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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

OJ C 386, 31.10.2014, p. 14–135 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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Official Journal

31.10.2014

Official Journal of the European Union

C 386/14

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014

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

2014/C 386/03

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision	Name(s) of the medicinal product	INN (International Non-Proprietary Name)	Holder(s) of the marketing authorisation	Member State concerned	Date of notification
1.9.2014	Domperidone	See Annex I	See Annex I	See Annex I	2.9.2014
4.9.2014	Diacerein	See Annex II	See Annex II	See Annex II	8.9.2014
18.9.2014	Anagrelide	anagrelide	Not applicable	Not applicable	19.9.2014
30.9.2014	Emergency contraceptives — levonorgestrel	See Annex III	See Annex III	See Annex III	1.10.2014
1.9.2014	Baytril (Art. 34)	See Annex IV	See Annex IV	See Annex IV	2.9.2014
1.9.2014	Baytril (Art. 35)	See Annex V	See Annex V	See Annex V	2.9.2014

— Revocation of a national marketing authorisation

Date of the decision	Name(s) of the medicinal product	INN (International Non-Proprietary Name)	Holder(s) of the marketing authorisation	Member State concerned	Date of notification
1.9.2014	Domperidone	See Annex I	See Annex I	See Annex I	2.9.2014

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

ANNEX I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States

Member State (in EEA)	Marketing authorisation holder	INN	Invented name	Strength	Pharmaceutical form	Route of administration
Austria	Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria	Domperidone	Motilium 10 mg — Filmtabletten	10 mg	film-coated tablet	oral use
Austria	Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria	Domperidone	Motilium 1 mg/ml — Suspension zum Einnehmen	1 mg/ml	oral suspension	oral use
Austria	Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria	Domperidone	Motilium 10 mg — Zäpfchen	10 mg	suppository	rectal use
Austria	Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria	Domperidone	Motilium 30 mg — Zäpfchen	30 mg	suppository	rectal use
Austria	Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria	Domperidone	Motilium 60 mg — Zäpfchen	60 mg	suppository	rectal use
Belgium	Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium	Domperidone maleate	Domperidon teva	10 mg	film-coated tablet	oral use
Belgium	Eurogenerics N.V. Heizel Esplanade b22 1020 Brussels Belgium	Domperidone maleate	Domperidone EG	10 mg	tablet	oral use
Belgium	Eurogenerics N.V. Heizel Esplanade b22 1020 Brussels Belgium	Domperidone	Domperidone instant EG	10 mg	orodispersible tablet	oral use
Belgium	Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium	Domperidone maleate	Domperidone mylan	10 mg	film-coated tablet	oral use
Belgium	Apotex NV Av Etienne Demunter 5/8 1090 Brussels Belgium	Domperidone maleate	Domperitop	10 mg	film-coated tablet	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone maleate	Motilium	1 mg/ml	oral suspension	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone maleate	Motilium	10 mg	film-coated tablet	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium	10 mg	suppository	rectal use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium	10 mg	effervescent granules	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium	10 mg	film-coated tablet	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium	1 mg/ml	oral suspension	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium	30 mg	suppository	rectal use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium	60 mg	suppository	rectal use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium instant	10 mg	orodispersible tablet	oral use
Belgium	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	Oroperidys	10 mg	orodispersible tablet	oral use
Belgium	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Cinnarizine/ Domperidone maleate	Touristil	20 mg/ 19 mg	tablet	oral use
Belgium	Kela Pharma nv Industriepark 68 9100 Sint-Niklaas Belgium	Domperidone maleate	Zilium	10 mg	tablet	oral use
Bulgaria	Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia	Domperidone	Motilium	10 mg	film-coated tablet	oral use
Bulgaria	Medochemie Ltd. 1-10 Astronafton Str.+ Limassol 3505 Cyprus	Domperidone	Costi	10 mg	tablet	oral use
Cyprus	MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus	Domperidone	COSTI TABLETS 10 MG	10 mg	tablet	oral use
Cyprus	Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium	Domperidone	MOTILIUM ORAL SUSPENSION 1 MG/ML	1 mg/ml	oral suspension	oral use
Cyprus	Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium	Domperidone	MOTILIUM SUPPOSITORY 30 MG	30 mg	suppository	rectal use
Cyprus	Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium	Domperidone	MOTILIUM TABLETS 10 MG	10 mg	tablet	oral use
Cyprus	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	OROPERIDYS ORODISPERSIBLE TABLETS 10 MG	10 mg	orodispersible tablet	oral use
Cyprus	REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus	Domperidone	PEPTOMET FILM COATED TABLETS 10 MG	10 mg	tablet	oral use
Czech Republic	Janssen-Cilag s.r.o. Karla Engliše 3201/6 150 00 Praha 5 — Smíchov Czech Republic	Domperidone	Motilium	10 mg	film-coated tablet	oral use
Czech Republic	Pierre Fabre Médicament 45 Place Abel Gance 92654 Boulogne Cedex France	Domperidone	Oroperidys 10 mg	10 mg	orodispersible tablet	oral use
Denmark	Janssen-Cilag (TIBOTEC) Hammerbakken 19 3460 Birkeroed Denmark	Domperidone	Motilium	10 mg	film-coated tablet	oral use
Denmark	Janssen-Cilag (TIBOTEC) Hammerbakken 19 3460 Birkeroed Denmark	Domperidone	Motilium	30 mg	suppository	rectal use
Denmark	Alternova A/S Lodhusvej 11 4230 Skaelskoer Denmark	Domperidone	Domperidon ‘Alternova’	10 mg	tablet	oral use
Estonia	Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Domperidone	Domperidon Actavis	10 mg	tablet	oral use
Estonia	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	Oroperidys 10 mg	10 mg	orodispersible tablet	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	BIPERIDYS 20 mg, comprimé pelliculé sécable	20 mg	film-coated tablet	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	BIPERIDYSFLASH 20 mg, comprimé orodispersible	20 mg	orodispersible tablet	oral use
France	ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France	Domperidone	DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France	Domperidone	DOMPERIDONE ALMUS 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE	Domperidone	DOMPERIDONE ALTER 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France	Domperidone	DOMPERIDONE ARROW 1 mg/ml, suspension buvable	1 mg/ml	oral suspension	oral use
France	ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France	Domperidone	DOMPERIDONE ARROW 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France	Domperidone	DOMPERIDONE ARROW 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France	Domperidone	DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France	Domperidone	DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France	Domperidone	DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France	Domperidone	DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	CRISTERS 22 quai Gallieni 92150 Suresnes France	Domperidone	DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France	Domperidone	DOMPERIDONE EG 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France	Domperidone	DOMPERIDONE EG 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France	Domperidone	DOMPERIDONE EG 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France	Domperidone	DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	SUBSTIPHARM 8, rue Bellini 75116 Paris France	Domperidone	DOMPERIDONE GERDA 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France	Domperidone	DOMPERIDONE MYLAN 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France	Domperidone	DOMPERIDONE MYLAN 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France	Domperidone	DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable	20 mg	film-coated tablet	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France	Domperidone	DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany	Domperidone	DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany	Domperidone	DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux France	Domperidone	DOMPERIDONE RPG 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France	Domperidone	DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France	Domperidone	DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France	Domperidone	DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France	Domperidone	DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France	Domperidone	DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable	20 mg	film-coated tablet	oral use
France	TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France	Domperidone	DOMPERIDONE TEVA 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France	Domperidone	DOMPERIDONE TEVA 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France	Domperidone	DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable	20 mg	film-coated tablet	oral use
France	Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris France	Domperidone	DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris France	Domperidone	DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris France	Domperidone	DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable.	20 mg	film-coated tablet	oral use
France	ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers 92000 Nanterre France	Domperidone	DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	Janssen-Cilag 1, rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 France	Domperidone	MOTILIUM 1 mg/ml, suspension buvable	1 mg/ml	oral suspension	oral use
France	Janssen-Cilag 1, rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 France	Domperidone	MOTILIUM 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
France	Janssen-Cilag 1, rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 France	Domperidone	MOTILIUM 10 mg, granulés effervescents en sachet-dose	10 mg	effervescent granules	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	OROPERIDYS 10 mg, comprimé orodispersible	10 mg	orodispersible tablet	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	PERIDYS 1 mg/ml, suspension buvable	1 mg/ml	oral suspension	oral use
France	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	PERIDYS 10 mg, comprimé pelliculé	10 mg	film-coated tablet	oral use
Germany	1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany	Domperidonemaleat	Domperidon — 1 A Pharma 10 mg Tabletten	12,72 mg	tablet	oral use
Germany	AbZ Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany	Domperidonemaleat	Domperidon-CT 10 mg Filmtabletten	12,73 mg	film-coated tablet	oral use
Germany	AbZ Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany	Domperidonemaleat	Domperidon AbZ 10 mg Filmtabletten	12,73 mg	film-coated tablet	oral use
Germany	Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex United Kingdom	Domperidonemaleat	Domperidon Accord 10 mg Tabletten	12,72 mg	tablet	oral use
Germany	ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany	Domperidonemaleat	Domperidon AL 10 mg Tabletten	12,72 mg	tablet	oral use
Germany	Betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany	Domperidonemaleat	Domperidon beta 10 mg Tabletten	12,72 mg	tablet	oral use
Germany	HEXAL AG Industriestr. 25 83607 Holzkirchen Germany	Domperidonemaleat	Domperidom Hexal 10 mg Tabletten	12,72 mg	tablet	oral use
Germany	RATIOPHARM GmbH Graf Arco Strasse 3 89079 Ulm Germany	Domperidonemaleat	Domperidon-ratiopharm 10 mg Filmtabletten	12,73 mg	film-coated tablet	oral use
Germany	Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany	Domperidonemaleat	Domperidon STADA 10 mg Tabletten	12,72 mg	tablet	oral use
Germany	Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany	Domperidone	Motilium Tropfen	10 mg	oral drops, suspension	oral use
Germany	Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany	Domperidone	Motilium	10 mg	tablet	oral use
Germany	TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany	Domperidonemaleat	Domperidon-TEVA 10 mg Filmtabletten	12,73 mg	film-coated tablet	oral use
Germany	TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany	Domperidonemaleat	Domidon 10 mg Filmtabletten	12,73 mg	film-coated tablet	oral use
Greece	JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA Epidarvou 4 & Aigialeias Maroussi 15125 Athens, Greece	Domperidone	CILROTON	10 mg	film-coated tablet	oral use
Greece	JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA Epidarvou 4 & Aigialeias Maroussi 15125 Athens, Greece	Domperidone	CILROTON	5 mg/5 ml	oral solution	oral use
Greece	PIERRE FABRE MEDICINES SA Messogeion 350, Agia Paraskevi 15341 Athens, Greece	Domperidone	OROPERIDYS	10 mg	orodispersible tablet	oral use
Hungary	Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary	Domperidone	Domperidon-EP 10 mg tabletta	10 mg	tablet	oral use
Hungary	Janssen-Cilag Kft. Tó park H-2045 Törökbálint Hungary	Domperidone	Motilium 10 mg filmtabletta	10 mg	film-coated tablet	oral use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium Fastmelts 10 mg Tablets	10 mg	tablet	oral use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium 10 mg Film-Coated Tablets	10 mg	tablet	oral use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium 10 mg Suppositories	10 mg	suppository	rectal use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium 30 mg Suppositories	30 mg	suppository	rectal use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium 60 mg Suppositories	60 mg	suppository	rectal use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium 1 mg/ml Oral Suspension	1 mg/ml	oral suspension	oral use
Ireland	McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland	Domperidone	Motilium Rx 10 mg Film-coated Tablets	10 mg	film-coated tablet	oral use
Ireland	Rowex Ltd Bantry Co Cork Ireland	Domperidone	DOMERID 10 mg Tablets.	10 mg	tablet	oral use
Ireland	Rowex Ltd Bantry Co Cork Ireland	Domperidone	Domerid Relief 10 mg Tablets.	10 mg	tablet	oral use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	10 mg	film-coated tablet	oral use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	60 mg	suppository	rectal use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	30 mg	suppository	rectal use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	10 mg	effervescent granules	oral use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	1 mg/ml	suspension	oral use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	20 mg	film-coated tablet	oral use
Italy	ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy	Domperidone	PERIDON	20 mg	effervescent granules	oral use
Italy	Janssen-Cilag SpA Via Michelangelo buonarroti 23 20093 Cologno Monzese — Milano Italy	Domperidone	MOTILIUM	1 mg/ml	suspension	oral use
Italy	Janssen-Cilag SpA Via Michelangelo buonarroti 23 20093 Cologno Monzese — Milano Italy	Domperidone	MOTILIUM	10 mg	film-coated tablet	oral use
Italy	Janssen-Cilag SpA Via Michelangelo buonarroti 23 20093 Cologno Monzese — Milano Italy	Domperidone	MOTILIUM	10 mg	effervescent granules	oral use
Italy	DR. REDDY'S S.R.L. Via Fernanda Wittgens 3 — 20123 Milano Italy	Domperidone	DOMPERIDONE DR. REDDY'S	10 mg	tablet	oral use
Italy	DR. REDDY'S S.R.L. Via Fernanda Wittgens 3 — 20123 Milano Italy	Domperidone	DOMPERIDONE DR. REDDY'S	100 mg/100 ml	syrup	oral use
Italy	GIULIANI S.P.A Via Palagi 2 20129 Milano Italy	Domperidone	DIGESTIVO GIULIANI	5 mg	effervescent granules	oral use
Italy	GIULIANI S.P.A Via Palagi 2 20129 Milano Italy	Domperidone	DIGESTIVO GIULIANI	5 mg	chewable tablet	oral use
Italy	GIULIANI S.P.A Via Palagi 2 20129 Milano Italy	Domperidone	DIGESTIVO GIULIANI	10 mg	film-coated tablet	oral use
Italy	TEVA ITALIA S.R.L. Via Messina 38 20154 Milano Italy	Domperidone	DOMPERIDONE TEVA	10 mg	film-coated tablet	oral use
Italy	GERMED PHARMA SpA Via Cantù 11 20092 Cinisello Balsamo — Milano — Italy	Domperidone	DOMPERIDONE GERMED	10 mg	film-coated tablet	oral use
Italy	GERMED PHARMA SpA Via Cantù 11 20092 Cinisello Balsamo — Milano — Italy	Domperidone	DOMPERIDONE GERMED	10 mg/10 ml	suspension	oral use
Italy	ABC FARMACEUTICI SpA, Corso Vittorio Emanuele II 72, 10121 Torino Italy	Domperidone	DOMPERIDONE ABC	10 mg	tablet	oral use
Italy	MYLAN SpA Via Vittor Pisani 20 20124 Milano Italy	Domperidone	DOMPERIDONE MYLAN GENERICS	10 mg	tablet	oral use
Italy	FG S.R.L. Via San Rocco 6 - 85033 Episcopia Potenza Italy	Domperidone	DOMPERIDONE FG	10 mg	tablet	oral use
Italy	EG SpA Via Domenico Scarlatti 31 20124 Milano Italy	Domperidone	DOMPERIDONE EG	10 mg	tablet	oral use
Italy	LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy	Domperidone	DOMPERIDONE ALTER	10 mg	tablet	oral use
Italy	CRINOS SpA Via Pavia 6 20136 Milano Italy	Domperidone	RIGES	10 mg	tablet	oral use
Italy	SANDOZ SpA Largo Umberto Boccioni 1 21040 Origgio — Varese Italy	Domperidone	PYNINAT	10 mg	tablet	oral use
Italy	DOC GENERICI S.R.L. Via Manunzio 7 20124 Milano Italy	Domperidone	DOMPERIDONE DOC GENERICI	10 mg	tablet	oral use
Italy	ALMUS S.R.L. Via Cesarea 11/10 16121 Genova Italy	Domperidone	DOMPERIDONE ALMUS	10 mg	tablet	oral use
Italy	FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy	Domperidone	DALIA	10 mg	effervescent tablet	oral use
Italy	SANDOZ SpA Largo Umberto Boccioni 1 21040 Origgio — Varese Italy	Domperidone	DOMPERIDONE SANDOZ	10 mg	tablet	oral use
Italy	PENSA PHARMA SpA Via Ippolito Rossellini 12 20124 Milano Italy	Domperidone	DOMPERIDONE PENSA	10 mg	effervescent tablet	oral use
Italy	FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy	Domperidone	GERDI	5 mg	effervescent tablet	oral use
Italy	FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy	Domperidone	GERDI	5 mg	effervescent granules	oral use
Italy	CRINOS SpA Via Pavia 6 20136 Milano Italy	Domperidone	RAXAR	10 mg	orodispersible tablet	oral use
Italy	PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano Italy	Domperidone	NEOPERIDYS	10 mg	orodispersible tablet	oral use
Italy	SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano Italy	Domperidone Maleato	PERMOTIL	10 mg	tablet	oral use
Italy	ANGENERICO S.p.a. Via Nocera Umbra 75, 00181 Roma Italy	Domperidone Maleato	DOMPERIDONE ANGENERICO	10 mg	tablet	oral use
Latvia	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	Oroperidys 10 mg orodispersible tablets	10 mg	orodispersible tablet	oral use
Latvia	UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania	Domperidone	Motilium 10 mg film-coated tablets	10 mg	film-coated tablet	oral use
Latvia	Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Domperidone	Domperidon Actavis 10 mg tablets	10 mg	tablet	oral use
Lithuania	Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Domperidone	Domperidon Actavis	10 mg	tablet	oral use
Lithuania	Torrent Pharma GmbH Sudwestpark 50 Nurnberg D-90449 Germany	Domperidone	Domstal	10 mg	tablet	oral use
Lithuania	UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania	Domperidone	Motilium	10 mg	film-coated tablet	oral use
Lithuania	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	Oroperidys	10 mg	orodispersible tablet	oral use
Luxembourg	Eurogenerics SA esplanade heysel b22 1020 bruxelles Belgium	Domperidone (maleate)	Domperidone EG-10	10 mg	tablet	oral use
Luxembourg	Eurogenerics SA esplanade heysel b22 1020 bruxelles Belgium	Domperidone	Domperidone EG-10	10 mg	orodispersible tablet	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium Domperidone Base	10 mg	coated tablet	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium Instant-10	10 mg	orodispersible tablet	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone (maleate)	Motilium-10	10 mg	coated tablet	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium pediatrie	1 mg/ml	oral suspension	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium-1 mg/ml	1 mg/ml	oral suspension	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium-10 supp	10 mg	suppository	rectal use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium-30 supp	30 mg	suppository	rectal use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Domperidone	Motilium-60 supp	60 mg	suppository	rectal use
Luxembourg	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	Oroperidys	10 mg	orodispersible tablet	oral use
Luxembourg	Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium	Cinnarizine/Domperidone (maleate)	Touristil	20 mg/ 15 mg	tablet	oral use
Malta	Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Domperidone	Domperidon Actavis	10 mg	tablet	oral use
Malta	Medochemie Limited PO Box 51409 Limassol CY-3505 Cyprus	Domperidone	Costi 10 mg Film coated tablets	10 mg	film-coated tablet	oral use
Malta	Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium	Domperidone	motilium 1 mg/ml oral suspension	1 mg/ml	oral suspension	oral use
Malta	Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium	Domperidone	motilium 10 mg film coated tablets	10 mg	film-coated tablet	oral use
Malta	Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium	Domperidone	motilium 30 mg Suppositories	30 mg	suppository	rectal use
Poland	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	Domperidone	Oroperidys	10 mg	orodispersible tablet	oral use
Portugal	Laboratório Medinfar — Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova 2700-547 Amadora Portugal	Domperidone	Cinet	10 mg	tablet	oral use
Portugal	Laboratório Medinfar — Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova 2700-547 Amadora Portugal	Domperidone	Cinet	10 mg	dispersible tablet	oral use
Portugal	Laboratório Medinfar — Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova 2700-547 Amadora Portugal	Domperidone	Cinet	1 mg/ml	oral suspension	oral use
Portugal	Actavis A/S Sucursal Rua Virgílio Correia, 11 — A 1600-219 Lisboa Portugal	Domperidone	Domperidona Actavis	10 mg	tablet	oral use
Portugal	Baldacci — Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal	Domperidone	Domperidona Baldacci	10 mg	film-coated tablet	oral use
Portugal	Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal	Domperidone	Domperidona Ciclum	10 mg	tablet	oral use
Portugal	GP — Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 — Venda Nova 2700-451 Amadora Portugal	Domperidone	Domperidona GP	10 mg	tablet	oral use
Portugal	Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal	Domperidone	Domperidona Generis	10 mg	film-coated tablet	oral use
Portugal	Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto 2790-012 Portela de Carnaxide Portugal	Domperidone	Domperidona Germed	10 mg	film-coated tablet	oral use
Portugal	Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal	Domperidone	Domperidona Labesfal	10 mg	tablet	oral use
Portugal	Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4 1990-095 Lisboa Portugal	Domperidone	Domperidona Mylan	10 mg	film-coated tablet	oral use
Portugal	Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal	Domperidone	Domperidona Ratiopharm	10 mg	film-coated tablet	oral use
Portugal	ToLife — Produtos Farmacêuticos, S.A. Avenida do Forte, 3 — Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal	Domperidone	Domperidona ToLife	10 mg	tablet	oral use
Portugal	Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras 1070-274 Lisboa Portugal	Domperidone	Domperidona Wynn	10 mg	tablet	oral use
Portugal	Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal	Domperidone	Motilium	1 mg/ml	oral suspension	oral use
Portugal	Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal	Domperidone	Motilium	10 mg	film-coated tablet	oral use
Portugal	Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal	Domperidone	Motilium	10 mg	effervescent granules	oral use
Portugal	Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal	Domperidone	Motilium Rapid	10 mg	orodispersible tablet	oral use
Portugal	Laboratórios Azevedos — Indústria Farmacêutica, S.A. Edifícios Azevedos — Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal	Domperidone	Remotil	10 mg	tablet	oral use
Romania	S.C. TERAPIA S.A. Str. Fabricii nr. 124, Cluj Napoca, Romania	DOMPERIDONE	MOTILIUM 10 mg	10 mg	film-coated tablet	oral use
Romania	Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France	DOMPERIDONE	OROPERIDYS 10 mg	10 mg	orodispersible tablet	oral use
Slovak Republic	Pierre Fabre Médicament 45 Place Abel Gance 92654 Boulogne Cedex France	Domperidone	OROPERIDYS 10 mg	10 mg	tablet	oral use
Slovak Republic	Medochemie Ltd. 1-10 Constantinoupoleos St. P.O. Box: 51409 3505 Limassol Cyprus	Domperidone	COSTI	10 mg	tablet	oral use
Slovenia	KRKA, tovarna zdravil, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia	Domperidone	Tametil 10 mg filmsko obložene tablete	10 mg	film-coated tablet	oral use
Spain	LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain	Domperidone	Motilium 30 mg supositorios niños	30 mg	suppository	rectal use
Spain	LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain	Domperidone	Motilium 10 mg comprimidos recubiertos con película	10 mg	film-coated tablet	oral use
Spain	LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain	Domperidone	Motilium 1 mg/ml suspensión oral	1 mg/ml	oral suspension	oral use
Spain	Janssen-Cilag, S.A. Po de Las Doce Estrellas, 5-7 28042 Madrid Spain	Domperidone	Nauzelin 1 mg/ml suspensión oral	1 mg/ml	oral suspension	oral use
Spain	Janssen-Cilag, S.A. Po de Las Doce Estrellas, 5-7 28042 Madrid Spain	Domperidone	Nauzelin 10 mg comprimidos recubiertos con película	10 mg	film-coated tablet	oral use
Spain	ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain	Domperidone	Domperidona Gamir 10 mg cápsulas duras	10 mg	capsule, hard	oral use
Spain	ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain	Domperidone	Domperidona Gamir 1 mg/ml suspensión oral	1 mg/ml	oral suspension	oral use
Spain	PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos Valencia 46015 Spain	Domperidone maleate	Domperidona Pensa 10 mg comprimidos EFG	12,72 mg	tablet	oral use
Spain	Pierre Fabre Médicament 45 place Abel Gance F-92100 Boulogne France	Domperidone	Orosperidys 10 mg comprimidos bucodispersables	10 mg	orodispersible tablet	oral use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Motilium filmomhulde tabletten 10 mg	10 mg	film-coated tablet	oral use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Motilium suspensie voor oraal gebruik 1 mg/ml	1 mg/ml	oral suspension	oral use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Motilium zetpillen voor zuigelingen 10 mg	10 mg	suppository	rectal use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Motilium zetpillen voor kinderen 30 mg	30 mg	suppository	rectal use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Motilium zetpillen voor volwassenen 60 mg	60 mg	suppository	rectal use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg	10 mg	suppository	rectal use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon 30 PCH voor kinderen, zetpillen 30 mg	30 mg	suppository	rectal use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon 60 PCH voor volwassenen, zetpillen 60 mg	60 mg	suppository	rectal use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Domperidon JJC filmomhulde tabletten 10 mg	10 mg	film-coated tablet	oral use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Domperidon JJC zetpillen voor volwassenen 60 mg	60 mg	suppository	rectal use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Domperidon JJC zetpillen voor kinderen 30 mg	30 mg	suppository	rectal use
The Netherlands	Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands	Domperidone	Domperidon JJC zetpillen voor zuigelingen 10 mg	10 mg	suppository	rectal use
The Netherlands	Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands	Domperidone	Domperidon 30 mg zetpillen Samenwerkende Apothekers	30 mg	suppository	rectal use
The Netherlands	Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands	Domperidone	Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen	60 mg	suppository	rectal use
The Netherlands	Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands	Domperidone	Domperidon Mylan 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Pharmacin B.V. Molenvliet 103 3335 LH Zwijndrecht The Netherlands	Domperidone	Domperidon Pharmacin 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon 10 PCH, filmomhulde tabletten 10 mg	10 mg	film-coated tablet	oral use
The Netherlands	Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom	Domperidone	Domperidon Accord 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands	Domperidone	Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Leidapharm B.V. Archimedesweg 2 2333 CN Leiden The Netherlands	Domperidone	Domperidon 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany	Domperidone	Domperidon STADA 10 mg tabletten	10 mg	tablet	oral use
The Netherlands	Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands	Domperidone	Domperidon Actavis 10 mg, omhulde tabletten	10 mg	coated tablet	oral use
The Netherlands	Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands	Domperidone	Domperidon CF 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon PCH 10, filmomhulde tabletten 10 mg	10 mg	film-coated tablet	oral use
The Netherlands	Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No7, Hardicker Street M19 2RB Manchester United Kingdom	Domperidone	Domperidon 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Marel B.V. Archimedesweg 2 2333 CN Leiden The Netherlands	Domperidone	Kruidvat Domperidon 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands	Domperidone	Domperidon Sandoz 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Sofar S.p.A. Via Firenze 40 20060 Trezzano Rosa (MI) Italy	Domperidone	Domperidon Sofar 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin Ireland	Domperidone	Domperidon Bellwood 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9o CDE 1600-160 Lissabon Portugal	Domperidone	Domperidon Faribérica 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Actavis Nordic A/S Ornegardsvej 16 2820 Gentofte Denmark	Domperidone	Domperidon Actavis 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht The Netherlands	Domperidone	Domperidon Mdq 10 mg, tabletten	10 mg	tablet	oral use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon 10 mg PCH, tabletten	10 mg	tablet	oral use
The Netherlands	Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands	Domperidone	Domperidon 10 mg tabletten Samenwerkende Apothekers	10 mg	tablet	oral use
The Netherlands	Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands	Domperidone	Domperidon 10 mg Pharmachemie, tabletten	10 mg	tablet	oral use
The Netherlands	KELA Pharma nv Industriepark West 68 9100 Sint-Niklaas Belgium	Domperidone	Domperidon Kela 10 mg, tabletten	10 mg	tablet	oral use
United Kingdom	Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom	Domperidone maleate	Domperidone Tablets 10 mg	10 mg	coated tablet	oral use
United Kingdom	Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom	Domperidone maleate	Motilium 10	10 mg	tablet	oral use
United Kingdom	McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom	Domperidone maleate	Motilium Instants	10 mg	orodispersible tablet	oral use
United Kingdom	Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom	Domperidone	Domperidone 1 mg/ml Oral Suspension	5 mg	oral suspension	oral use
United Kingdom	Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom	Domperidone maleate	Motilium 10 mg Film-coated Tablets	10 mg	film-coated tablet	oral use
United Kingdom	Bristol Laboratories Limited Unit 3, Canalside Northbridge Road, Berkhamsted Hertfordshire HP4 1EG United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	Focus Pharmaceuticals Limited Unit 5, Faraday Court First Avenue, Centrum 100 Burton Upon Trent, Staffordshire DE14 2WX United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	tablet	oral use
United Kingdom	Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	film-coated tablet	oral use
United Kingdom	Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon, Ireland	Domperidone maleate	Domperidone 10 mg Tablets	10 mg	film-coated tablet	oral use

ANNEX II

List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States

Member State (in EEA)	Marketing authorisation holder	Invented name	Strength	Pharmaceutical form	Route of administration
Austria	TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria	ARTROLYT 50 mg Kapseln	50 mg	capsule, hard	oral use
Austria	TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria	VERBORIL 50 mg Kapseln	50 mg	capsule, hard	oral use
Czech Republic	TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria	ARTRODAR	50 mg	capsule, hard	oral use
France	NEGMA 10, rue Paul Dautier 78140 Vélizy Villacoublay France	ART 50 mg, gélule	50 mg	capsule, hard	oral use
France	ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland	DIACEREINE ACTAVIS 50 mg, gélule	50 mg	capsule, hard	oral use
France	ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France	DIACEREINE ARROW 50 mg, gélule	50 mg	capsule, hard	oral use
France	BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France	DIACEREINE BIOGARAN 50 mg, gélule	50 mg	capsule, hard	oral use
France	CRISTERS 22 quai Gallieni 92150 Suresnes France	DIACEREINE CRISTERS 50 mg, gélule	50 mg	capsule, hard	oral use
France	EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France	DIACEREINE EG 50 mg, gélule	50 mg	capsule, hard	oral use
France	EVOLUPHARM rue Irène Caron Zone Industrielle d'Auneuil 60390 Auneuil France	DIACEREINE EVOLUGEN 50 mg, gélule	50 mg	capsule, hard	oral use
France	MAZAL PHARMACEUTIQUE 11, rue Rontgen BP 1309 29103 Quimper France	DIACEREINE MAZAL 50 mg, gélule	50 mg	capsule, hard	oral use
France	MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France	DIACEREINE MYLAN 50 mg, gélule	50 mg	capsule, hard	oral use
France	NEGMA 10, rue Paul Dautier 78140 Vélizy Villacoublay France	DIACEREINE NEGMA 50 mg, gélule	50 mg	capsule, hard	oral use
France	LABORATOIRES PHARMA 2000 10 rue Paul Dautier 78140 Vélizy Villacoublay France	DIACEREINE PHARMA 2000 50 mg, gélule	50 mg	capsule, hard	oral use
France	RANBAXY PHARMACIE GENERIQUES 11-15 Quai de Dion Bouton 92800 Puteaux France	DIACEREINE RANBAXY 50 mg, gélule	50 mg	capsule, hard	oral use
France	TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France	DIACEREINE RATIOPHARM 50 mg, gélule	50 mg	capsule, hard	oral use
France	BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France	DIACEREINE REF 50 mg, gélule	50 mg	capsule, hard	oral use
France	SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France	DIACEREINE SANDOZ 50 mg, gélule	50 mg	capsule, hard	oral use
France	SUBSTIPHARM DEVELOPPEMENT 24, rue Erlanger 75016 Paris FRANCE	DIACEREINE SUBSTIPHARM 50 mg, gélule	50 mg	capsule, hard	oral use
France	TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France	DIACEREINE TEVA 50 mg, gélule	50 mg	capsule, hard	oral use
France	SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France	DIACEREINE ZENTIVA 50 mg, gélule	50 mg	capsule, hard	oral use
France	ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers 92000 Nanterre France	DIACEREINE ZYDUS 50 mg, gélule	50 mg	capsule, hard	oral use
France	MAZAL PHARMACEUTIQUE 11, rue Rontgen BP 1309 29103 Quimper France	MAZART 50 mg, gélule	50 mg	capsule, hard	oral use
France	NIVERPHARM 10 rue Paul Dautier 78140 Vélizy Villacoublay France	ZONDAR 50 mg, gélule	50 mg	capsule, hard	oral use
Greece	ANGELINI PHARMA HELLAS Achaias and Troizinias, Nea Kifissia 14564, Athens Greece	VERBORIL	50 mg	capsule, hard	oral use
Greece	AURORA PHARMACEUTICALS S.A. Evrou 4 and Messinias 2, Gerakas 15344 Greece	ARTHROREIN	50 mg	capsule, hard	oral use
Greece	VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674 Athens Greece	ARTHROFAR	50 mg	capsule, hard	oral use
Greece	RAFARM AEBE korinthou 12, Neo Psychiko, 15451 Greece	IDEALITE	50 mg	capsule, hard	oral use
Greece	HELP ABEE Valaoritou 10, Metamorfosi, Attikis, 14452 Greece	INFLABION	50 mg	capsule, hard	oral use
Greece	BROS EPE Avgis & Gallinis 15, n. Kifissia, 14564 Greece	REUMANISAL	50 mg	capsule, hard	oral use
Greece	FARMEDIA A.E. Athinas 22 & Apollonos Gerakas, Attikis, 15344 Greece	OSTIREIN	50 mg	capsule, hard	oral use
Greece	GENEPHARM A.E. 18th km Marathonos Avenue, Pallini, Attikis, 15351 Greece	MYOBLOC	50 mg	capsule, hard	oral use
Greece	PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS Dilou 9, Peristeri, Attikis, 12134 Greece	DIACEREIN/PROEL	50 mg	capsule, hard	oral use
Greece	NORMA HELLAS A.E. Menandrou 54, Athens, 10431 Greece	DIACEREIN/NORMA	50 mg	capsule, hard	oral use
Greece	S.M. Pharmaceutical Products Ltd, Agiou Orous 43-45 Piraeus 18545 Greece	DESEREIN	50 mg	capsule, hard	oral use
Greece	PROTON PHARMA Achaias 4 and Trizoinias, Nea Kifissia 14564 Greece	DIACERIL	50 mg	capsule, hard	oral use
Italy	ABIOGEN PHARMA S.p.A. Via Meucci 36 56121 Ospedaletto — Pisa Italy	FISIODAR	50 mg	capsule, hard	oral use
Portugal	Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D-2o 1990-090 Lisboa Portugal	Artrolyt	50 mg	capsule, hard	oral use
Slovak Republic	TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria	ARTRODAR	50 mg	capsule, hard	oral use
Spain	ROTTAPHARM S.L. Avda. Diagonal, 67-69 08019 Barcelona ESPAÑA	GLIZOLAN 50 mg cápsulas	50 mg	capsule, hard	Oral use
Spain	NEGMA-LERADS Immeuble Strasbourg Avenue de L'Europe Toussus-le-Noble Magny-les Hameaux Cedex F-78771 France	ARTRIZAN 50 mg cápsulas	50 mg	capsule, hard	Oral use
Spain	LACER S.A. Sardenya, 350 08025 Barcelona Spain	GALAXDAR 50 mg cápsulas	50 mg	capsule, hard	Oral use
Spain	LABORATORIOS NORMON S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain	DIACEREINA NORMON 50 mg cápsulas duras EFG	50 mg	capsule, hard	Oral use
Spain	IBERMEDGEN S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain	DIACEREINA PANLUETOL 50 mg cápsulas duras EFG	50 mg	capsule, hard	Oral use
Spain	MG PHARMA 8, Rue Bellini 75116 Paris France	REINART 50 mg cápsulas duras EFG	50 mg	capsule, hard	Oral use

ANNEX III

List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States

Levonorgestrel-containing emergency contraceptive medicinal products

Member State (in EEA)	Marketing Authorisation Holder	Invented name	Strength	Pharmaceutical Form	Route of administration
Austria	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor 1 500 Mikrogramm-Tablette	1,5 mg	Tablet	Oral use
Austria	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Vikela 750 Mikrogramm- Tabletten	0,75 mg	Tablet	Oral use
Austria	Laboratoire HRA Pharma 15. rue Béranger FR-75003 Paris France	Vikela 1,5 Milligramm-Tablette	1,5 mg	Tablet	Oral use
Austria	Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany	Velafam 1,5 mg Tabletten	1,5 mg	Tablet	Oral use
Austria	Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany	Velafam 750 Mikrogramm Tabletten	0,75 mg	Tablet	Oral use
Belgium	Sandoz N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium	Levodonna	1,5 mg	Tablet	Oral use
Belgium	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Belgium	Laboratoire HRA Pharma 15. rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Belgium	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	1,5 mg	Tablet	Oral use
Belgium	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	0,75 mg	Tablet	Oral use
Bulgaria	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Escapelle	1,5 mg	Tablet	Oral use
Bulgaria	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Ramonna	1,5 mg	Tablet	Oral use
Bulgaria	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Postinor-Duo	0,75 mg	Tablet	Oral use
Bulgaria	Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre, Leon Spain	Etiyone	1,5 mg	Tablet	Oral use
Bulgaria	Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre, Leon Spain	Melkidos	0,75 mg	Tablet	Oral use
Croatia	Arenda d.o.o., Medarska ulica 56b Zagreb 10090 Croatia	Vikela 1,5 mg tableta	1,5 mg	Tablet	Oral use
Croatia	Sandoz d.o.o. Maksimirska 120 Zagreb 10000 Croatia	Escapelle	1,5 mg	Tablet	Oral use
Cyprus	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Cyprus	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Czech Republic	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Escapelle	1,5 mg	Tablet	Oral use
Czech Republic	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Postinor-2	0,75 mg	Tablet	Oral use
Czech Republic	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Ramonna	1,5 mg	Tablet	Oral use
Czech Republic	Egis Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary	Egianti 0,75 mg	0,75 mg	Tablet	Oral use
Czech Republic	Laboratorios León Farma S.A. Calle La Vallina s/n Polígono Industrial Navatejera 24008 — Navatejera — León Spain	Nopregy 1,5 mg tablety	1,5 mg	Tablet	Oral use
Denmark	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Denmark	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Denmark	Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark	Levodonna	1,5 mg	Tablet	Oral use
Estonia	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	RAMONNA	1,5 mg	Tablet	Oral use
Estonia	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	ESCAPELLE	1,5 mg	Tablet	Oral use
Estonia	Orivas UAB J.Jasinskio 16B LT-01112 Vilnius Lithuania	LEVIDON	0,75 mg	Tablet	Oral use
Estonia	Sandoz Pharmaceuticals Verovškova 57 1000 Ljubljana Slovenia	LEVODONNA	1,5 mg	Tablet	Oral use
Estonia	Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	LEVONORGESTREL ACTAVIS	0,75 mg	Tablet	Oral use
Estonia	Orivas UAB J.Jasinskio 16B LT-01112 Vilnius Lithuania	ELISTREL	1,5 mg	Tablet	Oral use
Finland	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Finland	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
France	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	ANTHIA 750 microgrammes, comprimé	0,75 mg	Tablet	Oral use
France	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	LEVONORGESTREL BIOGARAN 1 500 microgrammes, comprimé	1,5 mg	Tablet	Oral use
France	MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France	LEVONORGESTREL MYLAN 1,5 mg, comprimé	1,5 mg	Tablet	Oral use
France	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO 1,5 mg, comprimé	1,5 mg	Tablet	Oral use
France	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO 750 microgrammes, comprimé	0,75 mg	Tablet	Oral use
France	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	VIKELA 1,5 mg, comprimé	1,5 mg	Tablet	Oral use
France	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	VIKELA 750 microgrammes, comprimé	0,75 mg	Tablet	Oral use
Germany	VELVIAN Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany	Navela 0,75 mg Tabletten	0,75 mg	Tablet	Oral use
Germany	VELVIAN Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany	Navela 1,5 mg Tabletten	1,5 mg	Tablet	Oral use
Germany	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	PiDaNa 1,5 mg Tablette	1,5 mg	Tablet	Oral use
Germany	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor 1 500 Mikrogramm Tablette	1,5 mg	Tablet	Oral use
Germany	Hexal Aktiengesellschaft Industriestr. 25 83607 Holzkirchen Germany	unofem HEXAL 1,5 mg Tabletten	1,5 mg	Tablet	Oral use
Germany	Laboratorios Leon Farma, SA Poligono Industrial Navatejera C/La Vallina s/n 24008 Navatejera — Villaquilambre Spain	Etiyone 1 500 Mikrogramm Tabletten	1,5 mg	Tablet	Oral use
Greece	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO	0,75 mg	Tablet	Oral use
Greece	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO	1,5 mg	Tablet	Oral use
Greece	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	POSTINOR	1,5 mg	Tablet	Oral use
Hungary	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Escapelle	1,5 mg	Tablet	Oral use
Hungary	Egis Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary	Empil 0,75 mg tabletta	0,75 mg	Tablet	Oral use
Hungary	Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Helibona	1,5 mg	Tablet	Oral use
Hungary	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Rigesoft	0,75 mg	Tablet	Oral use
Iceland	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Iceland	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Iceland	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	1,5 mg	Tablet	Oral use
Ireland	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Levonelle 1 500 microgram Tablet	1,5 mg	Tablet	Oral use
Ireland	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO 750 micrograms tablet	0,75 mg	Tablet	Oral use
Ireland	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO 1,5 mg tablet	1,5 mg	Tablet	Oral use
Ireland	Laboratorios Leon Farma, S.A. C/Roa de la Vega 15, 1 24008 Leon Spain	Tyedra 1 500 micrograms tablet	1,5 mg	Tablet	Oral use
Italy	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO	0,75 mg	Tablet	Oral use
Italy	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO	1,5 mg	Tablet	Oral use
Italy	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	LONEL	1,5 mg	Tablet	Oral use
Latvia	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Escapelle 1,5 mg tablets	1,5 mg	Tablet	Oral use
Latvia	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Ramonna 1 500micrograms tablets	1,5 mg	Tablet	Oral use
Latvia	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Postinor-Duo 750 micrograms tablets	0,75 mg	Tablet	Oral use
Latvia	UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania	Elistrel 1 500 micrograms tablets	1,5 mg	Tablet	Oral use
Latvia	UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania	Levidon 750 micrograms tablets	0,75 mg	Tablet	Oral use
Latvia	Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Levonorgestrel Actavis 750 micrograms tablets	0,75 mg	Tablet	Oral use
Lithuania	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	ESCAPELLE	1,5 mg	Tablet	Oral use
Lithuania	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	RAMONNA	1,5 mg	Tablet	Oral use
Lithuania	UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania	Elistrel	1,5 mg	Tablet	Oral use
Lithuania	UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania	Levidon	0,75 mg	Tablet	Oral use
Lithuania	UAB Inteli Generics Nord Šeimyniškių 3 LT-09312 Vilnius Lithuania	Avodele	0,75 mg	Tablet	Oral use
Lithuania	UAB Inteli Generics Nord Šeimyniškių 3 LT-09312 Vilnius Lithuania	Avodele	1,5 mg	Tablet	Oral use
Lithuania	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	POSTINOR-DUO	0,75 mg	Tablet	Oral use
Luxembourg	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Luxembourg	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Luxembourg	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	0,75 mg	Tablet	Oral use
Luxembourg	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	1,5 mg	Tablet	Oral use
Norway	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO	0,75 mg	Tablet	Oral use
Norway	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO	1,5 mg	Tablet	Oral use
Norway	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	POSTINOR	1,5 mg	Tablet	Oral use
Norway	Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark	Isteranda	1,5 mg	Tablet	Oral use
Poland	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Escapelle tabletka 1 500 mikrogramów	1,5 mg	Tablet	Oral use
Poland	Gedeon Richter Polska Sp. z o.o. 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland	Ramonna	1,5 mg	Tablet	Oral use
Portugal	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Portugal	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Portugal	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	1,5 mg	Tablet	Oral use
Romania	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	ESCAPELLE	1,5 mg	Tablet	Oral use
Romania	Gedeon Richter Romania S.A. Str. Cuza-Vodă nr. 99-105 Târgu Mureş 540306 Romania	RAMONNA	1,5 mg	Tablet	Oral use
Romania	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	POSTINOR-2 750 micrograme	0,75 mg	Tablet	Oral use
Slovak Republic	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	ESCAPELLE	1,5 mg	Tablet	Oral use
Slovak Republic	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Ramona	1,5 mg	Tablet	Oral use
Slovak Republic	Egis Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary	EGIANTI 0,75 mg tablety	0,75 mg	Tablet	Oral use
Slovak Republic	Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Helibona 1,5 mg	1,5 mg	Tablet	Oral use
Slovenia	Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Hungary	Escapelle 1,5 mg tableta	1,5 mg	Tablet	Oral use
Slovenia	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	NORLEVO 1,5 mg tableta	1,5 mg	Tablet	Oral use
Slovenia	Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Hungary	Ramonna 1,5 mg tableta	1,5 mg	Tablet	Oral use
Spain	CHIESI ESPAÑA, S.A. Plaça d'Europa, 41-43 planta 10 08908 L'Hospitalet de Llobregat (Barcelona) Spain	Norlevo 750 microgramos comprimidos	0,75 mg	Tablet	Oral use
Spain	CHIESI ESPAÑA, S.A. Plaça d'Europa, 41-43 planta 10 08908 L'Hospitalet de Llobregat (Barcelona) Spain	Norlevo 1 500 microgramos comprimido	1,5 mg	Tablet	Oral use
Spain	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor 1 500 microgramos comprimido	1,5 mg	Tablet	Oral use
Spain	Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland	Julirona 1,5 mg comprimido EFG	1,5 mg	Tablet	Oral use
Sweden	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	0,75 mg	Tablet	Oral use
Sweden	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo	1,5 mg	Tablet	Oral use
Sweden	Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark	Levodonna	1,5 mg	Tablet	Oral use
Sweden	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor	1,5 mg	Tablet	Oral use
The Netherlands	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo, tabletten 0,75 mg	0,75 mg	Tablet	Oral use
The Netherlands	Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France	Norlevo 1,5 mg, tabletten	1,5 mg	Tablet	Oral use
The Netherlands	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Postinor 1 500 microgram, tablet	1,5 mg	Tablet	Oral use
The Netherlands	Perryment Ltd 42-46 High street Esher, KT10 9QY Surrey United Kingdom	Vikela, tabletten 750 microgram	0,75 mg	Tablet	Oral use
United Kingdom	Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom	Isteranda 1,5 mg Tablets	1,5 mg	Tablet	Oral use
United Kingdom	Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary	Upostelle 1 500 Microgram Tablets	1,5 mg	Tablet	Oral use
United Kingdom	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Levonelle-2 750 Microgram Tablet	0,75 mg	Tablet	Oral use
United Kingdom	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Levonelle 1 500Microgram Tablet	1,5 mg	Tablet	Oral use
United Kingdom	Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom	Levonelle One Step 1 500 Microgram Tablet/Boots Emergency Contraceptive 1,5 mg Tablet	1,5 mg	Tablet	Oral use
United Kingdom	Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain	Melkine 1,5 mg Tablet	1,5 mg	Tablet	Oral use

ANNEX IV

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

Member State EU/EEA	Marketing authorisation holder	Product name	INN	Strength	Pharmaceutical form	Animal species
Austria	Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria	Baytril 25 mg/ml — Injektionslösung für Tiere	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw)
Austria	Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria	Baytril 50 mg/ml — Injektionslösung für Tiere	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, pigs, calves
Austria	Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria	Baytril 100 mg/ml — Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium	Baytril 2,5 %	Enrofloxacin	25 mg/ml	Solution for injection	Cats, dogs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium	Baytril Piglet	Enrofloxacin	25 mg/ml	Solution for injection	Pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium	Baytril 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium	Baytril 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium	Baytril Swine	Enrofloxacin	100 mg/ml	Solution for injection	Pigs
Bulgaria	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Байтрил 5 % инжективен разтвор	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Cyprus	Bayer Animal Health GmbH D-51368 Leverkusen Germany	BAYTRIL INJECTION 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Czech Republic	BAYER s.r.o. Siemensova 2717/4 155 00 Praha 5 Czech Republic	BAYTRIL 2,5 % (w/v) injekční roztok	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Czech Republic	BAYER s.r.o. Siemensova 2717/4 155 00 Praha 5 Czech Republic	BAYTRIL 5 % (w/v) injekční roztok	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, pigs, calves
Denmark	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril Vet.	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, cats, cattle, poultry, pigs
Denmark	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril Vet.	Enrofloxacin	100 mg/ml	Solution for injection	Dogs, cats, cattle poultry, pigs
Finland	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril 5 % inj.	Enrofloxacin	50 mg/ml	Solution for injection	Cats, dogs, sheep, cattle, pigs, goats
Finland	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril 10 % inj.	Enrofloxacin	100 mg/ml	Solution for injection	Sheep, cattle, pigs, goats
France	Bayer Sante 220 Avenue de la Recherche 59120 Loos France	BAYTRIL 2,5 %	Enrofloxacin	25 mg/ml	Solution for injection	Pigs
France	Bayer Sante 220 Avenue de la Recherche 59120 Loos France	BAYTRIL 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
France	Bayer Sante 220 Avenue de la Recherche 59120 Loos France	BAYTRIL 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany	Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen	Enrofloxacin	25 mg/ml	Solution for injection	Pig, rabbits, dogs, cats
Germany	Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany	Baytril — Das Original — 5 % Injektionslösung	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dogs
Germany	Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany	Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Greece	Bayer Animal Health GmbH D-51368 Leverkusen Germany	BAYTRIL 2,5 % inj.sol	Enrofloxacin	25 mg/ml	Solution for injection	Dogs
Greece	Bayer Animal Health GmbH D-51368 Leverkusen Germany	BAYTRIL 5 % inj.sol	Enrofloxacin	50 mg/ml	Solution for injection	Calves, cattle, pigs, dogs
Hungary	Bayer Hungária Kft. Alkotás u. 50 1123 Budapest Hungary	Baytril 2,5 % injekció A.U.V.	Enrofloxacin	25 mg/ml	Solution for injection	Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles)
Hungary	Bayer Hungária Kft. Alkotás u. 50 1123 Budapest Hungary	Baytril 5 % injekció A.U.V.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Hungary	Bayer Hungária Kft. Alkotás u. 50 1123 Budapest Hungary	Baytril 10 % injekció A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Iceland	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril vet	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, poultry, dogs, cats
Iceland	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril vet	Enrofloxacin	100 mg/ml	Solution for injection	Calves, pigs, poultry, dogs, cats
Ireland	Bayer Limited Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland	Baytril 2,5 % Solution for Injection	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Ireland	Bayer Limited Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland	Baytril 5 % Solution for Injection	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Ireland	Bayer Limited Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland	Baytril 10 % Solution for Injection	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Italy	Bayer S.p.A. Viale Certosa, 130 20156 Milano Italy	Baytril	Enrofloxacin	25 mg/ml and 50 mg/ml	Solution for injection	Cattle, dogs, sheep, goats, cats, rabbits, pigs
Italy	Bayer S.p.A. Viale Certosa, 130 20156 Milano Italy	Baytril 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, sheep, goats
Norway	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril vet	Enrofloxacin	25 mg/ml	Solution for injection	Pigs, cattle, dogs, cats
Norway	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril vet	Enrofloxacin	100 mg/ml	Solution for injection	Pigs, cattle, dogs, cats
Poland	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Poland	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Portugal	Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal	BAYTRIL 2,5 % solução injectável	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Portugal	Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal	Baytril 5 % solução injectável	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, cattle, pigs
Portugal	Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal	Baytril 10 % solução injectável	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	Bayer Health Care AG D-51368 Leverkusen Germany	Baytril 5 %	Enrofloxacin	50 mg/ml	solution for injection	Calves, pigs, dogs
Romania	Bayer Health Care AG D-51368 Leverkusen Germany	Baytril 10 %	Enrofloxacin	100 mg/ml	solution for injection	Cattle, pigs
Slovakia	Bayer s.r.o. Litvínovská 609/3 190 21 Praha 9 Czech Republic	Baytril 2,5 %	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Slovakia	Bayer s.r.o. Litvínovská 609/3 190 21 Praha 9 Czech Republic	Baytril 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, pigs, calves
Slovenia	Bayer d.o.o. Bravničarjeva 13 Ljubljana Slovenia	Baytril® 5 % raztopina za injiciranje	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Slovenia	Bayer d.o.o. Bravničarjeva 13 Ljubljana Slovenia	Baytril® 10 % raztopina za injiciranje	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona Spain	Baytril 2,5 % solución inyectable	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))
Spain	Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona Spain	Baytril 5 % solución inyectable	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, cattle, pigs
Spain	Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona Spain	Baytril 10 % solución inyectable	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Sweden	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril®vet	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, pigs, cattle, cats
Sweden	Bayer Animal Health GmbH D-51368 Leverkusen Germany	Baytril®vet	Enrofloxacin	100 mg/ml	Solution for injection	Dogs, pigs, cattle, cats
The Netherlands	Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands	Baytril Piglet 25 mg/ml inspuitbare oplossing	Enrofloxacin	25 mg/ml	Solution for injection	Pigs
The Netherlands	Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands	BAYTRIL 2,5 % INJEKTIEVLOEISTOF	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
The Netherlands	Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands	BAYTRIL 5 % INJECTIEOPLOSSING	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
The Netherlands	Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands	BAYTRIL 5 % INJEKTIEVLOEISTOF	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
The Netherlands	Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands	BAYTRIL 10 % INJECTIEOPLOSSING	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands	BAYTRIL INJEKTIEVLOEISTOF 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Pigs, cattle
United Kingdom	Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom	Baytril 2,5 % Solution for Injection	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats and exotic animals (small mammals, reptiles and avian species)
United Kingdom	Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom	Baytril 5 % Solution for Injection	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
United Kingdom	Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom	Baytril 10 % Solution for Injection	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs

ANNEX V

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

Member State EU/EEA	Applicant/Marketing Authorisation Holder	Product name	INN	Strength	Pharmaceutical form	Animal species
Austria	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, pigs, rabbits
Austria	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (Calves), pigs, dogs
Austria	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 100, 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Austria	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml Injektionslösung für Tiere	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Austria	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Austria	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	Enrodexil, 100 mg/ml, Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Austria	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Austria	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Austria	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Unisol 100 mg/ml, Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Austria	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Austria	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	BAYTRIL PIGLET	Enrofloxacin	25 mg/ml	Solution for injection	Pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	BAYTRIL 2,5 %	Enrofloxacin	25 mg/ml	Solution for injection	Cats, dogs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	BAYTRIL 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	BAYTRIL SWINE	Enrofloxacin	100 mg/ml	Solution for injection	Pigs
Belgium	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	BAYTRIL 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle
Belgium	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	FENOFLOX 50 MG/ML	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Belgium	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	FENOFLOX 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium	FLOXADIL 50 MG/ML	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Belgium	EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium	FLOXADIL 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 25 MG/ML	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Belgium	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 50 MG/ML	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Belgium	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	ENRODEXIL 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	ROXACIN 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	COLMYC 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	Vandenbussche Farma Service Brusselsesteenweg 396 1980 Eppegem Belgium	FLOXAVET 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Belgium	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	DORAFLOX 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Belgium	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	UNISOL 100 MG/ML	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Bulgaria	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Байтрил 5 % инжективен разтвор	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Bulgaria	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	Ганадексил 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dogs
Bulgaria	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	Роксацин БГ инжективен	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Bulgaria	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	Ценеровиг — 10 ГБ Инж.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, dogs
Bulgaria	Laboratorios Hipra S.A. Avda. La Selva, 135 17170 Amer Girona Spain	Хипралона Енро — И	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Bulgaria	Laboratorios Syva S.A. Parroco Pablo Diez, 49 — 57 24010 Leon Spain	Сиваквинол — 100 Инжекционен разтвор	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Bulgaria	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Кинофлокс 100 mg/ml инжекционен разтвор за говеда и свине	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Bulgaria	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Колмик 100 мг/мл инжекционен разтвор за говеда и свине	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Cyprus	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril 5 %, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Czech Republic	Bayer s.r.o. Siemensova 2717/4 155 00 Praha 5 Czech Republic	BAYTRIL 2,5 % (w/v) injekční roztok Přípravek s indikačním omezením	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Czech Republic	BAYER s.r.o. Siemensova 2717/4 155 00 Praha 5 Czech Republic	BAYTRIL 5 % (w/v) injekční roztok Přípravek s indikačním omezením	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, pigs, calves
Czech Republic	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml injekční roztok pro psy, kočky a exotická zvířata	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats exotic animals (small mammals, reptiles and birds)
Czech Republic	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Czech Republic	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml injekční roztok pro skot a prasata	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Czech Republic	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 50 mg/ml injekční roztok	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, pigs, calves
Czech Republic	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 100 mg/ml injekční roztok	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Czech Republic	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	ROXACIN 100 mg/ml injekční roztok	Enrofloxacin	100 mg/ml	Solution for injection	Pigs and calves
Denmark	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril Vet	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, cattle, poultry, cats, pigs
Denmark	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril Vet	Enrofloxacin	100 mg/ml	Solution for injection	Dogs, cattle, poultry, cats, pigs
Denmark	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, cattle, poultry, cats, pigs
Estonia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Estonia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Estonia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Estonia	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	Ganadexil Enrofloxacina 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dogs
Estonia	Laboratorios Hipra S.A. Avda. La Selva, 135 17170 Amer Girona Spain	Hipralona Enro-I	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Estonia	Vetoquinol Biowet Sp z o.o. 13/14 Kosynierów Gdyńskich St. 66-400 Gorzów Wlkp. Poland	Enrobioflox5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dogs
Finland	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril vet	Enrofloxacin	50 mg/ml	Solution for injection	Cats, dogs, sheep, cattle, pigs, goats
Finland	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox vet	Enrofloxacin	50 mg/ml	Solution for injection	Cats, dogs, cattle, pigs
France	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	ENROCARE 25 MG/ML INJECTABLE POUR CHIENS CHATS ET NAC	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
France	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	ENROCARE 50 MG/ML INJECTABLE POUR BOVINS PORCINS CHIENS ET CHATS	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
France	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	ENROCARE 100 MG/ML INJECTABLE POUR BOVINS ET PORCINS	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
France	Bayer Sante 220 Avenue de la Recherche 59120 LOOS France	BAYTRIL 2,5 % SOLUTION INJECTABLE	Enrofloxacin	25 mg/ml	Solution for injection	Cattle, pigs, dogs
France	Bayer Sante 220 Avenue de la Recherche 59120 LOOS France	BAYTRIL 5 % SOLUTION INJECTABLE	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
France	Bayer Sante 220 Avenue de la Recherche 59120 LOOS France	BAYTRIL 10 % SOLUTION INJECTABLE	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
France	BIOLIS 21 Montee De La Garde 69340 Francheville France	QUINOTRYL 50 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
France	BIOLIS 21 Montee De La Garde 69340 Francheville France	QUINOTRYL 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCI NS	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
France	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	CHANENRO 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
France	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	FLOXIBAC 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
France	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	CHANENRO 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
France	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	FLOXIBAC 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Albrecht GmbH Hauptstr. 6-8 D-88326 Aulendorf Germany	Enro-Sleecol 50 mg/ml	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	Albrecht GmbH Hauptstr. 6-8 D-88326 Aulendorf Germany	Enro-Sleecol 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 25	Enrofloxacin	25 mg/ml	Solution for injection	Pigs, rabbits, dogs, cats
Germany	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 50	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 100	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen	Enrofloxacin	25 mg/ml	Solution for injection	Pigs, rabbits, dogs, cats
Germany	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril — Das Original — 5 % Injektionslösung	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Calluna Pharma bvba Treslong 34 B-2322 Hoogstraaten Belgium	Enrofloxacin 2,5 % WDT, Injektionslösung	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Germany	Calluna Pharma bvba Treslong 34 B-2322 Hoogstraaten Belgium	Enrofloxacin 5 % WDT, Injektionslösung	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	Calluna Pharma bvba Treslong 34 B-2322 Hoogstraaten Belgium	Enrofloxacin 10 % WDT, Injektionslösung	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Germany	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	Enrodexil 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	Roxacin 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Medistar Arzneimittel-Vertrieb GmbH Lüdinghauser Str. 23 D-59387 Ascheberg Germany	Enrostar 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	Medistar Arzneimittel-Vertrieb GmbH Lüdinghauser Str. 23 D-59387 Ascheberg Germany	Enrostar 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Serumwerk Bernburg AG Hallesche Landstr. 105b D-06406 Bernburg Germany	Ursofloxacin 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dog
Germany	Serumwerk Bernburg AG Hallesche Landstr. 105b D-06406 Bernburg Germany	Ursofloxacin 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc 100 mg/ml Inyectable	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Doraflox 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Unisol	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Germany	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Germany	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Greece	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril 2,5 %	Enrofloxacin	25 mg/ml	Solution for injection	Dogs
Greece	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs
Greece	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	FLOXIBAC 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Greece	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	FLOXIBAC 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Greece	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROFLOXACIN/HEALTHCARE	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
Greece	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROFLOXACIN/HEALTHCARE	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Greece	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROFLOXACIN/HEALTHCARE	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Greece	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	ENRODEXIL	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Greece	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	COLMYC	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Greece	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	DORAFLOX	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Bayer Hungária Kft. Alkotás u. 50. 1123 Budapest Hungary	Baytril 2,5 % injekció A.U.V.	Enrofloxacin	25 mg/ml	Solution for injection	Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)
Hungary	Bayer Hungária Kft. Alkotás u. 50. 1123 Budapest Hungary	Baytril 5 % injekció A.U.V.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Hungary	Bayer Hungária Kft. Alkotás u. 50. 1123 Budapest Hungary	Baytril 10 % injekció A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Hungary	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml injekció kutyák, macskák és egzotikus állatok részére A.U.V.	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Hungary	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Hungary	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml injekció szarvasmarha és sertés részére A.U.V	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	ENRODEXIL 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 5 % injekció A.U.V.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, sheep, goats
Hungary	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 10 % injekció A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Laboratorios Syva S.A. Parroco Pablo Diez, 49-57 24010 Leon Spain	Syvaquinol 100 injekció A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	DORAFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Hungary	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	LANFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Iceland	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril vet.	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, poultry dogs, cats
Iceland	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril vet.	Enrofloxacin	100 mg/ml	Solution for injection	Calves, pigs, poultry dogs, cats
Ireland	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats and exotic animals (small mammals, reptiles and avian species)
Ireland	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs weighing more than 25 kg, dogs, cats
Ireland	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs weighing more than 25 kg
Ireland	Bayer Limited The Atruim Blackthorn Road Dublin 18 Ireland	Baytril 2,5 % Solution for Injection	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Ireland	Bayer Limited The Atruim Blackthorn Road Dublin 18 Ireland	Baytril 5 % Solution for Injection	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Ireland	Bayer Limited The Atruim Blackthorn Road Dublin 18 Ireland	Baytril 10 % Solution for Injection	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Ireland	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Ireland	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml Solution for injection for dogs, cats and exotic animals	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Ireland	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Ireland	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml Solution for injection for cattle and pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Global Vet Health SL c/Capcanes, no 12-bajos Poligon Agro-Reus Reus 43206 Spain	Quinoflox 100 mg/ml solution for injection for cattle and pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	ENRODEXIL 100 mg/ml solution for injection for cattle and pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 50 mg/ml solution for injection for calves, pigs and dogs	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Ireland	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 100 mg/ml solution for injection for cattle and pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	ROXACIN 100 mg/ml solution for injection for cattle and pig	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Doraflox 100 mg/ml solution for injection for cattle and pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Unisol 100 mg/ml solution for injection for cattle and pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Ireland	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 50 mg/ml solution for injection for cattle, pigs, dogs and cats. Enrofloxacin.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Ireland	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 100 mg/ml solution for injection for cattle and pigs Enrofloxacin	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Italy	Bayer SpA Viale Certosa, 130 20156 Milano Italy	Baytril	Enrofloxacin	25 mg/ml and 50 mg/ml	Solution for injection	Cattle, dogs, sheep, goats, cats, rabbits, pigs
Italy	Bayer SpA Viale Certosa, 130 20156 Milano Italy	Baytril 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, sheep, goats
Italy	CEVA Salute Animale viale Colleoni, 15 20864 Agrate Brianza (MB) Italy	CEVAFLOX iniettabile, 100 mg/ml, soluzione iniettabile per bovini, ovini, suini	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, sheep
Italy	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	GELLIFLOX 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini e suini	Enrofloxacin	100 mg/ml (or 50 mg/ml)	Solution for injection	Cattle, pigs
Italy	Drugs Italia srl Via G. Puecher, 8 20037 Paderno Dugnano (MI) Italy	EFLOXIN soluzione iniettabile	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, sheep
Italy	Fatro s.p.a. Via Emilia, 285 Ozzano Emilia (BO) Italy	VALEMAS 10 (or 5) 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini, ovi-caprini e suini	Enrofloxacin	100 mg/ml (or 50 mg/ml)	Solution for injection	Cattle, pigs, sheep, goats
Italy	Friulchem via San Marco, 23 33099 Vivaro (PN) Italy	TENOTRIL 100 mg/ml soluzione iniettabile epr bovini, suini, ovicaprini	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, sheep, goats
Italy	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	ENRODEXIL 100 mg/ml soluzione iniettabile per bovini e suini	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Italy	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	ROXACIN 100 mg/ml soluzione iniettabile per bovini e suini	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Italy	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	COLMYC 100 mg/ml soluzione iniettabile	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Italy	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	LANFLOX 100 mg/ml soluzione iniettabile per bovini e suini	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Latvia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
Latvia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Latvia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Lithuania	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 25 mg/ml, injekcinis tirpalas šunims, katėms ir egzotiniams gyvūnams	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Lithuania	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Lithuania	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 100 mg/ml, injekcinis tirpalas galvijams ir kiaulėms	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Lithuania	Vetoquinol Biowet Sp z o.o. 13/14 Kosynierów Gdyńskich St. 66-400 Gorzów Wlkp. Poland	ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Luxembourg	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Floxadil 25 mg/ml Injektionsl! osung für Hunde, katzen und exotische Tiere	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals (small mammals, reptiles and birds)
Luxembourg	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Floxadil 50 mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs >25kg, dogs, cats
Luxembourg	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Floxadil 100 mg/ml Injektionslösung für Rinder und Schweine	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs >25kg
Luxembourg	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	Baytril piglet 25 mg/ml	Enrofloxacin	25 mg/ml	Solution for injection	Pigs
Luxembourg	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	Baytril 2,5 %	Enrofloxacin	25 mg/ml	Solution for injection	Cats, dogs
Luxembourg	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	Baytril 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Luxembourg	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	Baytril 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle
Luxembourg	Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Machelen Belgium	Baytril Swine 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Pigs
Luxembourg	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml solution injectable pour bovins, porcins, chiens et chats	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Luxembourg	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml solution injectable pour bovins et porcins	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Luxembourg	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc injectable Bovins Porcins	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Malta	Farmcare Ltd Florence A triq il Fran Qormi Malta	Baytril 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Malta	Industrial Veterinaria, S.A Esmeralda, 19, 08950 Esplugues de Llobreget Barcelona Spain	Ganadexil Enrofloxacino 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Malta	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	Roxacin injection	Enrofloxacin	100 mg/ml	Solution for injection	Pigs
Malta	Laboratorios Syva S.A. Parroco Pablo Diez, 49-57 24010 Leon Spain	Syvaquinol 25 %	Enrofloxacin	25 mg/ml	Solution for injection	Calves, piglets, dogs
Malta	Laboratorios Syva S.A. Parroco Pablo Diez, 49-57 24010 Leon Spain	Syvaquinol 100 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Norway	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril vet	Enrofloxacin	25 mg/ml	Solution for injection	Pigs, cattle, dogs, cats
Norway	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril vet	Enrofloxacin	100 mg/ml	Solution for injection	Pigs, cattle, dogs, cats
Norway	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Poland	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Poland	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Poland	Biowet Puławy Sp. z o.o. 2 Arciucha Str. 24-100 Puławy Poland	Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Poland	Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A. 6 Grójecka Str. 05-651 Drwalew Poland	Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła	Enrofloxacin	100 mg/ml	Solution for injection	Cattle
Poland	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
Poland	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Poland	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Poland	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	Enrodexil, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Poland	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Poland	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	Roxacin, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Poland	PFO ‘Vetos-Farma’ Sp. z o.o. 21 Dzierżoniowska Str. 58-260 Bielawa Poland	Enrofloxacyna 5 % iniekcja, enrofloxacyna 5 g/100ml, roztwór dla bydła, świń, psów i kotów	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Poland	PFO ‘Vetos-Farma’ Sp. z o.o. 21 Dzierżoniowska Str. 58-260 Bielawa Poland	Enrofloxacyna 10 % iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Poland	Pharmagal, s.r.o. Murgasova 5 949 01, Nitra Slovakia	Enrogal 50 mg/ml roztwór do wstrzykiwań	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Poland	Przedsiębiorstwo Wielobranżowe VET-AGRO Sp. z o.o. 32 Gliniana Str. 20-616 Lublin Poland	Enrocin 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Poland	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc 100 mg/ml roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Poland	Vetoquinol Biowet Sp z o.o. 13/14 Kosynierów Gdyńskich St. 66-400 Gorzów Wlkp. Poland	Enrobioflox 5 % Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Poland	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Lanflox, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal	BAYTRIL 2,5 % solução injectável	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Portugal	Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal	Baytril 5 % solução injectável	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, cattle and pigs
Portugal	Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal	Baytril 10 % solução injectável	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml solução injectável para bovinos, suínos, cães e gatos	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Portugal	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Portugal	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml solução injectável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 100 mg/ml solução injectável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	ESTEVE FARMA, LDA Av. Do Forte, 3 Edifício Suécia II Piso 4A 2794-044 Carnaxide Portugal	ALSIR 25 mg/ml solução injectável para Cães e Gatos	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Portugal	ESTEVE FARMA, LDA Av. Do Forte, 3 Edifício Suécia II Piso 4A 2794-044 Carnaxide Portugal	ALSIR 50Mmg/ml Solução Injectável	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Portugal	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml Solução injectável para cães, gatos e animais exóticos	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic Animals (small mammals, reptiles and avian species)
Portugal	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Portugal	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml solução injectável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Global Vet Health SL c/Capcanes, no 12-bajos Poligon Agro-Reus Reus 43206 Spain	Quinoflox 100 mg/ml solução injetável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	ROXACIN 100 mg/ml solução injectável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc 100 mg/ml Solução injectável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	LANFLOX 100 mg/ml solução injectável para bovinos e suínos.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Portugal	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	ENRODEXIL 100 mg/ml solução injectável para bovinos e suínos	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	CENAVISA SA LABORATORIOS Cami Pedra Estela s/n 43205 REUS Spain	CENAMICINA 10 PLUS	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs, dogs
Romania	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 25 mg/ml	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
Romania	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 50 mg/ml	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Romania	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	ENROTRON 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pig
Romania	Global Vet Health SL c/Capcanes, no 12-bajos Poligon Agro-Reus Reus 43206 Spain	QUINOFLOX 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	GANADEXIL ENROFLOXACINA 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs,
Romania	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROXIL 50 mg/ml	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, goats, sheep, dogs
Romania	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROXIL 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	Laboratorios Hipra S.A. Avda. La Selva, 135 17170 Amer Girona Spain	HIPRALONA ENRO I	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs
Romania	Laboratorios Syva S.A. Parroco Pablo Diez, 49-57 24010 Leon Spain	SYVAQUINOL 100 injectable	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B 09004 Burgos Spain	ENRODEXIL 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	PASTEUR Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud. Prahova Romania	Enrofloxacina 5 % injectable solution	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, sheep, goats, pigs, dogs, cats
Romania	PASTEUR Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud. Prahova Romania	Enrofloxacina 10 % injectable solution	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, sheep, goats, pigs, dogs, cats
Romania	S.C. ROMVAC COMPANY S.A. Şos. Centurii, nr. 7 Voluntari Romania	Enrofloxarom 5 %	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, sheep, pigs, dogs
Romania	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc 100 mg/ml inyectable solution	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Romania	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	DORAFLOX 100 mg/ml	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovakia	Bayer s.r.o. Litvínovská 609/3 190 21 Praha 9 Czech Republic	Baytril 2,5 % inj. ad us. vet.	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Slovakia	Bayer s.r.o. Litvínovská 609/3 190 21 Praha 9 Czech Republic	Baytril 5 % (w/v) injekčný roztok	Enrofloxacin	50 mg/ml	Solution for injection	Dogs, pigs, calves
Slovakia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml injekčný roztok pre psy, mačky a exotické živočíchy	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
Slovakia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
Slovakia	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml injekčný roztok	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovakia	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 5 % inj. ad us. vet.	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, sheep, goats, pigs, dogs
Slovakia	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 10 % inj. ad us. vet.	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovakia	Laboratorios Hipra S.A. Avda. La Selva, 135 17170 Amer Girona Spain	Hipralona Enro — I 50 mg/ml injekčný roztok	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs
Slovakia	Pharmagal, s.r.o. Murgasova 5 949 01, Nitra Slovakia	Enrogal 50 mg/ml injekčný roztok	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Slovenia	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, pigs, rabbits
Slovenia	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse	Enrofloxacin	50 mg/ml	Solution for injection	Cattle (calves), pigs, dogs
Slovenia	aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany	ENROTRON 100, 100 mg/ml raztopina za injiciranje za govedo in prašiče	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovenia	Bayer d.o.o. Bravničarjeva 13 Ljubljana Slovenia	Baytril® 5 % raztopina za injiciranje	Enrofloxacin	50 mg/ml	Solution for injection	Calves, pigs, dogs
Slovenia	Bayer d.o.o. Bravničarjeva 13 Ljubljana Slovenia	Baytril® 10 % raztopina za injiciranje	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovenia	GENERA Slovenia d.o.o. Dunajska 51 1000 Ljubljana Slovenia	VETOFLOK 10 % raztopina za injiciranje	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovenia	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, sheep, goats, pigs, dogs
Slovenia	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROX 100 mg/ml raztopina za injiciranje za govedo in prašiče	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Slovenia	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROXIL 100 mg/ml raztopina za injiciranje za govedo in prašiče	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	Hifarmax, Produtos e serviços veterinários, Lda Av. Marechal Craveiro Lopes no96 R/C Dto 2775-696 Carcavelos Portugal	ENROCILL 50 mg/ml solución inyectable para bovino, porcino y perros	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Spain	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	ENRODEXIL 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	ROXACIN 100 mg/ml SOLUCION INYECTABLE	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	Laboratorios Dr. Esteve, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain	ALSIR 2,5 % SOLUCION INYECTABLE	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
Spain	Laboratorios Dr. Esteve, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain	ALSIR 5 % SOLUCION INYECTABLE	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
Spain	Laboratorios Dr. Esteve, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain	ALSIR 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	QUINOLCEN 100 mg/ml SOLUCION INYECTABLE	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	FLOXAVEX 100 mg/ml SOLUCION INYECTABLE	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Spain	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	LANFLOX 100 mg/ml SOLUCION INYECTABLE	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
Sweden	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril® vet.	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, pigs, cattle, cats
Sweden	Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 51368 Leverkusen Germany	Baytril® vet.	Enrofloxacin	100 mg/ml	Solution for injection	Dog, pigs, cattle, cats
Sweden	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox vet	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, exotic animals
The Netherlands	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Floxadil 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
The Netherlands	Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Floxadil 100 mg/ml, oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Bayer B.V. Energieweg 1 3641 RT Mijdrecht Netherlands	BAYTRIL 2,5 % INJEKTIEVLOEISTOF	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats
The Netherlands	Bayer B.V. Energieweg 1 3641 RT Mijdrecht Netherlands	Baytril Piglet 25 mg/ml inspuitbare oplossing	Enrofloxacin	25 mg/ml	Solution for injection	Pigs
The Netherlands	Bayer B.V. Energieweg 1 3641 RT Mijdrecht Netherlands	BAYTRIL 5 % INJEKTIEVLOEISTOF	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
The Netherlands	Bayer B.V. Energieweg 1 3641 RT Mijdrecht Netherlands	BAYTRIL 5 % INJECTIEOPLOSSING	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, dogs, pigs
The Netherlands	Bayer B.V. Energieweg 1 3641 RT Mijdrecht Netherlands	BAYTRIL INJEKTIEVLOEISTOF 10 %	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Bayer B.V. Energieweg 1 3641 RT Mijdrecht Netherlands	BAYTRIL 10 % INJECTIEOPLOSSING	Enrofloxacin	100 mg/ml	Solution for injection	Pigs, cattle
The Netherlands	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml Oplossing voor injectie	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
The Netherlands	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml Oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml, oplossing voor injectie	Enrofloxacin	25 mg/ml	Solution for injection	Dogs, cats, cage birds, reptiles
The Netherlands	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
The Netherlands	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml, oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs
The Netherlands	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	ENROXIL 100 MG/ML SOLUTION FOR INJECTION	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Laboratorios Calier, S.A. c/Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Valles Barcelona Spain	Roxacin 100 mg/ml, oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona Spain	Enrodexil 100 mg/ml oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	SP Veterinaria SA Ctra. Reus Vinyols km 4.1 43330 Riudoms Tarragona Spain	Colmyc 100 mg/ml injectieoplossing voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Doraflox 100 mg/ml, oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Unisol 100 mg/ml, oplossing voor injectie voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
The Netherlands	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, pigs, dogs, cats
The Netherlands	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox Oplossing voor injectie 100 mg/ml voor runderen en varkens	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Animalcare Ltd 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals	Enrofloxacin	25 mg/ml	Solution for injection	Cage birds, cats, dogs, exotic animals, reptiles, small mammals
United Kingdom	Animalcare Ltd 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cats, cattle, dogs, pigs
United Kingdom	Animalcare Ltd 10 Great North Way York Business Park Nether Poppleton York YO26 6RB United Kingdom	Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom	Baytril 2,5 % Solution for Injection	Enrofloxacin	25 mg/ml	Solution for injection	Cage birds, cats, dogs, exotic animals, reptiles, small mammals
United Kingdom	Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom	Baytril 5 % Solution for Injection	Enrofloxacin	50 mg/ml	Solution for injection	Cats, cattle, dogs, pigs
United Kingdom	Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom	Baytril 10 % Solution for Injection	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cats, cattle, dogs, pigs
United Kingdom	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cats, cattle, dogs, Pigs
United Kingdom	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway Ireland	Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals	Enrofloxacin	25 mg/ml	Solution for injection	Cage birds, cats, dogs, exotic animals, reptiles, small mammals
United Kingdom	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats	Enrofloxacin	50 mg/ml	Solution for injection	Cats, cattle, dogs, pigs
United Kingdom	FORTE Healthcare Limited Cougar Lane Naul Co. Dublin Ireland	Enrotron 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Global Vet Health SL c/Capcanes, no 12-bajos Poligon Agro-Reus Reus 43206 Spain	Quinoflox 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Industrial Veterinaria SA C/Esmeralda 19-21 08950 Esplugues de Llobregat Barcelona Spain	Enrodexil 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 50 mg/ml Solution for Injection for Calves, Pigs and Dogs	Enrofloxacin	50 mg/ml	Solution for injection	Cattle, dogs, pigs
United Kingdom	Krka d.d. Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia	Enroxil 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Doraflox 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Vetpharma Animal Health, S.L. Les Corts 23. 08028 Barcelona Spain	Unisol 100 mg/ml Solution for Injection for Cattle and Pigs	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs
United Kingdom	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin	Enrofloxacin	50 mg/ml	Solution for injection	Cats, cattle, dogs, pigs
United Kingdom	Virbac S.A. 1ére Avenue L.I.D. 2065m 06516 Carros Cedex France	Powerflox 100 mg/ml Solution for Injection for Cattle and Pigs Enrofloxacin	Enrofloxacin	100 mg/ml	Solution for injection	Cattle, pigs

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