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) )

(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 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 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.

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 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

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 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 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 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 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 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 Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion 2 mg/ml Solution for infusion Intravenous use 200 mg/100 ml