EN Official Journal of the European Union C 53/10

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

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

2013/C 53/04

— 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 21.1.2013 Tolperisone and associated names - See Annex I See Annex I 23.1.2013





— 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 14.1.2013 Levothyroxine Alapis See Annex II See Annex II 15.1.2013





— Revocation 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 21.1.2013 Tolperisone and associated names - See Annex I See Annex I 23.1.2013

(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holders company name, address (Invented) Names Strengths Pharmaceutical forms Routes of administration Bulgaria Gedeon Richter Plc., Gyomroi ut 19/21, H- 1103 Budapest, Hungary Mydocalm 150 mg film-coated tablets oral use Cyprus M K STAVRINOS LTD, P.O. BOX 21074, 1501 LEFKOSIA, CYPRUS MYDOFLEX TABLET 150 MG 150 MG Tablets oral use Czech Republic Gedeon Richter Plc., Budapešť Gyömröi út 19-21 H-1103 Budapest Hungary MYDOCALM 150 MG 150 mg film-coated tablet oral use Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany Tolperisonhydrochlorid AL 150 mg Filmtabletten 150 mg film-coated tablet oral use Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany Tolperisonhydrochlorid AL 50 mg Filmtabletten 50 mg film-coated tablet oral use Germany HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany Tolperison HEXAL 50 mg 50 mg film-coated tablet oral use Germany Mylan dura GmbH Wittichstr. 6 D-64295 Darmstadt Germany Tolperison-HCL dura 150 mg Filmtabletten 150 mg film-coated tablet oral use Germany Mylan dura GmbH Wittichstr. 6 D-64295 Darmstadt Germany Tolperison-HCL dura 50 mg Filmtabletten 50 mg film-coated tablet oral use Germany Orion Corporation Orionintie 1 FIN-02200 ESPOO Finland Viveo 150 mg film-coated tablet oral use Germany PP Nature Balance Lizenz GmbH Habichthorst 34-36 D-22459 Hamburg Germany Mydocalm 50 mg film-coated tablet oral use Germany SANOCHEMIA Pharmazeutika AG Boltzmanngasse 9a-11 A-1090 Wien Austria Tolpomusc 150 mg Filmtabletten 150 mg film-coated tablet oral use Germany SANOCHEMIA Pharmazeutika AG Boltzmanngasse 9a-11 A-1090 Wien Austria Tolposan 150 mg Filmtabletten 150 mg film-coated tablet oral use Germany Stadapharm GmbH Stadastr. 2.18 D-61118 Bad-Vilbel Germany Tolperison-HCL STADA 150 mg Filmtabletten 150 mg film-coated tablet oral use Germany Stadapharm GmbH Stadastr. 2.18 D-61118 Bad-Vilbel Germany Tolperison-HCL STADA 50 mg Filmtabletten 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary MIDERIZONE 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary MIDERIZONE 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Flexirizon 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Flexirizon 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Meditolp 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Meditolp 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Merisone 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Merisone 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Myopax 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Myopax 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Myoperizone 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Myoperizone 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Myoson 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Myoson 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Meditop Gyógyszeripari Kft. Ady E. u. 1. 2097, Pilisborosjenő Hungary Tolperisone Meditop 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Richter Gedeon nyrt. Gyömrői út 19-21. 1103, Budapest Hungary MYDETON 50 mg filmtabletta 50 mg film-coated tablet oral use Hungary Richter Gedeon nyrt. Gyömrői út 19-21. 1103, Budapest Hungary MYDETON 150 mg filmtabletta 150 mg film-coated tablet oral use Hungary Richter Gedeon nyrt. Gyömrői út 19-21. 1103, Budapest Hungary MYDETON injekció 100 mg + 2,5 mg/ml solution for injection intravenous, intarmuscular Latvia Gedeon Richter Plc., Gyömrői út 19 – 21, 1103 Budapest, Hungary Mydocalm 50 mg apvalkotās tabletes 50 mg film-coated tablet oral use Latvia Gedeon Richter Plc., Gyömrői út 19 – 21, 1103 Budapest, Hungary Mydocalm 150 mg apvalkotās tabletes 150 mg film-coated tablet oral use Latvia Gedeon Richter Plc., Gyömrői út 19 – 21, 1103 Budapest, Hungary Mydocalm 100 mg/ml + 2,5 mg/ml šķīdums injekcijām 100 mg/ml + 2,5 mg/ml Solution for injection intramuscular use, intravenous use Lithuania Gedeon Richter Plc., Gyomroi ut 19-21, Budapest, H- 1103 Hungary MYDOCALM 150 mg film-coated tablet oral use Lithuania Gedeon Richter Plc., Gyomroi ut 19-21, Budapest, H- 1103 Hungary MYDOCALM 50 mg film-coated tablet oral use Lithuania Gedeon Richter Plc., Gyomroi ut 19-21, Budapest, H- 1103 Hungary MYDOCALM 100 mg/2,5 mg/ml Solution for injection Intramuscular/intravenous use Poland Gedeon Richter Plc. Budapest, Gyomroi 19-21 1103 Hungary Mydocalm 50 mg film- coated tablet oral use Poland Gedeon Richter Plc. Budapest, Gyomroi 19-21 1103 Hungary Mydocalm (100 mg + 2,5 mg)/ml solution for injection Intramuscular/intravenous use Poland Gedeon Richter Plc. Budapest, Gyomroi 19-21 1103 Hungary Mydocalm forte 150 mg film-coated tablet oral use Poland ICN Polfa Rzeszów S.A. Rzeszów, Przemysłowa 2 35-959 Poland Tolperis VP 50 mg film-coated tablet oral use Romania GEDEON RICHTER ROMÂNIA S.A. Str. Cuza-Vodă nr. 99-105,Târgu Mureș, România MYDOCALM 100 mg/ml solution for injection Intramuscular/intravenous use Romania GEDEON RICHTER ROMÂNIA S.A. Str. Cuza-Vodă nr. 99-105,Târgu Mureș, România MYDOCALM 50 mg 50 mg film-coated tablet oral use Romania GEDEON RICHTER ROMÂNIA S.A. Str. Cuza-Vodă nr. 99-105,Târgu Mureș, România MYDOCALM 150 mg 150 mg film-coated tablet oral use Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124, Cluj Napoca, România TOLPERISON 50 mg 50 mg coated tablet oral use Slovak Republic Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Hungary MYDOCALM 150 mg 150 mg film-coated tablet oral use Slovak Republic Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Hungary MYDOCALM 100 mg/1 ml Solution for injection Intramuscular/intravenous use