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Document 52009XC0327(03)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 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 authorizations in respect of medicinal products from 1 February 2009 to 28 February 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 authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
SL C 73, 27.3.2009, p. 16–40
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
27.3.2009 |
EN |
Official Journal of the European Union |
C 73/16 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
(2009/C 73/04)
— 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 |
||||||||||
|
4.2.2009 |
Nplate |
|
This Decision is addressed to the Member States |
6.2.2009 |
||||||||||
|
6.2.2009 |
Implanon |
See Annex I |
See Annex I |
9.2.2009 |
||||||||||
|
16.2.2009 |
Diovan |
See Annex II |
See Annex II |
17.2.2009 |
||||||||||
|
17.2.2009 |
FIRMAGON |
|
This Decision is addressed to the Member States |
18.2.2009 |
||||||||||
|
19.2.2009 |
Valdoxan |
|
This Decision is addressed to the Member States |
23.2.2009 |
||||||||||
|
19.2.2009 |
Opgenra |
|
This Decision is addressed to the Member States |
23.2.2009 |
||||||||||
|
19.2.2009 |
Thymanax |
|
This Decision is addressed to the Member States |
23.2.2009 |
||||||||||
|
24.2.2009 |
FABLYN |
|
This Decision is addressed to the Member States |
25.2.2009 |
||||||||||
|
25.2.2009 |
Ranexa |
|
This Decision is addressed to the Member States |
26.2.2009 |
||||||||||
|
25.2.2009 |
Efient |
|
This Decision is addressed to the Member States |
27.2.2009 |
||||||||||
|
26.2.2009 |
ReFacto AF |
|
This Decision is addressed to the Member States |
27.2.2009 |
(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, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORIZATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorization Holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
|
Implanon — Implantat |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Belgium |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Czech Republic |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Denmark |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Finland |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
France |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Germany |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Hungary |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Iceland |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Ireland |
|
|
Implanon 68 mg implant |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Italy |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Luxembourg |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Malta |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Netherlands |
|
|
Implanon 68 mg |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Norway |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Portugal |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Slovak Republic |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Spain |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
Sweden |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
||||||
|
United Kingdom |
|
|
Implanon |
68 mg |
Implant |
Subcutaneous use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORIZATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorization Holder |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Diovan 40 mg Filmtabletten |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Angiosan 40 mg Filmtabletten |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Diovan 80 mg Filmtabletten |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Angiosan 80 mg Filmtabletten |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Diovan 160 mg Filmtabletten |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Angiosan 160 mg Filmtabletten |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Diovan 320 mg Filmtabletten |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Austria |
|
Angiosan 320 mg Filmtabletten |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Diovane 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Novacard 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Diovane 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Novacard 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Diovane 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Novacard 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Diovane 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Novacard 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Bulgaria |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Bulgaria |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Bulgaria |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Cyprus |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Cyprus |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Cyprus |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Cyprus |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Czech Republic |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Czech Republic |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Denmark |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Denmark |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Denmark |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Denmark |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Estonia |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Estonia |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Estonia |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Estonia |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Finland |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Finland |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Finland |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Finland |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
France |
|
Tareg 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
France |
|
Tareg 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
France |
|
Tareg 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Cordinate 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Provas 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Cordinate 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Provas 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Cordinate 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Provas 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Cordinate 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Provas 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Dalzad 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Dalzad 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Dalzad 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Dalzad 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Diovan 80 mg |
80 mg |
Hard gelatine capsules |
Oral |
||||||
|
Greece |
|
Dalzad 80 mg |
80 mg |
Hard gelatine capsules |
Oral |
||||||
|
Greece |
|
Diovan 160 mg |
160 mg |
Hard gelatine capsules |
Oral |
||||||
|
Greece |
|
Dalzad 160 mg |
160 mg |
Hard gelatine capsules |
Oral |
||||||
|
Hungary |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Varexan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Varexan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Varexan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Iceland |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Iceland |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Iceland |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Iceland |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Ireland |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Ireland |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Ireland |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Ireland |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Tareg 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Rixil |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Tareg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Rixil |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Tareg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Rixil |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Tareg |
80 mg |
Hard capsules |
Oral |
||||||
|
Italy |
|
Rixil |
80 mg |
Hard capsules |
Oral |
||||||
|
Italy |
|
Tareg |
160 mg |
Hard capsules |
Oral |
||||||
|
Italy |
|
Rixil |
160 mg |
Hard capsules |
Oral |
||||||
|
Latvia |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Latvia |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Latvia |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Latvia |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Lithuania |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Lithuania |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Lithuania |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Luxembourg |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Luxembourg |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Luxembourg |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Luxembourg |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Malta |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Malta |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Malta |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Malta |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Netherlands |
|
Diovan 40 |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Netherlands |
|
Diovan 80 |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Netherlands |
|
Diovan 160 |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Netherlands |
|
Diovan 320 |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Norway |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Norway |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Norway |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Norway |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Poland |
|
Diovan |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Poland |
|
Diovan |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Poland |
|
Diovan |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Poland |
|
Diovan |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Portugal |
|
Diovan |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Portugal |
|
Diovan |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Portugal |
|
Diovan g |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Portugal |
|
Diovan |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Romania |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Romania |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Romania |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Slovak Republic |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Slovak Republic |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Slovak Republic |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Slovak Republic |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Slovak Republic |
|
Diovan 80 mg |
80 mg |
Hard gelatine capsules |
Oral |
||||||
|
Slovak Republic |
|
Diovan 160 mg |
160 mg |
Hard gelatine capsules |
Oral |
||||||
|
Slovenia |
|
Diovan 40 mg filmsko obložene tablete |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Slovenia |
|
Diovan 80 mg filmsko obložene tablete |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Slovenia |
|
Diovan 160 mg filmsko obložene tablete |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Slovenia |
|
Diovan 320 mg filmsko obložene tablete |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Diovan Cardio 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Kalpress Cardio 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Miten Cardio 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Diovan 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Kalpress 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Miten 80 mg |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Diovan 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Kalpress 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Miten 160 mg |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Kalpress 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Miten 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Diovan |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Angiosan |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Valsartan Novartis |
40 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Diovan |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Angiosan |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Valsartan Novartis |
80 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Diovan |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Angiosan |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Valsartan Novartis |
160 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Diovan |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Angiosan |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Valsartan Novartis |
320 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Diovan |
80 mg |
Hard gelatine capsules |
Oral |
||||||
|
Sweden |
|
Diovan |
160 mg |
Hard gelatine capsules |
Oral |
||||||
|
United Kingdom |
|
Diovan 40 mg |
40 mg |
Film-coated tablets |
Oral |
||||||
|
United Kingdom |
|
Diovan 320 mg |
320 mg |
Film-coated tablets |
Oral |
||||||
|
United Kingdom |
|
Diovan 40 mg |
40 mg |
Hard gelatine capsules |
Oral |
||||||
|
United Kingdom |
|
Diovan 80 mg |
80 mg |
Hard gelatine capsules |
Oral |
||||||
|
United Kingdom |
|
Diovan 160 mg |
160 mg |
Hard gelatine capsules |
Oral |