EN Official Journal of the European Union C 91/11

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014

(decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2014/C 91/03

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification 20.2.2014 Acipimox See Annex I See Annex I See Annex I 24.2.2014 28.2.2014 Nanotop See Annex II See Annex II See Annex II 3.3.2014 28.2.2014 Enrofloxacin See Annex III See Annex III See Annex III 4.3.2014 28.2.2014 Fentanyl fentanyl (single substance- transmucosal formulations) Not applicable Not applicable 3.3.2014

(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, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State (in EEA) Marketing authorisaton holder INN Invented name Strength Pharmaceutical form Route of administration Austria Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Vienna Austria Acipimox Olbetam - Kapseln 250 mg capsule oral use Belgium PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles Belgium Acipimox Olbetam 250 mg capsule oral use Denmark Pfizer ApS, Lautrupvang 8, 2750 Ballerup Denmark Acipimox Olbetam 250 mg capsule, hard oral use Hungary Pfizer Gyógyszerkereskedelmi Kft. Alkotás St 53 1123 Budapest Hungary Acipimox Olbetam 250 mg kemény kapszula 250 mg capsule, hard oral use Italy Pfizer Italia S.r.l. via Isonzo, 71 04100 Latina Italy Acipimox OLBETAM 250 mg capsule, hard oral use Luxembourg PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles Belgium Acipimox Olbetam 250 mg capsule oral use The Netherlands Pfizer B.V. Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands Acipimox Olbetam 250 mg capsule oral use United Kingdom Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom Acipimox Olbetam 250 mg Capsules 250 mg capsule oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/ MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Austria ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany NANOTOP 0,5 mg Kit für ein radioaktives Arzneimittel 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use Finland ROTOP Pharmaka AG Bautzner Landstraße 400 01328 Dresden Germany ROTOP-NanoHSA 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use France ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany ROTOP-NanoHSA 0,5 mg Trousse pour préparation radiopharmaceutique 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use Germany ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany NANOTOP 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use Italy ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany NANOTOP 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use Norway ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany Nanotop 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use Portugal ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany NANOTOP 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use or intravenous use Spain ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany ROTOP-NanoHSA 500 microgramos equipo de reactivos para preparación radiofarmacéutica 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use Sweden ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany NanoHSA 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use United Kingdom ROTOP Pharmaka AG Bautzner Landstraße 400 D-01328 Dresden Germany Nanotop 0,5 mg Kit for radiopharmaceutical preparation Subcutaneous use, Intravenous use