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 or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2007-08-31
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

C 203/10

EN

Official Journal of the European Union

31.8.2007

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))

(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

10.7.2007

Enurace 50

See Annex I

11.7.2007

Ciprofloxacin Hikma

See Annex II

See Annex I

See Annex II

20.7.2007 MIRCERA

30.7.2007

BeneFix

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

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

Date of
notification

11.7.2007

12.7.2007

24.7.2007

This Decision is addressed
to the Member States

This Decision is addressed
to the Member States

31.7.2007

30.7.2007

Vantas

See Annex III

See Annex III

31.7.2007

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

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

ANNEX I

Member State

Applicant or Marketing
Authorisation Holder

Product invented
name

Pharmaceutical
form

Strength

Animal species

Frequency and route of
administration

Recommended dose

.

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8
2
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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

administration
to be administered

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

ANNEX II

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

Austria

Germany

Ireland

Italy

United Kingdom

Ciprofloxacin Hikma 200 mg/
100 ml Oplossing voor Intra-
veneuze Infusie

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Ciprofloxacin Hikma 200 mg/
100 ml Infusionslösung

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Ciprofloxacin Hikma 200 mg/
100 ml Lösung zur
intrave-
nösen Anwendung

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Ciprofloxacin Hikma 200 mg/
100 ml Solution for Infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Ciprofloxacin Hikma 200 mg/
100 ml Soluzione per
Infu-
sione Endovenosa

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Ciprofloxacin Hikma 200 mg/
100 ml Solution for Infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

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

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

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

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

ANNEX III

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of
administration

Content
(concentration)

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

Denmark

Germany

Ireland

Italy

Spain

United
Kingdom

Vantas

50 mg

Implant

Subcutaneous

50 mg

Vantas

50 mg

Implant

Subcutaneous

50 mg

Vantas

50 mg

Implant

Subcutaneous

50 mg

Vantas

50 mg

Implant

Subcutaneous

50 mg

Vantas

50 mg

Implant

Subcutaneous

50 mg

Vantas

50 mg

Implant

Subcutaneous

50 mg

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

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

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

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

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

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