule, hard	oral
Lithuania	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil	10 mg	Capsule, hard	oral use
Lithuania	Abbott GmbH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany	Reductil	15 mg	Capsule, hard	oral use
Lithuania	Zentiva k. s. U kabelovny 130 10237 Prague 10 Dolni Mecholupy Czech Republic	Lindaxa	10 mg	Capsule, hard	oral use
Lithuania	Zentiva k. s. U kabelovny 130 10237 Prague 10 Dolni Mecholupy Czech Republic	Lindaxa	15 mg	Capsule, hard	oral use
Lithuania	Sandoz d.d. Verovskova 57 1000 Ljubljana Slovenia	Sibutril	10 mg	Capsule, hard	oral use
Lithuania	Sandoz d.d. Verovskova 57 1000 Ljubljana Slovenia	Sibutril	15 mg	Capsule, hard	oral use
Lithuania	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Sibutramine Teva	10 mg	Capsule, hard	oral use
Lithuania	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Sibutramine Teva	15 mg	Capsule, hard	oral use
Luxembourg	Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N. Belgium	Reductil	10mg	capsule	oral use
Luxembourg	Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N. Belgium	Reductil	15mg	capsules	oral use
Malta	Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom	Reductil	10mg	Capsule, hard	oral use
Malta	Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom	Reductil	15mg	Capsule, hard	oral use
Netherlands	Abbott B.V. Siriusdreef 51 2132 WT, Hoofddorp Netherlands	Reductil 10 mg, capsules, hard	10 mg	Capsule, hard	oral use
Netherlands	Abbott B.V. Siriusdreef 51 2132 WT, Hoofddorp Netherlands	Reductil 15 mg, capsules, hard	15 mg	Capsule, hard	oral use
Netherlands	Sandoz B.V. Veluwezoom 22 1327 AH, Almere Netherlands	Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules	10 mg	Capsule, hard	oral use
Netherlands	Sandoz B.V. Veluwezoom 22 1327 AH, Almere Netherlands	Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules	15 mg	Capsule, hard	oral use
Netherlands	Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 8226 JX, Lelystad Netherlands	Reductil 15 mg, capsules	15 mg	Capsule, hard	oral use
Netherlands	Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 8226 JX, Lelystad Netherlands	Reductil 10 mg, capsules	10 mg	Capsule, hard	oral use
Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA, Haarlem Netherlands	Sibutramine HCL- monohydraat 10 mg PCH, capsules	10 mg	Capsule, hard	oral use
Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA, Haarlem Netherlands	Sibutramine HCL- monohydraat 15 mg PCH, capsules	15 mg	Capsule, hard	oral use
Norway	Abbot Scandinavia AB Box 509 169 29 Solna Sweden	REDUCTIL	10 mg	Capsule, hard	oral use
Norway	Abbot Scandinavia AB Box 509 169 29 Solna Sweden	REDUCTIL	15 mg	Capsule, hard	oral use
Norway	Euromedica NorgeAS Jerikoveien 28 C 1067 Oslo Norway	REDUCTIL	10 mg	Capsule, hard	oral use
Norway	Euromedica NorgeAS Jerikoveien 28 C 1067 Oslo Norway	REDUCTIL	15 mg	Capsule, hard	oral use
Norway	Sandoz A/ Edvard Thomsens Vej 14 2300 København S Danmark	SIBUTRAMIN SANDOZ	10 mg	Capsule, hard	oral use
Norway	Sandoz A/ Edvard Thomsens Vej 14 2300 København S Danmark	SIBUTRAMIN SANDOZ	15 mg	Capsule, hard	oral use
Poland	Teva Pharmaceuticals Polska Sp. z o.o. 53 Emilii Plater St. 00-113 Warsaw Poland	Afibron	10 mg	Capsule, hard	oral use
Poland	Teva Pharmaceuticals Polska Sp. z o.o. 53 Emilii Plater St. 00-113 Warsaw Poland	Afibron	15 mg	Capsule, hard	oral use
Poland	Zentiva a.s. U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Czech Republic	Lindaxa 10	10 mg	Capsule, hard	oral use
Poland	Zentiva a.s. U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Czech Republic	Lindaxa 15	15 mg	Capsule, hard	oral use
Poland	Abbott Laboratories Poland Sp. z o. o. ul. Postępu 18A 02-676 Warsaw Poland	Meridia 10	10 mg	Capsule, hard	oral use
Poland	Abbott Laboratories Poland Sp. z o. o. ul. Postępu 18A 02-676 Warsaw Poland	Meridia 15	15 mg	Capsule, hard	oral use
Poland	Sandoz GmbH Biochemiestrasse 10 A–6250 Kundl Austria	Obesan	10 mg	Capsule, hard	oral use
Poland	Sandoz GmbH Biochemiestrasse 10 A–6250 Kundl Austria	Obesan	15 mg	Capsule, hard	oral use
Poland	1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching	Sibutramine-1A Pharma	10 mg	Capsule, hard	oral use
Poland	1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany	Sibutramine-1A Pharma	15 mg	Capsule, hard	oral use
Poland	Biofarm Sp. z o.o. Wałbrzyska 13, 60-198 Poznan Poland	Zelixa	10 mg	Film-coated tablet	oral use
Poland	Biofarm Sp. z o.o. Wałbrzyska 13, 60-198 Poznan Poland	Zelixa	15 mg	Film-coated tablet	oral use
Portugal	ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D, 2610-008 AMADORA Portugal	Zelium	10 mg	Capsule, hard	oral use
Portugal	ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D, 2610-008 AMADORA Portugal	Zelium	15 mg	Capsule, hard	oral use
Portugal	ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D, 2610-008 AMADORA Portugal	Reductil	10 mg	Capsule, hard	oral use
Portugal	ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D, 2610-008 AMADORA Portugal	Reductil	15 mg	Capsule, hard	oral use
Portugal	Teva Pharma – Produtos Farmacêuticos, Lda. EmpreendimentoLagoasPark Edifício 1 - 3 2740-264 Porto Salvo Portugal	Sibutramina Teva	10 mg	Capsule, hard	oral use
Portugal	Teva Pharma – Produtos Farmacêuticos, Lda. EmpreendimentoLagoasPark Edifício 1 - 3 2740-264 Porto Salvo Portugal	Sibutramina Teva	15 mg	Capsule, hard	oral use
Portugal	Solufarma - Produtos Farmacêuticos Unipessoal, Lda. Rua do Tejo, 56 - 9o A Esq 2775-325 Parede Portugal	Sibutramina Sibulaite	10 mg	Capsule, hard	oral use
Portugal	Solufarma - Produtos Farmacêuticos Unipessoal, Lda Rua do Tejo, 56 - 9o A Esq 2775-325 Parede Portugal	Sibutramina Sibulaite	15 mg	Capsule, hard	oral use
Portugal	Solufarma - Produtos Farmacêuticos Unipessoal, Lda Rua do Tejo, 56 - 9o A Esq 2775-325 Parede Portugal	Sibutramina Solufarma	10 mg	Capsule, hard	oral use
Portugal	Solufarma - Produtos Farmacêuticos Unipessoal, Lda Rua do Tejo, 56 - 9o A Esq 2775-325 Parede Portugal	Sibutramina Solufarma	15 mg	Capsule, hard	oral use
Portugal	Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Farmoz	10 mg	Capsule, hard	oral use
Portugal	Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Farmoz	15 mg	Capsule, hard	oral use
Portugal	Pentafarma - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, no 2 -Abrunheira 2710-089 Sintra Portugal	Sibutramina Egostar	10 mg	Capsule, hard	oral use
Portugal	Pentafarma - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, no 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Egostar	15 mg	Capsule, hard	oral use
Portugal	Pentafarma - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, no 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Blixie	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Blixie	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Atrolex	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Atrolex	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Argam	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Argam	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Orexinib	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Orexinib	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Snomas	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Snomas	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Arpedex	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Arpedex	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Marcoliz	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Marcoliz	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Ocram	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Ocram	15 mg	Capsule, hard	oral use
Portugal	Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.o 24, rés-do-chão esq São Sebastião da Pedreira 1000 Lisboa Portugal	Sibutramina Strami	10 mg	Capsule, hard	oral use
Portugal	Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.o 24, rés-do-chão esq, São Sebastião da Pedreira 1000 Lisboa Portugal	Sibutramina Strami	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Fililex	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina Fililex	15 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina West Pharma	10 mg	Capsule, hard	oral use
Portugal	Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal	Sibutramina West Pharma	15 mg	Capsule, hard	oral use
Portugal	Generis Farmacêutica, S.A. Office Park da Beloura, Edifício 4, Quinta da Beloura 2710-444 Sintra Portugal	Sibutramina Generis	8,37 mg	Capsule, hard	oral use
Portugal	Generis Farmacêutica, S.A. Office Park da Beloura, Edifício 4, Quinta da Beloura 2710-444 Sintra Portugal	Sibutramina Generis	12 556 mg	Capsule, hard	oral use
Portugal	Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal	Sibutramina Sandoz	10 mg	Capsule, hard	oral use
Portugal	Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal	Sibutramina Sandoz	15 mg	Capsule, hard	oral use
Romania	Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany	REDUCTIL 10 mg, capsule	10 mg	Capsule, hard	oral use
Romania	Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany	REDUCTIL 15 mg, capsule	15 mg	Capsule, hard	oral use
Romania	SANDOZ S.R.L. ROMÂNIA Str. Livezeni nr. 7A, Târgu Mureş, Romania	MINIMACIN 10 mg, capsule	10 mg	Capsule, hard	oral use
Romania	SANDOZ S.R.L. ROMÂNIA Str. Livezeni nr. 7A, Târgu Mureş, Romania	MINIMACIN 15 mg, capsule	15 mg	Capsule, hard	oral use
Romania	S.C. TERAPIA S.A. Str. Fabricii, nr. 124, Cluj-Napoca, Romania	SILUTON 10 mg, capsule	10 mg	Capsule, hard	oral use
Romania	S.C. TERAPIA S.A. Str. Fabricii, nr. 124, Cluj-Napoca, Romania	SILUTON 15 mg, capsule	15 mg	Capsule, hard	oral use
Romania	TEVA PHARMACEUTICALS S.R.L. Str. Domniţa Ruxandra nr 12, parter, Sector 2, Bucureşti Romania	SIBUTRAMINĂ TEVA 10 mg, capsule	10 mg	Capsule, hard	oral use
Romania	TEVA PHARMACEUTICALS S.R.L. Str. Domniţa Ruxandra nr 12, parter, Sector 2, Bucureşti Romania	SIBUTRAMINĂ TEVA 15 mg, capsule	15 mg	Capsule, hard	oral use
Romania	ZENTIVA a.s., U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic	LINDAXA 10 mg, capsule	10 mg	Capsule, hard	oral use
Romania	ZENTIVA a.s., U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Czech Republic	LINDAXA 15 mg, capsule	15 mg	Capsule, hard	oral use
Slovakia	Zentiva, k.s. Evropská 846/176a 160 00 Praha 6 Czech Republic	LINDAXA 10	10 mg	Capsule, hard	oral use
Slovakia	Zentiva, k.s. Evropská 846/176a 160 00 Praha 6 Czech Republic	LINDAXA 15	15 mg	Capsule, hard	oral use
Slovakia	TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02, Bratislava Slovak Republic	Sibutramin - Teva 10 mg kapsuly	10 mg	Capsule, hard	oral use
Slovakia	TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02 Bratislava Slovak Republic	Sibutramin - Teva 15 mg kapsuly	15 mg	Capsule, hard	oral use
Slovakia	Abbott Laboratories Slovakia s.r.o. Karadžicova 10 821 08 Bratislava Slovak Republic	Reductil 10 mg	10 mg	capsule	oral use
Slovakia	Abbott Laboratories Slovakia s.r.o. Karadžicova 10 821 08 Bratislava Slovak Republic	Reductil 15 mg	15 mg	capsule	oral use
Slovenia	Abbott Laboratories d.o.o. Dolenjska c. 242c SI–1000 Ljubljana Slovenia	Reductil 10 mg trde kapsule	10 mg	Capsule, hard	oral use
Slovenia	Abbott Laboratories d.o.o. Dolenjska c. 242c SI–1000 Ljubljana Slovenia	Reductil 15 mg trde kapsule	15 mg	Capsule, hard	oral use
Slovenia	Lek farmacevtska družba d.d., Verovškova c. 57 SI–1000 Ljubljana Slovenia	Sibutramin Lek 10 mg trde kapsule	10 mg	Capsule, hard	oral use
Slovenia	Lek farmacevtska družba d.d., Verovškova c. 57 SI–1000 Ljubljana Slovenia	Sibutramin Lek 15 mg trde kapsule	15 mg	Capsule, hard	oral use
Spain	ABBOTT LABORATORIES, S.A. Avda. de Burgos 28050 Madrid Spain	REDUCTIL	10mg	Capsule, hard	oral use
Spain	ABBOTT LABORATORIES, S.A. Avda. de Burgos 28050 Madrid Spain	REDUCTIL	15 mg	Capsule, hard	oral use
Spain	TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133 Edificio Britania 4oIzq. 28003 MADRID Spain	SIBUTRAMINA TEVA	10mg	Capsule, hard	oral use
Spain	TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133 Edificio Britania 4oIzq. 28003 MADRID Spain	SIBUTRAMINA TEVA	15 mg	Capsule, hard	oral use
Spain	IDIFARMA, DESARROLLO FARMACEUTICO Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) Spain	SIBUTRAMINA IDIFARMA	10 mg	Capsule, hard	oral use
Spain	IDIFARMA, DESARROLLO FARMACEUTICO. Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) Spain	SIBUTRAMINA IDIFARMA	15 mg	Capsule, hard	oral use
Sweden	Abbott ScandinaviaAB Box 509169 29 Solna Sweden	Reductil	10 mg	Capsule, hard	oral use
Sweden	Abbott ScandinaviaAB Box 509169 29 Solna Sweden	Reductil	15 mg	Capsule, hard	oral use
Sweden	Sandoz A/S, C.F. Tietgens Boulevard 40 DK–5220 Odense SØ Danmark	Sibutramin Sandoz	10 mg	Capsule, hard	oral use
Sweden	Sandoz A/S, C.F. Tietgens Boulevard 40 DK–5220 Odense SØ Danmark	Sibutramin Sandoz	15 mg	Capsule, hard	oral use
Sweden	Teva Sweden AB Box 1070 251 10 Helsingborg Sweden	Sibutramine Teva	10 mg	Capsule, hard	Oral use
Sweden	Teva Sweden AB Box 1070 251 10 Helsingborg Sweden	Sibutramine Teva	15 mg	Capsule, hard	Oral use
United Kingdom	Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom	Reductil 10mg	10mg	Capsule, hard	oral use
United Kingdom	Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom	Reductil 15mg	15mg	Capsule, hard	oral use
United Kingdom	Teva UK Limited Brampton Road HampdenPark Eastbourne, East Sussex BN22 9AG United Kingdom	Sibutramine Hydrochloride 15mg Capsules	10mg	Capsule, hard	oral use
United Kingdom	Teva UK Limited Brampton Road HampdenPark Eastbourne, East Sussex BN22 9AG United Kingdom	Sibutramine Hydrochloride 15mg Capsules	15mg	Capsule, hard	oral use

ANNEX XVII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

Marketing Authorisation Holder

Product Name

Strength/dextropropoxyphene/paracetamol/caffeine

Pharmaceutical Form

Route of Administration

Greece

Stargen Ltd

Favierou 48

Athens 10438

Greece

Romidon

75mg/2ml

Solution for injection

Intramuscular, intravenous use

Greece

Norma Hellas S.A.

Menandrou 54

Athens 10431

Greece

Zideron

75mg/2ml

Solution for injection

Intramuscular, intravenous use

ANNEX XVIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State	Marketing Authorisation Holder	Invented Name	Strength/dextropropoxyphene/paracetamol/caffeine	Pharmaceutical Form	Route of Administration
Belgium	Laboratories SMB s.a. 26-28 Rue de la Pastorale B–1080 Bruxelles Belgium	Algophene smb	30 mg/400 mg	Capsule, hard	Oral use
Cyprus	Remedica LTD PO Box 51706 3508 Lemesos Cyprus	Destirol	32,5 mg/325 mg	Tablet	Oral use
Cyprus	Interpak LTD PO Box 51166 3502 Lemesos Cyprus	Dologesic	32,5 mg/325 mg	Tablet	Oral use
Cyprus	Medochemie LTD MedochemieBuilding 1-10 Constantinoupoleos Str., 3011 Limassol, Cyprus	Medonol	32,5 mg/325 mg	Tablet	Oral use
Cyprus	Phadisco LTD PO Box 22173 1518 Lefkosia Cyprus	Distalgesic	32,5 mg/325 mg	Tablet	Oral use
France	Arrow Generiques 26, avenue Tony Garnier 69007 Lyon France	Dextropropoxyphene Paracetamol almus	30 mg/400 mg	Capsule, hard	Oral use
France	Arrow Generiques 26, avenue Tony Garnier 69007 Lyon France	Dextropropoxyphene Paracetamol arrow	30 mg/400 mg	Capsule, hard	Oral use
France	Sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris France	Dextropropoxyphene Paracetamol Biogalenique	30 mg/400 mg	Capsule, hard	Oral use
France	Sanofi- aventis France 1-13, boulevard Romain Rolland 75014 Paris France	Di-antalvic	30 mg/400 mg	Suppository	Rectal use
France	Biogaran 15, boulevard Charles de Gaulle 92700 Colombes France	Dextropropoxyphene Paracetamol biogaran	30 mg/400 mg	Capsule, hard	Oral use
France	Bouchara Recordati 68, rue Marjolin, BP 67 92302 Levallois-Perret Cedex France	Dioalgo	30 mg/400 mg	Capsule, hard	Oral use
France	Chemical Farma 3 quai Louis Blériot 75016 PARIS France	Dextroref	30 mg/400 mg	Capsule, hard	Oral use
France	Dci Pharma 180, rue Eugène Avinée 59120 Loos France	Dextropropoxyphene Paracetamol dci Pharma	30 mg/400 mg	Capsule, hard	Oral use
France	EG Labo - Laboratoires EuroGenerics ‘Le Quintet’ bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France	Dextropropoxyphene Paracetamol eg	30 mg/400 mg	Capsule, hard	Oral use
France	Expanpharm International 6, rue de la Rochefoucauld 16000 Angoulême France	Dextropropoxyphene Paracetamol Expanpharm	30 mg/400 mg	Capsule, hard	Oral use
France	Substipharm 8 Rue Bellini 75116 Paris France	Dextropropoxyphene Paracetamol hexal	30 mg/400 mg	Capsule, hard	Oral use
France	Teva Santé Le Palatin 1 1, cours du Triangle 92936 Paris La Défense Cedex France	Dextropropoxyphene Paracetamol ivax	30 mg/400 mg	Capsule, hard	Oral use
France	Labo Concept Pharm 26, boulevard Paul Vaillant Couturier 94200 Ivry Sur Seine France	Dextropropoxyphene Paracetamol isomed	30 mg/400 mg	Capsule, hard	Oral use
France	Qualimed 117 Allée des Parcs 69800 Saint Priest France	Dextropropoxyphene Paracetamol qualimed	30 mg/400 mg	Capsule, hard	Oral use
France	Ranbaxy Pharmacie Generiques 11-15 Quai de Dion Bouton 92800 Puteaux France	Dextropropoxyphene Paracetamol rpg	30 mg/400 mg	Capsule, hard	Oral use
France	Laboratoires Alter 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette France	Dextropropoxyphene Paracetamol alter	30 mg/400 mg	Capsule, hard	Oral use
France	Sanofi-aventis France 1-13, boulevard Romain Rolland 75014 Paris France	Di-antalvic	30 mg/400 mg	Capsule, hard	Oral use
France	Laboratoires Therabel Lucien Pharma 19 Rue Alphone de Neuville 75017 Paris France	Di dolko	30 mg/400 mg	Capsule, hard	Oral use
France	Leurquin Mediolanum 68-88, rue Louis Ampère 93330 Neuilly-sur-Marne France	Talvidol	30 mg/400 mg	Capsule, hard	Oral use
France	Mylan SAS 117 Allée des Parcs 69800 Saint Priest France	Dextropropoxyphene Paracetamol Mylan	30 mg/400 mg	Capsule, hard	Oral use
France	Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm Germany	Dextropropoxyphene Paracetamol Ratiopharm	30 mg/400 mg	Capsule, hard	Oral use
France	Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France	Dextropropoxyphene Paracetamol G Gam	30 mg/400 mg	Capsule, hard	Oral use
France	Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France	Dextropropoxyphene Paracetamol Sandoz	30 mg/400 mg	Capsule, hard	Oral use
France	Teva Santé Le Palatin 1 1, cours du Triangle 92936 Paris la Défense Cedex France	Dextropropoxyphene Paracetamol Teva	30 mg/400 mg	Capsule, hard	Oral use
France	Sodephar 176, rue de l'Arbrisseau 59000 Lille France	Dextropropoxyphene Paracetamol Sodephar	30 mg/400 mg	Capsule, hard	Oral use
France	Actavis France Centre d'Affaires la Boursidière 92357 le Plessis-Robinson France	Dextropropoxyphene Paracetamol Actavis	30 mg/400 mg	Capsule, hard	Oral use
France	Actavis France Centre d'Affaires la Boursidière 92357 le Plessis-Robinson France	Dexap	30 mg/400 mg	Capsule, hard	Oral use
France	Sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris France	Dialgirex	30 mg/400 mg	Capsule, hard	Oral use
France	Sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris France	Dextropropoxyphene/Paracetamol Theraplix	30 mg/400 mg	Capsule, hard	Oral use
France	Zydus France 25, rue des Peupliers ZAC Les Hautes Pâtures Parc d'Activités des Peupliers 92000 Nanterre France	Dextropropoxyphene Paracetamol Zydus	30 mg/400 mg	Capsule, hard	Oral use
France	Alter 3, avenue de la Baltique 91140 Villebon Sur Yvette France	Dextropropoxyphene/Paracetamol/Cafeine Alter	27 mg/400 mg/30 mg	Tablet	Oral use
France	Arrow Generiques 26, avenue Tony Garnier 69007 Lyon France	Dextropropoxyphene/Paracetamol/Cafeine Almus	27 mg/400 mg/30 mg	Tablet	Oral use
France	Arrow Generiques 26, avenue Tony Garnier 69007 Lyon France	Dextropropoxyphene/Paracetamol/Cafeine Arrow	27 mg/400 mg/30 mg	Tablet	Oral use
France	Arrow Generiques 26, avenue Tony Garnier 69007 Lyon France	Dextropropoxyphene/Paracetamol/Cafeine Offilink	27 mg/400 mg/30 mg	Tablet	Oral use
France	Plus Pharmacie 26, boulevard Paul Vaillant-Couturier 94200 Ivry-sur-Seine France	Dextropropoxyphene / Paracetamol / Cafeine Isomed	27 mg/400 mg/30 mg	Tablet	Oral use
France	Biogaran 15, boulevard Charles de Gaulle 92700 Colombes France	Dextropropoxyphene/Paracetamol/Cafeine Biogaran	27 mg/400 mg/30 mg	Tablet	Oral use
France	Eg Labo - Laboratoires EUROGENERICS ‘Le Quintet’ - bâtiment A 92517 Boulogne Billancourt Cedex France	Dextropropoxyphene/Paracetamol/Cafeine Eg	27 mg/400 mg/30 mg	Tablet	Oral use
France	Ranbaxy Pharmacie Generiques 1115 Quai de Dion Bouton Immeuble Avant Seine 92816 Puteaux Cédex France	Dextropropoxyphene/Paracetamol/Cafeine Rpg	27 mg/400 mg/30 mg	Tablet	Oral use
France	Mylan SAS 117 Allée des Parcs 69800 Saint Priest France	Dextropropoxyphene/Paracetamol/Cafeine Mylan	27 mg/400 mg/30 mg	Tablet	Oral use
France	Mylan SAS 117 Allée des Parcs 69800 Saint Priest France	Dextropropoxyphene/Paracetamol/Cafeine Mylan Pharma	27 mg/400 mg/30 mg	Tablet	Oral use
France	Qualimed (Lyon) 117 Allée des Parcs 69800 Saint Priest France	Dextropropoxyphene/Paracetamol/Cafeine Qualimed	27 mg/400 mg/30 mg	Tablet	Oral use
France	Laboratoire Ratiopharm 19, boulevard Paul Vaillant Couturier 94200 Ivry sur Seine France	Dextropropoxyphene/Paracetamol/Cafeine Ratiopharm	27 mg/400 mg/30 mg	Tablet	Oral use
France	Sandoz 49, avenue Georges Pompidou 92593 Levallois-Perret France	Dextropropoxyphene/Paracetamol/Cafeine G Gam	27 mg/400 mg/30 mg	Tablet	Oral use
France	Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France	Dextropropoxyphene/Paracetamol/Cafeine Sandoz	27 mg/400 mg/30 mg	Tablet	Oral use
France	TEVA Santé Le Palatin 1 1, cours du Triangle 92936 Paris la Défense Cedex France	Dextropropoxyphene/Paracetamol/Cafeine Teva	27 mg/400 mg/30 mg	Tablet	Oral use
France	Zydus France 25, rue des Peupliers ZAC Les Hautes Pâtures Parc d'Activités des Peupliers 92000 Nanterre France	Dextropropoxyphene/Paracetamol/Cafeine Zydus	27 mg/400 mg/30 mg	Tablet	Oral use
France	Sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris France	Propofan	27 mg/400 mg/30 mg	Tablet	Oral use
France	Sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris France	Dextropropoxyphene/Paracetamol/Cafeine Winthrop	27 mg/400 mg/30 mg	Tablet	Oral use
Luxembourg	S.M.B 26-28 rue de la Pastorale B–1080 Bruxelles Belgium	Algophene	30 mg/400 mg	Capsule	Oral use
Malta	Medochemie LTD MedochemieBuilding 1-10 Constantinoupoleos Str., 3011 Limassol, Cyprus	Medonol	32,5 mg/325 mg	Tablet	Oral use
Malta	Phadisco Ltd 185 Giannou Kranidioti Avenue CY–2235 Latsia Cyprus	Distalgesic	32,5 mg/325 mg	Tablet	Oral use
Norway	Actavis group hf Dalshraun 1 220 Hafnafjordur Iceland	Aporex	70 mg/400 mg	Tablet	Oral use
Portugal	Ferraz Lynce S.A Rua Consiglieri Pedroso 123 Queluz de Baixo Apartado 1001 2731901 Barcarena Portugal	Algifene	25 mg/300 mg	Coated tablet	Oral use

Member State	Marketing Authorisation Holder	Product Name	Strength/dextropropoxyphene/paracetamol/caffeine	Pharmaceutical Form	Route of Administration
Belgium	Pfizer s-a. Boulevard de la Plaine 111050 Bruxelles Belgium	Depronal	150 mg	Prolonged-release capsule, hard	Oral use
Denmark	Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør Denmark	Abalgin	65 mg	Capsule, hard	Oral use
Denmark	Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør Denmark	Abalgin	65 mg	Film-coated tablet	Oral use
Denmark	Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør Denmark	Abalgin retard	150 mg	Prolonged-release capsule	Oral use
Denmark	NordMedica A/S, Bredgade 41, DK–1260 Copenhagen K Denmark	Doloxene	100 mg	Capsule, hard	Oral use
Finland	Alternova A/S, Lodshusvej 11 4230 Skaelskoer Denmark	Abalgin	65 mg	Capsule, hard	Oral use
Finland	Alternova A/S, Lodshusvej 11 4230 Skaelskoer Denmark	Abalgin retard	150 mg	Prolonged-release capsule, hard	Oral use
France	Sanofi Aventis France 1-13 boulevard Romain Rolland 75014 Paris France	Antalvic adultes	65mg	Tablet	Oral use
Greece	Stargen Ltd Favierou 48 Athens 10439 Greece	Romidon	65 mg	Capsule, hard	Oral use
Luxembourg	PFIZER s-a. Boulevard de la Plaine 11 1050 Bruxelles Belgium	Depronal	150 mg	Prolonged-release capsule	Oral use
Netherlands	Pfizer B.V. Rivium Westlaan 142 2909 LD Capelle a/d Ijssel Nederlands	Depronal	150 mg	Modified release capsule	Oral use
Spain	Parke Davis, S.L. Avda. de Europa, 20 B. Parque Empresarial La Moraleja; Alcobendas; 28108 Madrid España	Deprancol a.s.	150 mg	Prolonged-release capsule, hard	Oral use
Sweden	Meda AB, Box 906 170 09 Solna Sweden	Doloxene	50 mg	Capsule, hard	Oral use
Sweden	Meda AB, Box 906 170 09 Solna Sweden	Doloxene	100 mg	Capsule, hard	Oral use
Sweden	BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm Sweden	Dexofen	50 mg	Tablet	Oral use
Sweden	BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm Sweden	Dexofen	100 mg	Tablet	Oral use

ANNEX XIX

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)

Member State (EEA)	Marketing Authorisation Holder	Invented Name	Strength	Pharmaceutical Form	Route of administration
CY - Cyprus	Les Laboratoires Servier 22, rue Garnier F- 92200 Neuilly-sur-Seine France	Lipophoral Tablets 150mg	150 mg	tablet	oral
FR - France	Les laboratoires Servier 22 rue Garnier F-92200 Neuilly-sur-Seine France	Mediator	150 mg	tablet	oral
FR - France	Mylan SAS 117 allée des Parcs 69800 Saint-Priest France	Benfluorex Mylan	150 mg	tablet	oral
FR - France	Qualimed 117 allée des Parcs 69800 Saint-Priest France	Benfluorex Qualimed	150 mg	tablet	oral
LU - Luxembourg	Les Laboratoires Servier 22, rue Garnier F- 92200 Neuilly-sur-Seine France	Mediator	150 mg	tablet	oral
PT - Portugal	Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar 128, 1069-133 Lisboa Portugal	Mediator	150 mg	coated tablet	oral

		ISSN 1725-2423 doi:10.3000/17252423.C_2010.258.eng
Official Journal of the European Union		C 258

English edition	Information and Notices	Volume 53 24 September 2010

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2010/C 258/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010[Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council]	1

2010/C 258/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010[Decisions taken pursuant to Article 34 of Directive 2001/83/CE or Article 38 of Directive 2001/82/CE]	32

Date of the decision	Name of the medicinal product	INN (International Non-Proprietary Name)	Holder of the marketing authorization	Number of the entry in the Community Register	Pharmaceutical form	ATC code (Anatomical Therapeutic Chemical Code)	Date of notification
11.3.2010	Revolade	Eltrombopag	GlaxoSmithKline Trading Services Limited 6900 CorkAirport Business Park, Kinsale Road, Cork, Ireland	EU/1/10/612/001-006	Film-coated tablet	B02BX05	15.3.2010
15.3.2010	DuoCover	clopidogrel / acetylsalicylic acid	Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/10/623/001-014	Film-coated tablet	B01AC30	17.3.2010
15.3.2010	DuoPlavin	clopidogrel / acetylsalicylic acid	Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France	EU/1/10/619/001-014	Film-coated tablet	B01AC30	17.3.2010
15.3.2010	ImmunoGam	Human Hepatitis B Immunoglobulin	Cangene Europe Limited Parkshot House, 5 Kew Road, Richmond, SurreyTW9 2PR, United Kingdom	EU/1/10/613/001-002	Solution for injection	J06BB04	17.3.2010
15.3.2010	Menveo	Meningococcal Group A, C, W135 and Y Conjugate Vaccine	Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 - Siena, Italia	EU/1/10/614/001	Powder and solution for injection	Pending	17.3.2010
15.3.2010	Ristaben	sitagliptin	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/10/621/001-018	Film-coated tablet	A10BH01	17.3.2010
15.3.2010	Ristfor	sitagliptin / metformin hydrochloride	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/10/620/001-016	Film-coated tablet	A10BD07	17.3.2010
15.3.2010	Temozolomide HEXAL	temozolomide	HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland	EU/1/10/616/001-024	Capsule, hard	L01AX03	17.3.2010
15.3.2010	Temozolomide Hospira	temozolomide	Hospira UK Ltd. Queensway, Royal Leamington Spa, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom	EU/1/10/615/001-024	Capsule, hard	L01AX03	17.3.2010
15.3.2010	Temozolomide Sandoz	temozolomide	Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland	EU/1/10/617/001-024	Capsule, hard	L01AX03	17.3.2010
15.3.2010	Tepadina	Thiotepa	ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia	EU/1/10/622/001-002	powder for concentrate for solution for infusion	L01AC01	17.3.2010
23.3.2010	Arepanrix	Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)	GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique	EU/1/10/624/001	Suspension and emulsion for emulsion for injection	J07BB02	25.3.2010
6.4.2010	Ribavirin BioPartners	Ribavirin	BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland	EU/1/10/626/001-004	Film-coated tablet	J05AB04	9.4.2010
19.4.2010	Arzerra	Ofatumumab	Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/10/625/001-002	Concentrate for solution for infusion	L01XC10	21.4.2010
29.4.2010	Raloxifene Teva	Raloxifene hydrochloride	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/10/627/001-003	Film-coated tablet	G03XC01	3.5.2010
10.5.2010	Docefrez	Docetaxel	Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland	EU/1/10/630/001-002	Powder and solvent for concentrate for solution for infusion	L01CD02	12.5.2010
26.5.2010	Prolia	denosumab	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/10/618/001-004	Solution for injection	M05BX04	28.5.2010
4.6.2010	Tolura	telmisartan	KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/10/632/001-021	Tablet	C09CA07	8.6.2010
8.6.2010	Humenza	Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)	Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France	EU/1/10/629/001	Suspension and emulsion for emulsion for injection	J07BB02	10.6.2010
8.6.2010	Nivestim	Filgrastim	Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom	EU/1/10/631/001-009	Solution for injection or infusion	L03AA02	10.6.2010
10.6.2010	Olanzapine Apotex	Olanzapine	Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland	EU/1/10/635/001-014	Film-coated tablet Orodispersible tablet	N05AH03	14.6.2010
10.6.2010	Ribavirin Three Rivers	Ribavirin	Three Rivers Global Pharma Limited 20-22 Bedford Row, London WC1R4JS, United Kingdom	EU/1/10/634/001-004	Capsule, hard	J05AB04	14.6.2010
10.6.2010	Topotecan Hospira	Topotecan	Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom	EU/1/10/633/001-002	Concentrate for solution for infusion	L01XX17	14.6.2010
14.6.2010	Votrient	Pazopanib hydrochloride	Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/10/628/001-004	Film-coated tablet	L01XE11	16.6.2010

Date of the decision	Name of the medicinal product	Holder of the marketing authorization	Number of the entry in the Community Register	Date of notification
15.3.2010	Aivlosin	ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom	EU/2/04/044/001-002	17.3.2010
15.3.2010	Draxxin	Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom	EU/2/03/041/004	17.3.2010
15.3.2010	Incurin	Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland	EU/2/00/018/001	17.3.2010
15.3.2010	Masivet	AB Science S.A. 3 avenue George V, 75008 Paris, France	EU/2/08/087/001-002	17.3.2010
15.3.2010	Meloxivet	Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België	EU/2/07/077/001-005	17.3.2010
15.3.2010	SevoFlo	Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM	EU/2/02/035/007	17.3.2010
16.3.2010	Rabigen SAG2	VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France	EU/2/00/021/001-002	19.3.2010
22.3.2010	Purevax FeLV	Merial 29 Avenue Tony Garnier, 69007 Lyon, France	EU/2/00/019/005-007	24.3.2010
23.3.2010	Ibraxion	Merial 29 Avenue Tony Garnier, 69007 Lyon, France	EU/2/99/017/001-006	23.3.2010
23.3.2010	Loxicom	Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom	EU/2/08/090/001-009	25.3.2010
26.3.2010	Meloxidyl	CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France	EU/2/06/070/001-007	30.3.2010
30.3.2010	Acticam	Omnipharm Ltd Suite 3, 24 High Street, Ruddington, Nottingham, NG11 6EA, United Kingdom	EU/2/08/088/001-004	1.4.2010
9.4.2010	Slentrol	Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom	EU/2/07/071/001-003	13.4.2010
27.4.2010	Vaxxitek HVT+ IBD	Merial 29 Avenue Tony Garnier, 69007 Lyon, France	EU/2/02/032/001-002	29.4.2010
29.4.2010	Trocoxil	Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ United Kingdom	EU/2/08/084/001-005	4.5.2010
26.5.2010	Ibaflin	Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland	EU/2/00/022/001a-001b EU/2/00/022/002a-002b EU/2/00/022/003a-003b EU/2/00/022/004a-004b EU/2/00/022/005-017	28.5.2010
26.5.2010	Naxcel	Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom	EU/2/05/053/001-003	28.5.2010
2.6.2010	Metacam	Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland	EU/2/97/004/026 EU/2/97/004/033-034	4.6.2010
10.6.2010	Flexicam	Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark	EU/2/06/058/001-004	14.6.2010