26.8.2016

Official Journal of the European Union

C 312/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016

(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2016/C 312/01)

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

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
1.7.2016	Zinbryta	daclizumab	Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom	EU/1/16/1107	Solution for injection	L04AC01	5.7.2016
6.7.2016	EndolucinBeta	Lutetium (177 Lu) chloride	ITG Isotope Technologies Garching GmbH Lichtenbergstr. 1, D-85748 Garching, Deutschland	EU/1/16/1105	Radiopharmaceutical precursor, solution	Pending	8.7.2016
6.7.2016	Epclusa	sofosbuvir/velpatasvir	Gilead Sciences International Ltd Cambridge, CB21 6GT, United Kingdom	EU/1/16/1116	Film-coated tablet	Pending	8.7.2016
15.7.2016	Qtern	saxagliptin/dapagliflozin	AstraZeneca AB SE-151 85 Södertälje, Sverige	EU/1/16/1108	Film-coated tablet	A10BD21	19.7.2016
22.7.2016	Bortezomib Hospira	bortezomib	Hospira UK Limited Horizon, Honey Lane, Hurley, SL6 6RJ, United Kingdom	EU/1/16/1114	Powder for solution for infusion	L01XX32	26.7.2016
22.7.2016	Bortezomib SUN	bortezomib	Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland	EU/1/16/1102	Powder for solution for injection	L01XX32	26.7.2016
22.7.2016	Pemetrexed Fresenius Kabi	pemetrexed	Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom	EU/1/16/1115	Powder for concentrate for solution for infusion	L01BA04	26.7.2016
22.7.2016	Zepatier	elbasvir/grazoprevir	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/16/1119	Film-coated tablet	J05A	26.7.2016

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

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
4.7.2016	BiResp Spiromax	Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland	EU/1/14/921	6.7.2016
4.7.2016	Clopidogrel Apotex	Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland	EU/1/09/568	6.7.2016
4.7.2016	Duloxetine Lilly	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/14/972	6.7.2016
4.7.2016	DuoResp Spiromax	Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland	EU/1/14/920	6.7.2016
6.7.2016	Arzerra	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/10/625	8.7.2016
6.7.2016	Budesonide/Formoterol Teva	Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland	EU/1/14/948	8.7.2016
6.7.2016	Mircera	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/07/400	8.7.2016
6.7.2016	Nivestim	Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom	EU/1/10/631	8.7.2016
6.7.2016	Olanzapine Mylan	Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom	EU/1/08/475	12.7.2016
6.7.2016	Oprymea	Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/08/469	8.7.2016
6.7.2016	Rapilysin	Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland	EU/1/96/018	8.7.2016
6.7.2016	Vylaer Spiromax	Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland	EU/1/14/949	8.7.2016
6.7.2016	Xarelto	Bayer Pharma AG D-13342 Berlin, Deutschland	EU/1/08/472	8.7.2016
8.7.2016	Otezla	Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom	EU/1/14/981	12.7.2016
8.7.2016	Revlimid	Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom	EU/1/07/391	12.7.2016
14.7.2016	Ariclaim	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/04/283	18.7.2016
14.7.2016	Votrient	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/10/628	18.7.2016
15.7.2016	ATryn	GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom	EU/1/06/355	19.7.2016
15.7.2016	Exjade	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/06/356	19.7.2016
15.7.2016	Jardiance	Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/14/930	19.7.2016
15.7.2016	Komboglyze	AstraZeneca AB SE-151 85 Södertälje, Sverige	EU/1/11/731	19.7.2016
15.7.2016	Leflunomide medac	medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland	EU/1/10/637	19.7.2016
15.7.2016	Levetiracetam Teva	Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland	EU/1/11/701	19.7.2016
15.7.2016	Luminity	Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom	EU/1/06/361	19.7.2016
15.7.2016	NeoRecormon	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/97/031	19.7.2016
15.7.2016	Noxafil	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/05/320	19.7.2016
15.7.2016	Opsumit	Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom	EU/1/13/893	19.7.2016
15.7.2016	Pramipexole Accord	Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom	EU/1/11/728	19.7.2016
15.7.2016	Remicade	Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland	EU/1/99/116	19.7.2016
15.7.2016	Sprycel	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/06/363	19.7.2016
15.7.2016	Stelara	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/08/494	19.7.2016
15.7.2016	Synjardy	Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/15/1003	19.7.2016
15.7.2016	Temozolomide HEXAL	Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland	EU/1/10/616	19.7.2016
15.7.2016	Temozolomide Sandoz	Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich	EU/1/10/617	19.7.2016
15.7.2016	Thalidomide Celgene	Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom	EU/1/08/443	19.7.2016
15.7.2016	Thyrogen	Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland	EU/1/99/122	19.7.2016
15.7.2016	Zoledronic acid Teva Pharma	Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland	EU/1/12/772	19.7.2016
22.7.2016	Byetta	AstraZeneca AB SE-151 85 Södertälje, Sverige	EU/1/06/362	26.7.2016
22.7.2016	Cialis	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/02/237	26.7.2016
22.7.2016	Conbriza	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/09/511	26.7.2016
22.7.2016	Cymbalta	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/04/296	26.7.2016
22.7.2016	EDURANT	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/11/736	26.7.2016
22.7.2016	Eviplera	Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom	EU/1/11/737	26.7.2016
22.7.2016	Granupas	Lucane Pharma 172 rue de Charonne, 75011 Paris, France	EU/1/13/896	26.7.2016
22.7.2016	Harvoni	Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom	EU/1/14/958	26.7.2016
22.7.2016	Levetiracetam Accord	Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom	EU/1/11/712	26.7.2016
22.7.2016	Noxafil	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/05/320	26.7.2016
22.7.2016	Ofev	Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/14/979	26.7.2016
22.7.2016	Rebif	Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom	EU/1/98/063	27.7.2016
22.7.2016	Ryzodeg	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/12/806	26.7.2016
22.7.2016	Temomedac	medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland	EU/1/09/605	26.7.2016
22.7.2016	Vizamyl	GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom	EU/1/14/941	26.7.2016
22.7.2016	Vyndaqel	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/11/717	26.7.2016
22.7.2016	Xeristar	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/04/297	26.7.2016
29.7.2016	Cervarix	GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique	EU/1/07/419	2.8.2016
29.7.2016	Firdapse	BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom	EU/1/09/601	2.8.2016
29.7.2016	Imnovid	Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom	EU/1/13/850	2.8.2016
29.7.2016	Jakavi	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/12/773	2.8.2016
29.7.2016	KEYTRUDA	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/15/1024	2.8.2016
29.7.2016	Nevanac	Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom	EU/1/07/433	2.8.2016
29.7.2016	ReFacto AF	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/99/103	3.8.2016
29.7.2016	Revatio	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/05/318	3.8.2016
29.7.2016	Ribavirin Mylan	Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom	EU/1/10/634	4.8.2016
29.7.2016	RoActemra	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/08/492	2.8.2016
29.7.2016	XALKORI	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/12/793	4.8.2016

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

29.7.2016

ChondroCelect

TiGenix NV

Romeinse straat 12/2, B-3001 Leuven, België

EU/1/09/563

2.8.2016

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

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
4.7.2016	Suvaxyn CSF Marker	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/14/179	6.7.2016
8.7.2016	Oxyglobin	OPK Biotech Netherlands BV Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland	EU/2/99/015	12.7.2016
19.7.2016	ERYSENG	Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España	EU/2/14/166	21.7.2016
25.7.2016	Eurican Herpes 205	Merial 29 avenue Tony Garnier, F-69007 Lyon, France	EU/2/01/029	27.7.2016
25.7.2016	Osurnia	Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM	EU/2/14/170	27.7.2016
25.7.2016	Porcilis ColiClos	Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland	EU/2/12/141	27.7.2016
25.7.2016	Prac-Tic	Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM	EU/2/06/066	27.7.2016
25.7.2016	STARTVAC	Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España	EU/2/08/092	27.7.2016
29.7.2016	Ingelvac CircoFLEX	Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland	EU/2/07/079	2.8.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

(1) OJ L 136, 30.4.2004, p. 1.

26.8.2016

Official Journal of the European Union

C 312/10

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016

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

(2016/C 312/02)

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	INN (International Non-Proprietary Name)	Holder(s) of the marketing authorization	Member State concerned	Date of notification
8.8.2016	Saizen (and associated names) and Humatrope (and associated names)	somatropin	Not applicable	Not applicable	9.8.2016

— Revocation of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	INN (International Non-Proprietary Name)	Holder(s) of the marketing authorization	Member State concerned	Date of notification
14.7.2016	Colistin combinations	colistin	See Annex I	See Annex I	15.7.2016

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

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

ANNEX

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States

Member State EU/EEA	Marketing authorisation holder	Name	INN	Strength	Pharmaceutical form	Animal species	Route of administration
Bulgaria	Farma vet Ltd 40 Otec Paisii str. Shumen Bulgaria	Колитетравит/COLI — TETRAVIT	Oxytetracycline hydrochloride Colistin sulphate	5,0 g 3 500 000 UI	Oral solution	Chickens and pigs	Oral administration
Bulgaria	COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS Cedex France	Колисултрикс/COLISULTRIX	Trimethoprim Colistin sulphate	3,75 g 50 MIU	Oral powder	Chickens, rabbits, pigs, calves and lambs	Oral administration
Croatia	Arnika Veterina d.o.o. Vodovodna 20a 10000 Zagreb Croatia	COLISULTRIX	Trimethoprim Colistin sulphate	3,75 g 50 MIU	Oral powder	Calves, lambs, kids, piglets, poultry and rabbits	Oral
Croatia	Ceva Santé Animale 10 Avenue de la Ballastière 33500 Libourne France	QUINOCOL	Enrofloxacin Colistin sulphate	100 g 41,67 g	Oral solution	Chicken, turkey	Oral
Cyprus	FATRO S.p.A. Via Emilia, 285 40064 Ozzano Emilia (Bologna) Italy	BACOLAM powder for oral solution for calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)	Amoxicillin trihydrate Colistin sulphate	100 mg 500 000 I.U.	Powder for oral solution	Calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)	Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk.
Cyprus	Vetoquinol Italia S.R.L Via Piana, 265 47032 Bertinoro Italy	ZEMAMIX premix for medicated feedingstuff for pigs	Amoxicillin trihydrate Colistin sulphate	11,48 g 4,00 g	Premix for medicated feedingstuff	Pigs	Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.
Czech Republic	LAVET Pharmaceuticals Ltd Ottó u.14 1161 Budapest Hungary	AMOXYCOL plv.sol.	Amoxicillin trihydrate Colistin sulphate	640 mg/g 3 200 000 IU/g	Powder for oral solution for use in drinking water or in feed	Pigs, chicken (broilers)	Oral
Czech Republic	COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS Cedex France	BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku	Colistin sulphate Spiramycin adipate	500 000 IU 650 000 IU	Powder for oral solution	Calves, piglets, foals, chicken	Oral
Czech Republic	COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS Cedex France	COLISULTRIX plv. sol.	Trimethoprim Colistin sulphate	37,5 mg 500 000 IU/g	Powder for oral solution	Chicken	Oral
Czech Republic	Industria Italiana Integratori Trei S.p.A. Via Corassori, 62 41100 Modena Italy	MICROAMOX COLI premix pro medikaci krmiva	Amoxicillin trihydrate Colistin sulphate	100 mg/g 600 000 IU/g	Premix for medicated feed	Pigs	Oral
France	MERIAL 29 avenue Tony Garnier 69007 LYON France	BELCOSPIRA ORAL	Colistin sulphate Spiramycin adipate	500 000 IU/g 650 000 IU/g	Powder for oral use	Cattle, pigs, poultry	Oral use
France	LABORATOIRES BIOVE 3 Rue de Lorraine 62510 Arques France	COLAMPI B	Ampicillin trihydrate Colistin sulphate	25 mg/g 0,075 MIU/g	Powder for oral use	Pigs, calves	Oral use
France	LABORATOIRES BIOVE 3 Rue de Lorraine 62510 Arques France	COLAMPI O	Ampicillin trihydrate Colistin sulphate	1 g/tablet 1 MIU/tablet	Tablet	Calves	Oral use
France	VETOQUINOL Magny Vernois 70200 Lure France	COLIDIARYL	Colistin sulphate Erythromycin estolate	83 400 IU/g 16 600 IU/g	Powder for oral use	Lamb, goat, piglets, foals, calves	Oral use
France	MERIAL 29 avenue Tony Garnier 69007 LYON France	COLISULTRIX POUDRE	Colistin sulphate Trimethoprim	500 000 IU/g 37,5 mg/g	Powder for oral use	Lamb, goat, rabbits, pigs, calves, poultry	Oral use
France	VIRBAC 1ere Avenue 2065m L.I.D. 06516 Carros Cedex France	ENTEROGEL 30	Colistin sulphate Scopolamine Sulfaguanidine	10,5 MIU/syringe 0,216 g/syringe 4,2 g/syringe	Oral paste	Foals, calves	Oral use
France	VIRBAC 1ere Avenue 2065m L.I.D. 06516 Carros Cedex France	INTESTIVO	Colistin sulphate Sulfaguanidine	2,5 MIU/tablet 1 g/tablet	Tablet	Lamb, goat, calve	Oral use
France	MERIAL 29 avenue Tony Garnier 69007 LYON France	N.P. 8	Colistin sulphate Neomycin sulfate	300 000 IU/g 60 000 IU/g	Powder for oral use	Lamb, goat, rabbits, pigs, calves, poultry	Oral use
France	QALIAN 34 rue Jean Monnet ZI D’Etiché BP20341 49503 Segré Cedex France	OXYCOLI	Colistin sulphate Oxytetracycline hydrochloride	200 000 IU/g 0,07 g/g	Premix for medicated feed	Pigs, calves	Oral use
France	Ceva Santé Animale 10 Avenue de la Ballastière 33500 Libourne France	PHADILACT	Ampicillin trihydrate Colistin sulphate	5,00 mg/g 1 000 000 IU/g	Powder for oral use	Lamb, goat, calves, poultry	Oral use
France	QALIAN 34 rue Jean Monnet ZI D’Etiché BP20341 49503 Segré Cedex France	PRÉMELANGE MÉDICAMENTEUX CS FRANVET	Colistin sulphate Sulfadimethoxine	700 000 IU/g 210 mg/g	Premix	Lamb, calves	Oral use
France	VETOQUINOL Magny Vernois 70200 Lure France	SEPTOTRYL-COLISTINE	Colistin sulphate Sulfamethoxypyridazine	2 MIU/tablet 1 g/tablet	Tablet	Lamb, dogs, foals, calves	Oral use
Hungary	Lavet Gyógyszergyártó Kft. Ottó u. 14 1161 Budapest Hungary	Amoxycol por belsőleges oldathoz A.U.V.	Amoxicillin trihydrate Colistin sulphate	640,0 mg/g 133,3 mg/g	Powder for oral solution	Pigs, chickens	In drinking water use
Hungary	Industria Italiana Integratori Trei S.p.A. Viale Corassori, 62 41100 Modena Italy	BETAMICYN gyógypremix sertések részére A.U.V.	Amoxicillin trihydrate Colistin sulphate	100 g/kg 600 MIU/kg	Premix for medicated feeding stuff	Pigs	In feed use
Hungary	Rhone Vet Kft. Petőfi u. 9. 2053 Herceghalom Hungary	Colisutrix belsőleges por	Trimethoprim Colistin sulphate	3,75 g/100 g 50 MIU/100 g	Powder for oral solution	Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat	In drinking water use
Italy	Fatro S.p.a. Via Emilia, 285 40064 Ozzano Emilia Italy	COMBOMIX	Amoxicillin trihydrate Colistin sulphate	115 mg/g 40 mg/g	Premix for medicated feeding stuff	Pigs, chickens (other than laying hens in lay)	Oral
Italy	Industria Italiana Integratori Trei S.P.A. Via Affarosa, 4 42010 — Rio Saliceto Italy	BETAMICYN	Amoxicillin trihydrate Colistin sulphate	100 g/kg 600 MIU/kg	Premix for medicated feeding stuff	Pigs	Oral
Italy	Doxal Italia S.p.a. largo Donegani 2 20121 — Milano Italy	CLOVER BMP	Amoxicillin trihydrate Colistin sulphate	115 g/kg 40 g/kg	Premix for medicated feeding stuff	Pigs	Oral
Italy	Industria Italiana Integratori Trei S.P.A. Via Affarosa, 4 42010 — Rio Saliceto Italy	DUOBAN	Doxycycline hyclate Colistin sulphate	60 mg/g 1 200 000 UI/g	Premix for medicated feeding stuff	Pigs, rabbits	Oral
Italy	Virbac S.r.l. Via Caldera 21 20153 Milano Italy	DUALMIX	Amoxicillin trihydrate Colistin sulphate	115 mg/g 4 mg/g (20 000 UI/mg)	Premix for medicated feeding stuff	Pigs, chickens (except hens producing eggs for human consumption)	Oral
Italy	Fatro S.p.a. Via Emilia, 285 40064 Ozzano Emilia Italy	BACOLAM	Amoxicillin trihydrate Colistin sulphate	500 mg/g 2 500 000 IU/g	Powder for oral solution	Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens)	Oral
Italy	Intervet Productions S.r.l. Via Nettunense, km 20,300 04011 — Aprilia Italy	NADASIN	Amoxicillin trihydrate Colistin sulphate	500 mg/g 200 mg/g	Oral powder for use in drinking water or liquid feed	Calves, pigs, chickens (other than laying hens), turkeys	Oral
Italy	Vetoquinol Italia S.r.l. Via Piana, 265 47032 Bertinoro Italy	NEOMIX COMPLEX	Neomycin sulfate Colistin sulphate	200 mg/g 20 000 IU/g	Oral powder, for use in drinking water or liquid feed	Calves, piglets, broilers and turkeys	Oral
Italy	Vétoquinol Italia S.r.l. Via Piana 265 47032 Bertinoro Italy	ZEMAMIX	Amoxicillin trihydrate Colistin sulphate	100 mg/g 40 mg/g	Oral powder	Pigs	Oral use
Italy	Virbac S.r.l. Via Caldera 21 20153 Milano Italy	STABOX COLI	Amoxicillin trihydrate Colistin sulphate	100 mg/g 800 000 IU/g	Premix for medicated feeding	Pigs, chickens (except hens producing eggs for human consumption)	Oral
Latvia	Ceva Santé Animale 10 Avenue de la Ballastière 33500 Libourne France	Quinocol Oral Solution	Enrofloxacin Colistin sulphate	100 g 41,67 g	Solution for oral use	Chicken, turkeys	Oral use
Lithuania	Lavet Pharmaceuticals Ltd Ottó u. 14. H-1161 Budapest Hungary	AMOXYCOL, geriamieji milteliai	Amoxicillin trihydrate Colistin sulphate	640 mg/ml 3 200 000 IU/ml	Water soluble oral solution	Pig, chicken	Oral
Lithuania	COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS Cedex France	COLISULTRIX, geriamieji milteliai	Trimethoprim Colistin sulphate	3,75 g/100 g 50 MIU/100 g	Oral powder	Calves, lamb, kid, piglets, poultry and rabbits	Oral
Lithuania	COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS Cedex France	BELCOSPIRA ORAL, geriamieji milteliai	Spiramycin adipate Colistin sulphate	65 MIU/100 g 50 MIU/100 g	Oral powder	Calves, lamb, kid, foals, piglets, poultry and rabbits.	Oral
Luxembourg	VETOQUINOL Magny Vernois 70200 Lure France	COLIDIARYL	Erythromycin estolate Colistin sulphate	83 400 UI/g 16 600 UI/g	Powder for oral use	Lamb, goat, piglets, foals, calves	Oral use
Luxembourg	VETOQUINOL Magny Vernois 70200 Lure France	SEPTOTRYL-COLISTINE	Colistin sulphate Sulfamethoxypyridazine	2 MIU/tablet 1 g/tablet	Tablet	Lamb, dogs, foals, calves	Oral use
Netherlands	Dopharma B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands	AMOXY-COL WSP	Amoxicillin trihydrate Colistin sulphate	150 mg/g 500 000 IU/g	Powder for oral use via drinking water	Pigs	Oral, via drinking water
Poland	Dopharma B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands	Amoxy-col WSP	Amoxicillin trihydrate Colistin sulphate	150 mg/g 500 000 IU/g	Powder for oral solution	Pigs	Oral use
Poland	Fatro S.p.A. Via Emilia 285-40064 Ozzano Emilia Italy	Bacolam	Amoxicillin trihydrate Colistin sulphate	100 mg/g 500 000 IU/g	Powder for administration in drinking water or milk	Cattle, chickens, pigs	Oral use
Poland	SkanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno Poland	Colamox 3200/640	Amoxicillin trihydrate Colistin sulphate	640 mg/g 3 200 000 IU/g	Powder for oral solution	Chicken, pigs	Oral use
Poland	Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A ul. Grójecka 6 05-651 Drwalew Poland	Spiracol AD	Spiramycin adipate Colistin sulphate	100 000 IU/g 130 000 IU/g	Powder for use in drinking water	Cattle, chickens, pigs	Oral use
Portugal	DIVASA FARMAVIC DE PORTUGAL Produtos e Equipamentos Veterinários, Lda. Praceta Jaime Cortesão, No 1 — R/C Loja Esq. 2625-170 Póvoa de Santa Iria Portugal	NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros	Ampicillin trihydrate Colistin sulphate	0,7 g 1 500 000 IU	Powder for oral suspension for administration in drinking water	Calves and lambs	Oral
Portugal	VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A. Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal	COLIMIX (116 g/kg/40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos	Amoxicillin trihydrate Colistin sulphate	116 g/kg 40 g/kg	Premix for medicated feeding stuff	Pigs	Oral
Portugal	Fatro S.p.A Via Emilia No 285 Ozzano Emilia Italy	Premaxol, 100 mg/g + 40 mg/g de pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras)	Amoxicillin trihydrate Colistin sulphate	100 mg/g 40 mg/g	Premix for medicated feeding stuff	Pigs and chickens (except laying)	Oral
Romania	Industria Italiana Integratori Trei S.p.A Viale Corassori, 62 41100 Modena Italy	DUOBAN	Doxycycline hyclate Colistin sulphate	60 mg/g 1 200 000 IU/g	Premix	Pigs	Mixed in feeding stuffs
Romania	Industria Italiana Integratori Trei S.p.A Viale Corassori, 62 41100 Modena Italy	MICROAMOX COLI	Amoxicillin trihydrate Colistin sulphate	100 mg/g 600 000 IU/g	Premix	Pigs	Mixed in feeding stuffs
Romania	COOPHAVET SAS Herblon 44150 Ancenis France	COLISULTRIX	Trimethoprim Colistin sulphate	37,5 mg 500 000 IU	Powder for oral solution	Calves, lambs, kids, pigs, rabbits and poultry	Oral administration in drinking water or liquid feed
Romania	SC ROMVAC COMPANY SA Sos. Centurii nr.7 077194 Voluntari Romania	GALIPROTECT C	Oxytetracycline hydrochloride Colistin sulphate	12 mg/tablet 5 mg/tablet	Tablets	Poultry (grouse and web-footed)	Oral administration individually
Romania	Lavet Pharmecuticals LTD. Otto u.14. H-1161 Budapest Hungary	AMOXYCOL	Amoxicillin trihydrate Colistin sulphate	640 mg/g 3 200 000 IU/g	Powder for oral solution	Pigs, chickens	Oral administration in drinking water
Slovakia	Pharmagal spol. s.r.o. Murgašova 5 949 01 Nitra Slovakia	Amikol perorálny prášok	Amoxicillin trihydrate Colistin sulphate	57,5 mg/g 8,1 mg/g	Oral powder	Pig, calves, poultry (chicken, turkey), pigeon	Oral administration, after incorporation into the feed
Slovakia	Pharmagal spol. s.r.o. Murgašova 5 949 01 Nitra Slovakia	Amikol premix na medikáciu krmiva	Amoxicillin trihydrate Colistin sulphate	57,5 mg/g 200 000 IU/g	Premix for medicated feeding stuff	Pig	Oral administration, after incorporation into the feed
Slovakia	Pharmagal spol. s.r.o. Murgašova 5 949 01 Nitra Slovakia	Amikol-S prášok na perorálny roztok	Amoxicillin trihydrate Colistin sulphate	575 mg/g 81 mg/g	Powder for oral solution	Pig, calves, poultry (chicken, turkey), pigeon	Oral administration via drinking water
Slovakia	Pharmagal spol. s.r.o. Murgašova 5 949 01 Nitra Slovakia	SUTRICOL prášok na perorálny roztok	Colistin sulphate Sulfadimidine sodium Trimethoprim	300 000 IU/g 50 mg/g 12,5 mg/g	Powder for oral solution	Broiler chicken, pig, rabbit, calve	Oral administration via drinking water
Slovakia	Pharmagal spol. s.r.o. Murgašova 5 949 01 Nitra Slovakia	TETRAKOL prášok na perorálny roztok	Chlortetracycline hydrochloride Colistin sulphate	120 mg/g 120 000 IU/g	Powder for oral solution	Pig, calves, poultry (chicken)	Oral administration via drinking water
Spain	CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona) 43205 Spain	TRISOL	Ampicillin trihydrate Colistin sulphate	200 mg/g 1 025 000 IU/g	Oral powder	Lambs	In drinking water use
Spain	LABORATORIOS MAYMO, S.A. Via Augusta, 302. Barcelona 08017 Spain	COLIPHUR 100 000 /1 200 000 UI/ml solución para administración en agua de bebida	Neomycin sulfate Colistin sulphate	100 000 IU/ml 1 200 000 IU/ml	Solution for use in drinking water	Pig for fattening	In drinking water use

		ISSN 1977-091X
Official Journal of the European Union		C 312

English edition	Information and Notices	Volume 59 26 August 2016

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2016/C 312/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)	1
2016/C 312/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)	10

	Corrigenda
2016/C 312/03	Corrigendum to Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016 ( OJ C 154, 29.4.2016 )	22