EN Official Journal of the European Union C 184/10

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013

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

2013/C 184/02

— 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 16.5.2013 Nuflor Swine Once 450 mg/ml See Annex I See Annex I 21.5.2013 27.5.2013 Simvastatin Vale and associated names See Annex II See Annex II 28.5.2013 23.5.2013 Florgane See Annex III See Annex III 24.5.2013





— Refusal 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 14.5.2013 Furosemide See Annex IV See Annex IV 15.5.2013





— 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 29.5.2013 Tetrazepam See Annex V See Annex V 29.5.2013

(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, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant Name INN Pharmaceutical form Strength Animal species Route of administration Austria (1) Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Belgium Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Bulgaria (1) Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Cyprus Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Czech Republic Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Denmark Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands PigFlor Once florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Estonia Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular France (1) Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Germany (1) Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Greece Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Hungary Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Ireland Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Italy Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands NUFLOR Suini One, 450 mg/ml soluzione iniettabile per suini florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Latvia Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Lithuania Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Luxembourg Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Malta Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular The Netherlands Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Poland Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Portugal Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Romania (1) Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Slovakia Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Slovenia Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular Spain Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Flomac porcino dosis única 450 mg/ml solución inyectable florfenicol Solution for injection 450 mg/ml Pigs Intramuscular United Kingdom Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Nuflor Swine Once 450 mg/ml solution for injection florfenicol Solution for injection 450 mg/ml Pigs Intramuscular (1) Marketing authorisation granted

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant (Invented) Name Strength Pharmaceutical form Route of administration Austria Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale 20 mg/5 ml Suspension zum Einnehmen 20 mg/5 ml oral suspension oral use Austria Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale 40 mg/5 ml Suspension zum Einnehmen 40 mg/5 ml oral suspension oral use Denmark Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Denmark Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Finland Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale 20 mg/5 ml oral suspension oral use Finland Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale 40 mg/5 ml oral suspension oral use France Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use France Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Germany Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Germany Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Greece Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Greece Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Ireland Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Ireland Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Italy Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatina Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Italy Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatina Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Netherlands Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatine Vale Pharmaceuticals 20 mg/5 ml suspensie voor oraal gebruik 20 mg/5 ml oral suspension oral use Netherlands Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatine Vale Pharmaceuticals 40 mg/5 ml suspensie voor oraal gebruik 40 mg/5 ml oral suspension oral use Norway Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Norway Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use Portugal Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Sinvastatina Vale 20 mg/5 ml oral suspension oral use Portugal Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Sinvastatina Vale 40 mg/5 ml oral suspension oral use Spain Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale 20 mg/5 ml suspensión oral 20 mg/5 ml oral suspension oral use Spain Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale 40 mg/5 ml suspensión oral 40 mg/5 ml oral suspension oral use Sweden Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use Sweden Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use United Kingdom Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 20 mg/5 ml oral suspension oral use United Kingdom Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel Co. Tipperary Ireland Simvastatin Vale Pharmaceuticals 40 mg/5 ml oral suspension oral use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant Name INN Pharmaceutical form Strength Animal species Route of administration Austria Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Belgium Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspensie voor injectie voor runderen en varkens florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Bulgaria Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml инжекционна суспензия за говеда и прасета florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Czech Republic Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml injekční suspenze pro skot a prasata florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Denmark Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml, injektionsvæske, suspension til kvæg og svin florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular France (1) Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspension injectable pour bovins et porcins florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Germany (1) Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Greece Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml Ενέσιμο εναιώρημα για Βοοειδή και χοίρους florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Hungary Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml injekció szarvasmarha és sertés részére A.U.V. florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Ireland Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspension for injection for cattle and pigs florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Italy Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml sospensione iniettabile per bovini e suini florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Lithuania Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml injekcinė suspensija galvijams ir kiaulėms florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Luxembourg Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspension injectable pour bovins et porcins florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular The Netherlands Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspensie voor injectie voor runderen en varkens florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Poland Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml, zawiesina do wstrzykiwań dla bydła i świń florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Portugal Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspensão injectável para bovinos e suínos florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Romania Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspensie injectabilă pentru bovine și porcine florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Slovakia Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml injekčná suspenzia pre hovädzí dobytok a ošípané florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular Spain (1) Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspensión inyectable para bovino y porcino florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular United Kingdom Emdoka bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium Florgane 300 mg/ml suspension for injection for cattle and pigs florfenicol Suspension for injection 300 mg/ml Cattle and pigs Intramuscular (1) Marketing authorisation granted

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant (Invented) Name Strength Pharmaceutical form Route of administration Czech Republic Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg tablety 40 mg Tablet Oral use Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemid Vitabalans 40 mg Tablet Oral use Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg tabletes 40 mg Tablet Oral use Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use Slovak Republic Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemid Vitabalans 40 mg tablety 40 mg Tablet Oral use Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemid Vitabalans 40 mg tablete 40 mg Tablet Oral use Sweden Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Furosemide Vitabalans 40 mg Tablet Oral use