EN Official Journal of the European Union C 123/8

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 2014

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

2014/C 123/02

— 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 5.3.2014 Tibolona Aristo See Annex I See Annex I See Annex I 6.3.2014 21.3.2014 Norbonex See Annex II See Annex II See Annex II 25.3.2014 10.3.2014 Valebo See Annex III See Annex III See Annex III 11.3.2014 5.3.2014 Tibocina See Annex IV See Annex IV See Annex IV 6.3.2014 21.3.2014 Rocephin See Annex V See Annex V See Annex V 25.3.2014

— Refusal 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 28.3.2014 Barium selenate See Annex VI See Annex VI See Annex VI 31.3.2014

— Suspension 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 28.3.2014 Barium selenate See Annex VI See Annex VI See Annex VI 31.3.2014

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

ANNEX I List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States Member State EU/EEA Applicant company name, address (Invented) Name Strength Pharmaceutical form Route of administration Germany Aristo Pharma GmbH Wallenroder Str. 8-10 D-13435 Berlin Germany Tibolon Aristo 2,5 mg tablet oral use Spain Aristo Pharma GmbH Wallenroder Str. 8-10 D-13435 Berlin Germany Tibolona Aristo 2,5 mg tablet oral use

ANNEX II List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States Member State EU/EEA Applicant Name INN Strength Pharmaceutical form Animal species Route of administration Germany Norbrook Laboratories Limited Station Works Camlough Road Newry Co. Down BT35 6JP Northern Ireland Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle Eprinomectin 5 mg/ml Pour-on solution Cattle Topical use The Netherlands Norbrook Laboratories Limited Station Works Camlough Road Newry Co. Down BT35 6JP Northern Ireland Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle Eprinomectin 5 mg/ml Pour-on solution Cattle Topical use United Kingdom Norbrook Laboratories Limited Station Works Camlough Road Newry Co. Down BT35 6JP Northern Ireland Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle Eprinomectin 5 mg/ml Pour-on solution Cattle Topical use

ANNEX III List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States Member State EU/EEA Applicant company name, address (Invented) Name Strength Pharmaceutical form Route of administration Austria TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg And 1 mcg Tablets And Capsules, Soft Oral Belgium TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Valebo 70 mg + 1 microgram Tabletten + capsules, zacht 70 mg And 1 mcg Tablets And Capsules, Soft Oral Bulgaria TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Teвабон 70 mg таблетки и 1 микрограм меки капсули 70 mg And 1 mcg Tablets And Capsules, Soft Oral Denmark TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg And 1 mcg Tablets And Capsules, Soft Oral France TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg et 1 microgramme, comprimé et capsule molle 70 mg And 1 mcg Tablets And Capsules, Soft Oral Germany TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Valebo 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg And 1 mcg Tablets And Capsules, Soft Oral Hungary TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg tabletta és 1 mikrogramm lágy kapszula 70 mg And 1 mcg Tablets And Capsules, Soft Oral Ireland TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Teboneva 70 mg tablets and 1 microgram capsules, soft 70 mg And 1 mcg Tablets And Capsules, Soft Oral Netherlands TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg tabletten en 1 microgram zachte capsules 70 mg And 1 mcg Tablets And Capsules, Soft Oral Portugal TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg And 1 mcg Tablets And Capsules, Soft Oral Slovak Republic TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg tablety a 1 mikrogram mäkké kapsuly 70 mg And 1 mcg Tablets And Capsules, Soft Oral Slovenia TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Valebo 70 mg tablete in 1 mikrogram mehke kapsule v kombiniranem pakiranju 70 mg And 1 mcg Tablets And Capsules, Soft Oral Spain TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Tevabone 70 mg comprimidos y 1 mcg capsulas blandas 70 mg And 1 mcg Tablets And Capsules, Soft Oral United Kingdom TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht, The Netherlands Valebo 70 mg + 1 microgram Tablets + Capsules, soft 70 mg And 1 mcg Tablets And Capsules, Soft Oral

ANNEX IV List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States Member State EU/EEA Applicant company name, address (Invented) Name Strength Pharmaceutical form Route of administration Belgium Aristo Pharma GmbH Wallenroder Str. 8-10 D-13435 Berlin Germany Tibolinia 2,5 mg tablet oral use Germany Aristo Pharma GmbH Wallenroder Str. 8-10 D-13435 Berlin Germany Tibolon Aristo Doublette 2,5 mg tablet oral use Netherlands Aristo Pharma GmbH Wallenroder Str. 8-10 D-13435 Berlin Germany Tibolinia 2,5 mg tablet oral use Spain Aristo Pharma GmbH Wallenroder Str. 8-10 D-13435 Berlin Germany Tibocina 2,5 mg tablet oral use

ANNEX V List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States Member State EU/EEA Marketing authorisation holder (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Belgium N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium Rocephine 2 g Powder for solution for infusion Intravenous use 2 g Belgium N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium Rocephine 1 g Powder and solvent for solution for IM injection Intramuscular use 1 g Belgium N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium Rocephine 1 g Powder and solvent for solution for IV injection Intravenous use 1 g Denmark Roche a/s Industriholmen 59, DK-2650 Hvidovre, Danmark Rocephalin 2 g Concentrate for solution for infusion Intravenous use 2 g Denmark Roche a/s Industriholmen 59, DK-2650 Hvidovre, Danmark Rocephalin 1 g Powder and solvent for solution for injection Intramuscular or intravenous use 1 g Denmark Roche a/s Industriholmen 59, DK-2650 Hvidovre, Danmark Rocephalin 500 mg Powder and solvent for solution for injection Intramuscular or intravenous use 500 mg Finland Roche Oy Klovinpellontie 3 PL 12 02181 Espoo Finland Rocephalin cum lidocain 1 g Powder and solvent for solution for injection Intramuscular use or intravenous use 1 g Finland Roche Oy Klovinpellontie 3 PL 12 02181 Espoo Finland Rocephalin cum lidocain 500 mg Powder and solvent for solution for injection Intramuscular use or intravenous use 500 mg France Roche 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex France Rocephine 1g/10 ml, powder and solvent for solution for injection (IV, SC) 1 g/10 ml Powder and solvent for solution for injection Intravenous use or subcutaneous use 1 g France Roche 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex France Rocephine 1 g/3.5 ml, powder and solvent for solution for injection (IM, SC) 1 g/3.5 ml Powder and solvent for solution for injection Intramuscular use or subcutaneous use 1 g France Roche 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex France Rocephine 500 mg/2ml, powder and solvent for solution for injection (IM, SC) 500 mg/2 ml Powder and solvent for solution for injection Intramuscular use or subcutaneous use 500 mg France Roche 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex France Rocephine 500 mg/5ml, powder and solvent for solution for injection (IV, SC) 500 mg/5 ml Powder and solvent for solution for injection Intravenous use or subcutaneous use 500 mg Germany Roche Pharma AG Emil-Barell-Str. 1 79639 Grenzach-Wyhlen Germany Rocephin zur Infusion 2 g 2 g Powder for solution for infusion Intravenous use 2 g Germany Roche Pharma AG Emil-Barell-Str. 1 79639 Grenzach-Wyhlen Germany Rocephin i.v. 1g 1 g Powder and solvent for solution for injection Intravenous use 1 g Germany Roche Pharma AG Emil-Barell-Str. 1 79639 Grenzach-Wyhlen Germany Rocephin 500 mg 500 mg Powder and solvent for solution for injection Intramuscular or intravenous use 500 mg Greece Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125, Attiki Greece Rocephin 2 g Powder for solution for Infusion Intravenous use 2 g Greece Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125, Attiki Greece Rocephin 1 g Powder and solvent for solution for Injection intravenous use 1 g Greece Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125, Attiki Greece Rocephin 1 g Powder and solvent for solution for Injection Intramuscular use 1 g Hungary Roche (Hungary) Ltd. Edison utca 1 Budaörs H-2040 Hungary Rocephin 1 g Powder and solvent for solution for injection Intravenous use 1000 mg Hungary Roche (Hungary) Ltd. Edison utca 1 Budaörs H-2040 Hungary Rocephin 500 mg Powder and solvent for solution for injection Intramuscular use 500 mg Hungary Roche (Hungary) Ltd. Edison utca 1 Budaörs H-2040 Hungary Rocephin 250 mg Powder and solvent for solution for injection Intramuscular use 250 mg Iceland Roche a/s Industriholmen 59, DK-2650 Hvidovre, Danmark Rocephalin 2 g Concentrate for solution for infusion Intravenous use 2 g Iceland Roche a/s Industriholmen 59, DK-2650 Hvidovre, Danmark Rocephalin 1 g Powder and solvent for solution for injection Intramuscular or intravenous use 1 g Ireland Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 1 g Powder for solution for injection or infusion Intramuscular or intravenous use 1 g Ireland Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 1 g Powder and solvent for solution for IM injection Intramuscular use 1 g Italy Roche S.p.A. Piazza Durante 11 20131 Milano Italy Rocefin 2 g Powder for solution for infusion Intravenous use 2 g Italy Roche S.p.A. Piazza Durante 11 20131 Milano Italy Rocefin 1 g Powder and solvent for solution for injection intravenous use 1 g Italy Roche S.p.A. Piazza Durante 11 20131 Milano Italy Rocefin 1 g Powder and solvent for solution for injection Intramuscular use 1 g Italy Roche S.p.A. Piazza Durante 11 20131 Milano Italy Rocefin 500 mg Powder and solvent for solution for injection Intramuscular use 500 mg Italy Roche S.p.A. Piazza Durante 11 20131 Milano Italy Rocefin 250 mg Powder and solvent for solution for injection Intramuscular use 250 mg Latvia Roche Latvija SIA 8b G.Astras Street, Riga, LV1082, Latvia Rocephin 1 g pulveris injekciju šķīduma pagatavošanai 1 g Powder for solution for injection Intramuscular or intravenous use 1 g Luxembourg N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium Rocephine 2 g Powder for solution for infusion Intravenous use 2 g Luxembourg N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium Rocephine 1 g Powder and solvent for solution for IV injection Intravenous use 1 g Luxembourg N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium Rocephine 1 g Powder and solvent for solution for IM injection Intramuscular use 1 g Malta Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 2 g Powder for solution for infusion Intravenous use 2 g Malta Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 1 g Powder for solution for injection Intramuscular or intravenous use 1 g Malta Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 250 mg Powder for solution for injection Intramuscular or intravenous use 250 mg Netherlands Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands Rocephin 2 i.v. 2 g Powder for solution for infusion Intravenous use 2 g Netherlands Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands Rocephin 1 i.m. 1 g Powder for solution for injection Intramuscular use 1 g Netherlands Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands Rocephin 1 i.v. 1 g Powder for solution for injection Intravenous use 1 g Netherlands Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands Rocephin 0,5 i.v. 500 mg Powder for solution for injection Intravenous use 500 mg Netherlands Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands Rocephin 0,25 i.m. 250 mg Powder for solution for injection Intramuscular use 250 mg Portugal Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal Rocephin 2 g Powder for solution for infusion Intravenous use 2 g Portugal Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal Rocephin 1000 mg/10 ml Powder and solvent for solution for injection intravenous use 1 g Portugal Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal Rocephin 1000 mg/3,5 ml Powder and solvent for solution for injection Intramuscular use 1 g Portugal Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal Rocephin 500 mg/2 ml Powder and solvent for solution for injection Intramuscular use 500 mg Portugal Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal Rocephin 250 mg/2 ml Powder and solvent for solution for injection Intramuscular use 250 mg Romania Roche România SRL Piaţa Presei Libere, Nr. 3-5, Clădirea City Gate–Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România Rocephin 2 g pulbere pentru soluţie perfuzabilă 2 g Powder for solution for infusion Intravenous use 2 g Sweden Roche AB Box 47327 100 74 Stockholm Sweden Rocephalin 2 g Powder for solution for infusion Intravenous use 2 g Sweden Roche AB Box 47327 100 74 Stockholm Sweden Rocephalin 1 g Powder and solvent for solution for injection Intramuscular or intravenous use 1 g Sweden Roche AB Box 47327 100 74 Stockholm Sweden Rocephalin 1 g Powder and solvent for solution for injection Intramuscular use 1 g United Kingdom Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 2 g Powder for solution for injection/infusion Intramuscular or intravenous use 2 g United Kingdom Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 1 g Powder for solution for injection Intramuscular or intravenous use 1 g United Kingdom Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom Rocephin 250 mg Powder for solution for injection Intramuscular or intravenous use 250 mg