27.5.2016

Official Journal of the European Union

C 189/9

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016

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

(2016/C 189/02)

— 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
4.4.2016	Baytril — Rectificative Decision — Article 34	Enrofloxacin	See Annex I	See Annex I	5.4.2016
4.4.2016	Baytril — Rectificative Decision — Article 35	Enrofloxacin	See Annex II	See Annex II	5.4.2016
28.4.2016	Cymevene intravenous — Art. 30	ganciclovir	See Annex III	See Annex III	2.5.2016
4.4.2016	Tobramycin VVB — Community Referrals — Article 29	tobramycin	See Annex IV	See Annex IV	5.4.2016
4.4.2016	Gutal 1 000 g/kg — Corrigendum — Article 33	zinc oxide	See Annex V	See Annex V	5.4.2016
28.4.2016	Iron containing intravenous medicinal products — Corrigendum — Article 31	ferric carboxymaltose, iron sucrose complex, sodium ferric gluconate complex, iron(III) isomaltoside complex, iron(III)-hydroxide dextran complex	See Annex VI	See Annex VI	29.4.2016
7.4.2016	Zoledronic acid — Rectificative Decision — PSUSA-3149-201408	zoledronic acid	Not applicable	Not applicable	8.4.2016
25.4.2016	Aripiprazole — PSUSA_234-201507 — Article 107b	aripiprazole	Not applicable	Not applicable	26.4.2016

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

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

ANNEX I

List of the names, pharmaceutical 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 II

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	Enrobioflox 5 %	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 PORCINS	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 PORCINS	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 PORCINS	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 PORCINS	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 s.r.l. 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 per 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 Injektionslösung 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 > 25 kg, 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 > 25 kg
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/100 ml, 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 50 Mmg/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 no 96 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

ANNEX III

List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holder in the member states

Member State EU/EEA	Marketing Authorisation Holder	Invented Name	Strength	Pharmaceutical Form	Route of Administration	Content (concentration)
Austria	Roche Austria GmbH Engelhorngasse 3 1211 Vienna Austria	Cymevene ‘Roche’ 500 mg — Trockensubstanz zur Infusionsbereitung	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Belgium	N.V. Roche S.A. Rue Dante 75 B-1070 Brussels Belgium	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Bulgaria	Roche Bulgaria EOOD 16, Byalo pole Str. 1618 Sofia, Bulgaria	Симевен 500 mg прах за инфузионен разтвор	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Croatia	Roche d.o.o. Ulica grada Vukovara 269a 10 000 Zagreb Croatia	Cymevene 500 mg prašak za otopinu za infuziju	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Cyprus	G. A. Stamatis & Co. Ltd 27, Andreas Araouzos P.O. Box 21305 1506 Nicosia Cyprus	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Czech Republic	Roche s.r.o. Dukelských hrdinů 567/52, 170 00 Praha 7 Czech Republic	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Denmark	Roche A/S Industriholmen 59 2650 Hvidovre Denmark	Cymevene	500 mg	Powder for concentrate for infusion for solution	Intravenous use	50 mg/ml
Estonia	Roche Eesti OÜ Lõõtsa 2, 11415 Tallinn, Estonia	Cymevene	500 mg	Powder for concentrate for solution for infusion	Intravenous use	50 mg/ml
Finland	Roche Oy Klovinpellontie 3 P.O. Box 12 02181 Espoo Finland	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
France	Roche 30, cours de l’Ile Seguin 92650 Boulogne Billancourt Cedex France	CYMEVAN 500 mg, lyophilisat pour usage parentéral (perfusion)	500 mg	Lyophilisate for parenteral use (infusion)	Intravenous use	50 mg/ml
Germany	Roche Pharma AG Emil-Barell-Straße 1 79639 Grenzach-Wyhlen Germany	Cymeven® i. v.	500 mg	Powder for concentrate for solution for infusion	Intravenous use	50 mg/ml
Greece	Roche Hellas A.E. 4, Alamanas & Delfon str. 151 25 Maroussi Greece	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Hungary	Roche (Hungary) Ltd Edison str 1. Budaörs H-2040 Hungary	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Iceland	Roche A/S Industriholmen 59 2650 Hvidovre Denmark	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Ireland	Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	Cymevene 500 mg Powder for Concentrate for Solution for Infusion	500 mg	Powder for Concentrate for Solution for Infusion	Intravenous use	50 mg/ml
Italy	Roche S.p.A., Piazza Durante 11 Milan Italy	Citovirax	500 mg	Powder for concentrate for solution for infusion	Intravenous use	50 mg/ml
Lithuania	UAB ‘Roche Lietuva’ J.Jasinskio str. 16B LT-03163 Vilnius Lithuania	Cymevene	500 mg	Powder for concentrate for solution for infusion	Intravenous use	50 mg/ml
Luxembourg	N.V. Roche S.A. Rue Dante 75 B-1070 Brussels Belgium	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
The Netherlands	Roche Nederland B.V. Beneluxlaan 2a 3446 GR Woerden The Netherlands	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Norway	Roche Norge AS Brynsengfaret 6B Postboks 6610 Etterstad 0607 Oslo Norway	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Poland	Roche Polska Sp. z o.o. ul. Domaniewska 39 B 02-672 Warsaw, Poland	Cymevene	500 mg	Powder for concentrate for solution for infusion	Intravenous use	50 mg/ml
Portugal	Roche Farmacêutica Química, Lda. Estrada Nacional 249-1 2720-413 Amadora Portugal	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg
Romania	Roche România SRL Piata Presei Libere, Nr. 3-5, Clădirea City Gate — Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti România	Cymevene 500 mg pulbere pentru soluţie perfuzabilă	500 mg	powder for solution for infusion	Intravenous use	50 mg/ml
Slovak Republic	Roche Slovensko s.r.o. Cintorínska 3/A Bratislava 811 08 Slovak Republic	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Spain	Roche Farma, S.A. Eucalipto no 33, 28016 Madrid Spain	Cymevene 500 mg polvo para solución para perfusión	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
Sweden	Roche AB Liljeholmsstranden 5 Box 47327 100 74 Stockholm Sweden	Cymevene	500 mg	Powder for solution for infusion	Intravenous use	50 mg/ml
United Kingdom	Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	Cymevene powder for infusion	500 mg	Powder for Infusion	Intravenous use	50 mg/ml

ANNEX IV

List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States

Member State EU/EEA	Applicant company name, address	(Invented) Name	Strength	Pharmaceutical form	Route of administration	Content (concentration)
Bulgaria	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Тобрамицин ВBБ	300 mg/5 ml	nebuliser solution	inhalation use	6 %
Estonia	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Tobramycin VVB	300 mg/5 ml	nebuliser solution	inhalation use	6 %
Hungary	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Tobramycin VVB	300 mg/5 ml	nebuliser solution	inhalation use	6 %
Latvia	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Tobramycin VVB 300 mg/5 ml šķīdums izsmidzināšanai	300 mg/5 ml	nebuliser solution	inhalation use	6 %
Lithuania	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Tobramycin VVB	300 mg/5 ml	nebuliser solution	inhalation use	6 %
Poland	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Tobramycin VVB	300 mg/5 ml	nebuliser solution	inhalation use	6 %
Romania	UAB ‘VVB’ 9-ojo Forto str. 70 LT-48179 Kaunas Lithuania	Tobramycin VVB	300 mg/5 ml	nebuliser solution	inhalation use	6 %

ANNEX V

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States

Member State (EU/EEA)	Applicant	Product name	INN	Strength	Pharmaceutical form	Animal species	Route of administration
Austria	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Belgium	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Bulgaria	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Cyprus	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Czech Republic	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Denmark	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Estonia	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
France	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Germany	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Greece	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Hungary	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Ireland	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Italy	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Latvia	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Lithuania	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Luxembourg	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Malta	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
The Netherlands	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Poland	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Portugal	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Romania	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Slovakia	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Slovenia	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
Spain	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.
United Kingdom	Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium	Gutal 1 000 g/kg premix for medicated feeding stuff for piglets	Zinc oxide	1 000 g/kg	Premix for medicated feeding stuff	Piglet (weaned piglets)	For incorporation into dry feed at the registered mill. Oral use only.

The annexes to Commission Implementing Decision C(2013)5970 final shall read as attached below.

ANNEX VI

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

Member State (in EEA)	Marketing authorisation holder	INN	Invented name	Strength	Pharmaceutical form	Route of administration
Austria	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	CosmoFer 50 mg/ml Injektionslösung und Infusionslösung	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Austria	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung	50 mg/ml	Solution for injection/infusion	Intravenous use
Austria	Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany	Iron sucrose complex	FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Austria	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Austria	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer 100 mg/ml Injektions- oder Infusionslösung	100 mg/ml	Solution for injection/infusion	Intravenous use
Austria	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	Iron sucrose complex	Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Belgium	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Intravenous use
Belgium	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monover	100 mg/ml	Solution for injection/infusion	Intravenous use
Belgium	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Belgium	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric Carboxymaltose	Injectafer	50,00 mg/ml	Solution for injection/infusion	Intravenous use
Bulgaria	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Bulgaria	Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia Bulgaria	Iron sucrose complex	Idafer	20 mg/ml	Solution for injection	Intravenous use
Bulgaria	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection	Intravenous use
Bulgaria	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Intravenous use
Cyprus	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	ferric carboxymaltose	FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML	50 mg/ml	Solution for injection/infusion	Intravenous use
Cyprus	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML	100 mg/ml	Solution for injection/infusion	Intravenous use
Cyprus	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML	50 mg/ml	Solution for injection/infusion	Intravenous use
Cyprus	The Star Medicines Importers & co ltd, 9A Loukis Akritas Street, P.O.box 50151, 3601 Lemesos, Cyprus	Iron sucrose complex	VENOFER INJECTION 100 MG IRON/5 ML	100 mg/5 ml	Solution for injection	Intravenous use
Cyprus	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML	20 mg/ml	Solution for injection/infusion	Intravenous use
Czech Republic	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	VENOFER	20 mg/ml	Solution for injection	Intravenous use
Czech Republic	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	FERROLOGIC 20 MG/ML	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Czech Republic	PHARMABIDE LTD 20, Lakonias str, 15234 Halandri Athens — Greece	Iron sucrose complex	IRON SUCROSE PHARMABIDE 20 MG/ML	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Czech Republic	Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland	Iron sucrose complex	FERION 20 MG/ML	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Czech Republic	Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Praha 6 Czech Republic	sodium ferric gluconate complex	FERRLECIT	12,5 mg/ml	Solution for injection	Intravenous use
Czech Republic	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	ferric carboxymaltose	FERINJECT	50 mg/ml	Solution for injection/infusion	Intravenous use
Denmark	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Intravenous use
Denmark	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Denmark	Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland	Iron sucrose complex	Ferion	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Denmark	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Denmark	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Jerndextran ‘Pharmacosmos’	50 mg/ml	Solution for injection/infusion	Intravenous use
Denmark	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	MonoFer	100 mg/ml	Solution for injection/infusion	Intravenous use
Denmark	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Estonia	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Estonia	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic 20 mg/ml	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Estonia	Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland	Iron sucrose complex	Ferion	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Estonia	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Estonia	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Intravenous use
Estonia	Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia	Iron (III) hydroxide dextran complex	Ferrum Lek	50 mg/ml	Solution for injection	Intramuscular use
Finland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Finland	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Finland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Finland	Alternova A/S Lodshusvej 11 4230 Skaelskoer Denmark	Iron sucrose complex	Venotrix	20 mg/ml	Concentrate for solution for infusion/solution for injection	Intravenous use
Finland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Intravenous use
Finland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Intravenous use
France	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric Carboxymaltose	FERINJECT 50 mg/ml, solution injectable/pour perfusion	50 mg/ml	Solution for injection/infusion	Intravenous use
France	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	VENOFER 20 mg/ml, solution injectable	20 mg/ml	Solution for injection	Intravenous use
France	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	FERRISAT 50 mg/ml, solution injectable ou pour perfusion	50 mg/ml	Solution for injection/infusion	Intravenous use
France	Pharmaki Generics Ltd 5 Bourlet Close W1W 7BL London United Kingdom	Iron sucrose complex	FER ACTAVIS 100 mg/5 ml, solution injectable	100 mg/5 ml	Solution for injection	Intravenous use
France	IBD3 Pharma Consulting Immeuble l’Orient 10, place Charles Béraudier 69003 Lyon France	Iron sucrose complex	FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
France	Mylan SAS 117, allée des Parcs 69800 Saint-Priest France	Iron sucrose complex	FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
France	SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France	Iron sucrose complex	FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
France	TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE	Iron sucrose complex	FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)	100 mg/5 ml	Solution for injection	Intravenous use
Germany	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung	1 709 mg/5 ml	Concentrate for solution for infusion/solution for injection	Intravenous use
Germany	Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany	Iron sucrose complex	FerMed	1 563 — 1 887 mg/5 ml	Concentrate for solution for infusion/solution for injection	Intravenous use
Germany	Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany	Iron sucrose complex	Nefro-Fer	1 563 — 1 887 mg/5 ml	Solution for injection	Intravenous use
Germany	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer 100 mg/ml Lösung zur Injektion/Infusion	377-465 mg/ml	Solution for injection/infusion	Intravenous use
Germany	Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany	sodium ferric gluconate complex	Ferrlecit 40 mg	1 288,9 mg/3,2 ml	Solution for injection	Intravenous use
Germany	Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany	sodium ferric gluconate complex	Ferrlecit 62,5 mg	2 013,9 mg/5 ml	Solution for injection	Intravenous use
Germany	Pharmacosmos A/S Roervangsvei 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	CosmoFer 50 mg/ml Injektionslösong und Infusionslösung	312,5 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Germany	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose complex	FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung	180 mg/ml	Solution for injection/infusion	Intravenous use
Germany	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer 20 mg FR/ml Injektionslösung	2 700 mg/5 ml	Concentrate for solution for infusion/solution for injection	Intravenous use
Greece	Medicus SA Valaoritou 10 Metamorfosi Attikis 14452 Greece	Iron sucrose complex	REOXYL	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Vianex S.A. Tatoiou Street Nea Erythrea 14671 Greece	Iron sucrose complex	INTRAFER	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Alapis ABEE Aftokratoros Nikolaou 2 Athens 17671 Greece	Iron sucrose complex	FAREMIO	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Intermed ABEE Kalyftaki 27 Athens 14564 Greece	Iron sucrose complex	DEXTRIFER-S	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	VENOFER	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Demo ABEE 21ST Km National Highway Athens-Lamia, 14565 Greece	Iron (III) hydroxide dextran	COSMOFER	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Greece	Rafarm AEBE Korinthou 12, N. Psychiko, 15451 Greece	Iron sucrose complex	FERROVIN	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Nephrotech S.A. Parnithos 44 Metamorfosi Attikis 14452 Greece	Iron sucrose complex	SUCRO-FER	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Uni-Pharma Kleon Tseitis Pharmaceutical Laboratories 14KM National Highway Athens-Lamia Kifissia 14564 Greece	Iron sucrose complex	HEMAFER-S	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
Greece	Verisfield (UK) Ltd, U.K. 41 Chalton street London, NW1 1JD United Kingdom	Iron sucrose complex	NEPHROFEROL	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	HELP ABEE Valaoritou 10 Metamorfosi Attikis, 14452 Greece	Iron sucrose complex	FERRINEMIA	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	Specifar AEBE 28th October Street 1 Agia Barbara 12351 Greece	Iron sucrose complex	ALVOFER	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
Greece	Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351 Greece	Iron sucrose complex	SUCROVEN	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
Greece	Target Pharma Ltd Menandrou 54 Athens 10431 Greece	Iron sucrose complex	IRONCROSE	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Greece	HELP ABEE Valaoritou 10 Metamorfosi Attikis, 14452 Greece	Iron (III) hydroxide dextran complex	IRONATE	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Greece	Demo ABEE 21st km National Highway Athens-Lamia, 14565 Greece	Iron(III) isomaltoside complex	MONOFER	100 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Greece	Viofar EPE Ethnikis Antistaseos & Trifyllias, Aharnai, 13671 Greece	Iron sucrose complex	VENIRON	100 mg/5 ml	Concentrate for solution for infusion	Intravenous use
Greece	Medicus SA Valaoritou 10 Metamorfosi Attikis 14452 Greece	Iron (III) hydroxide dextran complex	IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Hungary	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Hungary	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection/infusion	Intravenous use
Hungary	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Solution for injection/infusion	Intravenous use
Hungary	Sanofi-Aventis Zrt Tó utca 1-5, 1045 Budapest Hungary	Sodium ferric gluconate complex	Ferrlecit	12,5 mg/ml	Solution for injection	Intravenous use
Iceland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Iceland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for infusion	Intravenous use
Iceland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection	Intravenous use
Ireland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	CosmoFer 50 mg/ml solution for infusion and injection	50 mg/ml	Solution for injection/infusion	Intravenous use
Ireland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monover 100 mg/ml solution for injection/infusion (ampoules)	100 mg/ml	Solution for injection/infusion	Intravenous use
Ireland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monover 100 mg/ml solution for injection/infusion (vials)	100 mg/ml	Solution for injection/infusion	Intravenous use
Ireland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Ireland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	ferric carboxymaltose	FERINJECT 50 mg iron/ml solution for injection/infusion	50 mg/ml	Solution for injection/infusion	Intravenous use
Ireland	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex)	Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial	20 mg/ml	Solution for injection/infusion	Intravenous use
Ireland	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion	20 mg/ml	Solution for injection	Intravenous use
Italy	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	ferric carboxymaltose	FERINJECT	50 mg/ml	Solution for injection/infusion	Intravenous use
Italy	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	FERRO SACCARATO FME	20 mg/ml	Concentrate for solution for infusion/solution for injection	Intravenous use
Italy	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	VENOFER	20 mg/ml	Solution for injection	Intravenous use
Italy	Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy	sodium ferric gluconate complex	FERLIXIT	62,5 mg/5 ml	Oral solution or solution for infusion	Oral use Intravenous use
Latvia	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Latvia	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection	Intravenous use
Latvia	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	FerroLogic	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Latvia	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	CosmoFer	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Latvia	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Intravenous use
Lithuania	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Lithuania	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection	Intravenous use
Lithuania	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Lithuania	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Intravenous use
Lithuania	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Ferric (III) hydroxide dextran complex	CosmoFer	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Luxembourg	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Injectafer-50 mg/l	50 mg/ml	Solution for injection	Intravenous use
Luxembourg	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer-50 mg/ml	50 mg/ml	Solution for injection	Intravenous use
Luxembourg	Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany	Iron sucrose complex	Fermed-100 mg/5 ml	100 mg/5 ml	Solution for perfusion	Intravenous use
Luxembourg	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic-20 mg/ml	20 mg/ml	Solution for perfusion	Intravenous use
Malta	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	ferric carboxymaltose	FERINJECT 50 mg iron/ml solution for injection/infusion	50 mg/ml	Solution for injection/infusion	Intravenous use
Malta	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex.	Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Norway	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Parenteral use
Norway	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Parenteral use
Norway	Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland	Iron sucrose complex	Ferion	20 mg/ml	Solution for injection Concentrate for solution for infusion	Parenteral use
Norway	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Solution for injection Concentrate for solution for infusion	Parenteral use
Norway	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Parenteral use
Norway	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Uniferon	200 mg/ml	Solution for injection	Parenteral use
Norway	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection Concentrate for solution for infusion	Parenteral use
Poland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	CosmoFer	50 mg/ml	Solution for injection/infusion	Intravenous use
Poland	VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France	ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection	Intravenous use
Poland	VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection/infusion	Intravenous use
Poland	Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg Germany	Iron sucrose complex	Ferrologic 20 mg/ml	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Poland	Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria	Iron(III) isomaltoside complex	Ferrum-Lek	50 mg/ml	Solution for injection	Intramuscular use
Poland	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monover	100 mg/ml	Solution for injection/infusion	Intravenous use
Portugal	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Referen	100 mg/5 ml	Solution for injection	Intravenous use
Portugal	Vifor France, SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	100 mg/5 ml	Solution for injection	Intravenous use
Portugal	Combino Pharm Portugal, Unipessoal, Lda. Lagoas Park Edifício 8 Piso 0 2740-268 Porto Salvo Portugal	Iron sucrose complex	Óxido Férrico Sacarosado Combino	100 mg/5 ml	Solution for injection	Intravenous use
Portugal	Farmoz — Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal	Iron sucrose complex	Óxido Férrico Sacarosado Farmoz	100 mg/5 ml	Solution for injection	Intravenous use
Portugal	Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal	Iron sucrose complex	Óxido Férrico Sacarosado Generis	100 mg/5 ml	Solution for injection	Intravenous use
Portugal	Laboratórios Normon, S.A. Rua Armando Villar, Lote 42 1o Dto. Quinta das Patinhas, Cobre 2750 — 777 Cascais Portugal	Iron sucrose complex	Óxido Férrico Sacarosado Normon	100 mg/5 ml	Solution for injection	Intravenous use
Portugal	Vifor France, SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Portugal	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Portugal	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Monofar	100 mg/ml	Solution for injection/infusion	Intravenous use
Romania	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	VENOFER®	20 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Romania	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	MONOFER 100 mg/ml	100 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Romania	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	FERINJECT 50 mg fer/ml	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
Slovak Republic	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use
Slovak Republic	Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland	Iron sucrose complex	Ferion 20 mg/ml	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Slovak Republic	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic 20 mg/ml	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Slovak Republic	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection	Intravenous use
Slovenia	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Slovenia	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	carboxymaltose	Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje	50 mg/ml	Solution for injection/infusion	Intravenous use
Slovenia	Lek farmacevtska družba d.d., Verovškova 57, 1000 Ljubljana Slovenia	Iron sucrose complex	Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Spain	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION	50 mg/ml	Solution for injection Solution for infusion	Intravenous use intramuscular use
Spain	GUERBET B.P. 57400 ROISSY CdG Cedex F-95943 France	Iron sucrose complex	ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION	11,2 mg/ml	Concentrate for suspension for infusion	Intravenous use
Spain	G.E.S. Genericos Espanoles Laboratorio S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain	Iron sucrose complex	FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Spain	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61346 Bad Homburg Germany	Iron sucrose complex	HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Spain	Laboratorios Normon S.A. Ronda de Valdecarrizo 6 28760 Tres Cantos Madrid Spain	Iron sucrose complex	HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Spain	Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany	Iron sucrose complex	FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION	100 mg/5 ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Spain	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
Spain	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION	50 mg/ml	Solution for injection Solution for infusion	Intravenous use
Spain	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN	100 mg/ml	Solution for injection Solution for infusion	Intravenous use
Sweden	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	Iron sucrose complex	Venofer®	20 mg/ml	Concentrate for solution for injection	Intravenous use
Sweden	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer®	50 mg/ml	Solution for injection	Intravenous use
Sweden	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection	Intravenous use
Sweden	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61346 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Concentrate for solution for injection	Intravenous use
Sweden	Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland	Iron sucrose complex	Ferion	20 mg/ml	Concentrate for solution for injection	Intravenous use
Sweden	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	MonoFer®	100 mg/ml	Solution for injection	Intravenous use
The Netherlands	Pharmamatch B.V. Egelenburg 2 Amsterdam GK — 1081 The Netherlands	Iron sucrose complex	IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
The Netherlands	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
The Netherlands	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	MonoFer 100 mg/ml oplossing voor injectie/infusie	100 mg/ml	Solution for injection/infusion	Intravenous use
The Netherlands	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
The Netherlands	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie	50 mg/ml	Solution for injection/infusion	Intravenous use
The Netherlands	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	CosmoFer 50 mg/ml oplossing voor infusie en injectie	50 mg/ml	Solution for injection/infusion	Intravenous use
The Netherlands	Pharmachemie B.V. Haarlem — 2031 GA The Netherlands	Iron sucrose complex	IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
United Kingdom	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Iron sucrose complex	Venofer	20 mg/ml	Solution for injection/infusion	Intravenous use
United Kingdom	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Monofer	100 mg/ml	Solution for injection/infusion	Intravenous use
United Kingdom	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron(III) isomaltoside complex	Diafer	50 mg/ml	Solution for injection	Intravenous use
United Kingdom	Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark	Iron (III) hydroxide dextran complex	Cosmofer	50 mg/ml	Solution for injection/infusion	Intravenous use intramuscular use
United Kingdom	Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany	Iron sucrose complex	Ferrologic	20 mg/ml	Solution for injection Concentrate for solution for infusion	Intravenous use
United Kingdom	VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France	Ferric carboxymaltose	Ferinject	50 mg/ml	Solution for injection/infusion	Intravenous use

		ISSN 1977-091X
Official Journal of the European Union		C 189

English edition	Information and Notices	Volume 59 27 May 2016

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2016/C 189/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)	1
2016/C 189/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)	9

Date of the decision	Name of the medicinal product	INN (International Non-Proprietary Name)	Holder of the marketing authorisation	Number of the entry in the Community Register	Pharmaceutical form	ATC code (Anatomical Therapeutic Chemical Code)	Date of notification
4.4.2016	Rasagiline Mylan	rasagiline	Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France	EU/1/16/1090	Tablet	N04BD02	6.4.2016
8.4.2016	Palonosetron Hospira	palonosetron	Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom	EU/1/16/1100	Solution for injection	A04AA05	12.4.2016
21.4.2016	Descovy	emtricitabine/tenofovir alafenamide	Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom	EU/1/16/1099	Film-coated tablet	J05AR17	25.4.2016
25.4.2016	Lonsurf	trifluridine/tipiracil	Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France	EU/1/16/1096	Film-coated tablet	L01BC	27.4.2016
25.4.2016	Taltz	ixekizumab	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/15/1085	Solution for injection	L04AC13	28.4.2016

Date of the decision	Name of the medicinal product	Holder of the marketing authorisation	Number of the entry in the Community Register	Date of notification
4.4.2016	Gardasil 9	Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France	EU/1/15/1007	6.4.2016
4.4.2016	Humira	AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom	EU/1/03/256	6.4.2016
4.4.2016	Opdivo	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/15/1014	6.4.2016
4.4.2016	Revolade	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/10/612	6.4.2016
4.4.2016	Telzir	ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom	EU/1/04/282	6.4.2016
4.4.2016	Xgeva	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/11/703	6.4.2016
7.4.2016	Dafiro HCT	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/09/574	11.4.2016
7.4.2016	Imprida	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/06/373	11.4.2016
7.4.2016	Ziagen	ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom	EU/1/99/112	11.4.2016
8.4.2016	Entacapone Orion	Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi	EU/1/11/708	12.4.2016
8.4.2016	INCRELEX	Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France	EU/1/07/402	12.4.2016
8.4.2016	Zyprexa	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/96/022	12.4.2016
13.4.2016	Cholib	BGP Products Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom	EU/1/13/866	15.4.2016
13.4.2016	Ibandronic acid Sandoz	Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich	EU/1/11/685	15.4.2016
13.4.2016	Ixiaro	Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich	EU/1/08/501	15.4.2016
13.4.2016	Jakavi	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/12/773	15.4.2016
13.4.2016	Nemdatine	Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland	EU/1/13/824	15.4.2016
13.4.2016	Paliperidone Janssen	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/14/971	15.4.2016
13.4.2016	Ryzodeg	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/12/806	15.4.2016
13.4.2016	Tamiflu	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/02/222	15.4.2016
13.4.2016	Tresiba	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/12/807	15.4.2016
13.4.2016	Vectibix	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/07/423	15.4.2016
13.4.2016	Zypadhera	Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland	EU/1/08/479	15.4.2016
18.4.2016	Exjade	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/06/356	20.4.2016
18.4.2016	Tysabri	Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom	EU/1/06/346	20.4.2016
21.4.2016	Abilify	Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom	EU/1/04/276	25.4.2016
21.4.2016	Bonviva	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/03/265	25.4.2016
21.4.2016	Dasselta	Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/11/739	25.4.2016
21.4.2016	Desloratadine ratiopharm	ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland	EU/1/11/746	25.4.2016
21.4.2016	Exviera	AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom	EU/1/14/983	25.4.2016
21.4.2016	Helicobacter Test INFAI	INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142, D-44799 Bochum, Deutschland	EU/1/97/045	25.4.2016
21.4.2016	Nplate	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/08/497	25.4.2016
21.4.2016	Temozolomide SUN	Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland	EU/1/11/697	25.4.2016
21.4.2016	Yervoy	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/11/698	25.4.2016
21.4.2016	Zoely	Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland	EU/1/11/690	25.4.2016
25.4.2016	Bondronat	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/96/012	27.4.2016
25.4.2016	Competact	Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark	EU/1/06/354	27.4.2016
25.4.2016	Cubicin	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/05/328	27.4.2016
25.4.2016	Invokana	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/13/884	27.4.2016
25.4.2016	Jardiance	Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/14/930	27.4.2016
25.4.2016	Picato	Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark	EU/1/12/796	27.4.2016
25.4.2016	Trizivir	ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom	EU/1/00/156	27.4.2016
25.4.2016	Tysabri	Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom	EU/1/06/346	27.4.2016
28.4.2016	ABILIFY MAINTENA	Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom	EU/1/13/882	3.5.2016
28.4.2016	Forxiga	AstraZeneca AB SE-151 85 Södertälje, Sverige	EU/1/12/795	2.5.2016
28.4.2016	Levetiracetam ratiopharm	ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland	EU/1/11/702	2.5.2016
28.4.2016	Synjardy	Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/15/1003	2.5.2016
28.4.2016	Viekirax	AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom	EU/1/14/982	3.5.2016
28.4.2016	Vokanamet	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/14/918	2.5.2016
28.4.2016	Xigduo	AstraZeneca AB SE-151 85 Södertälje, Sverige	EU/1/13/900	2.5.2016
28.4.2016	ZALTRAP	Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France	EU/1/12/814	2.5.2016

Date of the decision	Name of the medicinal product	Holder of the marketing authorisation	Number of the entry in the Community Register	Date of notification
4.4.2016	Meloxidolor	Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland	EU/2/13/148	6.4.2016
12.4.2016	BTVPUR	Merial 29 avenue Tony Garnier, F-69007 Lyon, France	EU/2/10/113	14.4.2016
12.4.2016	Poulvac E. coli	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/12/140	14.4.2016
18.4.2016	CERTIFECT	Merial 29 avenue Tony Garnier, F-69007 Lyon, France	EU/2/11/125	20.4.2016
18.4.2016	Clomicalm	Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom	EU/2/98/007	20.4.2016
18.4.2016	ECOPORC SHIGA	IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland	EU/2/13/149	20.4.2016
18.4.2016	Pexion	Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/2/12/147	20.4.2016
18.4.2016	Profender	Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland	EU/2/05/054	20.4.2016
18.4.2016	Zulvac 1 Bovis	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/11/130	20.4.2016
18.4.2016	Zulvac 1 Ovis	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/11/131	20.4.2016
20.4.2016	Aftovaxpur Doe	Merial 29 avenue Tony Garnier, F-69007 Lyon, France	EU/2/13/153	22.4.2016
20.4.2016	Oncept IL-2	Merial 29 avenue Tony Garnier, F-69007 Lyon, France	EU/2/13/150	22.4.2016
27.4.2016	Draxxin	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/03/041	29.4.2016
27.4.2016	Naxcel	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/05/053	29.4.2016