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 or Article 38 of Directive 2001/82/EC)
Date: 2017-07-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017245EN.01001201.xml










28.7.2017   


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







ANNEX VI
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicant/marketing authorisation holder in the Member States












Member State EU/EEA


Applicant/Marketing authorisation holder


Name


INN


Pharmaceutical form


Strength


Animal species


Route of administration




France


Zoetis France
23-25 Avenue du Dr Lannelongue
75014 Paris
France


SOLU-MEDROL 120 MG


Methylprednisolone hydrogen succinate


Lyophilisate and diluent for solution for injection


120 mg per bottle


Cattle,
cats,
dogs


Intramuscular or intravenous




France


Zoetis France
23-25 Avenue du Dr Lannelongue
75014 Paris
France


SOLU-MEDROL 500 MG


Methylprednisolone hydrogen succinate


Lyophilisate and diluent for solution for injection


500 mg per bottle


Cattle,
cats,
dogs


Intramuscular or intravenous




Germany (1)



CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany


Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung


Methylprednisolone hydrogen succinate


Powder and solvent


500 mg per bottle


Cattle, cats, dogs


Intramuscular or intravenous






(1)  Marketing authorisation not granted for target species cattle.