EN Official Journal of the European Union C 102/10

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2017 to 28 February 2017

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

(2017/C 102/02)

— 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 27.2.2017 Gentamicin Gentamicin See Annex I See Annex I 18.2.2017 12.12.2016 Metformin Metformin See Annex II See Annex II 28.2.2017

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

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

ANNEX I List of the names, pharmaceutical form, 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 Name INN Strength Pharmaceutical form Animal species Route of administration Austria Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien Austria Gentavan 5 %-Durchstichflasche für Tiere gentamicin 50 mg/ml solution for injection Cattle, calves, pigs, horses, foals, dogs, cats SC, IM, slow IV Belgium EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Emdogent 100 gentamicin 100 mg/ml solution for injection Cattle, pigs, horses, dogs, cats SC, IM, slow IV Belgium VMD nv Hoge Mauw 900 B-2370 Arendonk Belgium Gentaveto 5 gentamicin 50 mg/ml solution for injection Pigs IM Belgium KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium Genta-Kel 5 % gentamicin 50 mg/ml solution for injection Cattle (calves) IM Bulgaria Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria ГЕНТАМИЦИН 10 % инжекционен разтвор GENTAMYCIN 10 % solution for injection gentamicin 100 mg/ml solution for injection Cattle, pigs, dogs, cats IM, SC, IV Bulgaria Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria ГЕНТАМИЦИН 4 % инжекционен разтвор GENTAMYCIN 4 % solution for injection gentamicin 40 mg/ml solution for injection Cattle, pigs, dogs, cats IM, SC, IV Bulgaria Interchemie werken ‘de Adelaar’ B.V. Hosterweg 26a 5811 AC Castenray The Netherlands ГЕНТА-100 GENTA-100 gentamicin 100 mg/ml solution for injection Cattle, calves, pigs IM Bulgaria VetProm JSC 26, Otets Paisii Str 2400 Radomir Bulgaria ГЕНТАМИЦИН 40 mg/ml инжекционен разтвор/ GENTAMICIN 40 mg/ml solutio pro injectionibus gentamicin 40 mg/ml solution for injection Calves, pigs, dogs, cats IM, SC Croatia Krka — Farma d.o.o. Radnička cesta 48 10000 Zagreb Croatia GENTAMICIN 80 mg/mL gentamicin 80 mg/ml solution for injection Cattle, non-food producing horses, pigs, dogs, cats IM (cattle, pigs), IV (horses), SC (dogs, cats) Croatia PROPHARMA VET d.o.o. Vijenac A. Cesarca 16 31000 Osijek Croatia NEOGENT gentamicin 80 mg/ml solution for injection Cattle, pigs, horses, dogs, cats IM, SC Cyprus FATRO S.p.A. Via Emilia, 285 40064 Ozzano Emilia (Bologna) Italy AAGENT, 50 mg/ml, solution for injection for calves and piglets up to one month old gentamicin 50 mg/ml solution for injection Calves and piglets up to one month old IM, SC, slow IV Cyprus Dimitrios Christophorou 169 Tseriou Av. 2048 Strovolos Nicosia Cyprus Gentamycin 5 % 50 mg/ml ενέσιμο διάλυμα για βοοειδή, σκύλους και γάτες gentamicin 85,0 mg/ml solution for injection Cattle, dogs, cats IM, SC, slow IV Czech Republic FATRO S.p.A. Via Emilia, 285 40064 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 IM, SC, slow IV Czech Republic KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium GENTA-KEL 50 000 IU/ml injekční roztok gentamicin 81 mg/ml solution for injection Calves, pigs, dogs IM, IV Estonia Interchemie werken ‘De Adelaar’ Eesti AS Vanapere tee 14, Pringi 74001 Viimsi Harju County Estonia Genta-100 EE gentamicin 100 mg/ml solution for injection Cattle, pigs, horses IM Estonia Interchemie werken ‘De Adelaar’ Eesti AS Vanapere tee 14, Pringi 74001 Viimsi Harju County Estonia Genta-100 gentamicin 100 mg/ml solution for injection Cattle, pigs IM Estonia KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium Genta-kel gentamicin 50 mg/ml solution for injection Calves, dogs IM, IV, SC Estonia Huvepharma AD 33 James Boucher Blvd. Sofia 1407 Bulgaria Gentacin gentamicin 100 mg/ml solution for injection Calves, dogs IM, IV France VIRBAC 1ere Avenue 2065 MLID 06516 Carros Cedex France PANGRAM 4 % gentamicin 40 000 UI/ml solution for injection Calves, dogs, cats IM, IV France Vetoquinol SA Magny-Vernois 70200 Lure France FORTICINE SOLUTION gentamicin 40 000 UI/ml solution for injection Calves IM, IV France VIRBAC 1ere Avenue 2065 MLID 06516 Carros Cedex France G.4 gentamicin 40 000 UI/ml solution for injection Calves, dogs, cats IM, IV France CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne France VETRIGEN gentamicin 50 000 UI/ml solution for injection Calves, piglets IM Germany CP-Pharma Handelsgesellschaft mbH Ostlandring 13 31303 Burgdorf Germany Genta 100 mg/ml gentamicin 100 mg/ml solution for injection Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats IM, IV, SC Germany aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Vepha-Gent forte gentamicin 50 mg/ml solution for injection Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats IM, IV, SC Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19 49377 Vechta Germany Gentacin gentamicin 50 mg/ml solution for injection Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats IM, IV, SC Germany aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Gentamicin 50 gentamicin 50 mg/ml solution for injection Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats IM, IV, SC Germany aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Genta-Sulfat 81 gentamicin 50 mg/ml solution for injection Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats IM, IV, SC Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19 49377 Vechta Germany Vetogent Inj. gentamicin 85 mg/ml solution for injection Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats IM, IV, SC Germany Bremer Pharma GmbH Werkstr. 42 34414 Warburg Germany Gentafromm gentamicin 50 mg/ml solution for injection Cattle, dogs, cats IM, IV, SC Germany Eurovet Animal Health B.V. Handelsweg 25 NL-5531 AE Bladel The Netherlands Genta 5 % gentamicin 50 mg/ml solution for injection Cattle, pigs, dogs, cats, pet birds IM, IV, SC Greece PROVET SA Aspropyrgos Attikis 19300 Greece GENTAMICIN/PROVET gentamicin 50 mg/ml solution for injection Calves, dogs, cats IM Greece KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium GENTAKEL gentamicin 50 mg/ml solution for injection Calves, pigs, dogs IM Hungary KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium Neogent 5 % injekció A.U.V. gentamicin 50 mg/ml solution for injection Cattle, pigs, dogs cattle, pigs: IM dogs: IM or SC Ireland KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium Genta 50 mg/ml solution for injection gentamicin 50 mg/ml solution for injection Cattle IM Italy FATRO S.p.A. Via Emilia, 285 40064 Ozzano Emilia (Bologna) Italy Aagent gentamicin 50 mg/ml solution for injection Calves, piglets (in the 1st month of life) IM, SC, slow IV Italy FATRO S.p.A. Via Emilia, 285 40064 Ozzano Emilia (Bologna) Italy Aagent 10 % gentamicin 100 mg/ml solution for injection Calves, piglets (in the 1st month of life) IM, SC, slow IV Italy Industria Italiana Integratori Trei S.p.A. Via Affarosa, 4 42010 Rio Saliceto (Reggio Emilia) Italy Gentabiotic gentamicin 100 mg/ml solution for injection Calves, piglets, dogs, cats IM, IV, endo peritoneal Latvia Huvepharma EOOD 3A Nikolay Haytov street Sofia 1113 Bulgaria Gentacin gentamicin 100 mg/ml solution for injection Cattle, pigs, horses, dogs, cats IM, IV, SC Latvia Bela-Pharm GmbH & Co. KG Lohner Str. 19 49377 Vechta Germany Gentamycin 5 gentamicin 85 mg/ml solution for injection Cattle, pigs, horses, dogs, cats IM, IV, SC Latvia CP-Pharma Handelsgesellschaft mbH Ostlandring 13 31303 Burgdorf Germany Genta- 100 gentamicin 100 mg/ml solution for injection Cattle, horses, dogs, cats IM, IV, SC Latvia KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium Genta-kel 10 % gentamicin 100 mg/ml solution for injection Cattle, pigs, horses, dogs IM, IV, SC Latvia Industrial Veterinaria, S.A. Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain Gentaprim trimethoprim gentamicin sulphate sulfadi-methoxinum 40 mg/ml 30 mg/ml 200 mg/ml solution for injection Cattle, pigs, horses, dogs, cats IM Latvia Bremer Pharma GmbH Werkstr. 42 34414 Warburg Germany Gentamicin BREMER PHARMA gentamicin 50 mg/ml solution for injection Cattle, dogs, cats IM, SC, slow IV Latvia KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium Genta-kel 5 % gentamicin 50 mg/ml solution for injection Cattle, pigs, dogs IM, SC, slow IV Latvia CP-Pharma Handelsgesellschaft mbH Ostlandring 13 31303 Burgdorf Germany Genta gentamicin 100 mg/ml solution for injection Cattle, horses, dogs, cats IM, SC, slow IV Lithuania CP-Pharma Handelsgesellschaft mbH Ostlandring 13 31303 Burgdorf Germany Genta 100 mg/ml, injekcinis tirpalas gentamicin 100 mg/ml solution for injection Cattle, pigs, horses, dogs, cats IM, IV, SC Lithuania Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer The Netherlands GENTA-JECT, injekcinis tirpalas gentamicin 100 mg/ml solution for injection Cattle, calves, pigs, piglets, horses, dogs, cats IM, IV, SC Lithuania Bela-Pharm GmbH & Co. KG Lohner Str. 19 49377 Vechta Germany Gentacin, injekcinis tirpalas gentamicin 85 mg/ml solution for injection Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats IM, IV, SC Lithuania Interchemie werken ‘de Adelaar’ B.V. Hosterweg 26a 5811 AC Castenray The Netherlands GENTA 100 mg/ml injekcinis tirpalas galvijams ir kiaulėms gentamicin 100 mg/ml solution for injection Cattle, calves, pigs IM Malta CENAVISA, S.L. Camí Pedra Estela s/n 43205 Reus (Tarragona) Spain Gentacen gentamicin 100 mg/ml solution for injection Calves up to 13 weeks IM Malta Industrial Veterinaria, S.A. Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain Gentaprim trimethoprim gentamicin sulfa-dimethoxin 40 mg/ml 30 mg/ml 200 mg/ml solution for injection Cattle, pigs IM Malta Laboratorios Calier, S.A. Barcelones, 26 — El Ramassar 08520 Les Franqueses del Valles (Barcelona) Spain GENTACALIER gentamicin 40 mg/ml solution for injection Cattle, calves, pigs, piglets IM, slow IV 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, cats IM, slow IV Portugal KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos gentamicin 50 mg/ml solution for injection Cattle, pigs, dogs, cats IM, SC (only dogs) Portugal VETLIMA — SOC. DISTRIBUIDORA DE PROD. AGRO-PECUÁRIOS, SA Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal GENTAVET solução injectavel gentamicin 40 mg/ml solution for injection Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats IM, slow IV Romania Alapis SA 19 300 Aspropyrgos mailbox 26 Athens Greece GENTAMICIN 5 % Gentamicin Provet 50 mg/ml gentamicin 50 mg/ml solution for injection Calves, piglets, dogs, cats IM Romania Dopharma B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands GENTA-JECT 10 % gentamicin 100 mg/ml solution for injection Cattle, pigs IV, IM, SC Romania PASTEUR — Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud. Prahova Romania GENTAMICINA FP 10 % gentamicin 100 mg/ml solution for injection Cattle, pigs, dogs, cats IM, slow IV, SC Slovak Republic FATRO S.p.A. Via Emilia, 285 40064 Ozzano Emilia (Bologna) Italy Aagent 50 mg/ml injekčný roztok gentamicin 50 mg/ml solution for injection Calves and piglets in the first month of life, horses declared as not intended for slaughter for human consumption IM, SC, slow IV Slovenia KRKA, d.d. Novo mesto, Šmarješka cesta 6 8501 Novo mesto Slovenia GENTAMICIN KRKA 80 mg/ml raztopina za injiciranje za govedo, prašiče, pse in mačke gentamicin 80 mg/ml solution for injection Cattle, pigs, dogs, cats IM Spain Laboratorios Maymo, S.A. Via Augusta, 302 08017 Barcelona Spain MAYCOLI INYECTABLE — 306 ESP gentamicin 40 mg/ml solution for injection Cattle (calves up to 250 kg), non-food-producing horses IM, slow IV Spain MEVET, S.A.U. Poligono Industrial El Segre Parcela 409-410 25191 Lérida Spain GENTAVALL 40 MG/ML SOLUCIÓN INYECTABLE — 307 ESP gentamicin 40 mg/ml solution for injection Cattle (calves up to 250 kg), non-food-producing horses, dogs, cats IM, slow IV Spain Laboratorios Calier, S.A. Barcelones, 26 — El Ramassar 08520 Les Franqueses del Valles (Barcelona) Spain GENTACALIER — 397 ESP gentamicin 40 mg/ml solution for injection Cattle (calves up to 250 kg), non-food-producing horses, dogs, cats IM, slow IV Spain Laboratorios e Industrias Iven, S.A. Luis I, 56 Poligono Industrial Vallecas 28031 Madrid Spain VETERSAN GENTAMICINA — 637 ES gentamicin 40 mg/ml solution for injection Cattle (calves up to 250 kg), non-food-producing horses, dogs, cats IM, slow IV Spain LABIANA LIFE SCIENCES, S.A. Venus, 26. Can Parellada Industrial 08228 Terrassa (Barcelona) Spain GENTASOL 80 — 638 ESP gentamicin 80 mg/ml solution for injection Cattle (calves up to 250 kg), non-food producing horses, dogs, cats IM, slow IV Spain Laboratorios e Industrias Iven, S.A. Luis I, 56 Poligono Industrial Vallecas 28031 Madrid Spain GENTAMICIVEN — 641 ESP gentamicin 40 mg/ml solution for injection Cattle (calves up to 250 kg), non-food-producing horses, dogs, cats IM, slow IV Spain SUPER'S DIANA, S.L. Ctra. C-17, Km 17 08150 Parets del Valles (Barcelona) Spain GENDIAN 60 mg/ml SOLUCIÓN INYECTABLE — 690 ESP gentamicin 60 mg/ml solution for injection Cattle (calves up to 250 kg), non-food-producing horses, dogs IM, slow IV Spain CENAVISA, S.L. Camí Pedra Estela s/n 43205 Reus (Tarragona) Spain PURMICINA 40 MG/ML SOLUCIÓN INYECTABLE — 2922 ESP gentamicin 40 mg/ml solution for injection Cattle (calves up to 250 kg), pigs (suckling pigs), horses not intended for human consumption, dogs, cats IM, slow IV Spain CENAVISA, S.L. Camí Pedra Estela s/n 43205 Reus (Tarragona) Spain GENTACEN 100 mg/ml SOLUCIÓN INYECTABLE — 2583 ESP gentamicin 100 mg/ml solution for injection Calves (up to 13 weeks of age) IM Spain S.P. VETERINARIA, S.A. Ctra Reus Vinyols, km 4.1 Riudoms (Tarragona) 43330 Spain GENTAVIN 100 mg/ml SOLUCIÓN INYECTABLE — 2584 ESP gentamicin 100 mg/ml solution for injection Calves (up to 13 weeks of age) IM Spain MEVET, S.A.U. Poligono Industrial El Segre Parcela 409-410 25191 Lérida Spain GENTAVALL 5 mg/ml SOLUCIÓN INYECTABLE — 304 ESP gentamicin 5 mg/ml solution for injection Piglets, dogs, cats IM Spain LABORATORIOS HIPRA, S.A. Avda. la Selva 135 Amer (Girona) 17170 Spain GENTIPRA — 305 ESP gentamicin 50 mg/ml solution for injection Cattle (calves up to 250kg) IM, slow IV The Netherlands Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer The Netherlands Genta-ject 10 % gentamicin 100 mg/ml solution for injection Calves up to 13 weeks of age IM