EN Official Journal of the European Union C 32/9

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

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

(2015/C 032/02)

— 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 16.12.2014 Plendil See Annex I See Annex I See Annex I 17.12.2014 11.12.2014 Suanovil 20 Captalin See Annex II See Annex II See Annex II 12.12.2014 22.12.2014 Oxynal-Targin See Annex III See Annex III See Annex III 23.12.2014 5.12.2014 Resflor See Annex IV See Annex IV See Annex IV 9.12.2014 16.12.2014 Polymyxin See Annex V See Annex V See Annex V 17.12.2014 22.12.2014 Docetaxel Docetaxel and alcohol in their formulation Not applicable Not applicable 23.12.2014

(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 product, route of administration, marketing authorisation holders in the Member States Member State EU/EEA Marketing authorisation holder (Invented) Name Strength Pharmaceutical form Route of administration Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 1037 Wien Austria Plendil retard 2,5 mg — Filmtabletten 2,5 mg Prolonged-release tablet Oral use Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 1037 Wien Austria Plendil retard 5 mg — Filmtabletten 5 mg Prolonged-release tablet Oral use Belgium NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium Plendil 5 mg Retard 5 mg Prolonged-release tablet Oral use Belgium NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium Plendil 10 mg Retard 10 mg Prolonged-release tablet Oral use Bulgaria AstraZeneca AB S-151 85 Södertälje Sweden Плендил (Plendil) 5 mg Prolonged-release tablet Oral use Croatia AstraZeneca d.o.o. Radnička cesta 80 10 000 Zagreb Croatia Plendil 5 mg tablete s produljenim oslobađanjem 5 mg Prolonged-release tablet Oral use Croatia AstraZeneca d.o.o. Radnička cesta 80 10 000 Zagreb Croatia Plendil 10 mg tablete s produljenim oslobađanjem 10 mg Prolonged-release tablet Oral use Cyprus AstraZeneca AB S-151 85 Södertälje Sweden Plendil 2,5 mg Prolonged-release tablets Oral use Cyprus AstraZeneca AB S-151 85 Södertälje Sweden Plendil 5 mg Prolonged-release tablet Oral use Cyprus AstraZeneca AB S-151 85 Södertälje Sweden Plendil 10 mg Prolonged-release tablet Oral use Czech Republic AstraZeneca UK Limited 2 Kingdom Street London W2 6BD United Kingdom PLENDIL ER 5 mg 5 mg Prolonged-release tablet Oral use Czech Republic AstraZeneca UK Limited 2 Kingdom Street London W2 6BD United Kingdom PLENDIL ER 10 mg 10 mg Prolonged-release tablet Oral use Denmark AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark Plendil 2,5 mg Prolonged-release tablet Oral use Denmark AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark Plendil 5 mg Prolonged-release tablet Oral use Denmark AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark Plendil 10 mg Prolonged-release tablet Oral use Estonia AstraZeneca AB S-151 85 Södertälje Sweden Plendil 2,5 mg Prolonged-release tablet Oral use Estonia AstraZeneca AB S-151 85 Södertälje Sweden Plendil 5 mg Prolonged-release tablet Oral use Estonia AstraZeneca AB S-151 85 Södertälje Sweden Plendil 10 mg Prolonged-release tablet Oral use Finland AstraZeneca Oy Itsehallintokuja 4 02600 Espoo Finland Plendil 2,5 mg Prolonged-release tablet Oral use Finland AstraZeneca Oy Itsehallintokuja 4 02600 Espoo Finland Plendil 5 mg Prolonged-release tablet Oral use Finland AstraZeneca Oy Itsehallintokuja 4 02600 Espoo Finland Plendil 10 mg Prolonged-release tablet Oral use France AstraZeneca 1 place Renault 92844 Rueil-Malmaison Cedex France FLODIL 5 mg Prolonged-release tablet Oral use Germany AstraZeneca GmbH 22876 Wedel Germany Modip 2,5 mg 2,5 mg Prolonged-release tablet Oral use Germany AstraZeneca GmbH 22876 Wedel Germany Modip 5 mg 5 mg Prolonged-release tablet Oral use Germany AstraZeneca GmbH 22876 Wedel Germany Modip 10 mg 10 mg Prolonged-release tablet Oral use Greece AstraZeneca S.A. Theotokopoulou & Astronafton str 151 25 Maroussi Greece Plendil 2,5 mg Prolonged-release tablet Oral use Greece AstraZeneca S.A. Theotokopoulou & Astronafton str 151 25 Maroussi Greece Plendil 5 mg Prolonged-release tablet Oral use Greece AstraZeneca S.A. Theotokopoulou & Astronafton str 151 25 Maroussi Greece Plendil 10 mg Prolonged-release tablet Oral use Hungary AstraZeneca Kft. H-1113 Budapest Bocskai út 134-146 Hungary Plendil 2,5 mg retard filmtabletta 2,5 mg Prolonged-release tablet Oral use Hungary AstraZeneca Kft. H-1113 Budapest Bocskai út 134-146 Hungary Plendil 5 mg retard filmtabletta 5 mg Prolonged-release tablet Oral use Iceland AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark Plendil 2,5 mg Prolonged-release tablet Oral use Iceland AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark Plendil 5 mg Prolonged-release tablet Oral use Iceland AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark Plendil 10 mg Prolonged-release tablet Oral use Ireland AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom Plendil 2,5 mg Prolonged-release, Film-coated Tablets 2,5 mg Prolonged-release tablet Oral use Ireland AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom Plendil 5 mg Prolonged-release, Film-coated Tablets 5 mg Prolonged-release tablet Oral use Ireland AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom Plendil 10 mg Prolonged-release, Film-coated Tablets 10 mg Prolonged-release tablet Oral use Italy AstraZeneca S.p.A Palazzo Volta Via F. Sforza 20080 Basiglio (MI) Italy Plendil 5 mg compresse a rilascio prolungato 5 mg Prolonged-release tablet Oral use Italy AstraZeneca S.p.A Palazzo Volta Via F. Sforza 20080 Basiglio (MI) Italy Plendil 10 mg compresse a rilascio prolungato 10 mg Prolonged-release tablet Oral use Italy AstraZeneca S.p.A Palazzo Volta Via F. Sforza 20080 Basiglio (MI) Italy Feloday 5 mg compresse a rilascio prolungato 5 mg Prolonged-release tablet Oral use Italy AstraZeneca S.p.A Palazzo Volta Via F. Sforza 20080 Basiglio (MI) Italy Feloday 10 mg compresse a rilascio prolungato 10 mg Prolonged-release tablet Oral use Italy SIMESA S.p.A Palazzo Galileo Via F. Sforza 20080 Basiglio (MI) Italy Prevex 5 mg compresse a rilascio prolungato 5 mg Prolonged-release tablet Oral use Italy SIMESA S.p.A Palazzo Galileo Via F. Sforza 20080 Basiglio (MI) Italy Prevex 10 mg compresse a rilascio prolungato 10 mg Prolonged-release tablet Oral use Latvia AstraZeneca AB S-151 85, Södertälje Sweden Plendil 5 mg ilgstošās darbības tabletes 5 mg Prolonged-release tablet Oral use Latvia AstraZeneca AB S-151 85, Södertälje Sweden Plendil 10 mg ilgstošās darbības tabletes 10 mg Prolonged-release tablet Oral use Lithuania AstraZeneca AB S-151 85, Södertälje Sweden Plendil 2,5 mg Prolonged-release tablet Oral use Lithuania AstraZeneca AB S-151 85, Södertälje Sweden Plendil 5 mg Prolonged-release tablet Oral use Lithuania AstraZeneca AB S-151 85, Södertälje Sweden Plendil 10 mg Prolonged-release tablet Oral use Luxembourg NV AstraZeneca SA Rue Egide van Ophemstraat B-1180 Brussel Belgium PLENDIL 5 mg Retard 5 mg Prolonged-release tablet Oral use Luxembourg NV AstraZeneca SA Rue Egide van Ophemstraat B-1180 Brussel Belgium PLENDIL 10 mg Retard 10 mg Prolonged-release tablet Oral use Malta Astra Zeneca AB Gartunavagen, S-151 85 Sodertalje, Sweden Plendil 5 mg Prolonged-release, Film-coated Tablets 5 mg Prolonged-release tablet Oral use Netherlands AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands Plendil 2,5 2,5 mg Prolonged-release tablet Oral use Netherlands AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands Plendil 5 5 mg Prolonged-release tablet Oral use Netherlands AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands Plendil 10 10 mg Prolonged-release tablet Oral use Norway AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway Plendil 2,5 mg Prolonged-release tablet Oral use Norway AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway Plendil 5 mg Prolonged-release tablet Oral use Norway AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway Plendil 10 mg Prolonged-release tablet Oral use Poland AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 5 mg Prolonged-release tablet Oral use Poland AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 10 mg Prolonged-release tablet Oral use Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7 Queluz de baixo 2730-097 Barcarena Portugal Preslow 5 mg Prolonged-release tablet Oral use Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7 Queluz de baixo 2730-097 Barcarena Portugal Preslow 10 mg Prolonged-release tablet Oral use Romania AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 2,5 mg Prolonged-release tablet Oral use Romania AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 5 mg Prolonged-release tablet Oral use Romania AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 10 mg Prolonged-release tablet Oral use Slovak Republic AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 2,5 mg 2,5 mg Prolonged-release tablet Oral use Slovak Republic AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 5 mg 5 mg Prolonged-release tablet Oral use Slovak Republic AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 10 mg 10 mg Prolonged-release tablet Oral use Spain AstraZeneca Farmacéutica Spain, S.A. C/Serrano Galvache 56 Edificio Roble 28033 Madrid Spain Plendil 5 mg comprimidos de liberación prolongada 5 mg Prolonged-release tablet Oral use Sweden AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 2,5 mg Prolonged-release tablet Oral use Sweden AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 5 mg Prolonged-release tablet Oral use Sweden AstraZeneca AB S-151 85 Sodertalje Sweden Plendil 10 mg Prolonged-release tablet Oral use Sweden AstraZeneca AB S-151 85 Sodertalje Sweden Felodipin AstraZeneca 2,5 mg Prolonged-release tablet Oral use Sweden AstraZeneca AB S-151 85 Sodertalje Sweden Felodipin AstraZeneca 5 mg Prolonged-release tablet Oral use Sweden AstraZeneca AB S-151 85 Sodertalje Sweden Felodipin AstraZeneca 10 mg Prolonged-release tablet Oral use United Kingdom AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom Plendil 2,5 mg Prolonged-release tablet Oral use United Kingdom AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom Plendil 5 mg Prolonged-release tablet Oral use United Kingdom AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU United Kingdom Plendil 10 mg Prolonged-release tablet Oral use

ANNEX II List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States Member State EU/EEA Applicant/Marketing Authorisation Holder Product name INN Strength Pharmaceutical form Animal species Belgium Merial Belgium SA Culliganlaan 1c 1831 Diegem Belgium Captalin Spiramycin 1 0 00 000 IU/ml Solution for injection Cattle Bulgaria Ceva Animal Health Bulgaria Ltd 26 Elemag Str., ent.B, app.1 Sofia 1113 Bulgaria Spirovet 6 00 000 IU/ml инжекционен разрвор за говеда и свине/Spirovet 6 00 000 IU/ml solution for injection for cattle and pigs Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Czech Republic Merial 29 avenue Tony Garnier 69007 Lyon France SUANOVIL 20 injekční roztok Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Czech Republic Ceva Sante Animale Z.I. La Ballastière Libourne France SPIROVET 6 00 000 IU/ml solution for injection for cattle and pigs Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Estonia Merial 29 avenue Tony Garnier 69007 Lyon France Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Estonia Ceva Sante Animale 10 avenue de la Ballastière 33500 Libourne France Spirovet Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs France Merial 29 avenue Tony Garnier 69007 Lyon France Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs France Merial 29 avenue Tony Garnier 69007 Lyon France Captalin Spiramycin 1 0 00 000 IU/ml Solution for injection Cattle France Ceva Sante Animale 10 avenue de la Ballastière 33500 Libourne France Spirovet Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs France Ceva Sante Animale 10 avenue de la Ballastière 33500 Libourne France Spiramycine CEVA 6 00 000 UI/ML solution injectable pour bovins et porcins Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Greece Merial 29 avenue Tony Garnier 69007 Lyon France Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Hungary Merial 29 avenue Tony Garnier 69007 Lyon France Suanovil 20 % injekció Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Hungary Ceva-Phylaxia Zrt. Szállás u. 5 1107 Budapest Hungary Spirovet 6 00 000 NE/ml, injekció szarvasmarha és sertés részére Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Ireland Ceva Sante Animale 10 avenue de la Ballastière 33500 Libourne France SPIROVET 6 00 000 IU/ml solution for injection for cattle and pigs Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Italy Merial Italia S.p.A. Via Vittor Pisani 16 20124 Milano Italy Captalin Spiramycin 1 0 00 000 IU/ml Solution for injection Cattle Italy Merial Italia S.p.A. Via Vittor Pisani 16 20124 Milano Italy Spiramin Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Italy Ceva Salute Animale S.p.A. Viale Colleoni, 15 20864 Agrate Brianza (MB) Italy Spiravet 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Latvia Merial 29 avenue Tony Garnier 69007 Lyon France Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Lithuania Ceva Sante Animale Z.I. La Ballastière 33500 Libourne France SPIROVET 6 00 000 TV/ml, injekcinis tirpalas galvijams ir kiaulėms Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Portugal Merial Portuguesa — Saúde Animal, LDA Av. Maria Lamas, lote 19 — BL. A Piso 2 Parque Industrial e Comercial Serra das Minas 2635-432 Rio de Mouro Portugal Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Portugal Ceva Saúde Animal — Produtos Farmacêuticos e Imunológicos, Lda. Rua Doutor António Loureiro Borges, 9/9A, 9oA Miraflores 1495-131 Algés Portugal SPIROVET 6 00 000 UI/ml solução injetável para bovinos e suínos Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Romania Ceva Sante Animale Z.I. de la Ballastière, BP 126 33500 Libourne Cedex FRANCE Spirovet Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Romania Merial Rue de Bourgelat 17 69002 Lyon France Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Slovakia Merial 29 avenue Tony Garnier 69007 Lyon France Suanovil 20 injekčný roztok Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Slovenia Ceva Sante Animale 10 avenue de la Ballastière 33500 Libourne France SPIROVET 6 00 000 IU/ml raztopina za injiciranje za govedo in prašiče Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs Spain Merial Laboratorios S.A. Tarragona, No 161 — Locales D/E 08820 Barcelona Spain Suanovil 20 Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs United Kingdom Ceva Animal Health Ltd Unit 3 Anglo Office Park White Lion Road Amersham Buckinghamshire HP7 9FB United Kingdom Spirovet Spiramycin 6 00 000 IU/ml Solution for injection Cattle Pigs

ANNEX III List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States Member State (in EEA) Marketing authorisation holder INN Product name Strength Pharmaceutical form Route of administration Austria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Austria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Austria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Austria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Belgium Mundipharma Comm. VA Blarenberglaan 3C, Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral Belgium Mundipharma Comm. VA Blarenberglaan 3C, Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral Belgium Mundipharma Comm. VA Blarenberglaan 3C, Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral Belgium Mundipharma Comm. VA Blarenberglaan 3C, Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Bulgaria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Bulgaria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Bulgaria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Bulgaria Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Cyprus Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral Cyprus Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral Cyprus Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral Cyprus Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Czech Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) Targin 5 mg/2,5 mg tablety s prodlouženým uvolňováním 5 mg/2,5 mg prolonged-release tablets oral Czech Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) Targin 10 mg/5 mg tablety s prodlouženým uvolňováním 10 mg/5 mg prolonged-release tablets oral Czech Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) Targin 20 mg/10 mg tablety s prodlouženým uvolňováním 20 mg/10 mg prolonged-release tablets oral Czech Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride) Targin 40 mg/20 mg tablety s prodlouženým uvolňováním 40 mg/20 mg prolonged-release tablets oral Denmark Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Denmark Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Denmark Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Denmark Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Estonia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral Estonia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral Estonia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral Estonia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Finland Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 10 mg/5 mg prolonged-release tablets oral Finland Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 20 mg/10 mg prolonged-release tablets oral Finland Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 5 mg/2,5 mg prolonged-release tablets oral Finland Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 40 mg/20 mg prolonged-release tablets oral France Mundipharma SAS 100, avenue de Suffren, Paris 75015 France Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral France Mundipharma SAS 100, avenue de Suffren Paris 75015 France Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral France Mundipharma SAS 100, avenue de Suffren Paris 75015 France Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral France Mundipharma SAS 100, avenue de Suffren Paris 75015 France Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Germany Mundipharma GmbH Mundipharma Str. 2 Limburg 65549 Germany Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Oxynal 10 mg/5 mg prolonged-release tablets oral Germany Mundipharma GmbH Mundipharma Str. 2, Limburg 65549 Germany Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Oxynal 20 mg/10 mg prolonged-release tablets oral Germany Mundipharma GmbH Mundipharma Str. 2, Limburg 65549 Germany Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Germany Mundipharma GmbH Mundipharma Str. 2 Limburg 65549 Germany Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Germany Mundipharma GmbH Mundipharma Str. 2 Limburg 65549 Germany Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Germany Mundipharma GmbH Mundipharma Str. 2 Limburg 65549 Germany Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Hungary Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral Hungary Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral Hungary Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral Hungary Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Iceland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Iceland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Iceland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Iceland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Ireland Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Ireland Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Ireland Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Ireland Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Italy Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano 20122 Italy Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Italy Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano 20122 Italy Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Italy Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano 20122 Italy Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Italy Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano 20122 Italy Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Latvia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride Targin 5 mg/2,5 mg prolonged-release tablets oral Latvia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride Targin 10 mg/5 mg prolonged-release tablets oral Latvia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride Targin 20 mg/10 mg prolonged-release tablets oral Latvia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride Targin 40 mg/20 mg prolonged-release tablets oral Luxembourg Mundipharma Comm. VA Blarenberglaan 3C, Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral Luxembourg Mundipharma Comm. VA Blarenberglaan 3C Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral Luxembourg Mundipharma Comm. VA Blarenberglaan 3C Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral Luxembourg Mundipharma Comm. VA Blarenberglaan 3C Mechelen 2800 Belgium Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Norway Mundipharma AS Dicks vei 10B, 1366 Lysaker Norway Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 10 mg/5 mg prolonged-release tablets oral Norway Mundipharma AS Dicks vei 10B, 1366 Lysaker Norway Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 20 mg/10 mg prolonged-release tablets oral Norway Mundipharma AS Dicks vei 10B, 1366 Lysaker Norway Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 5 mg/2,5 mg prolonged-release tablets oral Norway Mundipharma AS Dicks vei 10B, 1366 Lysaker Norway Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 40 mg/20 mg prolonged-release tablets oral Poland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Poland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Poland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Poland Norpharma A/S Slotsmarken 15, Horsholm 2970 Denmark Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Portugal Mundipharma Farmaceutica Lda Rua Duque de Palmela, no 23, Lisboa 1250-097 Portugal Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Portugal Mundipharma Farmaceutica Lda Rua Duque de Palmela, no 23, Lisboa 1250-097 Portugal Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Portugal Mundipharma Farmaceutica Lda Rua Duque de Palmela, no 23, Lisboa 1250-097 Portugal Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Portugal Mundipharma Farmaceutica Lda Rua Duque de Palmela, no 23, Lisboa 1250-097 Portugal Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Romania Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Romania Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Romania Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Romania Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Slovak Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Slovak Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Slovak Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Slovak Republic Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Slovenia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral Slovenia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral Slovenia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral Slovenia Mundipharma Gesellschaft m.b.H Apollogasse 16-18, Wien 1070 Austria Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral Spain Mundipharma Pharmaceuticals, S.L. C/Bahía de Pollensa, 11 Madrid 28042 Spain Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 5 mg/2,5 mg prolonged-release tablets oral Spain Mundipharma Pharmaceuticals, S.L. C/Bahía de Pollensa, 11 Madrid 28042 Spain Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 10 mg/5 mg prolonged-release tablets oral Spain Mundipharma Pharmaceuticals, S.L. C/Bahía de Pollensa, 11, Madrid 28042 Spain Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 20 mg/10 mg prolonged-release tablets oral Spain Mundipharma Pharmaceuticals, S.L. C/Bahía de Pollensa, 11 Madrid 28042 Spain Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targin 40 mg/20 mg prolonged-release tablets oral Sweden Mundipharma AB Mölndalsvägen 30B Göteborg 412 63 Sweden Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 10 mg/5 mg prolonged-release tablets oral Sweden Mundipharma AB Mölndalsvägen 30B Göteborg 412 63 Sweden Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 20 mg/10 mg prolonged-release tablets oral Sweden Mundipharma AB Mölndalsvägen 30B Göteborg 412 63 Sweden Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 5 mg/2,5 mg prolonged-release tablets oral Sweden Mundipharma AB Mölndalsvägen 30B Göteborg 412 63 Sweden Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targiniq 40 mg/20 mg prolonged-release tablets oral The Netherlands Mundipharma Pharmaceuticals B.V. De Wel 20, MV Hoevelaken 3871 The Netherlands Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral The Netherlands Mundipharma Pharmaceuticals B.V. De Wel 20, MV Hoevelaken 3871 The Netherlands Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral The Netherlands Mundipharma Pharmaceuticals B.V. De Wel 20, MV Hoevelaken 3871 The Netherlands Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral The Netherlands Mundipharma Pharmaceuticals B.V. De Wel 20, MV Hoevelaken 3871 The Netherlands Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral United Kingdom Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road CB4 0GW United Kingdom Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 10 mg/5 mg prolonged-release tablets oral United Kingdom Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road CB4 0GW United Kingdom Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 20 mg/10 mg prolonged-release tablets oral United Kingdom Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road CB4 0GW United Kingdom Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 5 mg/2,5 mg prolonged-release tablets oral United Kingdom Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road CB4 0GW United Kingdom Oxycodone hydrochloride/Naloxone hydrochloride dihydrate Targinact 40 mg/20 mg prolonged-release tablets oral

ANNEX IV List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States Member State EU/EEA Marketing authorisation holder Name INN Pharmaceutical form Strength Animal species Route of administration Austria Intervet GesmbH Siemensstrasse 107 1210 Wien Austria RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Belgium Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor 300, 16,5 mg/mL solution injectable pour bovines Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Bulgaria Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands РЕСФЛОР 300/16,5 мг/мл Разтвор за инжективно приложение при eдри преживни животни Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Cyprus Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Greece RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Czech Republic Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor injekční roztok pro skot Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Denmark Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor vet. injection, solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Estonia Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor vet. injection, solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Finland Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor vet. injection, solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous France Intervet MSD Santé Animale 7 Rue Olivier de Serres Angers Technopole CS 17144 49071 Beaucouzé France RESFLOR SOLUTION INJECTABLE Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Germany Intervet Deutschland GmbH Feldstraße 1a D-85716 Unterschleißheim Germany RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Greece Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Greece RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Hungary Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands RESFLOR INJEKCIÓS OLDAT Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Ireland Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest Rd. Dublin 24 Ireland RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Italy Intervet MSD Santé Animale 7 Rue Olivier de Serres Angers Technopole CS 17144 49071 Beaucouzé France RESFLOR 300/16,5 mg/mL SOLUZIONE INIETTABILE per bovini Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Latvia Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor vet. injection, solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Lithuania Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor vet. injection, solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Luxembourg Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor 300, 16,5 mg/mL solution injectable pour bovines Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous The Netherlands Intervet Nederland B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor 300, 16,5 mg/mL oplossing voor injectie voor runderen Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Norway Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor vet. injection, solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Poland Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor 300/16,5 mg/mL roztwór do wstrzykiwań dla bydła Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Portugal MSD Animal Health, Lda. Quinta da Fonte Edifício Vasco da Gama 19 2770-192 Paço de Arcos Portugal RESFLOR 300/16,5 mg/mL Solução Injectável para Bovinos Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Romania Intervet Romania s.r.l. Soseua de Centura no. 13A Comuna Chiajna Judet Ilfov Romania RESFLOR 300/16,5 mg/mL solutie injectabila pentru bovine Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Slovakia Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor injekčný roztok pre hovädzí dobytok Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Slovenia Intervet International B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Resflor 300/16,5 mg/mL raztopina za injiciranje za govedo Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous Spain Merck Sharp & Dohme Animal Health S.L. Polígono Industrial El Montalvo I c/Zeppelín no 6, parcela 38 37008 Carbajosa de la Sagrada — Salamanca Spain RESFLOR SOLUCIÓN INYECTABLE Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous United Kingdom Intervet UK Ltd. Walton Manor, Walton Milton Keynes MK7 7AJ United Kingdom RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle Florfenicol, flunixin Solution for injection 300 mg/ml 16,5 mg/ml Cattle Subcutaneous