Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-05-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012148EN.01001201.xml










25.5.2012   


EN


Official Journal of the European Union


C 148/12





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012

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

2012/C 148/02
—   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




24.4.2012


Orlistat


See Annex I


See Annex I


26.4.2012






(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State /EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Belgium







Eurogenerics NV




Heizel Esplanade b22




1020 Brussel




Belgium






Orlistat EG


60 mg


capsule, hard


oral use




Belgium







Eurogenerics NV




Heizel Esplanade b22




1020 Brussel




Belgium






Orlistat EG


120 mg


capsule, hard


oral use




Belgium







Pharmaceuticals Works Pharma SA




19, Pelplinska street




83-200 Starogard Gdanski




Poland






Orlistat Polpharma


60 mg


capsule, hard


oral use




Belgium







Pharmaceuticals Works Pharma SA




19, Pelplinska street




83-200 Starogard Gdanski




Poland






Orlistat Polpharma


120 mg


capsule, hard


oral use




Belgium







Sandoz NV/SA




Telecom Gardens




Medialaan 40




B-Vilvoorde




Belgium






Orlistat Sandoz


60 mg


capsule, hard


oral use




Belgium







Sandoz NV/SA




Telecom Gardens




Medialaan 40




B-Vilvoorde




Belgium






Orlistat Sandoz


120 mg


capsule, hard


oral use




Bulgaria







Pharmaceutical Works Polpharma S.A




19, Peplinska Street




83-200 Starogar Gdanski




Poland






Orlistat Polpharma


60 mg


capsule, hard


oral use




Bulgaria







Pharmaceutical Works Polpharma S.A




19, Peplinska Street




83-200 Starogar Gdanski




Poland






Orlistat Polpharma


120 mg


capsule, hard


oral use




Bulgaria







Teva Pharmaceuticals Bulgaria EOOD




15 N.V Gogol Str.




1124 Sofia




Bulgaria






Orlistat Teva


60 mg


capsule, hard


oral use




Bulgaria







Teva Pharmaceuticals Bulgaria EOOD




15 N.V Gogol Str.




1124 Sofia




Bulgaria






Orlistat Teva


120 mg


capsule, hard


oral use




Czech Republic







Sandoz s.r.o




U Nákladového nádraží 10




CZ-130 00, Praha 3,




Czech Republic






Orlistat Sandoz 60 mg


60 mg


capsule, hard


oral use




Czech Republic







Sandoz s.r.o




U Nákladového nádraží 10




CZ-130 00, Praha 3,




Czech Republic






Orlistat Sandoz 120 mg


120 mg


capsule, hard


oral use




Czech Republic







Teva Pharmaceuticals CR s.r.o.




Radlická 3185/1c




150 00 Prague




Czech Republic






Orlistat Teva 60 mg


60 mg


capsule, hard


oral use




Czech Republic







Teva Pharmaceuticals CR s.r.o.




Radlická 3185/1c




150 00 Prague




Czech Republic






Orlistat Teva 120 mg


120 mg


capsule, hard


oral use




Denmark







Sandoz A/S,




Edvard Thomsens Vej 14,




DK-2300 Copenhagen S,




Denmark






Orlistat "Sandoz"


60 mg


capsule, hard


oral use




Denmark







Teva Denmark A/S,




Parallelvej 10-12,




DK-2800 Kongens Lyngby,




Denmark






Orlistat "Teva"


60 mg


capsule, hard


oral use




Denmark







Teva Denmark A/S,




Parallelvej 10-12,




DK-2800 Kongens Lyngby,




Denmark






Orlistat "Teva"


120 mg


capsule, hard


oral use




Estonia







Teva Pharma B.V




Computerweg 10




3542 DR Utrecht




The Netherlands






ORLISTAT TEVA 60 MG


60 mg


capsule, hard


oral use




Estonia







Teva Pharma B.V




Computerweg 10




3542 DR Utrecht




The Netherlands






ORLISTAT TEVA 120 MG


120 mg


capsule, hard


oral use




Estonia







Pharmaceutical Works Polpharma S.A.




19 Pelplinska Str.




83-200 Starogard Gdanski




Poland






ORLISTAT POLPHARMA 60 MG


60 mg


capsule, hard


oral use




Estonia







Pharmaceutical Works Polpharma S.A.




19 Pelplinska Str.




83-200 Starogard Gdanski




Poland






ORLISTAT POLPHARMA 120 MG


120 mg


capsule, hard


oral use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






ORLISTAT SANDOZ 60 MG


60 mg


capsule, hard


oral use




Estonia







Sandoz d.d.




Verovskova 57




SI-1000 Ljubljana




Slovenia






ORLISTAT SANDOZ 120 MG


120 mg


capsule, hard


oral use




Finland







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Orlistat ratiopharm


120 mg


capsule, hard


oral use




Finland







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Orlistat ratiopharm


60 mg


capsule, hard


oral use




Finland







Sandoz A/S




Edvard Thomsens Vej 14




S 2300 Copenhagen




Denmark






Orlistat Sandoz


60 mg


capsule, hard


oral use




Finland







Stada Arzneimittel AG




Stadastrasse 2 - 18




61118 Bad Vilbel




Germany






Orlistat Stada


120 mg


capsule, hard


oral use




Finland







Stada Arzneimittel AG




Stadastrasse 2 - 18




61118 Bad Vilbel




Germany






Orlistat Stada


60 mg


capsule, hard


oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






ORLISTAT SANDOZ 120 mg, gélule


120 mg


capsule, hard


oral use




France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






ORLISTAT SANDOZ 60 mg, gélule


60 mg


capsule, hard


oral use




France







EG LABO - Laboratoires EuroGenerics




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






ORLISTAT EG 120 mg, gélule


120 mg


capsule, hard


oral use




France







EG LABO - Laboratoires EuroGenerics




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






ORLISTAT EG 60 mg, gélule


60 mg


capsule, hard


oral use




France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






ORLISTAT TEVA 120 mg, gélule


120 mg


capsule, hard


oral use




France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






ORLISTAT TEVA 60 mg, gélule


60 mg


capsule, hard


oral use




Germany







Aliud Pharma GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






Orlistat AL 60 mg Hartkapseln


60 mg


capsule, hard


oral use




Germany







HEXAL Aktiengesellschaft




Industriestr. 25




D-83607 Holzkirchen




Germany






Orlistat HEXAL 120 mg Hartkapseln


120 mg


capsule, hard


oral use




Germany







HEXAL Aktiengesellschaft




Industriestr. 25




D-83607 Holzkirchen




Germany






Orlistat HEXAL 60 mg Hartkapseln


60 mg


capsule, hard


oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






Orlistat-ratiopharm 120 mg Hartkapseln


120 mg


capsule, hard


oral use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






Orlistat-ratiopharm 60 mg Hartkapseln


60 mg


capsule, hard


oral use




Italy







EG S.P.A.




Via Scarlatti, 31




20124 Milano




Italy






ORLSTAT EUROGENERICI


60 mg


capsule, hard


oral use




Italy







EG S.P.A.




Via Scarlatti, 31




20124 Milano




Italy






ORLISTAT EG


120 mg


capsule, hard


oral use




Latvia







Sandoz d.d.,




Verovškova 57,




SI-1000 Ljubljana,




Slovenia






Orlistat Sandoz


60 mg


capsule, hard


oral use




Latvia







Sandoz d.d.,




Verovškova 57,




SI-1000 Ljubljana,




Slovenia






Orlistat Sandoz


120 mg


capsule, hard


oral use




Latvia







Pharmaceutical Works POLPHARMA SA,




19 Pelplińska Street,




83-200 Starogard Gdański,




Poland






Orlistat Polpharma


60 mg


capsule, hard


oral use




Latvia







Pharmaceutical Works POLPHARMA SA,




19 Pelplińska Street,




83-200 Starogard Gdański,




Poland






Orlistat Polpharma


120 mg


capsule, hard


oral use




Latvia







Teva Pharma B.V.,




Computerweg 10,




3542DR Utrecht,




The Netherlands






Orlistat Teva


60 mg


capsule, hard


oral use




Latvia







Teva Pharma B.V.,




Computerweg 10,




3542DR Utrecht,




The Netherlands






Orlistat Teva


120 mg


capsule, hard


oral use




Lithuania







Teva Pharma B.V.,




Computerweg 10,




3542DR Utrecht,




the Netherlands






Orlistat Teva


60 mg


capsule, hard


oral use




Lithuania







Teva Pharma B.V.,




Computerweg 10,




3542DR Utrecht,




The Netherlands






Orlistat Teva


120 mg


capsule, hard


oral use




Lithuania







Sandoz d.d.




Verovškova 57




SI-1000 Ljubljana




Slovėnia






Orlistat Sandoz


120 mg


capsule, hard


oral use




Lithuania







Sandoz d.d.




Verovškova 57




SI-1000 Ljubljana




Slovėnia






Orlistat Sandoz


60 mg


capsule, hard


oral use




Lithuania







Pharmaceutical Works POLPHARMA S.A.,




19 Pelplinska Street,




83-200 Starogard Gdanski




Poland






Orlistat Polpharma


60 mg


capsule, hard


oral use




Lithuania







Pharmaceutical Works POLPHARMA S.A.,




19 Pelplinska Street,




83-200 Starogard Gdanski




Poland






Orlistat Polpharma


120 mg


capsule, hard


oral use




Norway







Teva Sweden AB




Järnvägsgatan 11,




Box 1070,




251 10 Helsingborg




Sweden






Orlistat Teva


60 mg


capsule, hard


oral use




Norway







Teva Sweden AB




Järnvägsgatan 11,




Box 1070,




251 10 Helsingborg




Sweden






Orlistat Teva


120 mg


capsule, hard


oral use




Norway







Sandoz A/S,




Edvard Thomsens Vej 14,




2300 København S,




Denmark






Orlistat Sandoz


60 mg


capsule, hard


oral use




Poland







Pharmaceutical Works POLPHARMA SA




19, Pelplińska Street




83-200 Starogard Gdański




Poland






Orlistat Polpharma 120 mg


120 mg


capsule, hard


oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl,




Austria






Orlistat Sandoz 120 mg


120 mg


capsule, hard


oral use




Poland







STADA Arzneimittel AG




Stadastrasse 2-18




D-61118 Bad Vilbel




Germany






Orlistat STADA 120 mg


120 mg


capsule, hard


oral use




Poland







Teva Pharmaceuticals Polska Sp. z o.o.




ul. Emilii Plater 53




00-113 Warszawa




Poland






Orlistat Teva 120 mg


120 mg


capsule, hard


oral use




Poland







Pharmaceutical Works POLPHARMA SA




19, Pelplińska Street




83-200 Starogard Gdański




Poland






Orlistat Polpharma 60 mg


60 mg


capsule, hard


oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl,




Austria






Orlistat Sandoz 60 mg


60 mg


capsule, hard


oral use




Poland







STADA Arzneimittel AG




Stadastrasse 2-18




D-61118 Bad Vilbel




Germany






Orlistat STADA 60 mg


60 mg


capsule, hard


oral use




Portugal







Ciclum Farma Unipessoal, Lda.




Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B




2770-229 Paço de Arcos




Portugal






Orlistato Ciclum


60 mg


capsule, hard


oral use




Portugal







Ciclum Farma Unipessoal, Lda.




Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B




2770-229 Paço de Arcos




Portugal






Orlistato Ciclum


120 mg


capsule, hard


oral use




Portugal







Pharmaceutical Works Polpharma S.A.




19, Pelplinska street




83-200 Starogard Gdanski




Poland






Orlistato Ratiopharm


60 mg


capsule, hard


oral use




Portugal







Pharmaceutical Works Polpharma S.A.




19, Pelplinska street




83-200 Starogard Gdanski




Poland






Orlistato Ratiopharm


120 mg


capsule, hard


oral use




Romania







Pharmaceutical Works Polpharma SA,




Address: 19, Pelplińska Street,




83-200 Starogard Gdański,




Poland






Sulixa


60 mg


capsule, hard


oral use




Romania







Pharmaceutical Works Polpharma SA,




Address: 19, Pelplińska Street,




83-200 Starogard Gdański,




Poland






Orlistat Polpharma


120 mg


capsule, hard


oral use




Slovak Republic







TEVA Pharmaceuticals Slovakia s.r.o




Teslova 26




821 02 Bratislava




Slovak Republic






Orlistat Teva 60 mg


60 mg


capsule, hard


oral use




Slovak Republic







TEVA Pharmaceuticals Slovakia s.r.o.




Teslova 26




821 02 Bratislava




Slovak Republic






Orlistat Teva 120 mg


120 mg


capsule, hard


oral use




Slovak Republic







Pharmaceutical Works POLPHARMA SA




19, Pelpliňska Str.




83-200 Starogard Gdaňski




Poland






Orlistat Polpharma 60 mg


60 mg


capsule, hard


oral use




Slovak Republic







Pharmaceutical Works POLPHARMA SA




19, Pelpliňska Str.




83-200 Starogard Gdaňski




Poland






Orlistat Polpharma 120 mg


120 mg


capsule, hard


oral use




Sweden







Sandoz A/S,, Edvard Thomsens Vej 14




DK-2300 Köpenhamn S,




Denmark






Orlistat Sandoz


60 mg


capsule, hard


oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH ALMERE




The Netherlands






Orlistat Sandoz 60 mg


60 mg


capsule, hard


oral use




The Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH ALMERE




The Netherlands






Orlistat Sandoz 120 mg


120 mg


capsule, hard


oral use




United Kingdom







Teva UK Limited,




Brampton Road,




Hampden Park,




Eastbourne,




East Sussex




BN22 9AG




United Kingdom






TEVA UK Orlistat capsules 60 mg


60 mg


capsule, hard


oral use




United Kingdom







Teva UK Limited,




Brampton Road,




Hampden Park,




Eastbourne,




East Sussex




BN22 9AG




United Kingdom






TEVA UK Orlistat capsules 120 mg


120 mg


capsule, hard


oral use