EN Official Journal of the European Union C 252/10

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015

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

(2015/C 252/02)

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 5.6.2015 Ikorel and Dancor See Annex I See Annex I See Annex I 6.6.2015 25.6.2015 Merisone See Annex II See Annex II See Annex II 26.6.2015 25.6.2015 Myoson See Annex III See Annex III See Annex III 26.6.2015

(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, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States Member State (in EEA) Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration Austria MERCK Gesellschaft mbH Zimbagasse 5 1147 Wien Austria Dancor 10 mg — Tabletten 10 mg tablet oral use Austria MERCK Gesellschaft mbH Zimbagasse 5 1147 Wien Austria Dancor 20 mg — Tabletten 20 mg tablet oral use Denmark Sanofi-Aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark ANGICOR 10 mg tablet oral use Denmark Sanofi-Aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark ANGICOR 20 mg tablet oral use France Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014 Paris France IKOREL 10 mg scored tablet oral use France Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014 Paris France IKOREL 20 mg tablet oral use France Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014 Paris France NICORANDIL ZENTIVA 10 mg scored tablet oral use France Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014 Paris France NICORANDIL ZENTIVA 20 mg tablet oral use France Merck Santé 37, Rue Saint-Romain 69379 Lyon Cedex 08 France Adancor 10 mg scored tablet oral use France Merck Santé 37, Rue Saint-Romain 69379 Lyon Cedex 08 France Adancor 20 mg tablet oral use Ireland Sanofi-Aventis Ireland L Ltd., T/A SANOFI Citywest Business Campus Dublin 24 Ireland IKOREL 10 mg tablet oral use Ireland Sanofi-Aventis Ireland L Ltd., T/A SANOFI Citywest Business Campus Dublin 24 Ireland IKOREL 20 mg tablet oral use Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E Gouda Netherlands IKOREL 10 mg 10 mg tablet oral use Portugal Merck, S.A. Edifício DUO Miraflores Alameda Fernão Lopes, no 12 — 4o B, 1495-190 Algés Portugal Dancor 10 mg tablet oral use Portugal Merck, S.A. Edifício DUO Miraflores Alameda Fernão Lopes, no 12 — 4o B, 1495-190 Algés Portugal Dancor 20 mg tablet oral use United Kingdom Aventis Pharma Limited One Onslow Street Guildford Surrey GU1 4YS UK IKOREL 10 mg tablet oral use United Kingdom Aventis Pharma Limited One Onslow Street Guildford Surrey GU1 4YS UK IKOREL 20 mg tablet oral use

ANNEX II List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States Member State EU/EEA Applicant (Invented) Name Strength Pharmaceutical form Route of administration Germany Meditop Pharmaceutical Ltd., Ady Endre utca 1. H2097 Pilisborosjenő, Hungary Tolperison-neuraxpharm 50 mg Filmtabletten 50 mg film-coated tablet oral use Germany Meditop Pharmaceutical Ltd., Ady Endre utca 1. H2097 Pilisborosjenő, Hungary Tolperison-neuraxpharm 150 mg Filmtabletten 150 mg film-coated tablet oral use Hungary Meditop Pharmaceutical Ltd., Ady Endre utca 1. H2097 Pilisborosjenő, Hungary MERISONE 50 mg film-coated tablet oral use Hungary Meditop Pharmaceutical Ltd., Ady Endre utca 1. H2097 Pilisborosjenő, Hungary MERISONE 150 mg film-coated tablet oral use