EN Official Journal of the European Union C 328/14

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017

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

(2017/C 328/02)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 7.8.2017 Paracetamol/ibuprofen 500 mg/150 mg Film-coated tablets and associated names paracetamol/ibuprofen See Annex I See Annex I 8.8.2017 10.7.2017 Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. tylosin See Annex II See Annex II 11.7.2017 19.7.2017 Cardioxane dexrazoxane See Annex III See Annex III 24.7.2017 28.8.2017 Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) See Annex IV See Annex IV 30.8.2017 14.7.2017 Denagard 45 % and associated names Tiamulin hydrogen fumarate See Annex V See Annex V 17.7.2017

— Refusal of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 10.7.2017 Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. tylosin See Annex II See Annex II 11.7.2017

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

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

ANNEX I List of medicinal products and presentations Member State EU/EEA Applicant (Invented) Name INN + Strength Pharmaceutical form4 Route of administration5 Austria Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Ibucomb 500 mg/150 mg film coated tablet oral Belgium Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Combogesic 500 mg/150 mg film coated tablet oral Croatia Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Combogesic 500 mg/150 mg film coated tablet oral France Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Paracetamol/Ibuprofen Vale 500 mg/150 mg film coated tablet oral Germany Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Paracetamol/Ibuprofen Vale 500 mg/150 mg film coated tablet oral Ireland Clonmel Healthcare Waterford Road Clonmel Co. Tipperary E91 D768 Ireland Easolief Duo 500 mg/150 mg film coated tablet oral Luxembourg Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Paracomb 500 mg/150 mg film coated tablet oral The Netherlands Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Paraprofen 500 mg/150 mg film coated tablet oral Portugal Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Maxigesic 500 mg/150 mg film coated tablet oral Spain Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Dolostop Plus 500 mg/150 mg comprimidos recubiertos con película 500 mg/150 mg film coated tablet oral United Kingdom (UK/H/6034/001/DC) Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Paracetamol/Ibuprofen 500 mg/150 mg film coated tablets 500 mg/150 mg film coated tablet oral United Kingdom (UK/H/6035/001/DC) Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Paracetamol/Ibuprofen 500 mg/150 mg film coated tablets 500 mg/150 mg film coated tablet oral United Kingdom (UK/H/6176/001/DC) Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland Novogesic 500 mg/150 mg film coated tablets 500 mg/150 mg film coated tablet oral

ANNEX II List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration and applicants/marketing authorisation holders in the Member States Member State EU/EEA Applicant/Marketing authorisation holder Name INN Pharmaceutical form Strength Animal species Route of administration Austria Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium PHARMASIN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Austria Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLAXEN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Austria Vana GmbH Wolfgang Schmälzl-Gasse 6 1020 Wien Austria Vanatyl 200 mg/ml — Injektionslösung für Tiere Tylosin Solution for injection 200,000 IU/ml Cattle Calves Sheep Goats Pigs Dogs IM Belgium Cross Vetpharma Group Ltd Broomhill Road, Tallagh Dublin 24 Ireland Bilovet Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Belgium VETOQUINOL SA/NV Kontichsesteenweg 42 2630 Aartselaar Belgium Tylucyl Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Bulgaria Biovet JSC 39, Petar Rakov Str. 4550 Pesthera Bulgaria PHARMASIN 200 mg/ml solution for injection for cattle, sheep, goats and pigs Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Croatia VETOQUINOL SA Magny-Vernois 70200 Lure France Tylucyl 200 mg/mL otopina za injekcije za goveda i svinje Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Cyprus VETOQUINOL SA Magny-Vernois 70200 Lure France Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Denmark Biovet JSC 39, Petar Rakov Str. 4550 Pesthera Bulgaria Tylaxene Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Denmark Huvepharma NV Uitbreidingstraat 80 BE-2600 Antwerpen Belgium Tylmasin Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Denmark Vetoquinol Scandinavia AB Lyngbyvej 20 DK-2100 København Denmark Tylucyl Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Estonia Vétoquinol SA, Magny-Vernois 70200 Lure France Tylucyl Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Finland VETOQUINOL SA/NV Kontichsesteenweg 42 2630 Aartselaar Belgium Tylucyl Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) France LILLY France 24 Boulevard Vital Bouhot 92200 Neuilly Sur Seine France TYLAN 200 Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) France HUVEPHARMA Uitbredingstraat 53 2600 Antwerp Belgium PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) France Biovet JSC 39, Petar Rakov Str. 4550 Pesthera Bulgaria TYLAXEN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) France CROSS VETPHARM GROUP Broomhill Road Dublin 24 Tallaght Ireland BILOVET 200 MG/ML SOLUTION INJECTABLE Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) France VETOQUINOL Magny Vernois 70200 Lure France TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Germany Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Germany Vétoquinol GmbH Parkstr. 10 88212 Ravensburg Germany Tylucyl 200 mg/ml Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Germany HUVEPHARMA NV Uitbreidingstraat 80 2600 Antwerpen Belgium Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Germany Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd. Broomhill Road, Tallagh Dublin 24 Ireland Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Greece Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLAXEN Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Hungary Huvepharma N.V. Uitbreidingstraat 80 2600 Antwerpen Belgium PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Hungary Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLAXEN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Hungary VETOQUINOL SA Magny Vernois 70200 LURE France Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Ireland Eli Lilly & Company Limited Elanco Animal Health Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Tylan 200, 200 mg/ml Solution for Injection Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Ireland Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria Tylaxen 200 mg/ml solution for injection for cattle, sheep, goats and pigs. Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Ireland Huvepharma N.V. Uitbreidingsstraat 80 2600 Antwerpen Belgium Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Ireland Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24 Ireland Bilovet 200 mg/ml Solution for Injection for cattle and pigs. Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Italy Vetoquinol Italia S.r.l. Via Piana 265 47032 Bertinoro (FC) Italy TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Italy FATRO S.p.A. Via Emilia 285 40064 Ozzano Emilia (BO) Italy VETIL Tylosin Solution for injection 200,000 IU/ml Cattle Pigs Dogs IM Italy Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLAXEN 200 mg/ml soluzione iniettabile Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Italy ELI LILLY ITALIA S.p.A. Via Gramsci, 731/733 50019 Sesto Fiorentino Firenze Italy TYLAN 200 Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Italy HUVEPHARMA NV Uitbreidingstraat 80 2600 Anversa Belgium PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Latvia Vetoquinol S.A. Magny-Vernois B.P. 189 Lure Cedex France Tylucyl Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) The Netherlands CROSS VETPHARM GROUP Ltd. Broomhill Road, Tallaght Dublin 24 Ireland BILOVET 200 mg/ml oplossing voor injectie voor runderen en varkens Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Poland Huvepharma NV Uitbreidingstraat 80 2600 Antwerpia Belgium Pharmasin Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Poland Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria Tylaxen Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Poland Aniserve UG Geyerspergerstrasse 27 80689 Munich Germany Bilovet 200 Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Poland Vetoquinol Biowet Sp. z o.o. ul. Kosynierów Gdyńskich 13-14 66-400 Gorzów Wielkopolski Poland Tylucyl 200 mg/ml solution for injection Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Portugal Vetoquinol S.A. Magny-Vernois B.P. 189 Lure Cedex France Tylucyl 200 mg/ml, solução injetável para bovinos e suínos Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Portugal Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium PHARMASIN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Portugal Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLAXEN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Portugal Lilly Portugal — Produtos Farmacêuticos, Lda R. Cesário Verde, 5 — piso 4 Linda-a-Pastora 2790-326 Queijas Portugal Tylan 200 mg/ml Solução injetável para bovinos e suínos Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Romania Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria Tylaxen 200 mg/ml Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Romania Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24 Ireland Bilovet 200 mg/ml Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Slovak Republic Vétoquinol s.r.o. Zámečnická 411 288 02 Nymburk Czech Republic TYLUCYL 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Slovak Republic Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLOVET B-200 mg/ml injekčný roztok Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Slovenia VETOQUINOL SA Magny-Vernois 70200 Lure France Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Spain CROSS VETPHARM GROUP LIMITED. Broomhill Road, Tallaght Dublin 24 Ireland BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM Spain VETOQUINOL ESPECIALIDADES VETERINARIAS, S.A. A. Fuencarral Alcobendas km 15 700 Edificio Europa I Portal 3 2o5 28108 Alcobendas (Madrid) Spain TYLUCIL 200 mg/ml SOLUCIÓN INYECTABLE Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) Spain Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium PHARMASIN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PO Tylosin Solution for injection 200,000 IU/ml Cattle Sheep Goats Pigs IM slow IV (cattle) Spain Biovet JSC, 39 Petar Rakov Str. 4550 Peshtera Bulgaria TYLAXEN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PORC Tylosin Solution for injection 200,000 IU/ml Cattle sheep Goats Pigs IM slow IV (cattle) Sweden Vetoquinol Scandinavia AB Box 9 265 21 Åstorp Sweden Tylucyl Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle) United Kingdom Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24 Ireland Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM United Kingdom Eli Lilly & Company Ltd Elanco Animal Health Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Tylan 200, 200 mg/ml Solution for Injection Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM United Kingdom Vetoquinol UK Ltd Vetoquinol House Great Slade Buckingham Industrial Park Buckingham MK18 1PA United Kingdom Tylucyl 200 mg/ml solution for injection for cattle and pigs Tylosin Solution for injection 200,000 IU/ml Cattle Pigs IM slow IV (cattle)

ANNEX III List of medicinal products and presentations Member State EU/EEA Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration Czech Republic Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use France Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use Germany Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use Italy Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use The Netherlands Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use Poland Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use Spain Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg polvo para solución para perfusión 500 mg Powder for solution for infusion Intravenous use United Kingdom Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW United Kingdom Cardioxane 500 mg Powder for solution for infusion Intravenous use

ANNEX IV List of nationally authorised medicinal products Member state Marketing Authorisation Holder Short name of the Medicinal Product Active substance + Strength Pharmaceutical Form Austria Symbiopharm Gmbh Symbioflor E. Coli Escherichia Coli 15 — 45 Mega Cells/ml Oral Drops, Suspension Germany Symbiopharm Gmbh Symbioflor 2 Escherichia Coli 15 — 45 Mega Cells/ml Oral Drops, Suspension Hungary Symbiopharm Gmbh Symbioflor Escherichia Escherichia Coli 15 — 45 Mega Cells/ml Oral Drops, Suspension