EN Official Journal of the European Union C 231/30

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )

2009/C 231/06

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorisation Member State concerned Date of notification 3.8.2009 Fenflor See Annex I See Annex I 5.8.2009 3.8.2009 Shotaflor See Annex II See Annex II 5.8.2009

— Suspension of a national marketing authorisation

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorisation Member State concerned Date of notification 6.8.2009 Loratadine Sandoz 10 See Annex III See Annex III 7.8.2009

(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 PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES Member State Applicant/Marketing Authorisation Holder Invented name Pharmaceutical form Strength Animal species Frequency and route of administration Austria Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Belgium Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Germany Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart France Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Ireland Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Italy Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Poland Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Portugal Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Spain Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart The Netherlands Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart United Kingdom Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park Bristol UNITED KINGDOM Fenflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES Member State Applicant/Marketing Authorisation Holder Invented name Pharmaceutical form Strength Animal species Frequency and route of administration Austria Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Belgium Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Denmark Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Germany Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart France Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Greece Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Ireland Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Italy Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Portugal Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart Spain Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart The Netherlands Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart United Kingdom Virbac S.A. 1ère avenue 2065 m L.I.D 06516 Carros Cedex FRANCE Shotaflor 300 mg/ml solution for injection for cattle Solution for injection 300 mg/ml Cattle Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart