# C_2008245EN.01002101.xml

| 26.9.2008 | EN | Official Journal of the European Union | C 245/21 |
| --- | --- | --- | --- |

26.9.2008

EN

Official Journal of the European Union

C 245/21

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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)
  )

(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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

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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 | Zentiva a. s. |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Content

(Concentration)

Czech Republic

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Estonia

| Zentiva a. s. |
| --- |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneus use

30 mg/g

Hungary

| Zentiva a. s. |
| --- |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cuteaneus use

30 mg/g

Lithuania

| Zentiva a. s. |
| --- |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Latvia

| Zentiva a. s. |
| --- |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Poland

| Zentiva a. s. |
| --- |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

Slovakia

| Zentiva a. s. |
| --- |
| U Kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva a. s.

U Kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Coxtral Gel

30 mg/g

Gel

Cutaneous use

30 mg/g

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