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 or Article 38 of Directive 2001/82/EC )
Date: 2013-02-22
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013053EN.01001001.xml










22.2.2013   


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







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES











Member State
EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Belgium







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levothyroxine Alapis


100 microgram/ml


Oral drop solution


Oral use




Cyprus







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levothyroxine Alapis


100 microgram/ml


Oral drops, solution


Oral use




Greece







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levothyroxine/Alapis


100 microgram/ml


Oral drops, solution


Oral use




Malta







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levothyroxine Alapis


100 microgram/ml


Oral drops, solution


Oral use




Netherlands







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levothyroxine Alapis


100 microgram/ml


Oral drops, solution


Oral use




Portugal







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levotiroxina Alapis


100 microgram/ml


Oral drops, solution


Oral use




Romania







Alapis Romania SRL,




Romania, Leordeni nr.13 Street, Bragadiru, IIfov County, 077025 Romania






Levothyroxine Alapis


100 microgram/ml


Oral drops, solution


Oral use




United Kingdom







Alapis S.A.




2, Aftokratoros Nikolaou str.




17671 Athens




Greece






Levothyroxine sodium


100 microgram/ml


Oral Solution


Oral use