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Document 52009XC0731(09)
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
IO C 178, 31.7.2009, p. 24–27
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
31.7.2009 |
EN |
Official Journal of the European Union |
C 178/24 |
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2009/C 178/13
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
||||||
|
2.6.2009 |
Betavert N |
See Annex I |
See Annex I |
3.6.2009 |
||||||
|
10.6.2009 |
Renvela |
|
This Decision is addressed to the Member States |
11.6.2009 |
||||||
|
22.6.2009 |
Aclasta |
|
This Decision is addressed to the Member States |
24.6.2009 |
(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, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of Administration |
|||||
|
Austria |
|
|
Vertimen 8 mg Tabletten |
8 mg |
tablet |
oral use |
|||||
|
Austria |
|
|
Vertimen 16 mg Tabletten |
16 mg |
tablet |
oral use |
|||||
|
Bulgaria |
|
|
Vertisan 8 mg Таблетка |
8 mg |
tablet |
oral use |
|||||
|
Bulgaria |
|
|
Vertisan 16 mg Таблетка |
16 mg |
tablet |
oral use |
|||||
|
Czech Republic |
|
|
Vertisan® 8 mg Tableta |
8 mg |
tablet |
oral use |
|||||
|
Czech Republic |
|
|
Vertisan® 16 mg Tableta |
16 mg |
tablet |
oral use |
|||||
|
Germany |
|
|
Betavert® N 8 mg Tabletten |
8 mg |
tablet |
oral use |
|||||
|
Germany |
|
|
Betavert® N 16 mg Tabletten |
16 mg |
tablet |
oral use |
|||||
|
Hungary |
|
|
Vertisan® N 8 mg Tabletta |
8 mg |
tablet |
oral use |
|||||
|
Hungary |
|
|
Vertisan® N 16 mg Tabletta |
16 mg |
tablet |
oral use |
|||||
|
Poland |
|
|
Vertisan 8 |
8 mg |
tablet |
oral use |
|||||
|
Poland |
|
|
Vertisan 16 |
16 mg |
tablet |
oral use |
|||||
|
Romania |
|
|
Vertisan® 8 mg Comprimate |
8 mg |
tablet |
oral use |
|||||
|
Romania |
|
|
Vertisan® 16 mg Comprimate |
16 mg |
tablet |
oral use |
|||||
|
Slovak Republic |
|
|
Vertisan® 8 mg Tablety |
8 mg |
tablet |
oral use |
|||||
|
Slovak Republic |
|
|
Vertisan® 16 mg Tablety |
16 mg |
tablet |
oral use |