Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2015 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2015-03-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015104EN.01001001.xml










27.3.2015   


EN


Official Journal of the European Union


C 104/10





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2015
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2015/C 104/02)
—   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




11.2.2015


Gentamicin


See Annex I


See Annex I


See Annex I


13.2.2015






(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 products, animal species, 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


Vana GmbH
Wolfgang Schmälzl Gasse 6
1020 Wien
Austria


Gentavan 5 %-Durchstichflasche für Tiere


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Horse, foal, cattle, calf, pig, dog, cat




Belgium


EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium


Emdogent 100


Gentamicin


100 mg/ml


Solution for injection


Horses, cattle, pigs, dogs and cats




Belgium


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Genta Equine


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Horses (non food producing horses)




Croatia


Krka — Farma d.o.o.
Radnička cesta 48
10000 Zagreb
Croatia


GENTAMICIN 8 %


Gentamicin (as gentamicin sulphate)


80 mg/ml


Solution for injection


Cattle, horses (non-food producing), pigs, dogs and cats




Croatia


PROPHARMA VET d.o.o.
Vijenac A. Cesarca 16
31000 Osijek
Croatia


NEOGENT


Gentamicin (as gentamicin sulphate)


80 mg/ml


Solution for injection


Cattle, pigs, horses, dogs, cats




Czech Republic


FATRO S.p.A.
Via Emilia 285
Ozzano Emilia (Bologna)
Italy


AAGENT 50 mg/ml injekční roztok


Gentamicin


50 mg/ml


Solution for injection


Calves, foals and piglets at the age of one month




Denmark


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Genta Equine


Gentamicin


100 mg/ml


Solution for injection


Horses




Estonia


Interchemie werken ‘De Adelaar’ Eesti AS
Vanapere tee 14, Pringi
74001 Viimsi
Harjumaa
Estonia


Genta-100 EE


Gentamicin


100 mg/ml


Solution for injection


Cattle, horse, swine




Germany


CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
31303 Burgdorf
Germany


Genta 100 mg/ml


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog




Germany


Bela-Pharm GmbH & Co. KG
Lohner Str. 19
49377 Vechta
Germany


Gentacin


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Gentamicin 50


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Genta-Sulfat 81


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Vepha-Gent forte


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog




Germany


Bela-Pharm GmbH & Co. KG
Lohner Str. 19
49377 Vechta
Germany


Vetogent Inj.


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog




Iceland


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Genta Equine


Gentamicin


100 mg/ml


Solution for injection


Horses




Ireland


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Gentaject 10 % Solution for Injection


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Horses declared as not being intended for slaughter for human consumption




Latvia


CP — Pharma Handelsges. mbH
Ostlalandring 13
31303 Burgdorf,
Germany


Genta 100


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Cats, cattle, dogs, horses




Latvia


Huvepharma AD
33 James Boucher Blvd.
Sofia 1407
Bulgaria


Gentacin


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Pigs, cats, cattle, dogs, horses




Latvia


KELA N.V.
St. Lenaartseweg 48
2320 Hoogstraten
Belgium


Genta-kel 10 %


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Pigs, cattle, dogs, horses




Latvia


Bela-pharm GmbH & Co.KG
Lohner Str. 19
49377 Vechta
Germany


Gentamycin 5


Gentamicin (as gentamicin sulphate)


85 mg/ml


Solution for injection


Pigs, cats, cattle, dogs, horses




Lithuania


CP — Pharma Handelsges. mbH
Ostlalandring 13
31303 Burgdorf
Germany


Genta 100 mg/ml, injekcinis tirpalas


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Cats, dogs, cattle, pigs, horses




Lithuania


Bela-pharm GmbH & Co.KG
Lohner Str. 19
49377 Vechta
Germany


Gentacin, injekcinis tirpalas


Gentamicin (as gentamicin sulphate)


85 mg/ml


Solution for injection


Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat




Lithuania


Dopharma Research B.V.
Zalmweg 24m 4941 VX Raamsdonksveer
the Netherlands


GENTA-JECT, injekcinis tirpalas


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Cattle, calves, pigs, piglets, horses, cats and dogs




Lithuania


LABORATORIOS SYVA, S.A.
Av. Párroco Pablo Díez, 49-57
24010, León
Spain


GENTAYET 40 mg/ml injekcinis tirpalas arkliams, galvijams, kiaulėms, šunims ir katėms


Gentamicin


40 mg/ml


Solution for injection


Bovine, equine, pigs, dogs and cats




Malta


Laboratorios Calier S.A Barcelones
26 Place del Ramass
Les Franqueses del valles
Barcelona
Spain


GENTACALIER


Gentamicin


40 mg/ml


Solution for injection


Dog, cat, pig, piglets, cattle, calves, horses




Portugal


IAPSA PORTUGUESA PECUÁRIA, LDA
Avenida do Brasil no 88 7o Esq
1700-073 Lisboa
Portugal


GENTAYET 40 mg/ml solução injectável


Gentamicin


40 mg/ml


Solution for injection


Cattle, horses, dogs and cats




Slovakia


Fatro S.p.A.
Via Emilia 285
Ozzano Emília
Bologna
Italy


Aagent 50 mg/ml injekčný roztok


Gentamicin


50 mg/ml


Solution for injection


Foals, calves, sucklings — the first month of life




Spain


SUPER'S DIANA, S.L
Ctra. Barcelona — Ripoll, Km 17
08150 Parets del Vallès
Barcelona
Spain


GENDIAN-400


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


SUPER'S DIANA, S.L
Ctra. Barcelona — Ripoll, Km 17
08150 Parets del Vallès
Barcelona
Spain


GENDIAN-600


Gentamicin (as gentamicin sulphate)


60 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


FATRO IBERICA, S.L.
Constitución, 1 Planta baja 3
08960 Sant Just Desvern
Barcelona
Spain


GENTA 50


Gentamicin (as gentamicin sulphate)


50 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Genta Equine 100 mg/ml Solution for injection


Gentamicin (as gentamicin sulphate)


100 mg/ml


Solution for injection


Horses (non food producing horse)




Spain


LABORATORIOS CALIER, S.A.
C/Barcelonés, 26
08520 Les Franqueses del Valles
Barcelona
Spain


GENTACALIER


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


POLICHEM S.L.U.
C/Prudenci Bertrana, 5
Polígono Industrial Agro-Reus
Reus
43206 Tarragona
Spain


GENTACHEM


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


B.BRAUN VETCARE, S.A.
Crta. Tarrasa, 121
Rubí
Barcelona
Spain


GENTAMICINA 6 % BRAUN USO VETERINARIO


Gentamicin (as gentamicin sulphate)


60 mg/ml


Solution for injection


Equine not intended for human consumption, dogs, cats




Spain


Industrial Veterinaria, S.A.
Esmeralda, 19
08950 Esplugues de Llobregat
Barcelona
Spain


GENTAMICINA GANADEXIL


Gentamicin (as gentamicin sulphate)


35 mg/ml


Solution for injection


Horses, cattle, dogs and cats




Spain


Laboratorios e Industrias IVEN, S.A.
Polígono Industrial de Vallecas.
C/Luis I s/n.
28031 Madrid
Spain


GENTAMICIVEN


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


LABIANA LIFE SCIENCE, S.A.
C/Venus, 26
Can Parellada Industrial Terrassa
08228 Barcelona
Spain


GENTASOL 80


Gentamicin (as gentamicin sulphate)


80 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


MEVET, S.A.U
Poligono Industrial El Segre, Parcela 409-410
25191 Lérida
Spain


GENTAVALL 40 MG/ML SOLUCIÓN INYECTABLE


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Spain


LABORATORIOS SYVA, S.A.U.
Avda. Parroco Pablo Diez, 49-57
24010 León
Spain


GENTAYET


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, pigs, dogs and cats




Spain


LABORATORIOS MAYMO, S.A.
Via Augusta, 302
08017 Barcelona
Spain


MAYCOLI INYECTABLE


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle and pigs




Spain


CENAVISA
Camí Pedra Estela s/n
43205 Reus
Tarragona)
Spain


PURMICINA 40 MG/ML SOLUCIÓN INYECTABLE


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats




Spain


Laboratorios e Industrias IVEN, S.A
Luis I, 56
Poligono Industrial Vallecas
28031 Madrid
Spain


VETERSAN GENTAMICINA


Gentamicin (as gentamicin sulphate)


40 mg/ml


Solution for injection


Non food-producing horses, cattle, dogs and cats




Sweden


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Gentaject vet


Gentamicin


100 mg/ml


Solution for injection


Horse




United Kingdom


Franklin Pharmaceuticals Ltd.
Athboy Road
Trim
Co. Meath
Ireland


Genta-Equine 100 mg/ml Solution for Injection for Horses


Gentamicin


100 mg/ml


Solution for injection


Horses (non-food producing)