# C_2007203EN.01001001.xml

| 31.8.2007 | EN | Official Journal of the European Union | C 203/10 |
| --- | --- | --- | --- |

31.8.2007

EN

Official Journal of the European Union

C 203/10

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2007 to 31 July 2007

(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

)

(2007/C 203/04)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 10.7.2007 | Enurace 50 | See Annex I | See Annex I | 11.7.2007 |
| 11.7.2007 | Ciprofloxacin Hikma | See Annex II | See Annex II | 12.7.2007 |
| 20.7.2007 | MIRCERA | Roche Registration Limited |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City AL7 1TW |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.7.2007

Enurace 50

See Annex I

See Annex I

11.7.2007

11.7.2007

Ciprofloxacin Hikma

See Annex II

See Annex II

12.7.2007

20.7.2007

MIRCERA

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

This Decision is addressed to the Member States

24.7.2007

30.7.2007

BeneFix

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

This Decision is addressed to the Member States

31.7.2007

30.7.2007

Vantas

See Annex III

See Annex III

31.7.2007

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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

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| The Netherlands, Belgium, Germany, France, Italy, Spain and the United Kingdom | ACE Pharmaceuticals BV |
| Schepenveld 41 |
| 3891 ZK Zeewolde |
| Nederland |
| (31-36) 522 72 01 |
| (31-36) 522 90 96 |
| fs@ace-pharm.nl |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

The Netherlands, Belgium, Germany, France, Italy, Spain and the United Kingdom

ACE Pharmaceuticals BV

Schepenveld 41

3891 ZK Zeewolde

Nederland

(31-36) 522 72 01

(31-36) 522 90 96

fs@ace-pharm.nl

Enurace 50

Tablets

50 mg

Female dogs

For oral administration only, to be administered with food

A starting dose of 2 mg ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended

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ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| The Netherlands | Hikma Farmacêutica (Portugal), Lda. |
| Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença |
| P-2705-906 Terrugem SNT |

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

The Netherlands

Hikma Farmacêutica (Portugal), Lda.

Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença

P-2705-906 Terrugem SNT

Ciprofloxacin Hikma 200 mg/100 ml Oplossing voor Intraveneuze Infusie

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Austria

| Hikma Farmacêutica (Portugal), Lda. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença |
| P-2705-906 Terrugem SNT |

Hikma Farmacêutica (Portugal), Lda.

Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença

P-2705-906 Terrugem SNT

Ciprofloxacin Hikma 200 mg/100 ml Infusionslösung

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Germany

| Hikma Farmacêutica (Portugal), Lda. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença |
| P-2705-906 Terrugem SNT |

Hikma Farmacêutica (Portugal), Lda.

Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença

P-2705-906 Terrugem SNT

Ciprofloxacin Hikma 200 mg/100 ml Lösung zur intravenösen Anwendung

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Ireland

| Hikma Farmacêutica (Portugal), Lda. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença |
| P-2705-906 Terrugem SNT |

Hikma Farmacêutica (Portugal), Lda.

Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença

P-2705-906 Terrugem SNT

Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Italy

| Hikma Farmacêutica (Portugal), Lda. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença |
| P-2705-906 Terrugem SNT |

Hikma Farmacêutica (Portugal), Lda.

Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença

P-2705-906 Terrugem SNT

Ciprofloxacin Hikma 200 mg/100 ml Soluzione per Infusione Endovenosa

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

United Kingdom

| Hikma Farmacêutica (Portugal), Lda. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença |
| P-2705-906 Terrugem SNT |

Hikma Farmacêutica (Portugal), Lda.

Estrada do Rio da Mó n.o 8, 8A e 8B — Fervença

P-2705-906 Terrugem SNT

Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

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ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Denmark | Valera Pharmaceuticals Ireland Ltd |
| 25-28 North Wall Quay |
| Dublin |
| Ireland |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Denmark

Valera Pharmaceuticals Ireland Ltd

25-28 North Wall Quay

Dublin

Ireland

Vantas

50 mg

Implant

Subcutaneous

50 mg

Germany

| Valera Pharmaceuticals Ireland Ltd |
| --- |
| 25-28 North Wall Quay |
| Dublin |
| Ireland |

Valera Pharmaceuticals Ireland Ltd

25-28 North Wall Quay

Dublin

Ireland

Vantas

50 mg

Implant

Subcutaneous

50 mg

Ireland

| Valera Pharmaceuticals Ireland Ltd |
| --- |
| 25-28 North Wall Quay |
| Dublin |
| Ireland |

Valera Pharmaceuticals Ireland Ltd

25-28 North Wall Quay

Dublin

Ireland

Vantas

50 mg

Implant

Subcutaneous

50 mg

Italy

| Valera Pharmaceuticals Ireland Ltd |
| --- |
| 25-28 North Wall Quay |
| Dublin |
| Ireland |

Valera Pharmaceuticals Ireland Ltd

25-28 North Wall Quay

Dublin

Ireland

Vantas

50 mg

Implant

Subcutaneous

50 mg

Spain

| Valera Pharmaceuticals Ireland Ltd |
| --- |
| 25-28 North Wall Quay |
| Dublin |
| Ireland |

Valera Pharmaceuticals Ireland Ltd

25-28 North Wall Quay

Dublin

Ireland

Vantas

50 mg

Implant

Subcutaneous

50 mg

United Kingdom

| Valera Pharmaceuticals Ireland Ltd |
| --- |
| 25-28 North Wall Quay |
| Dublin |
| Ireland |

Valera Pharmaceuticals Ireland Ltd

25-28 North Wall Quay

Dublin

Ireland

Vantas

50 mg

Implant

Subcutaneous

50 mg

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