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 or Article 38 of Directive 2001/82/EC )
Date: 2013-06-28
Institutions: European Commission
Subjects: drug surveillance, legal code, market approval, marketing standard, medicinal product, veterinary drug








C_2013184EN.01001001.xml










28.6.2013   


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







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State (in EEA)


Marketing authorisaton holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Sanofi-Aventis GmbH




Leonard-Bernstein-Str. 10




Vienna DC




A-1220 Vienna




Austria






Myolastan 50 mg - Filmtabletten


50 mg


Film-coated tablet


Oral use




Austria







MIP Pharma GmbH




Kirkeler Straße 41




D-66440 Blieskastel-Niederwürzbach




Germany






Tetrazepam-MIP 50 mg Tabletten


50 mg


Tablet


Oral use




Belgium







Will Pharma S.A.




Monplaisirlaan 33




B-1030 Brussel




Belgium






Epsipam


50 mg


Film-coated tablet


Oral use




Belgium







Sanofi Aventis Belgium N.V




Culliganlaan 1C




1831 Diegem




Belgium






Myolastan


50 mg


Film-coated tablet


Oral use




Belgium







Eurogenerics NV




Heizel Esplanade b22




1020 Brussel




Belgium






Tetrazepam EG


50 mg


Film-coated tablet


Oral use




Bulgaria







Chephasaar Chemisch- Pharmazeutische Fabrik GmbH




Mühlstrasse 50




D-66386 Sankt Ingbert




Germany






Tetrazepam-MIP


50 mg


Tablet


Oral use




Czech Republic







Sanofi-Aventis, s.r.o.




Evropská 846/176a




Praha 6 - Vokovice, 160 00




Czech Republic






MYOLASTAN


50 mg


Film-coated tablet


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






MYOLASTAN 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Daiichi Sankyo France SAS




Immeuble le Corosa




1, rue Eugene et Armand Peugeot




92508 Rueil Malmaison




France






PANOS 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Sandoz




49, avenue Georges Pompidou




92300 Levallois-Perret




France






TETRAZEPAM SANDOZ 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Zydus France




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




923752 Nanterre




France






TETRAZEPAM ZYDUS 50 mg, comprimé enrobé sécable


50 mg


Coated tablet


Oral use




France







Teva Sante




110, Esplanade du Général de Gaulle




92931 Paris La Défense Cedex




France






TETRAZEPAM TEVA 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Cristers




22 quai Gallieni




92150 Suresnes




France






TETRAZEPAM CRISTERS 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Ranbaxy Pharmacie Generiques




11-15 Quai Dion Bouton




92816 Puteaux




France






TETRAZEPAM RPG 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






TETRAZEPAM ZENTIVA 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Mylan SAS




117, allée des Parcs




69800 Saint-Priest




France






TETRAZEPAM MYLAN 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







EG Labo - Laboratoires Eurogenerics




‘Le Quintet’ - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






TETRAZEPAM EG 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







ratiopharm GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






TETRAZEPAM RATIOPHARM 50 mg, comprimé enrobé sécable


50 mg


Coated tablet


Oral use




France







Arrow Generiques




26, avenue Tony Garnier




69007 Lyon




France






TETRAZEPAM ALMUS 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Arrow Generiques




26, avenue Tony Garnier




69007 Lyon




France






TETRAZEPAM ARROW 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




France







Biogaran




15, boulevard Charles de Gaulle




92700 Colombes




France






TETRAZEPAM BIOGARAN 50 mg, comprimé pelliculé sécable


50 mg


Film-coated tablet


Oral use




Germany







1 A Pharma GmbH




Keltenring 1+3




82041 Oberhaching




Germany






Tetrazepam - 1 A Pharma


50 mg


Tablet


Oral use




Germany







AbZ-Pharma GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Tetrazepam AbZ 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Germany







Aliud Pharma GmbH




Gottlieb-Daimler-Str. 19




89150 Laichingen




Germany






Tetrazepam AL 50


50 mg


Tablet


Oral use




Germany







Aristo Pharma GmbH




Wallenroder Str. 8-10




13435 Berlin




Germany






Spasmorelax 50 mg Tabletten


50 mg


Tablet


Oral use




Germany







Aristo Pharma GmbH




Wallenroder Str. 8-10




13435 Berlin




Germany






Tetrazepam-Aristo 50 mg Tabletten


50 mg


Tablet


Oral use




Germany







Chephasaar Chemisch- Pharmazeutische Fabrik GmbH




Mühlstrasse 50




D-66386 Sankt Ingbert




Germany






Tetra-saar 50 mg


50 mg


Tablet


Oral use




Germany







Chephasaar Chemisch- Pharmazeutische Fabrik GmbH




Mühlstrasse 50




D-66386 Sankt Ingbert




Germany






Tetrazepam-MIP 100 mg Tabletten


100 mg


Tablet


Oral use




Germany







Chephasaar Chemisch- Pharmazeutische Fabrik GmbH




Mühlstrasse 50




D-66386 Sankt Ingbert




Germany






Tetrazepam-MIP 25 mg Tabletten


25 mg


Tablet


Oral use




Germany







Chephasaar Chemisch- Pharmazeutische Fabrik GmbH




Mühlstrasse 50




D-66386 Sankt Ingbert




Germany






Tetrazepam-MIP 50 mg Tabletten


50 mg


Tablet


Oral use




Germany







CT Arzneimttel GmbH




- Geschäftsanschrift -




Graf-Arco-Str. 3




89079 Ulm




Germany






Tetrazep-CT 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Germany







Hexal Aktiengesellschaft




Industriestr. 25




83607 Holzkirchen




Germany






Tetrazepam HEXAL


50 mg


Tablet


Oral use




Germany







Krewel Meuselbach GmbH




Krewelstr. 2




53783 Eitorf




Germany






Musapam


50 mg


Tablet


Oral use




Germany







KSK-Pharma Vertriebs AG




Finkenstr. 1




76327 Pfinztal-Berghausen




Germany






Tetrazepam KSK


50 mg


Film-coated tablet


Oral use




Germany







Mylan dura GmbH




Wittichstr. 6




64295 Darmstadt




Germany






Tetramdura 50 mg


50 mg


Film-coated tablet


Oral use




Germany







neuraxpharm Arzneimittel GmbH




Elisabeth-Selbert-Str. 23




40764 Langenfeld




Germany






Tetrazepam-neuraxpharm 100 mg


100 mg


Tablet


Oral use




Germany







neuraxpharm Arzneimittel GmbH




Elisabeth-Selbert-Str. 23




40764 Langenfeld




Germany






Tetrazepam-neuraxpharm 50 mg


50 mg


Tablet


Oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Tetrazepam-ratiopharm 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Tetrazepam Sandoz 50 mg Tabletten


50 mg


Tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




Germany






Tetrazepam Sandoz 50 mg Tabletten


50 mg


Tablet


Oral use




Germany







Sanofi-Aventis Deutschland GmbH




Industriepark Höchst, Gebäude K703




65926 Frankfurt am Main




Germany






Musaril, 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Germany







Stadapharm GmbH




Stadastr. 2-18




61118 Bad Vilbel




Germany






Tetrazepam STADA 50 mg Filmtabletten


50 mg


Film-coated tablet


Oral use




Latvia







Sanofi – Aventis Latvia SIA




Kr. Valdemara str. 33-8




Riga LV 1010




Latvia






Myolastan 50 mg film-coated tablets


50 mg


Film-coated tablet


Oral use




Lithuania







UAB ‘Sanofi-Aventis Lietuva’




A. Juozapavičiaus g. 6/2




LT-09310 Vilnius




Lithuania






Myolastan


50 mg


Film-coated tablet


Oral use




Luxembourg







Will Pharma S.A.




Monplaisirlaan 33




B-1030 Brussel




Belgium






Epsipam


50 mg


Film-coated tablet


Oral use




Luxembourg







Sanofi Aventis Belgium N.V




Culliganlaan 1C




1831 Diegem




Belgium






Myolastan


50 mg


Film-coated tablet


Oral use




Luxembourg







Eurogenerics NV




Heizel Esplanade b22




1020 Brussel




Belgium






Tetrazepam EG


50 mg


Film-coated tablet


Oral use




Poland







Przedsiębiorstwo Farmaceutyczne Jelfa S.A.




Wincentego st. Pola 21




58-500, Jelenia Góra, Poland






Miozepam


50 mg


Film-coated tablet


Oral use




Poland







Sanofi Aventis France




1-13, boulevard Romain Rolland




75014 Paris




France






Myolastan


50 mg


Film-coated tablet


Oral use




Poland







MIP Pharma Polska Sp. z. o.o.




ul Orzechowa 5




80-175 Gdansk




Poland






Myopam 25


25 mg


Tablet


Oral use




Poland







MIP Pharma Polska Sp. z. o.o.




ul Orzechowa 5




80-175 Gdansk




Poland






Myopam 50


50 mg


Tablet


Oral use




Poland







MIP Pharma Polska Sp. z. o.o.




ul Orzechowa 5




80-175 Gdansk




Poland






Myopam 100


100 mg


Tablet


Oral use




Poland







ratiopharm GmbH




Graf-Arco-Str. 3




89079 Ulm




Germany






Tetraratio


50 mg


Film-coated tablet


Oral use




Romania







S.C. A.C. Helcor Pharma S.R.L.




Str. Victor Babeș nr. 50, Baia Mare




Jud. Maramureș




România






RELAXAM 50 mg, comprimate filmate


50 mg


Film-coated tablet


Oral use




Slovak Republic







Sanofi-Aventis Slovakia s.r.o.




Einsteinova 24




85101 Bratislava




Slovak Republic






MYOLASTAN


50 mg


Film-coated tablet


Oral use




Spain







Sanofi Aventis, S.A.




Josep Plá, 2




08019 Barcelona




Spain






MYOLASTAN 50 mg comprimidos recubiertos


50 mg


Film-coated tablet


Oral use