EN Official Journal of the European Union C 24/8

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2012 to 31 December 2012

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

2013/C 24/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 17.12.2012 HIPRALONA ENRO-S and its generics See Annex I See Annex I 19.12.2012 6.12.2012 Prefluce+l and associated names See Annex II See Annex II 10.12.2012





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 20.12.2012 Loraxin See Annex III See Annex III 21.12.2012 10.12.2012 Cilazapril Teva and associated names See Annex IV See Annex IV 12.12.2012

(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, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Applicant/Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species Belgium GLOBAL VET HEALTH SL C/Capçanes no 12-bajos Polígono Agro-Reus 43206 Reus SPAIN QUINOFLOX 100 mg/ml Enrofloxacin 100 mg/ml Oral solution Chickens (Broilers, replacement chickens, broiler breeders), Rabbits Cyprus LABORATORIOS KARIZOO, S.A. Polígono Industrial La Borda Mas Pujades, 11-12 08140 Caldes de Montbui Barcelona SPAIN K-Flox 100 mg/ml Πόσιμο διάλυμα για ορνίθια κρεοπαραγωγής και κουνέλια Enrofloxacin 100 mg/ml Oral solution Chickens (broilers), Rabbits Spain LABORATORIOS HIPRA, S.A.Avda. La Selva,135 17170 Amer SPAIN HIPRALONA ENRO - S Enrofloxacin 100 mg/ml Oral solution Poultry (Chicken and Turkeys), Rabbits Spain UNIVERSAL FARMA, S.L. Gran Via Carlos III 98 - 7a 08028 Barcelona SPAIN LEVOFLOK® 100 mg/ml Oral solution for chickens and rabbits Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits Spain LABORATORIOS KARIZOO, S.A. Polígono Industrial La Borda Mas Pujades, 11-12 08140 Caldes de Montbui Barcelona SPAIN K-FLOX 100 mg/ml Oral Solution for chickens and rabbits. Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits Spain Global Vet Health, SL Capcanes, 12 bajos Poligono Agro-Reus 43206 Reus SPAIN QUINOFLOX 100 mg/ml Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits Spain SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330 Ruidoms SPAIN COLMYC -C Enrofloxacin 100 mg/ml Oral solution Poultry (Chicken and Turkeys), Rabbits France GLOBAL VET HEALTH SL c/Capçanes, no 12-bajos. Polígon Agro-Reus. 43206 Reus SPAIN Quinoflox 100 mg/ml solution for use in drinking water, chicken and rabbits Enrofloxacin 100 mg/ml Oral solution Chickens (Broilers, replacement chickens, broiler breeders), Rabbits Italy GLOBAL VET HEALTH, S.L. Capsanes, 12 - Polígono Agro-Reus E-43206 - REUS (Tarragona) SPAIN QUINOLCEN Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits Italy LABORATORIOS KARIZOO, S.A. Polígono Industrial La Borda Mas Pujades, 11-12 08140 – CALDES DE MONTBUI (Barcelona) SPAIN K-FLOX 100 mg/ml Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits Italy VETPHARMA ANIMAL HEALTH, S.L. Les Corts, 23 08028 – BARCELONA SPAIN NIFLOX 100 mg/ml Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits Poland Medivet S.A. Szkolna 17 63-100 Śrem POLAND MEDOXIL ORAL 100 mg/ml roztwór doustny dla kur i królików Enrofloxacinum 100 mg/ml Oral solution Chickens, Rabbits Portugal GLOBAL VET HEALTH SL C/Capçanes no 12-bajos Polígono Agro-Reus 43206 Reus SPAIN Quinoflox 100 mg/ml solução para administração na água de bebida para frangos e coelhos Enrofloxacin 100 mg Oral solution Chickens (Broilers, replacement chickens, broiler breeders) and rabbits Portugal VETPHARMA ANIMAL HEALTH, S.L. Les Corts, 23 08028 Barcelona SPAIN LEVOFLOK® 100 mg/ml Solução oral para frangos de carne e coelhos Enrofloxacin 100 mg Oral solution Chickens (broilers), Rabbits Portugal LABORATORIOS KARIZOO, S.A. Polígono Industrial La Borda Mas Pujades, 11-12 08140 Caldes de Montbui Barcelona SPAIN K-FLOX 100 mg/ml Solução oral para frangos de carne e coelhos Enrofloxacin 100 mg Oral solution Chickens (broilers), Rabbits Portugal Prodivet-Zn,Nutrição e Comércio de Produtos Químicos Farmacêuticos e Cosméticos SA Av. Infante D. Henrique no 333 H 3o Piso Esc. 411800-282 Lisboa PORTUGAL Prodirox 100 mg/ml solução oral para frangos e coelhos Enrofloxacin 100 mg Oral solution Chickens (broilers), Rabbits Portugal VETLIMA Sociedade Distr. Produtos Agro-Pecuários LDA. Centro Empresarial da Rainha Lote 27 2050-501 Vila Nova Da Rainha PORTUGAL VETAFLOX 100 mg/ml solução oral para frangos de engorda e coelhos Enrofloxacin 100 mg Oral solution Chickens (broilers), Rabbits United Kingdom Global Vet Health S.L. Calle Capcanes n12 Bajos Poligono Agro-Reus 43206 Reus SPAIN Quinoflox 100 mg/ml Solution for Use in Drinking Water, Chicken and Rabbits Enrofloxacin 100 mg/ml Oral solution Chickens, Rabbits

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State (in EEA) Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Austria Baxter AG Industriestrasse 67 Vienna 1221 Austria Preflucel Injektionssuspen sion in einer Fertigspritze 15 micrograms haemagglutinin of each of the 3 specified strains as determined by WHO per 0,5 ml dose suspension for injection in a pre-filled syringe intramuscular use Belgium Baxter S.A. Bd René Branquart 80 7860 Lessines Belgium Preflucel 15 μg-0,5 ml suspension for injection intramuscular use Czech Republic Baxter AG Industriestrasse 67 Vienna 1221 Austria PREFLUCEL 0,5 ml per dose suspension for injection intramuscular use Denmark Baxter A/S Gydevang 43 DK-3450 Allerød Denmark Preflucel 15 microgram suspension for injection in a prefilled syringe intramuscular use Finland Baxter Oy Tammasaarenkatu 1 PL 119 00181 Helsinki Finland Preflucel 15 mikrog HA/0,5 ml 15 mikrog HA/0,5 ml 15 mikrog HA/0,5 ml suspension for injection in pre-filled syringe intramuscular use Germany Baxter Deutschland GmbH Edisonstraße 4 85716 Unterschleißheim Germany PREFLUCEL 15 μgHA 15 μgHA 15 μgHA suspension for injection in prefilled syringe intramuscular use Ireland Baxter Healthcare Limited Caxton Way Thetford Norfolk IP24 3SE United Kingdom Preflucel suspension for injection in a pre- filled syringe 15 microgram suspension for injection intramuscular use Italy Baxter S.p.A. Piazzale dell'Industria 20 Rome 00144 Italy PREFLUCELL 15 micrograms suspension for injection in a pre-filled syringe intramuscular use Norway Baxter AS Gjerdrums vei 11 N-0484 Oslo Norway Preflucel 15 μg hemagglutinin of each of the 3 influenza virus strains suspension for injection in a pre-filled syringe intramuscular use Poland Baxter Polska Sp. z o.o. Kruczkowskiego 8 00-380 Warszawa Poland Preflucel A/California/07/2009 (H1N1)- 15 micrograms HA A/Perth/16/2009 (H3N2) like strain used (A/Victoria/210/2009)- 15 micrograms HA B/Brisbane/60/2008 (B)- 15 micrograms HA/HA** per 0,5 ml dose suspension for injection in a pre-filled syringe intramuscular use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira Edifício 10 Sintra Business Park 2710-089 Sintra Portugal Preflucel A/California/7/2009 (H1N1) - like virus → 0,015 mg A/Perth/16/2009 (H3N2) - like virus → 0,015 mg B/Brisbane/60/2008 → 0,015 mg suspension for injection in a pre-filled syringe intramuscular Use Spain Baxter, S.L. Polígono Industrial Sector 14 Pouet de Camilo, 2 Ribarroja del Turia Valencia 46394 Spain PREFLUCEL SUSPENSION INYECTABLE EN JERINGA PRECARGADA A/California/07/2009 (H1N1)- 15 micrograms HA; A/Perth/16/2009 (H3N2) like strain used: (A/Victoria/210/2009)- 15 micrograms HA; B/Brisbane/60/2008 (B)- 15 micrograms HA, per 0,5 ml dose suspension for injection in prefilled syringe intramuscular use Sweden Baxter Medical AB Torshamnsgatan 35 Box 63 164 94 Kista Sweden Preflucel (NA) solution for injection, pre filled syringe intramuscular use The Netherlands Baxter B.V. Kobaltweg 49 3542 CE Utrecht The Netherlands Preflucel 2011/2012, suspensie voor injectie 0,5 ml 0,5 ml per dose suspension for injection intramuscular use United Kingdom Baxter Healthcare Limited Caxton Way Thetford Norfolk IP24 3SE United Kingdom Preflucel 15 mcg hemagglutinin of each of the 3 influenza virus strains suspension for injection in a pre-filled syringe intramuscular use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Czech Republic Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tablety 10 mg tablet oral use Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loraxin 10 mg tablet oral use Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tablet oral use Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loraxin 10 mg tablet oral use Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loraxin 10 mg tablet oral use Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tabletes 10 mg tablet oral use Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loraxin 10 mg tablet oral use Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tablet oral use Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tablet oral use Slovak Republic Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg 10 mg tablet oral use Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tablete 10 mg tablet oral use Sweden Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Loratadine Vitabalans 10 mg tablet oral use