# Official Journal C 245/28 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 245 |
| | |
| English edition | Information and Notices | Volume 6028 July 2017 |

ISSN 1977-091X

Official Journal

of the European Union

C 245

English edition

Information and Notices

Volume 6028 July 2017

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2017/C 245/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2017 to 30 June 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2017/C 245/02 | 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) | 12 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2017/C 245/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2017 to 30 June 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2017/C 245/02

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)

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

12

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.7.2017 | EN | Official Journal of the European Union | C 245/1 |
| --- | --- | --- | --- |

28.7.2017

EN

Official Journal of the European Union

C 245/1

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

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2017/C 245/01)

| — | Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.6.2017 | Elmiron | pentosan polysulfate sodium | bene-Arzneimittel GmbH
  Herterichstr. 1-3, 81479 München, Deutschland | EU/1/17/1189 | Capsule, hard | G04BX15 | 7.6.2017 |
| 2.6.2017 | Refixia | nonacog beta pegol | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/17/1193 | Powder and solvent for solution for injection | B02BD04 | 7.6.2017 |
| 15.6.2017 | Febuxostat Mylan | febuxostat | Mylan S.A.S.
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/17/1194 | Film-coated tablet | M04AA03 | 19.6.2017 |
| 15.6.2017 | Rixathon | rituximab | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/17/1185 | Concentrate for solution for infusion | L01XC02 | 19.6.2017 |
| 15.6.2017 | Riximyo | rituximab | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/17/1184 | Concentrate for solution for infusion | L01XC02 | 19.6.2017 |
| 23.6.2017 | Erelzi | etanercept | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/17/1195 | Solution for injection | L04AB01 | 27.6.2017 |
| 23.6.2017 | Kevzara | sarilumab | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/17/1196 | Solution for injection | L04AC14 | 27.6.2017 |
| 23.6.2017 | Skilarence | dimethyl fumarate | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/17/1201 | Gastro-resistant tablet | Pending | 27.6.2017 |
| 23.6.2017 | Ucedane | carglumic acid | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/17/1202 | Dispersible tablet | A16AA05 | 27.6.2017 |
| 29.6.2017 | Besponsa | inotuzumab ozogamicin | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1200 | Powder for concentrate for solution for infusion | L01XC26 | 3.7.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

2.6.2017

Elmiron

pentosan polysulfate sodium

bene-Arzneimittel GmbH

Herterichstr. 1-3, 81479 München, Deutschland

EU/1/17/1189

Capsule, hard

G04BX15

7.6.2017

2.6.2017

Refixia

nonacog beta pegol

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/17/1193

Powder and solvent for solution for injection

B02BD04

7.6.2017

15.6.2017

Febuxostat Mylan

febuxostat

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/17/1194

Film-coated tablet

M04AA03

19.6.2017

15.6.2017

Rixathon

rituximab

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/17/1185

Concentrate for solution for infusion

L01XC02

19.6.2017

15.6.2017

Riximyo

rituximab

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/17/1184

Concentrate for solution for infusion

L01XC02

19.6.2017

23.6.2017

Erelzi

etanercept

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/17/1195

Solution for injection

L04AB01

27.6.2017

23.6.2017

Kevzara

sarilumab

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/17/1196

Solution for injection

L04AC14

27.6.2017

23.6.2017

Skilarence

dimethyl fumarate

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/17/1201

Gastro-resistant tablet

Pending

27.6.2017

23.6.2017

Ucedane

carglumic acid

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/17/1202

Dispersible tablet

A16AA05

27.6.2017

29.6.2017

Besponsa

inotuzumab ozogamicin

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/17/1200

Powder for concentrate for solution for infusion

L01XC26

3.7.2017

| — | Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.6.2017 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 7.6.2017 |
| 2.6.2017 | Caspofungin Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1081 | 7.6.2017 |
| 2.6.2017 | Cerezyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/97/053 | 7.6.2017 |
| 2.6.2017 | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1133 | 7.6.2017 |
| 2.6.2017 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 7.6.2017 |
| 2.6.2017 | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 7.6.2017 |
| 2.6.2017 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 7.6.2017 |
| 2.6.2017 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 7.6.2017 |
| 2.6.2017 | PecFent | Archimedes Development Ltd
  Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom | EU/1/10/644 | 7.6.2017 |
| 2.6.2017 | Pregabalin Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/997 | 8.6.2017 |
| 2.6.2017 | Pregabalin Mylan Pharma | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/998 | 8.6.2017 |
| 2.6.2017 | Somavert | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/240 | 7.6.2017 |
| 8.6.2017 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 12.6.2017 |
| 12.6.2017 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/565 | 14.6.2017 |
| 12.6.2017 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 14.6.2017 |
| 15.6.2017 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/13/838 | 19.6.2017 |
| 15.6.2017 | Clopidogrel Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/09/559 | 19.6.2017 |
| 15.6.2017 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 19.6.2017 |
| 15.6.2017 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 19.6.2017 |
| 15.6.2017 | Zometa | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/176 | 19.6.2017 |
| 16.6.2017 | Atriance | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/403 | 20.6.2017 |
| 16.6.2017 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/802 | 20.6.2017 |
| 16.6.2017 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o.
  Slunná 16, CZ-61700 Brno, Česká republika | EU/1/09/541 | 20.6.2017 |
| 16.6.2017 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 20.6.2017 |
| 16.6.2017 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 20.6.2017 |
| 16.6.2017 | Intuniv | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1040 | 20.6.2017 |
| 16.6.2017 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 20.6.2017 |
| 16.6.2017 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/901 | 21.6.2017 |
| 16.6.2017 | Sivextro | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/991 | 20.6.2017 |
| 16.6.2017 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 20.6.2017 |
| 16.6.2017 | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 20.6.2017 |
| 16.6.2017 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 20.6.2017 |
| 16.6.2017 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 20.6.2017 |
| 16.6.2017 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 20.6.2017 |
| 16.6.2017 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 20.6.2017 |
| 16.6.2017 | Zoledronic acid Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/12/800 | 20.6.2017 |
| 16.6.2017 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 20.6.2017 |
| 23.6.2017 | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/16/1098 | 28.6.2017 |
| 23.6.2017 | Clopidogrel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/540 | 27.6.2017 |
| 23.6.2017 | Emselex | Merus Labs Luxco S.à R.L.
  26-28, rue Edward Steichen, L-2540 Luxembourg | EU/1/04/294 | 27.6.2017 |
| 23.6.2017 | Evra | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/02/223 | 27.6.2017 |
| 23.6.2017 | Farydak | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1023 | 27.6.2017 |
| 23.6.2017 | Flixabi | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/16/1106 | 27.6.2017 |
| 23.6.2017 | Izba | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/905 | 27.6.2017 |
| 23.6.2017 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 27.6.2017 |
| 23.6.2017 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 27.6.2017 |
| 23.6.2017 | Pandemic influenza vaccine H5N1 AstraZeneca | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1089 | 28.6.2017 |
| 23.6.2017 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 27.6.2017 |
| 23.6.2017 | Rapamune | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/01/171 | 27.6.2017 |
| 23.6.2017 | Revestive | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/12/787 | 27.6.2017 |
| 23.6.2017 | Sebivo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/388 | 27.6.2017 |
| 23.6.2017 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/952 | 27.6.2017 |
| 23.6.2017 | Tadalafil Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/14/961 | 27.6.2017 |
| 23.6.2017 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 27.6.2017 |
| 23.6.2017 | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 27.6.2017 |
| 26.6.2017 | Grastofil | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/13/877 | 28.6.2017 |
| 26.6.2017 | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 28.6.2017 |
| 26.6.2017 | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/05/325 | 28.6.2017 |
| 26.6.2017 | Noxafil | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/320 | 28.6.2017 |
| 26.6.2017 | Onglyza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/545 | 28.6.2017 |
| 26.6.2017 | Pregabalin Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1027 | 28.6.2017 |
| 26.6.2017 | Renvela | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/521 | 28.6.2017 |
| 26.6.2017 | Triumeq | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/14/940 | 28.6.2017 |
| 26.6.2017 | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/835 | 28.6.2017 |
| 29.6.2017 | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 3.7.2017 |
| 29.6.2017 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 4.7.2017 |
| 29.6.2017 | Clopidogrel ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/975 | 3.7.2017 |
| 29.6.2017 | Ibandronic acid Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/11/685 | 3.7.2017 |
| 29.6.2017 | IKERVIS | Santen Oy
  Niittyhaankatu 20, FI-33720 Tampere, Suomi | EU/1/15/990 | 3.7.2017 |
| 29.6.2017 | Uptravi | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | 3.7.2017 |
| 29.6.2017 | Vizamyl | GE Healthcare Ltd
  Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom | EU/1/14/941 | 3.7.2017 |
| 29.6.2017 | Xyrem | UCB Pharma Ltd
  208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | EU/1/05/312 | 3.7.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.6.2017

Avastin

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300

7.6.2017

2.6.2017

Caspofungin Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1081

7.6.2017

2.6.2017

Cerezyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/97/053

7.6.2017

2.6.2017

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/16/1133

7.6.2017

2.6.2017

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

7.6.2017

2.6.2017

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

7.6.2017

2.6.2017

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

7.6.2017

2.6.2017

Opdivo

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1014

7.6.2017

2.6.2017

PecFent

Archimedes Development Ltd

Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom

EU/1/10/644

7.6.2017

2.6.2017

Pregabalin Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/997

8.6.2017

2.6.2017

Pregabalin Mylan Pharma

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/998

8.6.2017

2.6.2017

Somavert

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/240

7.6.2017

8.6.2017

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

12.6.2017

12.6.2017

Biopoin

Teva GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/565

14.6.2017

12.6.2017

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

14.6.2017

15.6.2017

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

19.6.2017

15.6.2017

Clopidogrel Mylan

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/09/559

19.6.2017

15.6.2017

Eporatio

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/573

19.6.2017

15.6.2017

Nexium Control

Pfizer Consumer Healthcare Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/13/860

19.6.2017

15.6.2017

Zometa

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/176

19.6.2017

16.6.2017

Atriance

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/403

20.6.2017

16.6.2017

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/802

20.6.2017

16.6.2017

Clopidogrel ratiopharm GmbH

Archie Samuel s.r.o.

Slunná 16, CZ-61700 Brno, Česká republika

EU/1/09/541

20.6.2017

16.6.2017

Cubicin

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/328

20.6.2017

16.6.2017

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

20.6.2017

16.6.2017

Intuniv

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1040

20.6.2017

16.6.2017

KEYTRUDA

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1024

20.6.2017

16.6.2017

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/901

21.6.2017

16.6.2017

Sivextro

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/991

20.6.2017

16.6.2017

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

20.6.2017

16.6.2017

Trizivir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/00/156

20.6.2017

16.6.2017

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

20.6.2017

16.6.2017

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

20.6.2017

16.6.2017

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

20.6.2017

16.6.2017

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

20.6.2017

16.6.2017

Zoledronic acid Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/12/800

20.6.2017

16.6.2017

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

20.6.2017

23.6.2017

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/16/1098

28.6.2017

23.6.2017

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

27.6.2017

23.6.2017

Emselex

Merus Labs Luxco S.à R.L.

26-28, rue Edward Steichen, L-2540 Luxembourg

EU/1/04/294

27.6.2017

23.6.2017

Evra

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/02/223

27.6.2017

23.6.2017

Farydak

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1023

27.6.2017

23.6.2017

Flixabi

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/16/1106

27.6.2017

23.6.2017

Izba

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/905

27.6.2017

23.6.2017

KEYTRUDA

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1024

27.6.2017

23.6.2017

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

27.6.2017

23.6.2017

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1089

28.6.2017

23.6.2017

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

27.6.2017

23.6.2017

Rapamune

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/01/171

27.6.2017

23.6.2017

Revestive

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/12/787

27.6.2017

23.6.2017

Sebivo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/388

27.6.2017

23.6.2017

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/952

27.6.2017

23.6.2017

Tadalafil Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/14/961

27.6.2017

23.6.2017

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

27.6.2017

23.6.2017

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

27.6.2017

26.6.2017

Grastofil

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/13/877

28.6.2017

26.6.2017

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

28.6.2017

26.6.2017

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/05/325

28.6.2017

26.6.2017

Noxafil

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/320

28.6.2017

26.6.2017

Onglyza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/545

28.6.2017

26.6.2017

Pregabalin Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1027

28.6.2017

26.6.2017

Renvela

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/521

28.6.2017

26.6.2017

Triumeq

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/14/940

28.6.2017

26.6.2017

Voriconazole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/835

28.6.2017

29.6.2017

alli

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/07/401

3.7.2017

29.6.2017

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

4.7.2017

29.6.2017

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

3.7.2017

29.6.2017

Ibandronic acid Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/11/685

3.7.2017

29.6.2017

IKERVIS

Santen Oy

Niittyhaankatu 20, FI-33720 Tampere, Suomi

EU/1/15/990

3.7.2017

29.6.2017

Uptravi

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/15/1083

3.7.2017

29.6.2017

Vizamyl

GE Healthcare Ltd

Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom

EU/1/14/941

3.7.2017

29.6.2017

Xyrem

UCB Pharma Ltd

208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312

3.7.2017

| — | Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.6.2017 | Removab | Neovii Biotech GmbH
  Am Haag 6-7, 82166 Graefelfing, Deutschland | EU/1/09/512 | 7.6.2017 |
| 15.6.2017 | Clopidogrel Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/561 | 19.6.2017 |
| 23.6.2017 | Zontivity | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/14/976 | 27.6.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.6.2017

Removab

Neovii Biotech GmbH

Am Haag 6-7, 82166 Graefelfing, Deutschland

EU/1/09/512

7.6.2017

15.6.2017

Clopidogrel Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/561

19.6.2017

23.6.2017

Zontivity

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/14/976

27.6.2017

| — | Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.6.2017 | Prevomax | maropitant | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/17/211 | Solution for injection | QA04AD90 | 21.6.2017 |
| 27.6.2017 | CLYNAV | Salmon pancreas disease vaccine (recombinant DNA plasmid) | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/16/197 | Solution for injection | QI10AX | 29.6.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

19.6.2017

Prevomax

maropitant

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/17/211

Solution for injection

QA04AD90

21.6.2017

27.6.2017

CLYNAV

Salmon pancreas disease vaccine (recombinant DNA plasmid)

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/16/197

Solution for injection

QI10AX

29.6.2017

| — | Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.6.2017 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 8.6.2017 |
| 7.6.2017 | Econor | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM | EU/2/98/010 | 9.6.2017 |
| 8.6.2017 | Cardalis | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/12/142 | 12.6.2017 |
| 13.6.2017 | BROADLINE | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/157 | 15.6.2017 |
| 13.6.2017 | Circovac | Ceva-Phylaxia Zrt.
  1107 Budapest, Szállás u. 5., MAGYARORSZÁG | EU/2/07/075 | 15.6.2017 |
| 13.6.2017 | Clomicalm | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/007 | 15.6.2017 |
| 13.6.2017 | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 16.6.2017 |
| 29.6.2017 | EQUIOXX | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/08/083 | 3.7.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.6.2017

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

8.6.2017

7.6.2017

Econor

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM

EU/2/98/010

9.6.2017

8.6.2017

Cardalis

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/12/142

12.6.2017

13.6.2017

BROADLINE

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/157

15.6.2017

13.6.2017

Circovac

Ceva-Phylaxia Zrt.

1107 Budapest, Szállás u. 5., MAGYARORSZÁG

EU/2/07/075

15.6.2017

13.6.2017

Clomicalm

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/98/007

15.6.2017

13.6.2017

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

16.6.2017

29.6.2017

EQUIOXX

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/08/083

3.7.2017

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 28.7.2017 | EN | Official Journal of the European Union | C 245/12 |
| --- | --- | --- | --- |

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 |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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

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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 |

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

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

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