EN Official Journal of the European Union C 245/12

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2017 to 30 June 2017

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

(2017/C 245/02)

— 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 23.6.2017 Micro therapeutic Research Labs Not applicable Not applicable See Annex I 26.6.2017 26.6.2017 Etopophos and associated names etoposide phosphate Not applicable See Annex II 27.6.2017 26.6.2017 Vepesid and associated names etoposide Not applicable See Annex III 27.6.2017 12.6.2017 Haldol and associated names haloperidol Not applicable See Annex V 13.6.2017 20.6.2017 Veterinary medicinal products containing methylprednisolone hydrogen succinat Methylprednisolone hydrogen succinate Not applicable See Annex VI 21.6.2017

— 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 6.6.2017 Veterinary medicinal products containing Zinc oxide zinc oxide Not applicable See Annex IV 27.6.2017 20.6.2017 Veterinary medicinal products containing methylprednisolone hydrogen succinat Methylprednisolone hydrogen succinate Not applicable See Annex VI 21.6.2017

— 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 23.6.2017 Micro therapeutic Research Labs Not applicable Not applicable See Annex I 26.6.2017

— Revocation 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 26.6.2017 Veterinary medicinal products containing Zinc oxide zinc oxide Not applicable See Annex IV 27.6.2017

(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 Annex Ia: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established Member State EU/EEA Marketing authorisation holder Applicant Invented name Active Substance Strength Pharmaceutical form Route of administration Czech Republic SVUS Pharma a.s. MORYSA 10 MG POTAHOVANÉ TABLETY memantine 10 mg Film-coated tablet Oral use Czech Republic SVUS Pharma a.s. MORYSA 20 MG POTAHOVANÉ TABLETY memantine 20 mg Film-coated tablet Oral use Denmark Alternova A/S Hydrokortison Alternova hydrocortisone 10 mg Tablet Oral use Denmark Alternova A/S Hydrokortison Alternova hydrocortisone 20 mg Tablet Oral use France Pharmascope Ltd. Memantin Pharmascope 10 mg Filmtabletten memantine 10 mg Film-coated tablet Oral use France Pharmascope Ltd. Memantin Pharmascope 20 mg Filmtabletten memantine 20 mg Film-coated tablet Oral use Germany Pharmascope Ltd. Memantin Pharmascope 10 mg Filmtabletten memantine 10 mg Film-coated tablet Oral use Germany Pharmascope Ltd. Memantin Pharmascope 20 mg Filmtabletten memantine 20 mg Film-coated tablet Oral use Hungary SVUS Pharma a.s. Morysa memantine 10 mg Film-coated tablet Oral use Hungary SVUS Pharma a.s. Morysa memantine 20 mg Film-coated tablet Oral use Poland SVUS Pharma a.s. Morysa memantine 10 mg Film-coated tablet Oral use Poland SVUS Pharma a.s. Morysa memantine 20 mg Film-coated tablet Oral use Portugal SVUS Pharma a.s. Morysa memantine 10 mg Film-coated tablet Oral use Portugal SVUS Pharma a.s. Morysa memantine 20 mg Film-coated tablet Oral use Romania Pharmascope Ltd. Memantin Pharmascope 10 mg Filmtabletten memantine 10 mg Film-coated tablet Oral use Romania Pharmascope Ltd. Memantin Pharmascope 20 mg Filmtabletten memantine 20 mg Film-coated tablet Oral use Slovak Republic SVUS Pharma a.s. Morysa memantine 10 mg Film-coated tablet Oral use Slovak Republic SVUS Pharma a.s. Morysa memantine 20 mg Film-coated tablet Oral use Sweden Pharmascope Ltd. Memantine Pharmascope memantine 10 mg Film-coated tablet Oral use Sweden Pharmascope Ltd. Memantine Pharmascope memantine 20 mg Film-coated tablet Oral use Sweden Alternova A/S Bendro-flumetiazid Alternova bendro-flumethiazide 2,5 mg Tablet Oral use Sweden BBS Consult Aps Hydrokortison BBS hydrocortisone 10 mg Tablet Oral use Sweden BBS Consult Aps Hydrokortison BBS hydrocortisone 20 mg Tablet Oral use The Netherlands Pharmascope Ltd. Memantine Pharmascope 10 mg filmomhulde tabletten memantine 10 mg Film-coated tablet Oral use The Netherlands Pharmascope Ltd. Memantine Pharmascope 20 mg filmomhulde tabletten memantine 20 mg Film-coated tablet Oral use United Kingdom Dawa Limited Memantine Dawa 10 mg film-coated tablets memantine 10 mg Film-coated tablet Oral use United Kingdom Dawa Limited Memantine Dawa 20 mg film-coated tablets memantine 20 mg Film-coated tablet Oral use United Kingdom Dawa Limited Paracetamol 1000 mg Film-Coated Tablets paracetamol 1000 mg Film-coated tablet Oral use Annex Ib: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation Member State EU/EEA Marketing authorisation holder Applicant Invented name Active Substance Strength Pharmaceutical form Route of administration Austria Sandoz GmbH Bupropion Sandoz 300 mg — Tablette mit veränderter Wirkstofffreisetzung bupropion 300 mg Modified-release tablet Oral use Austria 1A Pharma GmbH Bupropion 1A Pharma 300 mg — Tablette mit veränderter Wirkstofffreisetzung bupropion 300 mg Modified-release tablet Oral use Belgium Aurobindo Pharma BV Amlodipine-Valsartan AB amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use Belgium Aurobindo Pharma BV Amlodipine-Valsartan AB amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Belgium Aurobindo Pharma BV Amlodipine-Valsartan AB amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Belgium Sandoz n.v./s.a. Betados 8 mg betahistine 8 mg Tablet Oral use Belgium Sandoz n.v./s.a. Betados 16 mg betahistine 16 mg Tablet Oral use Belgium Sandoz n.v./s.a. Betahistine Sandoz 24 mg betahistine 24 mg Tablet Oral use Belgium Aurobindo Pharma BV Voriconazole AB voriconazol 50 mg Tablet Oral use Belgium Aurobindo Pharma BV Voriconazole AB voriconazol 200 mg Tablet Oral use Belgium Aurobindo Pharma BV Tadalafil AB tadalafil 5 mg Film-coated tablet Oral use Belgium Aurobindo Pharma BV Tadalafil AB tadalafil 10 mg Film-coated tablet Oral use Belgium Aurobindo Pharma BV Tadalafil AB tadalafil 20 mg Film-coated tablet Oral use Belgium Aurobindo Pharma BV Naproxen Aurobindo naproxen 250 mg Tablet Oral use Belgium Sandoz n.v./s.a. Bupropion HCl Sandoz bupropion 300 mg Modified-release tablet Oral use Belgium Aurobindo Pharma BV Naproxen Aurobindo naproxen 500 mg Tablet Oral use Bulgaria Sandoz B.V. Betahistin HEXAL 16 mg Tabletten betahistine 16 mg Tablet Oral use Bulgaria Sandoz B.V. Betahistin HEXAL 24 mg Tabletten betahistine 24 mg Tablet Oral use Bulgaria Sandoz B.V. Betahistin HEXAL 8 mg Tabletten betahistine 8 mg Tablet Oral use Bulgaria Proenzi s.r.o. Etrixenal naproxen 250 mg Tablet Oral use Czech Republic Famy Care Europe Ltd. LARCIA 125 MIKROGRAMŮ/30 MIKROGRAMŮ ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg Tablet Oral use Czech Republic Famy Care Europe Ltd. Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol/levonorgestrel 0.03 mg/0,125 mg Tablet Oral use Czech Republic Sandoz B.V. BETAHISTIN SANDOZ 8 MG betahistine dihydrochloride 8 mg Tablet Oral use Czech Republic Sandoz B.V. BETAHISTIN SANDOZ 16 MG betahistine dihydrochloride 16 mg Tablet Oral use Czech Republic Sandoz B.V. BETAHISTIN SANDOZ 24 MG betahistine dihydrochloride 24 mg Tablet Oral use Czech Republic Proenzi s.r.o. ETRIXENAL 250 MG TABLETY naproxen 250 mg Tablet Oral use Denmark EQL Pharma AB Hydroxyzinhydrochlorid EQL Pharma hydroxyzine 25 mg Film-coated tablet Oral use Denmark Alternova A/S Dicloxacillin Alternova dicloxacillin 250 mg Capsule, hard Oral use Denmark Alternova A/S Dicloxacillin Alternova dicloxacillin 500 mg Capsule, hard Oral use Denmark 2care4 Aps Betahistin 2care4 betahistine 8 mg Tablet Oral use Denmark 2care4 Aps Betahistin 2care4 betahistine 16 mg Tablet Oral use Denmark 2care4 Aps Betahistin 2care4 betahistine 24 mg Tablet Oral use Denmark Alternova A/S Novertigo betahistine 8 mg Tablet Oral use Denmark Alternova A/S Novertigo betahistine 16 mg Tablet Oral use Denmark Orifarm Generics A/S Loperamid Orifarm loperamide 2 mg Tablet Oral use Denmark Alternova A/S Baklofen Alternova baclofen 10 mg Tablet Oral use Denmark Orion Corporation, Finland Tadalafil Orion tadalafil 5 mg Film-coated tablet Oral use Denmark Orion Corporation, Finland Tadalafil Orion tadalafil 10 mg Film-coated tablet Oral use Denmark Orion Corporation, Finland Tadalafil Orion tadalafil 20 mg Film-coated tablet Oral use Denmark Alternova A/S Etodolac Alternova etodolac 300 mg Film-coated tablet Oral use Denmark Aurobindo Pharma (Malta) Limited Naproxen Orion naproxen 250 mg Tablet Oral use Denmark Aurobindo Pharma (Malta) Limited Naproxen Orion naproxen 500 mg Tablet Oral use Estonia Sandoz B.V. Betahistidine Sandoz betahistine 8 mg Tablet Oral use Estonia Sandoz B.V. Betahistidine Sandoz betahistine 16 mg Tablet Oral use Estonia Sandoz B.V. Betahistidine Sandoz betahistine 24 mg Tablet Oral use Estonia Proenzi s.r.o. Etrixenal naproxen 250 mg Tablet Oral use Finland Orion Corporation Bupropion Orion bupropion 300 mg modified-release tablet Oral use Finland Sandoz A/S, Denmark Hydroxyzine Sandoz hydroxyzine 25 mg Film-coated tablet Oral use Finland Orion Corporation Orion Pharma, Finland Tadalafil Orion tadalafil 5 mg Film-coated tablet Oral use Finland Orion Corporation Orion Pharma, Finland Tadalafil Orion tadalafil 10 mg Film-coated tablet Oral use Finland Orion Corporation Orion Pharma, Finland Tadalafil Orion tadalafil 20 mg Film-coated tablet Oral use Finland Aurobindo Pharma Ltd, Malta Naproxen Orion naproxen 250 mg Tablet Oral use Finland Sandoz A/S, Denmark Bupropion Sandoz bupropion 300 mg Modified-release tablet Oral use Finland Aurobindo Pharma Ltd, Malta Naproxen Orion naproxen 500 mg Tablet Oral use Finland Alternova A/S Prednisolon Alternova prednisolone 20 mg France Arrow Génériques amlodipine/valsartan Arrow amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use France Arrow Génériques amlodipine/valsartan Arrow amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use France Arrow Génériques amlodipine/valsartan Arrow amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use France Sandoz B.V. BETAHISTINE GNR betahistine 8 mg Tablet Oral use France Sandoz B.V. BETAHISTINE GNR betahistine 24 mg Tablet Oral use France Sanofi Aventis France Hydroxyzine ZENTIVA hydroxyzine 25 mg Film-coated tablet Oral use France Mylan SAS Hydroxyzine MYLAN hydroxyzine 25 mg Film-coated tablet Oral use France Sandoz Hydroxyzine SANDOZ hydroxyzine 25 mg Film-coated tablet Oral use France Biogaran hydroxyzine BIOGARAN hydroxyzine 25 mg Film-coated tablet Oral use France Arrow Génériques Hydroxyzine ARROW hydroxyzine 25 mg Film-coated tablet Oral use France Cristers Hydroxyzine CRISTERS hydroxyzine 25 mg Film-coated tablet Oral use France EG LABO — Laboratoires Eurogenerics Hydroxyzine EG hydroxyzine 25 mg Film-coated tablet Oral use France Teva Sante Hydroxyzine TEVA hydroxyzine 25 mg Film-coated tablet Oral use France Special Concept Development (UK) Ltd Metformine Almus metformin hydrochloride 500 mg Tablet Oral use France Special Concept Development (UK) Ltd Metformine Almus metformin hydrochloride 850 mg Tablet Oral use France Special Concept Development (UK) Ltd Metformine Almus metformin hydrochloride 1000 mg Tablet Oral use France ELC Group s.r.o. Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90 1 g Capsule, soft Oral use France ARROW GENERIQUES tadalafil Arrow tadalafil 2,5 mg Film-coated tablet Oral use France ARROW GENERIQUES tadalafil Arrow tadalafil 5 mg Film-coated tablet Oral use France ARROW GENERIQUES tadalafil Arrow tadalafil 10 mg Film-coated tablet Oral use France ARROW GENERIQUES tadalafil Arrow tadalafil 20 mg Film-coated tablet Oral use France AUROVITAS UNIPESSOAL Lda Tadalafil Quiver tadalafil 20 mg Film-coated tablet Oral use France ZYDUS France TIANEPTINE ZYDUS tianeptine 12,5 mg Tablet Oral use France SUBSTIPHARM DEVELOPPEMENT PERURCIL ursodeoxycholic acid 500 mg Film-coated tablet Oral use France SUBSTIPHARM DEVELOPPEMENT acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet Oral use France SUBSTIPHARM DEVELOPPEMENT VALDINE ursodeoxycholic acid 500 mg Film-coated tablet Oral use France ARROW GENERIQUES voriconazole Arrow voriconazol 50 mg Film-coated tablet Oral use France ARROW GENERIQUES voriconazole Arrow voriconazol 200 mg Film-coated tablet Oral use France Special Concept Development (UK) Limited Paracetamol Almus Pharma paracetamol 500 mg Tablet Oral use France Special Concept Development (UK) Limited Paracetamol Almus Pharma paracetamol 1000 mg Tablet Oral use France ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 2 mg/0,625 mg Tablet Oral use France ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg/1,25 mg Tablet Oral use France ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 8 mg/2,5 mg Tablet Oral use Germany Hormosan Pharma GmbH Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol/levonorgestrel 0,03 mg/0,15 mg Film-coated tablet Oral use Germany neuraxpharm Arzneimittel GmbH Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung bupropion 300 mg Modified-release tablet Oral use Germany HEC Pharm GmbH Irbesartan HEC Pharm 75 mg Filmtabletten irbesartan 75 mg Film-coated tablet Oral use Germany HEC Pharm GmbH Irbesartan HEC Pharm 150 mg Filmtabletten irbesartan 150 mg Film-coated tablet Oral use Germany HEC Pharm GmbH Irbesartan HEC Pharm 300 mg Filmtabletten irbesartan 300 mg Film-coated tablet Oral use Germany Famy Care Europe Ltd. Ethinylestradiol/Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg Film-coated tablet Oral use Germany Mylan Dura GmbH Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg Film-coated tablet Oral use Germany HEC Pharm GmbH Olanzapin HEC Pharm 5 mg Schmelztabletten olanzapin 5 mg Orodispersible tablet Oral use Germany HEC Pharm GmbH Olanzapin HEC Pharm 10 mg Schmelztabletten olanzapin 10 mg Orodispersible tablet Oral use Germany HEC Pharm GmbH Olanzapin HEC Pharm 15 mg Schmelztabletten olanzapin 15 mg Orodispersible tablet Oral use Germany HEC Pharm GmbH Olanzapin HEC Pharm 20 mg Schmelztabletten olanzapin 20 mg Orodispersible tablet Oral use Germany Sandoz B.V. Betahistin HEXAL 8 mg Tabletten betahistine 8 mg Tablet Oral use Germany Sandoz B.V. Betahistin HEXAL 16 mg Tabletten betahistine 16 mg Tablet Oral use Germany Sandoz B.V. Betahistin HEXAL 24 mg Tabletten betahistine 24 mg Tablet Oral use Germany Sandoz B.V. Betahistin HEXAL bei Schwindel 8 mg Tabletten betahistine 8 mg Tablet Oral use Germany Sandoz B.V. Betahistin HEXAL bei Schwindel 16 mg Tabletten betahistine 16 mg Tablet Oral use Germany Sandoz B.V. Betahistin HEXAL bei Schwindel 24 mg Tabletten betahistine 24 mg Tablet Oral use Germany Sandoz B.V. Betahistin — 1 A Pharma 8 mg Tabletten betahistine 8 mg Tablet Oral use Germany Sandoz B.V. Betahistin — 1 A Pharma 16 mg Tabletten betahistine 16 mg Tablet Oral use Germany Sandoz B.V. Betahistin — 1 A Pharma 24 mg Tabletten betahistine 24 mg Tablet Oral use Germany PUREN Pharma GmbH & Co. KG (in Germany) Tadalafil Aurovitas tadalafil 5 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG (in Germany) Tadalafil Aurovitas tadalafil 10 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG (in Germany) Tadalafil Aurovitas tadalafil 20 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG (in Germany) Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany) amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG (in Germany) Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany) amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG (in Germany) Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany) amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Germany Aurovitas Unipessoal, Lda. Tadalafil Ritista tadalafil 20 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG Voriconazol PUREN 50 mg Filmtabletten voriconazol 50 mg Film-coated tablet Oral use Germany PUREN Pharma GmbH & Co. KG Voriconazol PUREN 200 mg Filmtabletten voriconazol 200 mg Film-coated tablet Oral use Germany Hexal AG, Germany Buproprionhydrochlorid Hexal 300 mg bupropion 300 mg Modified-release tablet Oral use Germany 1 A Pharma GmbH, Germany Bupropion 1 A Pharma 300 mg bupropion 300 mg Modified-release tablet Oral use Greece Pharmanel Commercial Pharmaceutical S.A. PRABEX ibuprofen 200 mg Film-coated tablet Oral use Greece Pharmanel Commercial Pharmaceutical S.A. DUARIDE dutasteride 0,5 mg Capsule, soft Oral use Greece ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ. PHARMAZAC AE AMLODIPINE+ VALSARTAN/PHARMAZAC amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use Greece ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ. PHARMAZAC AE AMLODIPINE+ VALSARTAN/PHARMAZAC amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Greece ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ. PHARMAZAC AE AMLODIPINE+ VALSARTAN/PHARMAZAC amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Greece BRADEX AEBE DUTASTERIDE/BRADEX dutasteride 0,5 mg Capsule, soft Oral use Greece Pharmanel Commercial Pharmaceutical S.A. PRABEX ibuprofen 400 mg Film-coated tablet Oral use Greece Pharmanel Commercial Pharmaceutical S.A. PRABEX ibuprofen 600 mg Film-coated tablet Oral use Hungary Proenzi s.r.o. ETRIXENAL naproxen 250 mg Tablet Oral use Ireland Stasisport Pharma N.V. Miofen ibuprofen 200 mg Film-coated tablet Oral use Ireland Stasisport Pharma N.V. Miofen ibuprofen 400 mg Film-coated tablet Oral use Ireland Stasisport Pharma N.V. Miofen ibuprofen 600 mg Film-coated tablet Oral use Ireland Alissa Healthcare Research Limited Carbocisteine 375 mg Capsules, Hard carbocisteine 375 mg Capsule, hard Oral use Italy Aurobindo Pharma (Italia), srl Tadalafil Aurobindo tadalafil 5 mg Film-coated tablet Oral use Italy Aurobindo Pharma (Italia) srl Voriconazolo Aurobindo voriconazol 50 mg Film-coated tablet Oral use Italy Sandoz SpA Bupropione Sandoz bupropion 300 mg Modified-release tablet Oral use Italy Strides Arcolab International Limited Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90 1000 mg Capsule, soft Oral use Italy Special Concept Development (UK) Ltd Metformina Almus metformin hydrochloride 850 mg Film-coated tablet Oral use Italy Special Concept Development (UK) Ltd Metformina Almus metformin hydrochloride 1000 mg Film-coated tablet Oral use Italy Aurobindo Pharma (Italia), srl Tadalafil Aurobindo tadalafil 10 mg Film-coated tablet Oral use Italy Aurobindo Pharma (Italia), srl Tadalafil Aurobindo tadalafil 20 mg Film-coated tablet Oral use Italy Aurobindo Pharma (Italia) srl Voriconazolo Aurobindo voriconazol 200 mg Film-coated tablet Oral use Italy Strides Arcolab International Limited Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90 1000 mg Capsule, soft Oral use Italy Special Concept Development (UK) Ltd Metformina Almus metformin hydrochloride 500 mg Film-coated tablet Oral use Latvia Sandoz B.V. Betahistin Sandoz 8 mg tabletes betahistine 8 mg Tablet Oral use Latvia Sandoz B.V. Betahistin Sandoz 16 mg tabletes betahistine 16 mg Tablet Oral use Latvia Sandoz B.V. Betahistin Sandoz 24 mg tabletes betahistine 24 mg Tablet Oral use Latvia Proenzi s.r.o Etrixenal 250 mg tabletes naproxen 250 mg Tablet Oral use Lithuania Proenzi s.r.o Etrixenal naproxen 250 mg Tablet Oral use Lithuania Sandoz B. V. Betahistine Sandoz betahistine 8 mg Tablet Oral use Lithuania Sandoz B. V. Betahistine Sandoz betahistine 16 mg Tablet Oral use Lithuania Sandoz B. V. Betahistine Sandoz betahistine 24 mg Tablet Oral use Luxembourg Aurobindo Pharma B.V. Naproxen Aurobindo naproxen 250 mg Tablet Oral use Luxembourg Sandoz B.V. Bupropion HCl Sandoz bupropion 300 mg Modified-release tablet Oral use Luxembourg Aurobindo Pharma B.V. Naproxen Aurobindo naproxen 500 mg Tablet Oral use Norway EQL Pharma AB Hydroxyzine EQL Pharma hydroxyzine 25 mg Film-coated tablet Oral use Norway Alternova A/S Dicloxacillin Alternova dicloxacillin 250 mg Capsule, hard Oral use Norway Alternova A/S Dicloxacillin Alternova dicloxacillin 500 mg Capsule, hard Oral use Norway Orion Corporation Tadalafil Orion tadalafil 5 mg Film-coated tablet Oral use Norway Orion Corparation Tadalafil Orion tadalafil 10 mg Film-coated tablet Oral use Norway Orion Corporation Tadalafil Orion tadalafil 20 mg Film-coated tablet Oral use Norway Aurobindo Pharma Limited Naproxen Orion naproxen 250 mg Tablet Oral use Norway Aurobindo Pharma Limited Naproxen Orion naproxen 500 mg Tablet Oral use Poland Bluefish Pharmaceuticals AB Betahistyna Bluefish betahistine dihydrochloride 8 mg Tablet Oral use Poland VITAMA S.A. Sarpin amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Poland VITAMA S.A. Napritum naproxen 250 mg Tablet Oral use Poland VITAMA S.A. Napritum naproxen 500 mg Tablet Oral use Poland Bluefish Pharmaceuticals AB Betahistyna Bluefish betahistine dihydrochloride 16 mg Tablet Oral use Poland Bluefish Pharmaceuticals AB Betahistyna Bluefish betahistine dihydrochloride 24 mg Tablet Oral use Poland Orion Corporation Bupropion Orion bupropion 300 mg Modified-release tablet Oral use Poland Proenzi s.r.o. Etrixenal naproxen 250 mg Tablet Oral use Portugal Sandoz B.V. Beta-histina Sandoz betahistine 16 mg Tablet Oral use Portugal Sandoz B.V. Beta-histina Sandoz betahistine 24 mg Tablet Oral use Portugal Special Concept Development (UK) Ltd Metformina Almus metformin hydrochloride 850 mg Film-coated tablet Oral use Portugal Special Concept Development (UK) Ltd Metformina Almus metformin hydrochloride 1000 mg Film-coated tablet Oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Tadalafil Aurobindo tadalafil 5 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Tadalafil Aurovitas tadalafil 2,5 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Amlodipina + Valsartan Aurovitas amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use Portugal Bluefish Pharmaceuticals AB Beta- histina Bluefish betahistine 8 mg Tablet Oral use Portugal Farmoz — Sociedade Técnico Medicinal, S.A. Beta- histina Farmoz betahistine 16 mg Tablet Oral use Portugal Farmoz — Sociedade Técnico Medicinal, S.A. Beta-histina Farmoz betahistine 24 mg Tablet Oral use Portugal Pharma Bavaria International (PBI) Portugal, Unip. Lda. Vasobex betahistine 8 mg Tablet Oral use Portugal Pharma Bavaria International (PBI) Portugal, Unip. Lda. Vasobex betahistine 16 mg Tablet Oral use Portugal Pharma Bavaria International (PBI) Portugal, Unip. Lda. Vasobex betahistine 24 mg Tablet Oral use Portugal Generic Speciality Pharma Limited Histabal betahistine 8 mg Tablet Oral use Portugal Generic Speciality Pharma Limited Histabal betahistine 16 mg Tablet Oral use Portugal Generic Speciality Pharma Limited Histabal betahistine 24 mg Tablet Oral use Portugal Aurovitas Unipessoal, Lda. Tadalafil Aurobindo tadalafil 20 mg Film-coated tablet Oral use Portugal Laboratórios Basi — Indústria Farm Beta-histina Basi betahistine 8 mg Tablet Oral use Portugal Generis Farmacêutica, S.A. Baclofeno Generis baclofen 10 mg Tablet Oral use Portugal Aurovitas Unipessoal, Lda. Voriconazol Aurovitas voriconazol 50 mg Film-coated tablet Oral use Portugal Glob Ltd. Voriconazol Glob voriconazol 50 mg Film-coated tablet Oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Naproxen Aurobindo naproxen 250 mg Tablet Oral use Portugal Sandoz Farmacêutica, Lda. Bupropion HCl Sandoz bupropion 300 mg Modified-release tablet Oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Naproxeno Aurobindo naproxen 500 mg Tablet Oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Tadalafil Aurobindo tadalafil 10 mg Film-coated tablet Oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Tadalafil Aurobindo tadalafil 20 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Tadalafil Aurovitas tadalafil 5 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Tadalafil Aurovitas tadalafil 10 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Tadalafil Aurovitas tadalafil 20 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Amlodipina + Valsartan Aurovitas amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Amlodipina + Valsartan Aurovitas amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Portugal Aurovitas Unipessoal, Lda. Voriconazol Aurovitas voriconazol 200 mg Film-coated tablet Oral use Portugal Glob Ltd. Voriconazol Glob voriconazol 200 mg Film-coated tablet Oral use Portugal Bluefish Pharmaceuticals AB Beta- histina Bluefish betahistine dihydrochloride 16 mg Tablet Oral use Portugal Bluefish Pharmaceuticals AB Beta- histina Bluefish betahistine dihydrochloride 24 mg Tablet Oral use Portugal Special Concept Development (UK) Ltd Metformina Almus metformin hydrochloride 500 mg Film-coated tablet Oral use Portugal Almus, Lda. Paracetamol 500 mg Tablets paracetamol 500 mg Tablet Oral use Portugal Almus, Lda. Paracetamol 1000 mg Tablets paracetamol 1000 mg Tablet Oral use Portugal SVUS Pharma a.s. Belfada aripiprazole 10 mg Tablet Oral use Portugal SVUS Pharma a.s. Belfada aripiprazole 15 mg Tablet Oral use Romania Sandoz B.V. Betahistin HEXAL 8 mg Tabletten betahistine 8 mg Tablet Oral use Romania Sandoz B.V. Betahistin HEXAL 16 mg Tabletten betahistine 16 mg Tablet Oral use Romania Sandoz B.V. Betahistin HEXAL 24 mg Tabletten betahistine 24 mg Tablet Oral use Romania Aurobindo Pharma (Malta) Limited Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use Romania Aurobindo Pharma (Malta) Limited Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Romania Aurobindo Pharma (Malta) Limited Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Romania Aurobindo Pharma (Malta) Limited Naproxen Aurobindo naproxen 250 mg Tablet Oral use Romania Aurobindo Pharma (Malta) Limited Naproxen Aurobindo naproxen 500 mg Tablet Oral use Romania Proenzi s.r.o. Etrixenal naproxen 250 mg Tablet Oral use Slovak Republic Sandoz B.V. Betahistin Sandoz 8 mg betahistine 8 mg Tablet Oral use Slovak Republic Sandoz B.V. Betahistin Sandoz 16 mg betahistine 16 mg Tablet Oral use Slovak Republic Sandoz B.V. Betahistin Sandoz 24 mg betahistine 24 mg Tablet Oral use Slovak Republic Proenzi s.r.o. Etrixenal naproxen 250 mg Tablet Oral use Slovenia Sandoz B.V. Betahistin Sandoz 8 mg tablete betahistine 8 mg Tablet Oral use Slovenia Sandoz B.V. Betahistin Sandoz 16 mg tablete betahistine 16 mg Tablet Oral use Slovenia Sandoz B.V. Betahistin Sandoz 24 mg tablete betahistine 24 mg Tablet Oral use Slovenia Sandoz GmbH Bupropion Sandoz 300 mg tablete s prirejenim sproščanjem bupropion 300 mg Modified-release tablet Oral use Spain AUROVITAS SPAIN, SAU Tadalafilo Aurovitas 5 mg comprimidos recubiertos con película EFG tadalafil 5 mg Film-coated tablet Oral use Spain AUROVITAS SPAIN, SAU Tadalafilo Aurovitas 10 mg comprimidos recubiertos con película EFG tadalafil 10 mg Film-coated tablet Oral use Spain AUROVITAS SPAIN, SAU Tadalafilo Aurovitas 20 mg comprimidos recubiertos con película tadalafil 20 mg Film-coated tablet Oral use Spain AUROVITAS UNIPESSONAL, LDA Tadalafilo Aurovit 20 mg comprimidos recubiertos con película EFG tadalafil 20 mg Film-coated tablet Oral use Spain Strides Arcolab International Limited Ácidos Omega 3 Strides 1000 mg cápsulas blandas EFG omega-3-acid-ethyl esters 90 1000 mg Capsule, soft Oral use Spain ALMUS FARMACEUTICA, SA Metformina Almus Pharma 850 mg comprimdos recubiertos con película EFG metformin hydrochloride 850 mg Film-coated tablet Oral use Spain ALMUS FARMACEUTICA, SA Metformina Almus Pharma 1000 mg comprimdos recubiertos con película EFG metformin hydrochloride 1000 mg Film-coated tablet Oral use Spain Bluefish Pharmaceuticals AB Betahistina Bluefish betahistine dihydrochloride 8 mg Tablet Oral use Spain Bluefish Pharmaceuticals AB Betahistina Bluefish betahistine dihydrochloride 16 mg Tablet Oral use Spain LABORATORIOS AUROBINDO, SLU Amlodipino/Valsartán Aurobindo 5 mg/160 mg comprimidos recubiertos con película EFG amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Spain LABORATORIOS AUROBINDO, SLU Amlodipino/Valsartán Aurobindo 10 mg/160 mg comprimidos recubiertos con película EFG amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Spain LABORATORIOS AUROBINDO, SLU Naproxeno Aurobindo 250 mg comprimidos EFG naproxen 250 mg Tablet Oral use Spain LABORATORIOS AUROBINDO, SLU Naproxeno Aurobindo 500 mg comprimidos EFG naproxen 500 mg Tablet Oral use Spain Aurovitas Spain Voriconazol Aurovitas 50 mg comprimidos recubiertos con película EFG voriconazol 50 mg Tablet Oral use Spain Aurovitas Spain SAU Voriconazol Aurovitas 200 mg comprimidos recubiertos con película EFG voriconazol 200 mg Tablet Oral use Spain AUROVITAS SPAIN, SAU Amlodipino/Valsartan Aurovitas 5 mg/160 mg comprimidos recubiertos con película EFG amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use Spain AUROVITAS SPAIN, SAU Amlodipino/Valsartan Aurovitas 10 mg/160 mg comprimidos recubiertos con película EFG amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use Spain QUALIGEN, SL Hidroxizina Qualigen 25 mg comprimidos recubiertos con película EFG hydroxyzine 25 mg Film-coated tablet Oral use Spain LABORATORIOS COMBIX, SLU Perindopril/Indapamida Combix 2 mg/0,625 mg comprimidos EFG perindopril/indapamide 2 mg/0,625 mg Tablet Oral use Spain LABORATORIOS COMBIX, SLU Perindopril/Indapamida Combix 4 mg/1,25 mg comprimidos EFG perindopril/indapamide 4 mg/1,25 mg Tablet Oral use Spain LABORATORIOS COMBIX, SLU Perindopril/Indapamida Combix 8 mg/2,5 mg comprimidos EFG perindopril/indapamide 8 mg/2,5 mg Tablet Oral use Spain LABORATORIOS CINFA, SA Bupropion Cinfa 300 mg comprimidos de liberación modificada EFG bupropion 300 mg Modified-release tablet Oral use Spain SANDOZ FARMACEUTICA, SA Bupropion Sandoz 300 mg comprimidos de liberación modificada EFG bupropion 300 mg Modified-release tablet Oral use Spain ALMUS FARMACEUTICA, SA Paracetamol Almus 500 mg comprimidos EFG paracetamol 500 mg Tablet Oral use Spain ALMUS FARMACEUTICA, SA Paracetamol Almus 1000 mg comprimidos EFG paracetamol 1000 mg Tablet Oral use Sweden Orion Corporation Bupropion Orion bupropion 300 mg modified-release tablet Oral use Sweden EQL Pharma AB Hydroxyzine EQL Pharma hydroxyzine 25 mg Film-coated tablet Oral use Sweden 2care4 Aps Betahistin 2care4 betahistine 8 mg Tablet Oral use Sweden 2care4 Aps Betahistin 2care4 betahistine 16 mg Tablet Oral use Sweden 2care4 Aps Betahistin 2care4 betahistine 24 mg Tablet Oral use Sweden Orion Corporation Tadalafil Orion tadalafil 5 mg Film-coated tablet Oral use Sweden Orion Corporation Tadalafil Orion tadalafil 10 mg Film-coated tablet Oral use Sweden Orion Corporation Tadalafil Orion tadalafil 20 mg Film-coated tablet Oral use Sweden 2care4 Generics ApS Ibuprofen 2care4 ibuprofen 200 mg Film-coated tablet Oral use Sweden 2care4 Generics ApS Ibuprofen 2care4 ibuprofen 400 mg Film-coated tablet Oral use Sweden 2care4 Generics ApS Ibuprofen 2care4 ibuprofen 600 mg Film-coated tablet Oral use Sweden Alternova A/S Metoklopramid Alternova metoclopramide 10 mg Film-coated tablet Oral use Sweden EQL Pharma AB Atyxine hydroxyzine 25 mg Film-coated tablet Oral use Sweden Alternova A/S Clindamycin Alternova clindamycin 150 mg Capsule, hard Oral use Sweden Apofri AB Loperamid Apofri loperamide 2 mg Tablet Oral use Sweden Evolan Pharma AB Loperamid ABECE loperamide 2 mg Tablet Oral use Sweden Evolan Pharma AB Loperamid Evolan loperamide 2 mg Tablet Oral use Sweden BBS Consult ApS Loperamid BBS loperamide 2 mg Tablet Oral use Sweden Aurobindo Pharma (Malta) Limited Naproxen Orion naproxen 250 mg Tablet Oral use Sweden Aurobindo Pharma (Malta) Limited Naproxen Orion naproxen 500 mg Tablet Oral use Sweden Sandoz A/S Bupropion Sandoz bupropion 300 mg Modified-release tablet Oral use The Netherlands Aurobindo Pharma B.V. Tadalafil Aurobindo 5 mg, filmomhulde tabletten tadalafil 5 mg Film-coated tablet Oral use The Netherlands Aurobindo Pharma B.V. Tadalafil Aurobindo 10 mg, filmomhulde tabletten tadalafil 10 mg Film-coated tablet Oral use The Netherlands Aurobindo Pharma B.V. Tadalafil Aurobindo 20 mg, filmomhulde tabletten tadalafil 20 mg Film-coated tablet Oral use The Netherlands Aurobindo Pharma B.V. Amlodipine/Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine/valsartan 5 mg/80 mg Film-coated tablet Oral use The Netherlands Aurobindo Pharma B.V. Amlodipine/Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine/valsartan 5 mg/160 mg Film-coated tablet Oral use The Netherlands Aurobindo Pharma B.V. Amlodipine/Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine/valsartan 10 mg/160 mg Film-coated tablet Oral use The Netherlands Sandoz B.V. Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte bupropion 300 mg Modified-release tablet Oral use The Netherlands Sandoz B.V. Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte bupropion 300 mg Modified-release tablet Oral use The Netherlands Aurobindo Pharma B.V. Naproxen Aurobindo 250 mg, tabletten naproxen 250 mg Tablet Oral use The Netherlands Aurobindo Pharma B.V. Naproxen Aurobindo 500 mg, tabletten naproxen 500 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 8 mg, tabletten betahistine 8 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 16 mg, tabletten betahistine 16 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 24 mg, tabletten betahistine 24 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 8 mg, tabletten betahistine 8 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 16 mg, tabletten betahistine 16 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 24 mg, tabletten betahistine 24 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 8 mg, tabletten betahistine 8 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 16 mg, tabletten betahistine 16 mg Tablet Oral use The Netherlands Sandoz B.V. Betahistine Sandoz 24 mg, tabletten betahistine 24 mg Tablet Oral use The Netherlands Aurobindo Pharma B.V. Voriconazol Aurobindo 50 mg, filmomhulde tabletten voriconazol 50 mg Film-coated tablet Oral use The Netherlands Aurobindo Pharma B.V. Voriconazol Aurobindo 200 mg, filmomhulde tabletten voriconazol 200 mg Film-coated tablet Oral use United Kingdom Aurovitas Unipessoal, Lda. Tadalafil Aurobindo tadalafil 20 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Tadalafil Milpharm 2,5 mg film-coated tablets tadalafil 2,5 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Tadalafil Milpharm 5 mg film-coated tablets tadalafil 5 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Tadalafil Milpharm 10 mg film-coated tablets tadalafil 10 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Tadalafil Milpharm 20 mg film-coated tablets tadalafil 20 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Voriconazole Milpharm 50 mg film-coated tablets voriconazol 50 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Voriconazole Milpharm 200 mg film-coated tablets voriconazol 200 mg Film-coated tablet Oral use United Kingdom Milpharm Limited Naproxen 250 mg tablets naproxen 250 mg Tablet Oral use United Kingdom Milpharm Limited Naproxen 500 mg tablets naproxen 500 mg Tablet Oral use United Kingdom HEC Pharm GmbH Irbesartan 75 mg Film-coated Tablets irbesartan 75 mg Film-coated tablet Oral use United Kingdom HEC Pharm GmbH Irbesartan 150 mg Film-coated tablets irbesartan 150 mg Film-coated tablet Oral use United Kingdom HEC Pharm GmbH Irbesartan 300 mg Film-coated tablets irbesartan 300 mg Film-coated tablet Oral use United Kingdom Strides Arcolab International Limited Omega 3-acid-ethyl esters 1000 mg soft capsules omega-3-acid-ethyl esters 90 1000 mg Capsule, soft Oral use United Kingdom Dawa Limited Paracetamol 500 mg Film-Coated Tablets paracetamol 500 mg Film-coated tablet Oral use United Kingdom Lupin (Europe) Limited Maexeni 150/30 microgram Film-Coated Tablets ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg Film-coated tablet Oral use United Kingdom Kinedexe UK Limited (previously NRIM Limited) Sodium Cromoglicate 100 mg hard Capsules sodium cromoglicate 100 mg Capsule, hard Oral use United Kingdom Milpharm Limited Tadalafil Milpharm 20 mg film-coated tablets tadalafil 20 mg Film-coated tablet Oral use United Kingdom Crescent Pharma Limited Aripiprazole 5 mg tablets aripiprazole 5 mg Tablet Oral use United Kingdom Crescent Pharma Limited Aripiprazole 10 mg tablets aripiprazole 10 mg Tablet Oral use United Kingdom Crescent Pharma Limited Aripiprazole 15 mg tablets aripiprazole 15 mg Tablet Oral use United Kingdom Crescent Pharma Limited Aripiprazole 30 mg tablets aripiprazole 30 mg Tablet Oral use United Kingdom Medreich PLC Gliclazide 40 mg tablets gliclazide 40 mg Tablet Oral use United Kingdom Medreich PLC Hydroxyzine hydrochloride 25 mg film-coated tablets hydroxyzine hydrochloride 25 mg Film-coated tablet Oral use United Kingdom Alissa Healthcare Research Limited Carbocisteine 375 mg Capsules, Hard carbocisteine 375 mg Capsule, hard Oral use United Kingdom Special Concept Development (UK) Limited Metformin 500 mg Film-coated tablet metformin hydrochloride 500 mg Film-coated tablet Oral use United Kingdom Special Concept Development (UK) Limited Metformin 850 mg Film-coated tablet metformin hydrochloride 850 mg Film-coated tablet Oral use United Kingdom Special Concept Development (UK) Limited Metformin 1000 mg Film-coated tablet metformin hydrochloride 1000 mg Film-coated tablet Oral use United Kingdom Special Concept Development (UK) Limited Paracetamol 500 mg Tablets paracetamol 500 mg Tablet Oral use United Kingdom Special Concept Development (UK) Limited Paracetamol 1000 mg Tablets paracetamol 1000 mg Tablet Oral use United Kingdom Special Concept Development (UK) Limited Paracetamol 500 mg Tablets paracetamol 500 mg Tablet Oral use United Kingdom Special Concept Development (UK) Limited Paracetamol 1000 mg Tablets paracetamol 1000 mg Tablet Oral use United Kingdom Flamingo Pharma (UK) Limited Gliclazide 80 mg Tablets gliclazide 80 mg Tablet Oral use United Kingdom Flamingo Pharma (UK) Limited Gliclazide 40 mg Tablets gliclazide 40 mg Tablet Oral use United Kingdom HBS Healthcare Limited Carbimazole 20 mg Tablets carbimazole 20 mg Tablet Oral use United Kingdom Strides Arcolab International Limited Omega 3-acid-ethyl esters 1000 mg soft capsules omega-3-acid-ethyl esters 90 1000 mg Capsule, soft Oral use United Kingdom Generic Partners UK Limited Vzole 50 mg film-coated tablets voriconazol 50 mg Tablet Oral use United Kingdom Generic Partners UK Limited Vzole 200 mg film-coated tablets voriconazol 200 mg Tablet Oral use United Kingdom Dawa Limited Carbimazole 5 mg Tablets carbimazole 5 mg Tablet Oral use United Kingdom Dawa Limited Carbimazole 20 mg Tablets carbimazole 20 mg Tablet Oral use United Kingdom Essential-Healthcare Limited Carbimazole 5 mg Tablets carbimazole 5 mg Tablet Oral use United Kingdom Essential-Healthcare Limited Carbimazole 20 mg Tablets carbimazole 20 mg Tablet Oral use

ANNEX II List of medicinal products and presentations Member State EU/EEA Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration France Bristol-Myers Squibb 3, Rue Joseph Monier — BP 325, Rueil-Malmaison, 92506, France Etopophos 100 mg Powder for Solution for Injection Intravenous Use Germany Bristol-Myers Squibb GmbH & Co. KGaA Arnulfstrasse 29, München, 80636,Germany Etopophos 100 mg Powder for Solution for Infusion Intravenous Use Germany Bristol-Myers Squibb GmbH & Co. KGaA Arnulfstrasse 29, München, 80636,Germany Etopophos 1000 mg Powder for Solution for Infusion Intravenous Use Sweden Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden Etopofos 100 mg Powder for Solution for Infusion Intravenous Use United Kingdom Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, United Kingdom Etopophos 100 mg Powder for Solution for Injection Intravenous Use

ANNEX III List of medicinal products and presentations Member State EU/EEA Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Austria Bristol-Myers Squibb GesmbH Rivergate/Gate 1/5.OG, Handelskai 92, 1200 Vienna, Austria Vepesid 100 mg Capsule Oral Use Belgium Bristol-Myers Squibb Belgium S.A. Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgium Vepesid 100 mg Capsule, Soft Oral Use Croatia Bristol-Myers Squibb spol. s.r.o. Budějovická 778/3, Michle, 140 00 Prague, Czech Republic Vepesid 100 mg Capsule, Soft Oral Use Denmark Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden Vepesid 50 mg Capsule, soft Oral Use Estonia Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lövőház u. 39, 1024 Budapest, Hungary Vepesid 100 mg Capsule, Soft Oral Use Finland Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden Vepesid 50 mg Capsule, Soft Oral Use Germany Bristol-Myers Squibb GmbH & Co. KGaA Arnulfstrasse 29, München, 80636,Germany Vepesid K 50 mg Capsule Oral Use Germany Bristol-Myers Squibb GmbH & Co. KGaA Arnulfstrasse 29, München, 80636,Germany Vepesid K 100 mg Capsule Oral Use Ireland Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Ireland Vepesid 50 mg Capsules, Soft Oral Use Ireland Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Ireland Vepesid 100 mg Capsules, Soft Oral Use Italy Bristol-Myers Squibb S.R.L. Via Virgilio Maroso, 50, 00142 Rome, Italy Vepesid 50 mg Capsule, Soft Oral Use Italy Bristol-Myers Squibb S.R.L. Via Virgilio Maroso, 50, 00142 Rome, Italy Vepesid 100 mg Capsule, Soft Oral Use Luxembourg Bristol-Myers Squibb Belgium S.A. Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgium Vepesid 100 mg Capsule, Soft Oral Use Netherlands Bristol-Myers Squibb B.V. Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands Vepesid 50 mg Capsule, Soft Oral Use Netherlands Bristol-Myers Squibb B.V. Orteliuslaan 1000, Utrecht, 3528 BD, The Netherlands Vepesid 100 mg Capsule, Soft Oral Use Norway Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden Vepesid 50 mg Capsule, Soft Oral Use Romania Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lövőház u. 39, 1024 Budapest, Hungary Vepesid 50 mg Capsule, Soft Oral Use Romania Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lövőház u. 39, 1024 Budapest, Hungary Vepesid 100 mg Capsule, Soft Oral Use Slovenia Bristol-Myers Squibb spol. s.r.o. Budějovická 778/3, Michle 140 00 Prague 4, Czech Republic Vepesid 100 mg Capsule, Soft Oral Use Spain Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain Vepesid 50 mg Capsule, Soft Oral Use Spain Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain Vepesid 100 mg Capsule, Soft Oral Use Sweden Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden Vepesid 50 mg Capsule, Soft Oral Use United Kingdom Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, United Kingdom Vepesid 50 mg Capsule, Soft Oral Use United Kingdom Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, United Kingdom Vepesid 100 mg Capsule, Soft Oral Use

ANNEX IV List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States Member State EU/EEA Applicant/Marketing authorisation holder Name INN Strength Pharmaceutical form Animal species Route of administration Austria Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Ferkel Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Belgium Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g premix voor gemedicineerd voeder Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Bulgaria Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g premix for medicated feeding stuff for piglets Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Bulgaria Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOPREMIX 1000 mg/g Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Cyprus Laboratorios Calier, S.A. C/Barcelonès, 26 Pla del Ramassà Les Franqueses del Vallès 08520 Barcelona Spain OXIDO DE ZINC CALIER 1000 mg/g, πρόμιγμα για φαρμακούχο ζωοτροφή για χοίρους Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Cyprus Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOPREMIX 1000 MG/G πρόμιγμα για φαρμακούχο ζωοτροφή για χοίρους Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Cyprus Vetpharma Animal Health, S.L. C/Les Corts, 23. 08028 Barcelona Spain ZINTESTIN 1000 MG/G πρόμιγμα για φαρμακούχο ζωοτροφή για χοίρους Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Czech Republic Trouw Nutrition Biofaktory s.r.o. Na Chvalce 2049 193 00 Praha 9 Horní Počernice Czech Republic BIOZINK 600 mg/g premix pro medikaci krmiva pro selata Zinc oxide 600 mg/g Premix Pigs (piglets) Oral Czech Republic Tekro, spol. s r.o. Višňová 2/484 140 00 Praha 4 Czech Republic MEDITEK Zn 500 mg/g perorální prášek Zinc oxide 622 mg/g Oral powder Pigs (piglets) Oral Czech Republic Tekro, spol. s r.o. Višňová 2/484 140 00 Praha 4 Czech Republic MEDITEK Zn 500 mg/g premix pro medikaci krmiva Zinc oxide 622 mg/g Premix Pigs (piglets) Oral Czech Republic MIKROP ČEBÍN a.s. Čebín 416 664 23 Čebín Czech Republic MIKROP — VLP ZINEK premix Zinc oxide 492 mg/g Premix Pigs (piglets) Oral Czech Republic Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOPREMIX 1000 mg/g premix pro medikaci krmiva pro prasata Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Denmark Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Denmark Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark VetZink Zinc oxide 1000 mg/g Oral powder Pigs (piglets) Oral Denmark Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark VetZink Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Denmark Vilofarm A/S Sjellebrovej 10 DK-8544 Mørke Denmark Vilocare Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Denmark Vilofarm A/S Søagervej 9, Sdr. Onsild DK-9500 Hobro Denmark Zicare Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Denmark Vilofarm A/S Søagervej 9, Sdr. Onsild DK-9500 Hobro Denmark Zicare Zinc oxide 1000 mg/g Oral powder Pigs (piglets) Oral Denmark ScanVet Animal Health A/S Kongevejen 66 DK-3480 Fredensborg Denmark Zingovet Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Denmark ScanVet Animal Health A/S Kongevejen 66 DK-3480 Fredensborg Denmark Zingovet Zinc oxide 1000 mg/g Oral powder Pigs (piglets) Oral Denmark Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark Zinkoxid Vepidan Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Estonia Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Finland Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark Vetzin vet. 1000 mg/g esisekoite lääkerehua varten Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral France Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium GUTAL PREMELANGE MEDICAMENTEUX POUR PORCELETS Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Germany Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Germany aniMedica GmbH Im Südfeld 9 D-48308 Senden-Bösensell Germany Enteroxid N AMV aniMedica Zinc oxide Colistin sulfate 480 mg/g 25 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Germany aniMedica GmbH Im Südfeld 9 D-48308 Senden-Bösensell Germany aniMedica Enteroxid N Zinc oxide Colistin sulfate 480 mg/g 25 mg/g Powder for oral administration Pigs (piglets) Oral Hungary Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g gyógypremix malacok számára A.U.V. Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Hungary Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOPREMIX 1000 mg/g gyógypremix sertések számára A.U.V. Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Hungary Sintofarm S.p.A. Via Togliatti 5 42016 Guastalla (RE) Italy ZINCOSINT G 1000 mg/g gyógypremix sertések részére A.U.V. Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Hungary Dunavet-B Zrt. Dolgos u. 2 1126 Budapest Hungary Zintestin Forte 1000 mg/g gyógypremix sertések részére A.U.V. Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Iceland Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark VetZin Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Ireland DSM Nutritional Products (UK) Limited Delves Road Heanor Gate Industrial Estate Heanor Derbyshire, DE75 7SG United Kingdom Pigzin Premix, 100 % w/w Premix for medicated feeding stuff. Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Ireland Provimi Limited Eastern Avenue Lichfield Staffordshire WS13 7SE United Kingdom ZincoTec — Zinc Oxide 100 % Premix for medicated Feeding Stuff. Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Ireland Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g premix for medicated feeding stuff for piglets Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Italy Laboratorios Calier, S.A. C/Barcelonès, 26 Pla del Ramassà Les Franqueses del Vallès 08520 Barcelona Spain OXIDO DE ZINC Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Italy Vetpharma Animal Health, S.L. C/Les Corts, 23. 08028 Barcelona Spain ZINTESTIN Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Italy Sintofarm S.p.A. Via Togliatti 5 42016 Guastalla (RE) Italy ZINCOFARM G Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Italy Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOPREMIX Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Italy Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium GUTAL 1000 mg/g Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Latvia Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Lithuania Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium GUTAL 1 000 mg/g, vaistinis premiksas paršeliams Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral The Netherlands Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium GUTAL 1000 mg/g premix for piglets Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Norway Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark VetZin Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Poland Vetoquinol Biowet Sp. z o. o. ul. Kosynierów Gdyńskich 13-14 66-400 Gorzów Wielkopolski Poland Suibicol Premiks (30 g +18,45 g)/100 g premiks do sporządzania paszy leczniczej dla świń Zinc oxide Sulfaguanidinum 30 g/100 g 18,45 g/100 g Premix for medicated feeding stuff Pigs (piglets) Oral Poland Laboratorios Calier, S.A. C/Barcelonès, 26 Pla del Ramassà Les Franqueses del Vallès 08520 Barcelona Spain Tlenek cynku Calier 1000 mg/1 g, premiks do sporządzania paszy leczniczej dla świń Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Poland Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain Zincopremix 1000 mg/g premiks do sporządzania paszy leczniczej dla świń Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Poland Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 g/kg premix for medicated feeding staff Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Poland Vetoquinol Biowet Sp. z o. o. ul. Kosynierów Gdyńskich 13-14 66-400 Gorzów Wielkopolski Poland Suibicol proszek Zinc oxide Sulfaguanidine 30 g/100 g 18,45 g/100 g Oral powder Pigs (piglets) Oral Portugal Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g premix for medicated feeding stuff for piglets Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Portugal Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain APSAMIX ZINC 1000 mg/g medicated premix for pigs Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Portugal CALIER PORTUGAL, S.A. Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 — 335 Sintra Portugal OXIDO DE ZINCO CALIER 1000 mg/g Pré-mistura medicamentosa para suínos (leitões) Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Portugal Vetlima S.A. Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal Vetazinco 1000 mg/g Pré-mistura medicamentosa para suínos (leitões) Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Romania Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain Zincopremix 1000 mg/g premix pentru furaje medicamentate la porcine Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Romania Sintofarm S.p.A. Via Togliatti 5 42016 Guastalla (RE) Italy Zincosint G 1000 mg/g premix pentru furaje medicamentate la porcine Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Romania S.C. CRIDA PHARM S.R.L. 2 Intrarea Vagonetului, Bl. 101, Ap. 47 sector 6, Bucharest Romania Colistop premix 1000 mg/g premix medicamentat pentru purcei dupa intarcare Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Slovak Republic Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain Zincopremix 1000 mg/g premix na medikovanie kŕmnej zmesi pre ošípané Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Slovak Republic Tekro, spol. s r.o. Višňová 2/484 140 00 Praha 4 Czech Republic Tekrozink 500 mg/g perorálny prášok Zinc oxide 622 mg/g (500 mg zinc/g) Pulvis for oral use Pigs (piglets) Oral Slovak Republic Tekro, spol. s r.o. Višňová 2/484 140 00 Praha 4 Czech Republic Tekrozink 500 mg/g premix na medikáciu krmiva Zinc oxide 622 mg/g (500 mg zinc/g) Premix for medicated feedingstuff Pigs (piglets) Oral Slovak Republic Trouw Nutrition Biofaktory s.r.o. Na Chvalce 2049 193 00 Praha 9 Horní Počernice Czech Republic Biozink 600 mg/g premix na medikáciu krmiva Zinc oxide 600 mg/g Premix for medicated feedingstuff Pigs (piglets) Oral Slovenia Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g predmešanica za pripravo zdravilne krmne mešanice za pujske Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Industrial Veterinaria, S.A. Esmeralda, 19 E-08950 Esplugues de Llobregat (Barcelona) Spain ZETAPREX Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOPREMIX 1000 MG/G Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Laboratorios Support Pharma, S.L. General Alvarez de Castro, 39 28010 Madrid Spain ZINCOSINT G 100 MG/G PREMIX Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1.000 mg/g premezcla medicamentosa para lechones Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Laboratorios Calier, S.A. C/Barcelonès, 26 Pla del Ramassà Les Franqueses del Vallès 08520 Barcelona Spain ÓXIDO DE ZINC CALIER 1000 mg/g PREMEZCLA MEDICAMENTOSA PARA CERDOS Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Vetpharma Animal Health, S.L. C/Les Corts, 23. 08028 Barcelona Spain ZINTESTIN 1000 mg/g Premezcla medicamentosa para porcino Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain APSAMIX ZINC 1000 mg/g premezcla medicamentosa para porcino Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Spain Andrés Pintaluba, S.A. Pol. Ind. Agro-Reus C/Prudenci Bertrana 5 43206 Reus (Tarragona) Spain ZINCOTRAX Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Sweden Vepidan ApS Østerbrogade 23 DK-9670 Løgstør Denmark Vetzin vet Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral Sweden Biovet ApS Kongevejen 66 3480 Fredensborg Denmark Zingovet Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral United Kingdom Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgium Gutal 1000 mg/g premix for medicated feeding stuff for piglets Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral United Kingdom DSM Nutritional Products (UK) Limited Delves Road Heanor Gate Industrial Estate Heanor Derbyshire, DE75 7SG United Kingdom Pigzin Premix, 100 % w/w Premix for Medicated Feeding Stuff Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral United Kingdom SCA NuTec (Provimi Ltd) Eastern Avenue Lichfield Staffordshire WS13 7SE United Kingdom ZincoTec Zinc Oxide 100 % Premix for Medicated Feeding Stuff Zinc oxide 1000 mg/g Premix for medicated feeding stuff Pigs (piglets) Oral

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 Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206B AT-1020 Vienna Austria Haldol 2 mg/ml Oral solution Oral use 2 mg/ml Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206B AT-1020 Vienna Austria Haldol 150 mg/30 ml Solution for injection Intramuscular use 5 mg/ml Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206B AT-1020 Vienna Austria Haldol 1 mg Tablet Oral use N/A Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206B AT-1020 Vienna Austria Haldol 10 mg Tablet Oral use N/A Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 30 mg/15 ml Oral solution Oral use 2 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 60 mg/30 ml Oral solution Oral use 2 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 200 mg/100 ml Oral solution Oral use 2 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 300 mg/30 ml Oral solution Oral use 10 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 1000 mg/100 ml Oral solution Oral use 10 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 5 mg/ml Solution for injection Intramuscular use; Intravenous use 5 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 2 mg Tablet Oral use N/A Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 5 mg Tablet Oral use N/A Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 20 mg Tablet Oral use N/A Cyprus Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium Haldol 30 mg/15 ml Oral solution Oral use 2 mg/ml Cyprus Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Cyprus Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium Haldol 5 mg Tablet Oral use N/A Denmark JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase 2 mg/ml Oral solution Oral use 2 mg/ml Denmark JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase 5 mg/ml Solution for injection Intramuscular use; Intravenous use 5 mg/ml Denmark JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase 2 mg Tablet Oral use N/A Denmark JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase 5 mg Tablet Oral use N/A Denmark JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase 20 mg Tablet Oral use N/A Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Finland Serenase 2 mg/ml Oral solution Oral use 2 mg/ml Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Serenase 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Finland Serenase 1 mg Tablet Oral use N/A Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Finland Serenase 4 mg Tablet Oral use N/A Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Finland Serenase 10 mg Tablet Oral use N/A France Janssen-Cilag 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 France Haldol 2 mg/ml in bottles of 15 ml, 30 ml, 100 ml and 195 ml Oral solution Oral use 2 mg/ml France Janssen-Cilag 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 France Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml France Janssen-Cilag 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 France Haldol 1 mg Tablet Oral use N/A France Janssen-Cilag 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 France Haldol 5 mg Tablet Oral use N/A Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol-Janssen 2 mg/ml in bottles of 30 ml and 100 ml) Oral solution Oral use 2 mg/ml Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol-Janssen 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol-Janssen 1 mg Tablet Oral use N/A Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol-Janssen 2 mg Tablet Oral use N/A Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol-Janssen 5 mg Tablet Oral use N/A Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol-Janssen 10 mg Tablet Oral use N/A Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki Athens GR-151 21 Greece Aloperidin 30 mg/15 ml Oral Drops, Solution Oral use 2 mg/ml Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki Athens GR-151 21 Greece Aloperidin 150 mg/15 ml 300 mg/30 ml Oral Drops, Solution Oral use 10 mg/ml Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki Athens GR-151 21 Greece Aloperidin 5 mg/ml (BTx5AMP x1ML, BTx50AMP x1ML) Solution for injection Intramuscular use 5 mg/ml Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece Aloperidin 1 mg Tablet Oral use N/A Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece Aloperidin 2 mg Tablet Oral use N/A Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece Aloperidin 5 mg Tablet Oral use N/A Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece Aloperidin 10 mg Tablet Oral use N/A Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece Aloperidin 20 mg Tablet Oral use N/A Iceland Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Iceland Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 1 mg Tablet Oral use N/A Iceland Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 4 mg Tablet Oral use N/A Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol 60 mg/30 ml Oral drops, Oral use 2 mg/ml Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol 300 mg/30 ml Oral drops, solution Oral use 10 mg/ml Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol 1 mg Tablet Oral use N/A Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol 5 mg Tablet Oral use N/A Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 30 mg/15 ml Oral solution Oral use 2 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 60 mg/30 ml Oral solution Oral use 2 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 200 mg/100 ml Oral solution Oral use 2 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 300 mg/30 ml Oral solution Oral use 10 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 1000 mg/100 ml Oral solution Oral use 10 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 5 mg/ml Solution for injection Intramuscular use; Intravenous use 5 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 2 mg Tablet Oral use N/A Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 5 mg Tablet Oral use N/A Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol 20 mg Tablet Oral use N/A Malta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Haldol 5 mg Tablet Oral use N/A The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands Haldol druppels 2 mg/ml 60 mg/30 ml Oral solution Oral use 2 mg/ml The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands Haldol oplossing voor injectie 5 mg/ml 5 mg/ml Solution for injection Intramuscular use; Intravenous use 5 mg/ml The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands Haldol tabletten 10 mg 10 mg Tablet Oral use N/A Norway JANSSEN-CILAG AS Drammensveien 288 0283 Oslo Norway Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Norway JANSSEN-CILAG AS Drammensveien 288 0283 Oslo Norway Haldol 1 mg Tablet Oral use N/A Norway JANSSEN-CILAG AS Drammensveien 288 0283 Oslo Norway Haldol 4 mg Tablet Oral use N/A Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal Haldol 2 mg/ml Oral solution Oral use 2 mg/ml Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal Haldol 1 mg Tablet Oral use N/A Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal Haldol 2 mg Tablet Oral use N/A Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal Haldol 5 mg Tablet Oral use N/A Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal Haldol 10 mg Tablet Oral use N/A Romania Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse Belgium Haldol 5 mg Tablet Oral use N/A Sweden Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 200 mg/100 ml Oral solution Oral use 2 mg/ml Sweden Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml Sweden Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 1 mg Tablet Oral use NA Sweden Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol 4 mg Tablet Oral use NA United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Haldol 2 mg/ml Oral solution Oral use N/A United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Haldol 5 mg/ml Solution for injection Intramuscular use 5 mg/ml United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Haldol 10 mg/2 ml Solution for injection Intramuscular use 5 mg/ml