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Document 52008XC0926(03)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
OJ C 245, 26.9.2008, p. 21–22
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
26.9.2008 |
EN |
Official Journal of the European Union |
C 245/21 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )
(2008/C 245/04)
— Suspension 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 |
|
13.8.2008 |
Coxtral gel |
See Annex I |
See Annex I |
18.9.2008 |
(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 PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (Concentration) |
||||
|
Czech Republic |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cutaneous use |
30 mg/g |
||||
|
Estonia |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cutaneus use |
30 mg/g |
||||
|
Hungary |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cuteaneus use |
30 mg/g |
||||
|
Lithuania |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cutaneous use |
30 mg/g |
||||
|
Latvia |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cutaneous use |
30 mg/g |
||||
|
Poland |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cutaneous use |
30 mg/g |
||||
|
Slovakia |
|
|
Coxtral Gel |
30 mg/g |
Gel |
Cutaneous use |
30 mg/g |