# Official Journal C 496/29 D

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 496 |
| | |
| English edition | Information and Notices | Volume 6529 December 2022 |

ISSN 1977-091X

Official Journal

of the European Union

C 496

English edition

Information and Notices

Volume 6529 December 2022

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2022/C 496/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 1 |
| 2022/C 496/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 12 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2022/C 496/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 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 or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

1

2022/C 496/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

12

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.12.2022 | EN | Official Journal of the European Union | C 496/1 |
| --- | --- | --- | --- |

29.12.2022

EN

Official Journal of the European Union

C 496/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2022/C 496/01)

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.11.2022 | Melatonin Neurim | melatonin | RAD Neurim Pharmaceuticals EEC SARL |
| 4 rue de Marivaux, 75002 Paris, France |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.11.2022

Melatonin Neurim

melatonin

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/22/1694

Prolonged-release tablet

N05CH01

8.11.2022

9.11.2022

LIVTENCITY

maribavir

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| 50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland

EU/1/22/1672

Film-coated tablet

J05AX10

10.11.2022

9.11.2022

Pyrukynd

mitapivat

| Agios Netherlands B.V. |
| --- |
| Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, Nederland |

Agios Netherlands B.V.

Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, Nederland

EU/1/22/1662

Film-coated tablet

B06AX04

10.11.2022

9.11.2022

Rubraca

rucaparib

| Clovis Oncology Ireland Limited |
| --- |
| 1st Floor, Building Two, The Green, Dublin Airport Central, Dublin Airport, Swords, Co. Dublin, K67 E2H3, Ireland. |

Clovis Oncology Ireland Limited

1st Floor, Building Two, The Green, Dublin Airport Central, Dublin Airport, Swords, Co. Dublin, K67 E2H3, Ireland.

EU/1/17/1250

Film-coated tablet

L01XK03

10.11.2022

9.11.2022

Sorafenib Accord

sorafenib

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/22/1696

Film-coated tablet

L01EX02

10.11.2022

9.11.2022

Teriflunomide Accord

teriflunomide

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/22/1693

Film-coated tablet

L04AA31

10.11.2022

9.11.2022

Teriflunomide Mylan

teriflunomide

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/22/1698

Film-coated tablet

L04AA31

10.11.2022

9.11.2022

Ximluci

ranibizumab

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/22/1691

Solution for injection

S01LA04

11.11.2022

15.11.2022

Enjaymo

sutimlimab

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/22/1687

Solution for infusion

L04AA55

23.11.2022

18.11.2022

Teriparatide SUN

teriparatide

| Sun Pharmaceutical Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

EU/1/22/1697

Solution for injection

H05AA02

22.11.2022

28.11.2022

Caprelsa

vandetanib

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

Film-coated tablet

L01EX04

30.11.2022

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.11.2022 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | KRKA d d., Novo mesto |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.11.2022

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

9.11.2022

7.11.2022

EXPAREL liposomal

| Pacira Ireland Ltd |
| --- |
| Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland |

Pacira Ireland Ltd

Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland

EU/1/20/1489

9.11.2022

9.11.2022

Aclasta

| Sandoz Pharmaceuticals d.d. |
| --- |
| Verovškova ulica 57, 1000 Ljubljana, Slovenija |

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/05/308

11.11.2022

9.11.2022

Adempas

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

10.11.2022

9.11.2022

ADYNOVI

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

10.11.2022

9.11.2022

Alkindi

| Diurnal Europe B.V. |
| --- |
| Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland |

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/17/1260

10.11.2022

9.11.2022

Darunavir Krka

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1249

15.11.2022

9.11.2022

Dexmedetomidine Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1418

10.11.2022

9.11.2022

Elaprase

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/06/365

10.11.2022

9.11.2022

Eylea

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

10.11.2022

9.11.2022

GHRYVELIN

| Consilient Health Ltd |
| --- |
| 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/18/1337

16.11.2022

9.11.2022

Hycamtin

| Sandoz Pharmaceuticals d.d. |
| --- |
| Verovškova ulica 57, 1000 Ljubljana, Slovenija |

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/96/027

11.11.2022

9.11.2022

Incruse Ellipta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

10.11.2022

9.11.2022

Isturisa

| Recordati Rare Diseases |
| --- |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/19/1407

10.11.2022

9.11.2022

Kentera

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/03/270

14.11.2022

9.11.2022

Laventair Ellipta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

10.11.2022

9.11.2022

Lucentis

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/374

11.11.2022

9.11.2022

Memantine ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/13/836

11.11.2022

9.11.2022

Rilutek

| Sanofi Mature IP |
| --- |
| 54 rue La Boétie, 75008, Paris, France |

Sanofi Mature IP

54 rue La Boétie, 75008, Paris, France

EU/1/96/010

14.11.2022

9.11.2022

Rolufta Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1174

14.11.2022

9.11.2022

Segluromet

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

11.11.2022

9.11.2022

Stelara

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

10.11.2022

9.11.2022

Stocrin

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

11.11.2022

9.11.2022

Talzenna

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/19/1377

10.11.2022

9.11.2022

Torisel

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/07/424

10.11.2022

9.11.2022

Vargatef

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

10.11.2022

9.11.2022

Vyndaqel

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/11/717

10.11.2022

10.11.2022

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

11.11.2022

10.11.2022

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

11.11.2022

11.11.2022

JCOVDEN

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

14.11.2022

15.11.2022

Brukinsa

| BeiGene Ireland Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland |

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland

EU/1/21/1576

16.11.2022

15.11.2022

Caprelsa

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

18.11.2022

15.11.2022

IMBRUVICA

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

16.11.2022

15.11.2022

Lamivudine Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/566

21.11.2022

15.11.2022

Mylotarg

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/18/1277

16.11.2022

15.11.2022

Riluzole Zentiva

| Zentiva k.s. |
| --- |
| U kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/12/768

18.11.2022

15.11.2022

Steglatro

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

17.11.2022

15.11.2022

Tecartus

| Kite Pharma EU B.V. |
| --- |
| Tufsteen 1, 2132 NT Hoofddorp, Nederland |

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

22.11.2022

15.11.2022

Xevudy

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

16.11.2022

18.11.2022

Anoro Ellipta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

22.11.2022

18.11.2022

Aripiprazole Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1045

22.11.2022

18.11.2022

Byfavo

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/20/1505

22.11.2022

18.11.2022

Fasturtec

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/00/170

22.11.2022

18.11.2022

Kevzara

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1196

22.11.2022

18.11.2022

Latuda

| Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A. |
| --- |
| Viale Amelia 70, 00181 Roma, Italia |

Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

22.11.2022

18.11.2022

LIBTAYO

| Regeneron Ireland Designated Activity Company (DAC) |
| --- |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

21.11.2022

18.11.2022

Lyumjev

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1422

22.11.2022

18.11.2022

Matever

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

22.11.2022

18.11.2022

Methylthioninium chloride Proveblue

| Provepharm S.A.S. |
| --- |
| 22 rue Marc Donadille, 13013 Marseille, France |

Provepharm S.A.S.

22 rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

23.11.2022

18.11.2022

Vaborem

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1 avenue de la Gare, 1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/18/1334

23.11.2022

18.11.2022

Yselty

| Theramex Ireland Limited |
| --- |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/21/1606

23.11.2022

18.11.2022

Zeposia

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/20/1442

21.11.2022

21.11.2022

Aldara

| Viatris Healthcare Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/98/080

22.11.2022

21.11.2022

Anagrelide Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1256

22.11.2022

21.11.2022

AUBAGIO

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/13/838

22.11.2022

21.11.2022

Biktarvy

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

22.11.2022

21.11.2022

Eucreas

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/425

22.11.2022

21.11.2022

Imatinib Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

22.11.2022

21.11.2022

Jylamvo

| Therakind (Europe) Limited |
| --- |
| Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland |

Therakind (Europe) Limited

Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland

EU/1/17/1172

24.11.2022

21.11.2022

Lumykras

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1603

23.11.2022

21.11.2022

Multaq

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/09/591

22.11.2022

21.11.2022

Obiltoxaximab SFL

| SFL Pharmaceuticals Deutschland GmbH |
| --- |
| Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland |

SFL Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/20/1485

28.11.2022

21.11.2022

Qtern

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

22.11.2022

21.11.2022

Skyrizi

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1361

22.11.2022

21.11.2022

Tasmar

| Viatris Healthcare Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/97/044

22.11.2022

21.11.2022

Veklury

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

21.11.2022

21.11.2022

Voncento

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/13/857

22.11.2022

21.11.2022

ZALTRAP

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/12/814

22.11.2022

25.11.2022

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

| Valneva Austria GmbH |
| --- |
| Campus Vienna Biocenter 3, 1030 Wien, Österreich |

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/21/1624

25.11.2022

28.11.2022

Adenuric

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1 avenue de la Gare, 1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/08/447

29.11.2022

28.11.2022

Beromun

| BELPHARMA s.a. |
| --- |
| 2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg |

BELPHARMA s.a.

2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg

EU/1/99/097

29.11.2022

28.11.2022

Deferasirox Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/19/1386

29.11.2022

28.11.2022

Dengvaxia

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

29.11.2022

28.11.2022

Dimethyl fumarate Polpharma

| Zakłady Farmaceutyczne POLPHARMA S.A. |
| --- |
| ul. Pelplińska 19, 83-200 Starogard Gdański, Polska |

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański, Polska

EU/1/22/1635

2.12.2022

28.11.2022

Docetaxel Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/769

30.11.2022

28.11.2022

IKERVIS

| Santen Oy |
| --- |
| Niittyhaankatu 20, 33720 Tampere, Suomi |

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/15/990

30.11.2022

28.11.2022

Kivexa

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/04/298

30.11.2022

28.11.2022

Mircera

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/07/400

30.11.2022

28.11.2022

Nityr

| Cycle Pharmaceuticals (Europe) Ltd |
| --- |
| 70 Sir John Rogerson's Quay, Dublin 2, Ireland |

Cycle Pharmaceuticals (Europe) Ltd

70 Sir John Rogerson's Quay, Dublin 2, Ireland

EU/1/18/1290

29.11.2022

28.11.2022

Nordimet

| Nordic Group B.V. |
| --- |
| Siriusdreef 41, 2132 WT Hoofddorp, Nederland |

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

29.11.2022

28.11.2022

Olanzapine Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/08/475

29.11.2022

28.11.2022

Onpattro

| Alnylam Netherlands B.V. |
| --- |
| Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/18/1320

2.12.2022

28.11.2022

Paxlovid

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/22/1625

28.11.2022

28.11.2022

Pegasys

| zr pharma& GmbH |
| --- |
| Hietzinger Hauptstrasse 37, 1130 Wien, Österreich |

zr pharma& GmbH

Hietzinger Hauptstrasse 37, 1130 Wien, Österreich

EU/1/02/221

29.11.2022

28.11.2022

Potactasol

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/10/660

29.11.2022

28.11.2022

Praluent

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/15/1031

29.11.2022

28.11.2022

Sixmo

| L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A |
| --- |
| Strada Statale 67, 50018 Scandicci (Firenze), Italia |

L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A

Strada Statale 67, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

29.11.2022

28.11.2022

Stivarga

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

29.11.2022

28.11.2022

Taltz

| Eli Lilly and Company (Ireland) Limited |
| --- |
| Dunderrow, Kinsale, Co. Cork, Ireland |

Eli Lilly and Company (Ireland) Limited

Dunderrow, Kinsale, Co. Cork, Ireland

EU/1/15/1085

2.12.2022

28.11.2022

Zessly

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1280

29.11.2022

28.11.2022

Zoely

| Theramex Ireland Limited |
| --- |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

6.12.2022

—   Withdrawal of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 18.11.2022 | Hepsera | Gilead Sciences Ireland UC |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

18.11.2022

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

22.11.2022

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 22.11.2022 | Mometamax Ultra | gentamicin, posaconazole, mometasone furoate | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

22.11.2022

Mometamax Ultra

gentamicin, posaconazole, mometasone furoate

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/22/289

Ear drops, suspension

Pending

24.11.2022

30.11.2022

DogStem

equine umbilical cord mesenchymal stem cells

| EquiCord S.L. |
| --- |
| 103-D Loeches, Polígono Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España |

EquiCord S.L.

103-D Loeches, Polígono Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España

EU/2/22/285

Suspension for injection

QM09AX90

1.12.2022

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 9.11.2022 | BROADLINE | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

9.11.2022

BROADLINE

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/13/157

11.11.2022

9.11.2022

Purevax RCPCh FeLV

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/047

10.11.2022

9.11.2022

Zuprevo

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/124

10.11.2022

11.11.2022

Bravecto Plus

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

15.11.2022

11.11.2022

Librela

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/20/261

14.11.2022

11.11.2022

Rheumocam

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, Co. Galway, Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

15.11.2022

11.11.2022

Simparica

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/15/191

15.11.2022

18.11.2022

Bravecto Plus

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

21.11.2022

18.11.2022

CircoMax Myco

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/20/264

22.11.2022

18.11.2022

MiPet Easecto

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/220

21.11.2022

30.11.2022

Arti-Cell Forte

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/18/228

1.12.2022

30.11.2022

CircoMax

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/21/281

1.12.2022

30.11.2022

Meloxoral

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/10/111

1.12.2022

30.11.2022

ProZinc

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

8.12.2022

30.11.2022

Simparica Trio

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/19/243

2.12.2022

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

(2)  OJ L 4, 7.1.2019, p. 43.

---

| 29.12.2022 | EN | Official Journal of the European Union | C 496/12 |
| --- | --- | --- | --- |

29.12.2022

EN

Official Journal of the European Union

C 496/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3))

(2022/C 496/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 9.11.2022 | Toltrazuril oral 25 mg/ml for chickens | Toltrazuril | See Annex I | See Annex I | 10.11.2022 |
| 28.11.2022 | Synchron Research Services | Synchron Research Services | See Annex II | See Annex II | 28.11.2022 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

9.11.2022

Toltrazuril oral 25 mg/ml for chickens

Toltrazuril

See Annex I

See Annex I

10.11.2022

28.11.2022

Synchron Research Services

Synchron Research Services

See Annex II

See Annex II

28.11.2022

—   Suspension of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.11.2022 | Synchron Research Services | Synchron Research Services | See Annex II | See Annex II | 28.11.2022 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

28.11.2022

Synchron Research Services

Synchron Research Services

See Annex II

See Annex II

28.11.2022

---

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

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

(3)  OJ L 4, 7.1.2019, p. 43.

---

ANNEX I

List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States

| Member State EU/EEA | Marketing authorisation holders | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Austria | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox Direct 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Belgium | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25mg/ml,
  solution pour administration dans l’eau de boisson pour poulets et dindes / oplossing voor gebruik in drinkwater voor kippen en kalkoenen
  toltrazuril / Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Belgium | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  %
  25 mg/ml, solution buvable / drank / Lösung zum Einnehmen | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Belgium | Avimedical B.V.
  Abbinkdijk 1,
  7255 LX Hengelo Gld
  The Netherlands | Coccinox | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Belgium | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Bulgaria | Pharma Vet Ltd
  Shumen, ul. ‘Otec Paisij’ No 40,
  Bulgaria | Фармакокс разтвор
  Pharmacox liquid | Toltrazuril | 2.5 g/ 100 ml | Oral solution | Chicken, turkey | Oral use |
| Bulgaria | Interchemie Werken De
  Adelaar BV
  Metaalweg 8,
  5804 CG Venray,
  The Netherlands | Intracox oral | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Bulgaria | Kepro B.V.
  Maagdenburgstraat 17,
  7421 ZA Deventer
  The Netherlands | Кепкокс 2.5 % орал /Kepcox 2.5 % oral | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Bulgaria | Ceva Santé Animale
  10, Av. de La Ballastière
  33500 Libourne
  France | Севазурил/Cevazuril | Toltrazuril | 25 mg/ml | Oral solution | Broilers, growing parents of chickens, bright, turkeys | Oral use |
| Bulgaria | Bayer Animal Health
  51368 Leverkusen,
  Germany | Байкокс 2,5  % разтвор/Baycox 2,5  % solution | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Bulgaria | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml разтвор за перорална употреба с питейната вода при пилета / Dozuril 25 mg/ml solution for use in drinking water for chicken | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Croatia | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25 mg/ml, otopina za primjenu u vodi za piće, za kokoši i purane | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Cyprus | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  % w/v
  Πόσιμο διάλυμα για ορνίθια κρεοπαραγωγής και ινδορνίθια. | Toltrazuril | 25 mg/ml | Oral solution | Broiler, turkey | Oral use |
| Czech Republic | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  % (w/v) perorální roztok | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broiler), turkey | Oral use |
| Denmark | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Estonia | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Estonia | Interchemie Werken De Adelaar Eesti AS
  Vanapere tee 14, Puunsi Village, Viimsi Rural Municipality, Harju County, 74013
  Estonia | Intracox Oral | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Estonia | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| France | Ceva Santé Animale
  10, Av. de La Ballastière
  33500 Libourne
  France | Cevazuril 25 mg/ml solution buvable pour poulets de chair, poulettes et reproducteurs | Toltrazuril | 25 mg/ml | Oral solution | Chicken (broilers, pullets, breeders) | Oral use |
| France | Virbac
  1ere avenue, 2065 m, LID, 06516 Carros,
  France | Toltracox 2,5  % | Toltrazuril | 25 mg/ml | Oral solution | Chicken (broilers, pullets, breeders) | Oral use |
| France | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml solution buvable pour poulets | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| France | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel 25 mg/ml solution pour administration dans l'eau de boisson pour poulets et dindes | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| France | Elanco GmbH
  Heinz-Lohmann-Straße 4
  27472 Cuxhaven
  Germany | Baycox 25 mg/ml solution pour administration dans l'eau de boisson des poules et des dindes | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| France | Avimedical B.V.
  Abbinkdijk 1,
  7255 LX Hengelo Gld
  The Netherlands | Coccinox 25 mg/ml solution orale pour administration dans l'eau de boisson pour poulets et dindes | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey, pigeon | Oral use |
| France | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Cozuril CT 25 mg/ml solution pour administration dans l'eau de boisson pour poulets et dindes | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Germany | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Germany | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril CT | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Germany | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml Lösung zum Eingeben über das Trinkwasser | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Germany | Elanco GmbH
  Heinz-Lohmann-Straße 4
  27472 Cuxhaven
  Germany | Baycox 25 mg/ml, Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Germany | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Germany | Bremer Pharma GmbH,
  Werkstr. 42,
  D-34414 Warburg, Scherfede,
  Germany | Bremacox 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Germany | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Greece | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  % | Toltrazuril | 25 mg/ml | Oral solution | Broiler, turkey | Oral use |
| Greece | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Greece | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Greece | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol, Διάλυμα για χoρήyηση με πόσιμο νερό 25 mg/ml | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Hungary | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  % koncentrátum belsőleges oldathoz A.U.V. | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Hungary | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml, oldat ivóvízbe keveréshez házityúkoknak A.U.V. | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Hungary | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml oldat ivóvízbe keveréshez házityúkok részére A.U.V. | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Hungary | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K 25 mg/ml oldat ivóvízbe keveréshez házityúkok és pulykák számára A.U.V. | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Ireland | Elanco GmbH
  Heinz-Lohmann-Straße 4
  27472 Cuxhaven
  Germany | Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Ireland | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml solution for use in drinking water for chickens | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Ireland | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml solution for use in drinking water for chickens | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Italy | Elanco Italia S.p.A
  Via dei Colatori, 12
  50019 Sesto Fiorentino (FI)
  Italy | Baycox PT 25 mg/ml soluzione per uso in acqua di bevanda per polli da carne e tacchini | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Italy | Elanco Italia S.p.A
  Via dei Colatori, 12
  50019 Sesto Fiorentino (FI)
  Italy | Baycox Soluzione orale 25 mg/ml per polli da carne e tacchini | Toltrazuril | 25 mg/ml | Oral solution | Broiler, turkey | Oral use |
| Italy | Ceva Salute Animale S.p.A. Viale Colleoni 15
  20864 Agrate Brianza (MB)
  Italy | Cevazuril, 25 mg/ml, soluzione orale, per polli da carne e tacchini, da somministrare diluita in acqua da bere. | Toltrazuril | 25 mg/ml | Oral solution | Broiler, turkey | Oral use |
| Italy | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril CT 25 mg/ml, soluzione per l'uso in acqua da bere per polli e tacchini | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Italy | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K-25 Soluzione da usare nell’acqua di bevanda per polli e tacchini | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Italy | Industria Italiana Integratori Trei S.p.A.
  Viale Corassori, 62
  41100 Modena
  Italy | Treizuril, 25 mg/ml, soluzione orale per polli da carne e tacchini | Toltrazuril | 25 mg/ml | Oral solution | Broiler, turkey | Oral use |
| Italy | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml soluzione per uso in acqua da bere per polli | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Latvia | Interchemie Werken De Adelaar Eesti AS
  Vanapere tee 14, Puunsi Village, Viimsi Rural Municipality, Harju County, 74013
  Estonia | LV Intracox Oral 25 mg/ml šķīdums iekšķīgai lietošanai tītariem un vistām | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Latvia | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml šķīdums lietošanai ar dzeramo ūdeni vistām | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Latvia | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml šķīdums lietošanai ar dzeramo ūdeni vistām | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Lithuania | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml, tirpalas naudoti su geriamuoju vandeniu vištoms | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Lithuania | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml, tirpalas, naudoti su geriamuoju vandeniu vištoms | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Lithuania | UAB Interchemie werken De Adelaar LT,
  Terminalo str. 13, Biruliškes, 54469, Kaunas distr.
  Lithuania | Intracox oral, 25 mg/ml tirpalas naudoti su ger. vandeniu vištoms ir kalakutams | Toltrazuril | 25 mg/ml | Oral solution | Chicken (broiler), turkey | Oral use |
| Luxembourg | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25 mg/m, solution pour administration dans l’eau de boisson pour poulets et dindes / Lösung zum Eingeben über das Trinkwasser für Hühner und Puten | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Luxembourg | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  %
  25 mg/ml, solution buvable / Lösung zum Einnehmen | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Luxembourg | Avimedical B.V.
  Abbinkdijk 1,
  7255 LX Hengelo Gld
  The Netherlands | Coccinox | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Luxembourg | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Malta | Kepro B.V.
  Maagdenburgstraat 17,
  7421 ZA Deventer
  The Netherlands | Kepcox 2.5 % | Toltrazuril | 25 mg/ml | Oral solution | Chicken (pullets, breeders), turkey | Oral use |
| Netherlands | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25 mg/ml, oplossing voor gebruik in drinkwater voor kippen en kalkoenen | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Netherlands | Avimedical B.V.
  Abbinkdijk 1,
  7255 LX Hengelo Gld
  The Netherlands | Coccinox 25 mg/ml orale oplossing voor gebruik in drinkwater voor kippen, kalkoenen, duiven en konijnen | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey, pigeon | Oral use |
| Netherlands | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril CT 25 mg/ml oplossing voor toediening in drinkwater voor kippen en kalkoenen | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Netherlands | Pantex Holland B.V.
  Smaragdweg 15
  5525 LA Hapert
  The Netherlands | Toltrapan 25 mg/ml, oplossing voor gebruik in drinkwater voor kippen en kalkoenen | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Netherlands | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml oplossing voor toediening in drinkwater voor kippen | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Poland | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  %, (2,5  g/100 ml, roztwór doustny dla kur i indyków) | Toltrazuril | 2.5 g/ 100 ml | Oral solution | Chicken (pullets), turkey | Oral use |
| Poland | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Poland | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril CT | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Poland | Biofaktor Sp. z o. o.
  Czysta 4 st., 96-100 Skierniewice,
  Poland | Endocox | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Poland | Lovapharm Consulting B.V.
  Rijsven 3
  5645 KH Eindhoven
  The Netherlands | Lovacox oral | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, pullets, breeders), turkey | Oral use |
| Poland | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Poland | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Poland | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Portugal | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25 mg/ml, solução para administração na água de bebida para galinhas e perus | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Portugal | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel 25 mg/ml solução para administração na água de bebida para galinhas e perus | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Portugal | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K 25 mg/ml solução para administração na água de bebida para galinhas e perus | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| Portugal | Calier Portugal, S.A.
  Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 — 335 Sintra
  Portugal | Zuritol 25 mg/ml solução para administração na água de bebida para galinhas | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Romania | Ceva Santé Animale
  10, Av. de La Ballastière
  33500 Libourne
  France | Cevazuril | Toltrazuril | 25 mg/ml | Oral solution | Broilers, replacements, pullets, turkeys | Oral use |
| Romania | Dopharma Research B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Dozuril 25 mg/ml | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| Romania | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Slovak Republic | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 2,5  % (w/v) perorálny roztok | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Slovenia | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25 mg/ml peroralna raztopina za piščance in purane | Toltrazuril | 25 mg/ml | Oral solution | Chicken, turkey | Oral use |
| Spain | Bayer Animal Health
  51368 Leverkusen,
  Germany | Baycox 25 mg/ml solución para administración en agua de bebida para aves | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (broilers, chick for replacement), turkey | Oral use |
| Spain | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K 25 mg/ml solución para administración en agua de bebida para pollos y pavos | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Spain | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel 25 mg/ml solucion para administracion en agua de bebida para pollos y pavos | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders), turkey | Oral use |
| Spain | Laboratorios Calier, S.A.
  Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Vallès (Barcelona)
  Spain | Zuritol 25 mg/ml solucion para uso en agua de bebida para pollos | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken (pullets, breeders) | Oral use |
| UK (Northern Ireland) (1) | Elanco Europe Ltd,
  Form 2, Bartley Way, Bartley Wood Business Park, Hook,
  RG 27 9XA,
  United Kingdom | Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| UK (Northern Ireland) (1) | Laboratorios Karizoo, S.A.
  Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,
  08140 Barcelona
  Spain | Toltra-K 25 mg/ml solution for use in drinking water for chickens and turkeys | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |
| UK (Northern Ireland) (1) | VetPharma Animal Health S.L.
  Les Corts 23,
  08028 Barcelona,
  Spain | Zorabel 25 mg/ml solution for use in drinking water for chickens and turkeys | Toltrazuril | 25 mg/ml | Solution for use in drinking water | Chicken, turkey | Oral use |

Member State EU/EEA

Marketing authorisation holders

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Austria

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox Direct 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Belgium

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25mg/ml,

solution pour administration dans l’eau de boisson pour poulets et dindes / oplossing voor gebruik in drinkwater voor kippen en kalkoenen

toltrazuril / Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Belgium

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  %

25 mg/ml, solution buvable / drank / Lösung zum Einnehmen

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Belgium

Avimedical B.V.

Abbinkdijk 1,

7255 LX Hengelo Gld

The Netherlands

Coccinox

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Belgium

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Bulgaria

Pharma Vet Ltd

Shumen, ul. ‘Otec Paisij’ No 40,

Bulgaria

Фармакокс разтвор

Pharmacox liquid

Toltrazuril

2.5 g/ 100 ml

Oral solution

Chicken, turkey

Oral use

Bulgaria

Interchemie Werken De

Adelaar BV

Metaalweg 8,

5804 CG Venray,

The Netherlands

Intracox oral

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Bulgaria

Kepro B.V.

Maagdenburgstraat 17,

7421 ZA Deventer

The Netherlands

Кепкокс 2.5 % орал /Kepcox 2.5 % oral

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Bulgaria

Ceva Santé Animale

10, Av. de La Ballastière

33500 Libourne

France

Севазурил/Cevazuril

Toltrazuril

25 mg/ml

Oral solution

Broilers, growing parents of chickens, bright, turkeys

Oral use

Bulgaria

Bayer Animal Health

51368 Leverkusen,

Germany

Байкокс 2,5  % разтвор/Baycox 2,5  % solution

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Bulgaria

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml разтвор за перорална употреба с питейната вода при пилета / Dozuril 25 mg/ml solution for use in drinking water for chicken

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Croatia

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25 mg/ml, otopina za primjenu u vodi za piće, za kokoši i purane

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Cyprus

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  % w/v

Πόσιμο διάλυμα για ορνίθια κρεοπαραγωγής και ινδορνίθια.

Toltrazuril

25 mg/ml

Oral solution

Broiler, turkey

Oral use

Czech Republic

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  % (w/v) perorální roztok

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broiler), turkey

Oral use

Denmark

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Estonia

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Estonia

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14, Puunsi Village, Viimsi Rural Municipality, Harju County, 74013

Estonia

Intracox Oral

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Estonia

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

France

Ceva Santé Animale

10, Av. de La Ballastière

33500 Libourne

France

Cevazuril 25 mg/ml solution buvable pour poulets de chair, poulettes et reproducteurs

Toltrazuril

25 mg/ml

Oral solution

Chicken (broilers, pullets, breeders)

Oral use

France

Virbac

1ere avenue, 2065 m, LID, 06516 Carros,

France

Toltracox 2,5  %

Toltrazuril

25 mg/ml

Oral solution

Chicken (broilers, pullets, breeders)

Oral use

France

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml solution buvable pour poulets

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

France

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel 25 mg/ml solution pour administration dans l'eau de boisson pour poulets et dindes

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

France

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Baycox 25 mg/ml solution pour administration dans l'eau de boisson des poules et des dindes

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

France

Avimedical B.V.

Abbinkdijk 1,

7255 LX Hengelo Gld

The Netherlands

Coccinox 25 mg/ml solution orale pour administration dans l'eau de boisson pour poulets et dindes

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey, pigeon

Oral use

France

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Cozuril CT 25 mg/ml solution pour administration dans l'eau de boisson pour poulets et dindes

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Germany

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Germany

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril CT

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Germany

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml Lösung zum Eingeben über das Trinkwasser

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Germany

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Baycox 25 mg/ml, Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Germany

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Germany

Bremer Pharma GmbH,

Werkstr. 42,

D-34414 Warburg, Scherfede,

Germany

Bremacox 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Germany

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Greece

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  %

Toltrazuril

25 mg/ml

Oral solution

Broiler, turkey

Oral use

Greece

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Greece

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Greece

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol, Διάλυμα για χoρήyηση με πόσιμο νερό 25 mg/ml

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Hungary

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  % koncentrátum belsőleges oldathoz A.U.V.

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Hungary

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml, oldat ivóvízbe keveréshez házityúkoknak A.U.V.

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Hungary

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml oldat ivóvízbe keveréshez házityúkok részére A.U.V.

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Hungary

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K 25 mg/ml oldat ivóvízbe keveréshez házityúkok és pulykák számára A.U.V.

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Ireland

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven

Germany

Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Ireland

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml solution for use in drinking water for chickens

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Ireland

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml solution for use in drinking water for chickens

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Italy

Elanco Italia S.p.A

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Baycox PT 25 mg/ml soluzione per uso in acqua di bevanda per polli da carne e tacchini

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Italy

Elanco Italia S.p.A

Via dei Colatori, 12

50019 Sesto Fiorentino (FI)

Italy

Baycox Soluzione orale 25 mg/ml per polli da carne e tacchini

Toltrazuril

25 mg/ml

Oral solution

Broiler, turkey

Oral use

Italy

Ceva Salute Animale S.p.A. Viale Colleoni 15

20864 Agrate Brianza (MB)

Italy

Cevazuril, 25 mg/ml, soluzione orale, per polli da carne e tacchini, da somministrare diluita in acqua da bere.

Toltrazuril

25 mg/ml

Oral solution

Broiler, turkey

Oral use

Italy

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril CT 25 mg/ml, soluzione per l'uso in acqua da bere per polli e tacchini

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Italy

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K-25 Soluzione da usare nell’acqua di bevanda per polli e tacchini

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Italy

Industria Italiana Integratori Trei S.p.A.

Viale Corassori, 62

41100 Modena

Italy

Treizuril, 25 mg/ml, soluzione orale per polli da carne e tacchini

Toltrazuril

25 mg/ml

Oral solution

Broiler, turkey

Oral use

Italy

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml soluzione per uso in acqua da bere per polli

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Latvia

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14, Puunsi Village, Viimsi Rural Municipality, Harju County, 74013

Estonia

LV Intracox Oral 25 mg/ml šķīdums iekšķīgai lietošanai tītariem un vistām

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Latvia

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml šķīdums lietošanai ar dzeramo ūdeni vistām

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Latvia

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml šķīdums lietošanai ar dzeramo ūdeni vistām

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Lithuania

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml, tirpalas naudoti su geriamuoju vandeniu vištoms

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Lithuania

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml, tirpalas, naudoti su geriamuoju vandeniu vištoms

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Lithuania

UAB Interchemie werken De Adelaar LT,

Terminalo str. 13, Biruliškes, 54469, Kaunas distr.

Lithuania

Intracox oral, 25 mg/ml tirpalas naudoti su ger. vandeniu vištoms ir kalakutams

Toltrazuril

25 mg/ml

Oral solution

Chicken (broiler), turkey

Oral use

Luxembourg

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25 mg/m, solution pour administration dans l’eau de boisson pour poulets et dindes / Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Luxembourg

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  %

25 mg/ml, solution buvable / Lösung zum Einnehmen

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Luxembourg

Avimedical B.V.

Abbinkdijk 1,

7255 LX Hengelo Gld

The Netherlands

Coccinox

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Luxembourg

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Malta

Kepro B.V.

Maagdenburgstraat 17,

7421 ZA Deventer

The Netherlands

Kepcox 2.5 %

Toltrazuril

25 mg/ml

Oral solution

Chicken (pullets, breeders), turkey

Oral use

Netherlands

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25 mg/ml, oplossing voor gebruik in drinkwater voor kippen en kalkoenen

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Netherlands

Avimedical B.V.

Abbinkdijk 1,

7255 LX Hengelo Gld

The Netherlands

Coccinox 25 mg/ml orale oplossing voor gebruik in drinkwater voor kippen, kalkoenen, duiven en konijnen

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey, pigeon

Oral use

Netherlands

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril CT 25 mg/ml oplossing voor toediening in drinkwater voor kippen en kalkoenen

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Netherlands

Pantex Holland B.V.

Smaragdweg 15

5525 LA Hapert

The Netherlands

Toltrapan 25 mg/ml, oplossing voor gebruik in drinkwater voor kippen en kalkoenen

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Netherlands

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml oplossing voor toediening in drinkwater voor kippen

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Poland

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  %, (2,5  g/100 ml, roztwór doustny dla kur i indyków)

Toltrazuril

2.5 g/ 100 ml

Oral solution

Chicken (pullets), turkey

Oral use

Poland

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Poland

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril CT

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Poland

Biofaktor Sp. z o. o.

Czysta 4 st., 96-100 Skierniewice,

Poland

Endocox

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Poland

Lovapharm Consulting B.V.

Rijsven 3

5645 KH Eindhoven

The Netherlands

Lovacox oral

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, pullets, breeders), turkey

Oral use

Poland

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Poland

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Poland

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Portugal

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25 mg/ml, solução para administração na água de bebida para galinhas e perus

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Portugal

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel 25 mg/ml solução para administração na água de bebida para galinhas e perus

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Portugal

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K 25 mg/ml solução para administração na água de bebida para galinhas e perus

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

Portugal

Calier Portugal, S.A.

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 — 335 Sintra

Portugal

Zuritol 25 mg/ml solução para administração na água de bebida para galinhas

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Romania

Ceva Santé Animale

10, Av. de La Ballastière

33500 Libourne

France

Cevazuril

Toltrazuril

25 mg/ml

Oral solution

Broilers, replacements, pullets, turkeys

Oral use

Romania

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Dozuril 25 mg/ml

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

Romania

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Slovak Republic

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 2,5  % (w/v) perorálny roztok

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Slovenia

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25 mg/ml peroralna raztopina za piščance in purane

Toltrazuril

25 mg/ml

Oral solution

Chicken, turkey

Oral use

Spain

Bayer Animal Health

51368 Leverkusen,

Germany

Baycox 25 mg/ml solución para administración en agua de bebida para aves

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (broilers, chick for replacement), turkey

Oral use

Spain

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K 25 mg/ml solución para administración en agua de bebida para pollos y pavos

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Spain

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel 25 mg/ml solucion para administracion en agua de bebida para pollos y pavos

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders), turkey

Oral use

Spain

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Vallès (Barcelona)

Spain

Zuritol 25 mg/ml solucion para uso en agua de bebida para pollos

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken (pullets, breeders)

Oral use

UK (Northern Ireland) (1)

Elanco Europe Ltd,

Form 2, Bartley Way, Bartley Wood Business Park, Hook,

RG 27 9XA,

United Kingdom

Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

UK (Northern Ireland) (1)

Laboratorios Karizoo, S.A.

Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui,

08140 Barcelona

Spain

Toltra-K 25 mg/ml solution for use in drinking water for chickens and turkeys

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

UK (Northern Ireland) (1)

VetPharma Animal Health S.L.

Les Corts 23,

08028 Barcelona,

Spain

Zorabel 25 mg/ml solution for use in drinking water for chickens and turkeys

Toltrazuril

25 mg/ml

Solution for use in drinking water

Chicken, turkey

Oral use

---

(1)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

---

ANNEX II

List of nationally authorised medicinal products and marketing authorisation applications

Annex IA. Medicinal products for which the marketing authorisations are recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established or may continue to be assessed by the relevant national competent authorities

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | Invented name | INN | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Austria | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Belgium | Eurogenerics N.V./S.A. | | Tramadol/Paracetamol EG 37,5 /325 mg filmomhulde tabletten | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Croatia | Pliva Hrvatska d.o.o. | | Diuver 5 mg tablets | Torasemide | 5 mg | tablet | Oral use |
| Croatia | Pliva Hrvatska d.o.o. | | Diuver 10 mg tablets | Torasemide | 10 mg | tablet | Oral use |
| Cyprus | Accord Healthcare S.L.U | | Amlodipin Accord tablet 5mg | Amlodipine | 5 mg | Tablet | Oral use |
| Cyprus | Accord Healthcare S.L.U | | Amlodipin Accord tablet 10mg | Amlodipine | 10 mg | Tablet | Oral use |
| Cyprus | Delorbis Pharmaceutica LS LTD | | Zormid Eye Drops, Solution 20Mg/Ml | Dorzolamide | 20 mg/ml | Eye drops, solution | Ocular use |
| Czech Republic | Accord Healthcare Polska Sp. z o.o. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Czech Republic | Accord Healthcare Polska Sp. z o.o. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Czech Republic | Mylan Ireland Limited | | TRAMYLPA | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Denmark | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Denmark | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Denmark | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Denmark | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Estonia | Teva Pharma B.V. | | Torasemide Teva | Torasemide | 5 mg | Tablet | Oral use |
| Estonia | Teva Pharma B.V. | | Torasemide Teva | Torasemide | 10 mg | Tablet | Oral use |
| Finland | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Finland | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| France | Mylan SAS | | TIANEPTINE MYLAN PHARMA 12,5  mg, comprimé enrobé | Tianeptine | 12,5  mg | Coated tablet | Oral use |
| Germany | Heumann Pharma GmbH & Co. Generica KG | | Azithromycin Heumann | Azithromycin | 250 mg | Film-coated tablet | Oral use |
| Germany | Heumann Pharma GmbH & Co. Generica KG | | Azithromycin Heumann | Azithromycin | 500 mg | Film-coated tablet | Oral use |
| Germany | Heumann Pharma GmbH & Co. Generica KG | | Dorzolamid Heumann 20 mg/ml Augentropfen | Dorzolamide | 20 mg/ml | Eye drops, solution | Ocular use |
| Germany | | Hormosan Pharma | Tianesan 12,5  mg Filmtabletten | Tianeptine | 12,5  mg | film-coated tablet | Oral use |
| Germany | Aliud Pharma GmbH | | Torasemid AL 5 mg Tabletten | Torasemide | 5 mg | Tablet | Oral use |
| Germany | Aliud Pharma GmbH | | Torasemid AL 10 mg Tabletten | Torasemide | 10 mg | Tablet | Oral use |
| Germany | ratiopharm GmbH | | Torasemid-ratiopharm 5 mg Tabletten | Torasemide | 5 mg | Tablet | Oral use |
| Germany | ratiopharm GmbH | | Torasemid-ratiopharm 10 mg Tabletten | Torasemide | 10 mg | Tablet | Oral use |
| Germany | STADAPHARM GmbH | | Torasemid STADA 5 mg Tabletten | Torasemide | 5 mg | Tablet | Oral use |
| Germany | STADAPHARM GmbH | | Torasemid STADA 10 mg Tabletten | Torasemide | 10 mg | Tablet | Oral use |
| Germany | Abz-Pharma Gmbh | | Torasemid AbZ 5 mg Tabletten | Torasemide | 5 mg | Tablet | Oral use |
| Germany | Abz-Pharma Gmbh | | Torasemid AbZ 10 mg Tabletten | Torasemide | 10 mg | Tablet | Oral use |
| Germany | STADAPHARM | | Tramadolhydrochlorid/Paracetamol STADA 37,5  mg/325 mg Filmtabletten | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Greece | Rafarm A.E.B.E | | Rexazon | Dexamethasone | 2 mg | Soluble tablet | Oral use |
| Greece | Rafarm A.E.B.E | | Rexazon | Dexamethasone | 4 mg | Soluble tablet | Oral use |
| Greece | Rafarm A.E.B.E | | Rexazon | Dexamethasone | 8 mg | Soluble tablet | Oral use |
| Ireland | Accord Healthcare Ireland Ltd | | Amlodipine 5mg tablets | Amlodipine | 5 mg | Tablet | Oral use |
| Ireland | Accord Healthcare Ireland Ltd | | Amlodipine 10mg tablets | Amlodipine | 10 mg | Tablet | Oral use |
| Ireland | Clonmel Healthcare Ltd, | | Xymel Comp 37.5mg/325mg Film-Coated Tablets | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Italy | Accord Healthcare S.L.U | | Amlodipina Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Italy | Accord Healthcare S.L.U | | Amlodipina Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Italy | Epionpharma S.r.l. | | Varcodes | Dexamethasone | 2 mg | Effervescent tablet | Oral use |
| Italy | Epionpharma S.r.l. | | Varcodes | Dexamethasone | 4 mg | Effervescent tablet | Oral use |
| Italy | Epionpharma S.r.l. | | Varcodes | Dexamethasone | 8 mg | Effervescent tablet | Oral use |
| Italy | Aurora Biofarma Srl. | | AUROZEB | Rosuvastatin/ezetimibe | 5 mg/10 mg | Film-coated tablet | Oral use |
| Italy | Aurora Biofarma Srl. | | AUROZEB | Rosuvastatin/ezetimibe | 10 mg/10 mg | Film-coated tablet | Oral use |
| Italy | Aurora Biofarma Srl. | | AUROZEB | Rosuvastatin/ezetimibe | 20 mg/10 mg | Film-coated tablet | Oral use |
| Italy | Aurora Biofarma Srl. | | AUROZEB | Rosuvastatin/ezetimibe | 40 mg/10 mg | Film-coated tablet | Oral use |
| Italy | Teva Italia S.r.l. | | Torasemide Teva Italia 10 mg compresse | Torasemide | 10 mg | Tablet | Oral use |
| Latvia | Teva Pharma B.V. | | Torasemide Teva 5 mg tabletes | Torasemide | 5 mg | Tablet | Oral use |
| Latvia | Teva Pharma B.V. | | Torasemide Teva 10 mg tabletes | Torasemide | 10 mg | Tablet | Oral use |
| Lithuania | Teva Pharma B.V. | | Torasemide Teva 5 mg tabletės | Torasemide | 5 mg | Tablet | Oral use |
| Lithuania | Teva Pharma B.V. | | Torasemide Teva 10 mg tabletės | Torasemide | 10 mg | Tablet | Oral use |
| Luxembourg | Eurogenerics N.V./S.A. | | Tramadol/Paracetamol EG 37,5 / 325mg comprimés pelliculés | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Norway | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Norway | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Poland | Accord Healthcare Polska Sp. z o.o. | | Almiden | Amlodipine | 5 mg | Tablet | Oral use |
| Poland | Accord Healthcare Polska Sp. z o.o. | | Almiden | Amlodipine | 10 mg | Tablet | Oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o. | | Diuver | Torasemide | 5 mg | Tablet | Oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o. | | Diuver | Torasemide | 10 mg | Tablet | Oral use |
| Portugal | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Portugal | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Portugal | Mylan, Lda. | | Tianeptina Mylan | Tianeptine | 12,5  mg | Film-coated tablet | Oral use |
| Portugal | Lupin Europe GmbH | | Neluptin | Tianeptine | 12,5  mg | Film-coated tablet | Oral use |
| Portugal | Mylan, Lda. | | Tramadol + Paracetamol Mylan | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Romania | Antibiotice S.A | | NOBIXAL 12,5  mg | Tianeptine | 12,5  mg | Film-coated tablet | Oral use |
| Slovakia | Mylan Ireland Limited | | Tianeptin Mylan 12,5  mg | Tianeptine | 12,5  mg | Film-coated tablet | Oral use |
| Slovakia | Mylan Ireland Limited | | Tramylpa 37,5  mg/325 mg | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Slovenia | Pliva Ljubljana d.o.o. | | Diuver | Torasemide | 5 mg | Tablet | Oral use |
| Slovenia | Pliva Ljubljana d.o.o. | | Diuver | Torasemide | 10 mg | Tablet | Oral use |
| Spain | Accord Healthcare S.L.U | | AMLODIPINO ACCORD 5 mg comprimidos EFG | Amlodipine | 5 mg | Tablet | Oral use |
| Spain | Accord Healthcare S.L.U | | AMLODIPINO ACCORD 10 mg comprimidos EFG | Amlodipine | 10 mg | Tablet | Oral use |
| Spain | | Laboratorios Alter, S.A. | ARROX PLUS 10 mg/10 mg comprimidos recubiertos con película | Rosuvastatin/ezetimibe | 10 mg/10 mg | Film-coated tablet | Oral use |
| Spain | | Laboratorios Alter, S.A. | ARROX PLUS 20 mg/10 mg comprimidos recubiertos con película | Rosuvastatin/ezetimibe | 20 mg/10 mg | Film-coated tablet | Oral use |
| Spain | | Laboratorios Alter, S.A. | ARROX PLUS 40 mg/10 mg comprimidos recubiertos con película | Rosuvastatin/ezetimibe | 40 mg/10 mg | Film-coated tablet | Oral use |
| Spain | | Laboratorios Alter, S.A. | ROSUVASTATINA/EZETIMIBA ALTER 10 mg/10mg comprimidos recubiertos con película | Rosuvastatin/ezetimibe | 10 mg/10 mg | Film-coated tablet | Oral use |
| Spain | | Laboratorios Alter, S.A. | ROSUVASTATINA/EZETIMIBA ALTER 20 mg/10mg comprimidos recubiertos con película | Rosuvastatin/ezetimibe | 20 mg/10 mg | Film-coated tablet | Oral use |
| Spain | Laboratorio STADA, S.L. | | Torasemida STADA 5 mg | Torasemide | 5 mg | Tablet | Oral use |
| Spain | Laboratorio STADA, S.L. | | Torasemida STADA 10 mg | Torasemide | 10 mg | Tablet | Oral use |
| Spain | Laboratorio Stada, S.L. | | TRAMADOL/PARACETAMOL STADA 37,5  mg/325 mg comprimidos recubiertos con película EFG | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Spain | Mylan Pharmaceuticals, S.L. | | TRAMADOL/PARACETAMOL MYLAN PHARMACEUTICALS 37,5  mg/325 mg comprimidos recubiertos con película EFG | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Spain | Laboratorios Alter, S.A. | | TRAMADOL/PARACETAMOL ALTER 37,5  mg/325 mg comprimidos recubiertos con película EFG | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Sweden | Jubilant Pharmaceuticals N.V. | | Amlodipin Jubilant | Amlodipine | 5 mg | Tablet | Oral use |
| Sweden | Jubilant Pharmaceuticals N.V. | | Amlodipin Jubilant | Amlodipine | 10 mg | Tablet | Oral use |
| Sweden | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 5 mg | Tablet | Oral use |
| Sweden | Accord Healthcare B.V. | | Amlodipin Accord | Amlodipine | 10 mg | Tablet | Oral use |
| Sweden | Orifarm Generics A/S | | Hydrokortison Orifarm | Hydrocortisone | 10 mg | Tablet | Oral use |
| Sweden | Orifarm Generics A/S | | Hydrokortison Orifarm | Hydrocortisone | 20 mg | Tablet | Oral use |
| The Netherlands | Jubilant Pharmaceuticals N.V. | | Amlodipine (als besilaat) Jubilant 5 mg, tabletten | Amlodipine | 5 mg | Tablet | Oral use |
| The Netherlands | Jubilant Pharmaceuticals N.V. | | Amlodipine (als besilaat) Jubilant 10 mg, tabletten | Amlodipine | 10 mg | Tablet | Oral use |
| The Netherlands | Accord Healthcare B.V. | | Amlodipine (als besilaat) Accord 5 mg, tabletten | Amlodipine | 5 mg | Tablet | Oral use |
| The Netherlands | Accord Healthcare B.V. | | Amlodipine (als besilaat) Accord 10 mg, tabletten | Amlodipine | 10 mg | Tablet | Oral use |
| The Netherlands | Aurora Biofarma Srl. | | Rozemib 5 mg/10 mg, filmomhulde tabletten | Rosuvastatin/ezetimibe | 5 mg/10 mg | Film-coated tablet | Oral use |
| The Netherlands | Aurora Biofarma Srl. | | Rozemib 10 mg/10 mg, filmomhulde tabletten | Rosuvastatin/ezetimibe | 10 mg/10 mg | Film-coated tablet | Oral use |
| The Netherlands | Aurora Biofarma Srl. | | Rozemib 20 mg/10 mg, filmomhulde tabletten | Rosuvastatin/ezetimibe | 20 mg/10 mg | Film-coated tablet | Oral use |
| The Netherlands | Aurora Biofarma Srl. | | Rozemib 40 mg/10 mg, filmomhulde tabletten | Rosuvastatin/ezetimibe | 40 mg/10 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Accord Healthcare Limited | | Amlodipine 5 mg Tablets | Amlodipine | 5 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Accord Healthcare Limited | | Amlodipine 10 mg Tablets | Amlodipine | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Teva UK Limited | | Torasemide 5 mg Tablets | Torasemide | 5 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Teva UK Limited | | Torasemide 10 mg Tablets | Torasemide | 10 mg | Tablet | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

Invented name

INN

Strength

Pharmaceutical form

Route of administration

Austria

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Austria

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Belgium

Eurogenerics N.V./S.A.

Tramadol/Paracetamol EG 37,5 /325 mg filmomhulde tabletten

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Croatia

Pliva Hrvatska d.o.o.

Diuver 5 mg tablets

Torasemide

5 mg

tablet

Oral use

Croatia

Pliva Hrvatska d.o.o.

Diuver 10 mg tablets

Torasemide

10 mg

tablet

Oral use

Cyprus

Accord Healthcare S.L.U

Amlodipin Accord tablet 5mg

Amlodipine

5 mg

Tablet

Oral use

Cyprus

Accord Healthcare S.L.U

Amlodipin Accord tablet 10mg

Amlodipine

10 mg

Tablet

Oral use

Cyprus

Delorbis Pharmaceutica LS LTD

Zormid Eye Drops, Solution 20Mg/Ml

Dorzolamide

20 mg/ml

Eye drops, solution

Ocular use

Czech Republic

Accord Healthcare Polska Sp. z o.o.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Czech Republic

Accord Healthcare Polska Sp. z o.o.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Czech Republic

Mylan Ireland Limited

TRAMYLPA

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Denmark

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Denmark

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Denmark

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Denmark

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Estonia

Teva Pharma B.V.

Torasemide Teva

Torasemide

5 mg

Tablet

Oral use

Estonia

Teva Pharma B.V.

Torasemide Teva

Torasemide

10 mg

Tablet

Oral use

Finland

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Finland

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

France

Mylan SAS

TIANEPTINE MYLAN PHARMA 12,5  mg, comprimé enrobé

Tianeptine

12,5  mg

Coated tablet

Oral use

Germany

Heumann Pharma GmbH & Co. Generica KG

Azithromycin Heumann

Azithromycin

250 mg

Film-coated tablet

Oral use

Germany

Heumann Pharma GmbH & Co. Generica KG

Azithromycin Heumann

Azithromycin

500 mg

Film-coated tablet

Oral use

Germany

Heumann Pharma GmbH & Co. Generica KG

Dorzolamid Heumann 20 mg/ml Augentropfen

Dorzolamide

20 mg/ml

Eye drops, solution

Ocular use

Germany

Hormosan Pharma

Tianesan 12,5  mg Filmtabletten

Tianeptine

12,5  mg

film-coated tablet

Oral use

Germany

Aliud Pharma GmbH

Torasemid AL 5 mg Tabletten

Torasemide

5 mg

Tablet

Oral use

Germany

Aliud Pharma GmbH

Torasemid AL 10 mg Tabletten

Torasemide

10 mg

Tablet

Oral use

Germany

ratiopharm GmbH

Torasemid-ratiopharm 5 mg Tabletten

Torasemide

5 mg

Tablet

Oral use

Germany

ratiopharm GmbH

Torasemid-ratiopharm 10 mg Tabletten

Torasemide

10 mg

Tablet

Oral use

Germany

STADAPHARM GmbH

Torasemid STADA 5 mg Tabletten

Torasemide

5 mg

Tablet

Oral use

Germany

STADAPHARM GmbH

Torasemid STADA 10 mg Tabletten

Torasemide

10 mg

Tablet

Oral use

Germany

Abz-Pharma Gmbh

Torasemid AbZ 5 mg Tabletten

Torasemide

5 mg

Tablet

Oral use

Germany

Abz-Pharma Gmbh

Torasemid AbZ 10 mg Tabletten

Torasemide

10 mg

Tablet

Oral use

Germany

STADAPHARM

Tramadolhydrochlorid/Paracetamol STADA 37,5  mg/325 mg Filmtabletten

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Greece

Rafarm A.E.B.E

Rexazon

Dexamethasone

2 mg

Soluble tablet

Oral use

Greece

Rafarm A.E.B.E

Rexazon

Dexamethasone

4 mg

Soluble tablet

Oral use

Greece

Rafarm A.E.B.E

Rexazon

Dexamethasone

8 mg

Soluble tablet

Oral use

Ireland

Accord Healthcare Ireland Ltd

Amlodipine 5mg tablets

Amlodipine

5 mg

Tablet

Oral use

Ireland

Accord Healthcare Ireland Ltd

Amlodipine 10mg tablets

Amlodipine

10 mg

Tablet

Oral use

Ireland

Clonmel Healthcare Ltd,

Xymel Comp 37.5mg/325mg Film-Coated Tablets

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Italy

Accord Healthcare S.L.U

Amlodipina Accord

Amlodipine

5 mg

Tablet

Oral use

Italy

Accord Healthcare S.L.U

Amlodipina Accord

Amlodipine

10 mg

Tablet

Oral use

Italy

Epionpharma S.r.l.

Varcodes

Dexamethasone

2 mg

Effervescent tablet

Oral use

Italy

Epionpharma S.r.l.

Varcodes

Dexamethasone

4 mg

Effervescent tablet

Oral use

Italy

Epionpharma S.r.l.

Varcodes

Dexamethasone

8 mg

Effervescent tablet

Oral use

Italy

Aurora Biofarma Srl.

AUROZEB

Rosuvastatin/ezetimibe

5 mg/10 mg

Film-coated tablet

Oral use

Italy

Aurora Biofarma Srl.

AUROZEB

Rosuvastatin/ezetimibe

10 mg/10 mg

Film-coated tablet

Oral use

Italy

Aurora Biofarma Srl.

AUROZEB

Rosuvastatin/ezetimibe

20 mg/10 mg

Film-coated tablet

Oral use

Italy

Aurora Biofarma Srl.

AUROZEB

Rosuvastatin/ezetimibe

40 mg/10 mg

Film-coated tablet

Oral use

Italy

Teva Italia S.r.l.

Torasemide Teva Italia 10 mg compresse

Torasemide

10 mg

Tablet

Oral use

Latvia

Teva Pharma B.V.

Torasemide Teva 5 mg tabletes

Torasemide

5 mg

Tablet

Oral use

Latvia

Teva Pharma B.V.

Torasemide Teva 10 mg tabletes

Torasemide

10 mg

Tablet

Oral use

Lithuania

Teva Pharma B.V.

Torasemide Teva 5 mg tabletės

Torasemide

5 mg

Tablet

Oral use

Lithuania

Teva Pharma B.V.

Torasemide Teva 10 mg tabletės

Torasemide

10 mg

Tablet

Oral use

Luxembourg

Eurogenerics N.V./S.A.

Tramadol/Paracetamol EG 37,5 / 325mg comprimés pelliculés

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Norway

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Norway

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Poland

Accord Healthcare Polska Sp. z o.o.

Almiden

Amlodipine

5 mg

Tablet

Oral use

Poland

Accord Healthcare Polska Sp. z o.o.

Almiden

Amlodipine

10 mg

Tablet

Oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

Diuver

Torasemide

5 mg

Tablet

Oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

Diuver

Torasemide

10 mg

Tablet

Oral use

Portugal

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Portugal

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Portugal

Mylan, Lda.

Tianeptina Mylan

Tianeptine

12,5  mg

Film-coated tablet

Oral use

Portugal

Lupin Europe GmbH

Neluptin

Tianeptine

12,5  mg

Film-coated tablet

Oral use

Portugal

Mylan, Lda.

Tramadol + Paracetamol Mylan

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Romania

Antibiotice S.A

NOBIXAL 12,5  mg

Tianeptine

12,5  mg

Film-coated tablet

Oral use

Slovakia

Mylan Ireland Limited

Tianeptin Mylan 12,5  mg

Tianeptine

12,5  mg

Film-coated tablet

Oral use

Slovakia

Mylan Ireland Limited

Tramylpa 37,5  mg/325 mg

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Slovenia

Pliva Ljubljana d.o.o.

Diuver

Torasemide

5 mg

Tablet

Oral use

Slovenia

Pliva Ljubljana d.o.o.

Diuver

Torasemide

10 mg

Tablet

Oral use

Spain

Accord Healthcare S.L.U

AMLODIPINO ACCORD 5 mg comprimidos EFG

Amlodipine

5 mg

Tablet

Oral use

Spain

Accord Healthcare S.L.U

AMLODIPINO ACCORD 10 mg comprimidos EFG

Amlodipine

10 mg

Tablet

Oral use

Spain

Laboratorios Alter, S.A.

ARROX PLUS 10 mg/10 mg comprimidos recubiertos con película

Rosuvastatin/ezetimibe

10 mg/10 mg

Film-coated tablet

Oral use

Spain

Laboratorios Alter, S.A.

ARROX PLUS 20 mg/10 mg comprimidos recubiertos con película

Rosuvastatin/ezetimibe

20 mg/10 mg

Film-coated tablet

Oral use

Spain

Laboratorios Alter, S.A.

ARROX PLUS 40 mg/10 mg comprimidos recubiertos con película

Rosuvastatin/ezetimibe

40 mg/10 mg

Film-coated tablet

Oral use

Spain

Laboratorios Alter, S.A.

ROSUVASTATINA/EZETIMIBA ALTER 10 mg/10mg comprimidos recubiertos con película

Rosuvastatin/ezetimibe

10 mg/10 mg

Film-coated tablet

Oral use

Spain

Laboratorios Alter, S.A.

ROSUVASTATINA/EZETIMIBA ALTER 20 mg/10mg comprimidos recubiertos con película

Rosuvastatin/ezetimibe

20 mg/10 mg

Film-coated tablet

Oral use

Spain

Laboratorio STADA, S.L.

Torasemida STADA 5 mg

Torasemide

5 mg

Tablet

Oral use

Spain

Laboratorio STADA, S.L.

Torasemida STADA 10 mg

Torasemide

10 mg

Tablet

Oral use

Spain

Laboratorio Stada, S.L.

TRAMADOL/PARACETAMOL STADA 37,5  mg/325 mg comprimidos recubiertos con película EFG

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Spain

Mylan Pharmaceuticals, S.L.

TRAMADOL/PARACETAMOL MYLAN PHARMACEUTICALS 37,5  mg/325 mg comprimidos recubiertos con película EFG

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Spain

Laboratorios Alter, S.A.

TRAMADOL/PARACETAMOL ALTER 37,5  mg/325 mg comprimidos recubiertos con película EFG

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Sweden

Jubilant Pharmaceuticals N.V.

Amlodipin Jubilant

Amlodipine

5 mg

Tablet

Oral use

Sweden

Jubilant Pharmaceuticals N.V.

Amlodipin Jubilant

Amlodipine

10 mg

Tablet

Oral use

Sweden

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

5 mg

Tablet

Oral use

Sweden

Accord Healthcare B.V.

Amlodipin Accord

Amlodipine

10 mg

Tablet

Oral use

Sweden

Orifarm Generics A/S

Hydrokortison Orifarm

Hydrocortisone

10 mg

Tablet

Oral use

Sweden

Orifarm Generics A/S

Hydrokortison Orifarm

Hydrocortisone

20 mg

Tablet

Oral use

The Netherlands

Jubilant Pharmaceuticals N.V.

Amlodipine (als besilaat) Jubilant 5 mg, tabletten

Amlodipine

5 mg

Tablet

Oral use

The Netherlands

Jubilant Pharmaceuticals N.V.

Amlodipine (als besilaat) Jubilant 10 mg, tabletten

Amlodipine

10 mg

Tablet

Oral use

The Netherlands

Accord Healthcare B.V.

Amlodipine (als besilaat) Accord 5 mg, tabletten

Amlodipine

5 mg

Tablet

Oral use

The Netherlands

Accord Healthcare B.V.

Amlodipine (als besilaat) Accord 10 mg, tabletten

Amlodipine

10 mg

Tablet

Oral use

The Netherlands

Aurora Biofarma Srl.

Rozemib 5 mg/10 mg, filmomhulde tabletten

Rosuvastatin/ezetimibe

5 mg/10 mg

Film-coated tablet

Oral use

The Netherlands

Aurora Biofarma Srl.

Rozemib 10 mg/10 mg, filmomhulde tabletten

Rosuvastatin/ezetimibe

10 mg/10 mg

Film-coated tablet

Oral use

The Netherlands

Aurora Biofarma Srl.

Rozemib 20 mg/10 mg, filmomhulde tabletten

Rosuvastatin/ezetimibe

20 mg/10 mg

Film-coated tablet

Oral use

The Netherlands

Aurora Biofarma Srl.

Rozemib 40 mg/10 mg, filmomhulde tabletten

Rosuvastatin/ezetimibe

40 mg/10 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Accord Healthcare Limited

Amlodipine 5 mg Tablets

Amlodipine

5 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Accord Healthcare Limited

Amlodipine 10 mg Tablets

Amlodipine

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Teva UK Limited

Torasemide 5 mg Tablets

Torasemide

5 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Teva UK Limited

Torasemide 10 mg Tablets

Torasemide

10 mg

Tablet

Oral use

Annex IB. Medicinal 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 | INN | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 200 mg Filmtabletten | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Austria | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 400 mg | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Austria | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 600 mg | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Austria | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 800 mg | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Austria | | Fair-med Healthcare GmbH | Ibuprofen FMH 200 mg Filmtabletten | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Austria | | Fair-med Healthcare GmbH | Ibuprofen FMH 400 mg Filmtabletten | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Austria | | Fair-med Healthcare GmbH | Ibuprofen FMH 600 mg Filmtabletten | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Austria | | Fair-med Healthcare GmbH | Ibuprofen FMH 800 mg Filmtabletten | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Austria | Aziende Chimiche Riunite Angelini Francesco S.p.A | | BoxaGrippal 200 mg/30 mg Weichkapseln | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Atorvastatine Mylan 10 mg filmomhulde tabletten | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Atorvastatine Mylan 20 mg filmomhulde tabletten | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Atorvastatine Mylan 40 mg filmomhulde tabletten | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Atorvastatine Mylan 80 mg filmomhulde tabletten | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | AtorvastaMylan 10 mg filmomhulde tabletten | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | AtorvastaMylan 20 mg filmomhulde tabletten | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | AtorvastaMylan 40 mg filmomhulde tabletten | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | AtorvastaMylan 80 mg filmomhulde tabletten | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Mylanatorvastigen 10 mg [Film-coated tablet] | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Mylanatorvastigen 20 mg [Film-coated tablet] | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Mylanatorvastigen 40 mg [Film-coated tablet] | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Belgium | Mylan S.P.R.L.-B.V.B.A. | | Mylanatorvastigen 80 mg [Film-coated tablet] | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Belgium | JOHNSON & JOHNSON CONSUMER N.V./S.A. | | Bronchosedal Dextromethorphan Unidose 15 mg oral solution in sachet | Dextromethorphan | 15 mg/5 ml | Oral solution in sachet | Oral use |
| Belgium | Mylan bvba/sprl | | Efavirenz Mylan | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| Belgium | | Tillomed Pharma GmbH | Paliperidon Tillomed 3 mg, tabletten met verlengde afgifte | Paliperidone | 3 mg | Prolonged-release tablet | Oral use |
| Belgium | | Tillomed Pharma GmbH | Paliperidon Tillomed 6 mg, tabletten met verlengde afgifte | Paliperidone | 6 mg | Prolonged-release tablet | Oral use |
| Belgium | | Tillomed Pharma GmbH | Paliperidon Tillomed 9 mg, tabletten met verlengde afgifte | Paliperidone | 9 mg | Prolonged-release tablet | Oral use |
| Belgium | | Theramex Ireland Limited | Ovalute 100 mg, zachte capsule | Progesterone | 100 mg | Capsule, soft | Oral use |
| Belgium | | Theramex Ireland Limited | Ovalute 200 mg, zachte capsule | Progesterone | 200 mg | Capsule, soft | Oral use |
| Belgium | Mylan bvba/sprl | | Zolmitriptan ODIS Mylan | Zolmitriptan | 2,5  mg | Orodispersible tablet | Oral use |
| Belgium | Mylan bvba/sprl | | Zolmitriptan ODIS Mylan | Zolmitriptan | 5 mg | Orodispersible tablet | Oral use |
| Bulgaria | Mylan Ireland Limited | | Atorgen 10 mg film — coated tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Bulgaria | Mylan Ireland Limited | | Atorgen 20 mg film — coated tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Bulgaria | | STADA Arzneimittel AG | Parabol | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Bulgaria | STADA Arzneimittel AG | | Grippostad StopCold | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Croatia | | STADA Arzneimittel AG | Combodolor 200 mg/500 mg meke kapsule | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Cyprus | Generics Pharma Hellas Ltd | | Atorvastatin Generics 10 mg film-coated tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Cyprus | Generics Pharma Hellas Ltd | | Atorvastatin Generics 20 mg film-coated tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Cyprus | Generics Pharma Hellas Ltd | | Atorvastatin Generics 40 mg film-coated tablets | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Cyprus | Hellas Ltd | | Cencipral Tablet, Film Coated 30Mg | Cinacalcet | 30 mg | Film-coated tablet | Oral use |
| Cyprus | Remedica LTD | | Cencipral Tablet, Film Coated 60Mg | Cinacalcet | 60 mg | Film-coated tablet | Oral use |
| Cyprus | Remedica LTD | | Cencipral Tablet, Film Coated 90Mg | Cinacalcet | 90 mg | Film-coated tablet | Oral use |
| Cyprus | Nassington LTD | | Zircos Tablet, Film Coated 5Mg | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Cyprus | Nassington LTD | | Zircos Tablet, Film Coated 10Mg | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Cyprus | Nassington LTD | | Zircos Tablet, Film Coated 20Mg | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Czech Republic | Mylan Ireland Limited | | Atorvastatin Mylan 10 mg potahované tablety | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Czech Republic | Mylan Ireland Limited | | Atorvastatin Mylan 20 mg potahované tablety | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Czech Republic | Mylan Ireland Limited | | Atorvastatin Mylan 40 mg potahované tablety | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Czech Republic | | Strides Pharma (Cyprus) Limited | IBUPROFEN STRIDES | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Czech Republic | | Strides Pharma (Cyprus) Limited | IBUPROFEN STRIDES | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Czech Republic | | Strides Pharma (Cyprus) Limited | IBUPROFEN STRIDES | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Czech Republic | | Strides Pharma (Cyprus) Limited | IBUPROFEN STRIDES | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Czech Republic | | PharmConsul s.r.o. | Brumet (previously Ibuber) | Ibuprofen | 400 mg | Capsule, soft | Oral use |
| Czech Republic | | PharmConsul s.r.o. | Ibamed (previously Ibuprofen Pharmconsul) | Ibuprofen | 400 mg | Capsule, soft | Oral use |
| Czech Republic | | PharmConsul s.r.o. | Ibivil (previously Ibunex) | Ibuprofen | 400 mg | Capsule, soft | Oral use |
| Czech Republic | | STADA Arzneimittel AG | STADALGEN | Paracetamol/ibuprofen | 200 mg/500 mg | Capsule, soft | Oral use |
| Czech Republic | Actavis Group PTC ehf. | | FOXIS | Tramadol/paracetamol | 37,5  mg/325 mg | film-coated tablet | oral use |
| Czech republic | Mylan Ireland Limited | | PIOGLITAZON MYLAN | Pioglitazone | 15 mg | Tablet | Oral use |
| Czech republic | Mylan Ireland Limited | | PIOGLITAZON MYLAN | Pioglitazone | 30 mg | Tablet | Oral use |
| Denmark | Orifarm Generics A/S | | Alfacalcidol ‘Orifarm’ | Alfacalcidol | 0,25 mcg | Capsule, soft | Oral use |
| Denmark | Orifarm Generics A/S | | Alfacalcidol ‘Orifarm’ | Alfacalcidol | 0,5 mcg | Capsule, soft | Oral use |
| Denmark | Orifarm Generics A/S | | Alfacalcidol ‘Orifarm’ | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Denmark | Mylan AB | | Atorvastatin ‘Mylan’ | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Denmark | Mylan AB | | Atorvastatin ‘Mylan’ | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Denmark | Mylan AB | | Atorvastatin ‘Mylan’ | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Denmark | Mylan AB | | Atorvastatin ‘Mylan’ | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Denmark | | Amarox Pharma B.V. | Atorvastatin ‘Amarox’ | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Denmark | | Amarox Pharma B.V. | Atorvastatin ‘Amarox’ | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Denmark | | Amarox Pharma B.V. | Atorvastatin ‘Amarox’ | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Denmark | | Amarox Pharma B.V. | Atorvastatin ‘Amarox’ | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Denmark | 2care4 Generics Aps | | Carexarit | Clonidine | 25 mcg | Coated tablet | Oral use |
| Denmark | | Strides Pharma (Cyprus) Limited | Ibuprofen ‘Strides’ | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Denmark | | Strides Pharma (Cyprus) Limited | Ibuprofen ‘Strides’ | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Denmark | | Strides Pharma (Cyprus) Limited | Ibuprofen ‘Strides’ | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Denmark | | Strides Pharma (Cyprus) Limited | Ibuprofen ‘Strides’ | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Denmark | Bristol Laboratories Ltd. | | Ibuprofen ‘Bril’ | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Denmark | Bristol Laboratories Ltd. | | Ibuprofen ‘Bril’ | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Denmark | Bristol Laboratories Ltd. | | Ibuprofen ‘Bril’ | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Denmark | Orifarm Generics A/S | | Farmidur | Isosorbide mononitrate | 30 mg | Prolonged-release tablet | Oral use |
| Denmark | Aristo Pharma GmbH | | Kagitz | Quetiapine | 50 mg | Prolonged-release tablet | Oral use |
| Denmark | Aristo Pharma GmbH | | Kagitz | Quetiapine | 300 mg | Prolonged-release tablet | Oral use |
| Denmark | Aristo Pharma GmbH | | Kagitz | Quetiapine | 400 mg | Prolonged-release tablet | Oral use |
| Finland | Orifarm Generics A/S | | Alfacalcidol Orifarm | Alfacalcidol | 0,25 mcg | Capsule, soft | Oral use |
| Finland | Orifarm Generics A/S | | Alfacalcidol Orifarm | Alfacalcidol | 0,5 mcg | Capsule, soft | Oral use |
| Finland | Orifarm Generics A/S | | Alfacalcidol Orifarm | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Finland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Finland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Finland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Finland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Finland | | Fair-med Healthcare GmbH | Ibuprofen Fmh | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Finland | | Fair-med Healthcare GmbH | Ibuprofen Fmh | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Finland | | Fair-med Healthcare GmbH | Ibuprofen Fmh | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Finland | | Fair-med Healthcare GmbH | Ibuprofen Fmh | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| France | Viatris Santé | | Atorvastatine Viatris 10mg, comprimé pelliculé | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| France | Viatris Santé | | Atorvastatine Viatris 20mg, comprimé pelliculé | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| France | Viatris Santé | | Atorvastatine Viatris 40mg, comprimé pelliculé | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| France | Viatris Santé | | Atorvastatine Viatris 80mg, comprimé pelliculé | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| France | Mylan SAS | | EFAVIRENZ MYLAN 600 mg, comprimé pelliculé | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| France | | Fair-Med Healthcare GmbH | IBUPROFÈNE FMH 200 mg, comprimé pelliculé | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| France | | Fair-Med Healthcare GmbH | IBUPROFÈNE FMH 400 mg, comprimé pelliculé | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| France | | Fair-Med Healthcare GmbH | IBUPROFÈNE FMH 600 mg, comprimé pelliculé | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| France | | Fair-Med Healthcare GmbH | IBUPROFÈNE FMH 800 mg, comprimé pelliculé | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| France | | Theramex Ireland Limited | OVALUTE 100 mg, capsule molle | Progesterone | 100 mg | Capsule, soft | Oral use |
| France | | Theramex Ireland Limited | OVALUTE 200 mg, capsule molle | Progesterone | 200 mg | Capsule, soft | Oral use |
| France | Mylan SAS | | ZOLMITRIPTAN MYLAN 2,5  mg, comprimé pelliculé | Zolmitriptan | 2,5  mg | Film-coated tablet | Oral use |
| France | Mylan SAS | | ZOLMITRIPTAN MYLAN 2,5  mg, comprimé orodispersible | Zolmitriptan | 2,5  mg | Orodispersible tablet | Oral use |
| Germany | 1 A Pharma GmbH | | Alfacalcidol — 1 A Pharma 0,25 mcg Weichkapseln | Alfacalcidol | 0,25 mcg | Capsule, soft | Oral use |
| Germany | 1 A Pharma GmbH | | Alfacalcidol — 1 A Pharma 0,5 mcg Weichkapseln | Alfacalcidol | 0,5 mcg | Capsule, soft | Oral use |
| Germany | 1 A Pharma GmbH | | Alfacalcidol — 1 A Pharma 1 mcg Weichkapseln | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Germany | Hexal AG | | Alfacalcidol HEXAL 0.25 mcg Weichkapseln | Alfacalcidol | 0,25 mcg | Capsule, soft | Oral use |
| Germany | Hexal AG | | Alfacalcidol HEXAL 0.5 mcg Weichkapseln | Alfacalcidol | 0,5 mcg | Capsule, soft | Oral use |
| Germany | Hexal AG | | Alfacalcidol HEXAL 1 mcg Weichkapseln | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Germany | | Amarox Pharma B.V. | Atorvastatin Amarox 10 mg Filmtabletten | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Germany | | Amarox Pharma B.V. | Atorvastatin Amarox 20 mg Filmtabletten | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Germany | | Amarox Pharma B.V. | Atorvastatin Amarox 40 mg Filmtabletten | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Germany | | Amarox Pharma B.V. | Atorvastatin Amarox 80 mg Filmtabletten | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Germany | Tillomed Pharma GmbH | | Ezetimib/Simvastatin Tillomed 10 mg/ 10 mg Tabletten | Ezetimibe/simvastatin | 10 mg/10 mg | Tablet | Oral use |
| Germany | Tillomed Pharma GmbH | | Ezetimib/Simvastatin Tillomed 10 mg/ 20 mg Tabletten | Ezetimibe/simvastatin | 10 mg/20 mg | Tablet | Oral use |
| Germany | Tillomed Pharma GmbH | | Ezetimib/Simvastatin Tillomed 10 mg/ 40 mg Tabletten | Ezetimibe/simvastatin | 10 mg/40 mg | Tablet | Oral use |
| Germany | Tillomed Pharma GmbH | | Ezetimib/Simvastatin Tillomed 10 mg/ 80 mg Tabletten | Ezetimibe/simvastatin | 10 mg/80 mg | Tablet | Oral use |
| Germany | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 200 mg Filmtabletten | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Germany | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 400 mg Filmtabletten | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Germany | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 600 mg Filmtabletten | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Germany | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 800 mg Filmtabletten | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Germany | | Fair-Med Healthcare GmbH | Ibuprofen FMH 200 mg Filmtabletten | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Germany | | Fair-Med Healthcare GmbH | Ibuprofen FMH 400 mg Filmtabletten | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Germany | | Fair-Med Healthcare GmbH | Ibuprofen FMH 600 mg Filmtabletten | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Germany | | Fair-Med Healthcare GmbH | Ibuprofen FMH 800 mg Filmtabletten | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Germany | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Germany | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Germany | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Germany | Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.P.A. | | BoxaGrippal 200 mg/30 mg Weichkapseln | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Germany | | PharmaMatch B.V. | Ibuprofen 200 mg/ Pseudoephedrine 30 mg Kapsel | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Germany | Infectopharm Arzneimittel und Consilium GmbH | | MetfoLiquid Geriasan 1 000  mg/5 ml, Lösung zum Einnehmen | Metformin | 1 000  mg/5 ml | Oral solution | Oral use |
| Germany | Tillomed Pharma GmbH | | Oxybutyninhydrochlorid Creative 2,5  mg Tabletten | Oxybutynin | 2,5  mg | Tablet | Oral use |
| Germany | Tillomed Pharma GmbH | | Oxybutyninhydrochlorid Creative 5 mg Tabletten | Oxybutynin | 5 mg | Tablet | Oral use |
| Germany | | PharmaMatch B.V. | Progesteron PharmaMatch 100 mg Weichkapseln | Progesterone | 100 mg | Capsule, soft | Oral use |
| Germany | | PharmaMatch B.V. | Progesteron PharmaMatch 200 mg Weichkapseln | Progesterone | 200 mg | Capsule, soft | Oral use |
| Germany | | Theramex Ireland Limited | Ovalute 100 mg Weichkapseln | Progesterone | 100 mg | Capsule, soft | Oral use |
| Germany | | Theramex Ireland Limited | Ovalute 200 mg Weichkapseln | Progesterone | 200 mg | Capsule, soft | Oral use |
| Germany | | Micro Labs GmbH | Rosuvastatin Micro Labs 10 mg Filmtabletten | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Rosuvastatin Micro Labs 20 mg Filmtabletten | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Rosuvastatin Micro Labs 40 mg Filmtabletten | Rosuvastatin | 40 mg | Film-coated tablet | Oral use |
| Germany | Mylan Germany GmbH | | Zolmitriptan dura Filmtabletten | Zolmitriptan | 2,5  mg | Film-coated tablet | Oral use |
| Germany | Mylan Germany GmbH | | Zolmitriptan dura Filmtabletten | Zolmitriptan | 5 mg | Film-coated tablet | Oral use |
| Germany | Mylan Germany GmbH | | Zolmitriptan dura Schmelztabletten | Zolmitriptan | 2,5  mg | Orodispersible tablet | Oral use |
| Germany | Mylan Germany GmbH | | Zolmitriptan dura Schmelztabletten | Zolmitriptan | 5 mg | Orodispersible tablet | Oral use |
| Greece | Mylan Ireland Limited | | Atorvastatin/Mylan Film-coated Tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | Mylan Ireland Limited | | Atorvastatin/Mylan Film-coated Tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | Mylan Ireland Limited | | Atorvastatin/Mylan Film-coated Tablets | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Greece | Bennet Pharmaceutica L A.E. | | Memaben | Memantine | 5 mg + 10 mg + 15 mg + 20 mg | Soluble tablet | Oral use |
| Greece | Bennet Pharmaceutica L A.E. | | Memaben | Memantine | 10 mg | Soluble tablet | Oral use |
| Greece | Bennet Pharmaceutica L A.E. | | Memaben | Memantine | 20 mg | Soluble tablet | Oral use |
| Greece | Vita Longa I.K.E. (Vita Longa P.C.) | | Lycis | Metformin | 1 000  mg/5 ml | Oral solution | Oral use |
| Greece | | Tillomed Pharma GmbH | Paliperidone Tillomed | Paliperidone | 3 mg | Prolonged-release tablet | Oral use |
| Greece | | Tillomed Pharma GmbH | Paliperidone Tillomed | Paliperidone | 6 mg | Prolonged-release tablet | Oral use |
| Greece | | Tillomed Pharma GmbH | Paliperidone Tillomed | Paliperidone | 9 mg | Prolonged-release tablet | Oral use |
| Greece | Nassington LTD | | Rosupose | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Greece | Nassington LTD | | Rosupose | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | Nassington LTD | | Rosupose | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | Medicair Bioscience Laboratories CY LTD | | Rosuvanox | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Greece | Medicair Bioscience Laboratories CY LTD | | Rosuvanox | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | Medicair Bioscience Laboratories CY LTD | | Rosuvanox | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | VELKA Hellas A.E.B.E. | | Rosuvastatin/Velka | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Greece | VELKA Hellas A.E.B.E. | | Rosuvastatin/Velka | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | VELKA Hellas A.E.B.E. | | Rosuvastatin/Velka | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | Lavipharm AE | | Rovastine | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Greece | Lavipharm AE | | Rovastine | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | Lavipharm AE | | Rovastine | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | Rafarm A.E.B.E | | Zircos | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Greece | Rafarm A.E.B.E | | Zircos | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | Rafarm A.E.B.E | | Zircos | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | Nassington LTD | | Zolvara | Rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| Greece | Nassington LTD | | Zolvara | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Greece | Nassington LTD | | Zolvara | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Greece | | Nassington LTD | Mesi-2 | Sitagliptin/metformin | 50 mg/850 mg | Film-coated tablet | Oral use |
| Greece | | Nassington LTD | Mesi-2 | Sitagliptin/metformin | 50 mg/1 000  mg | Film-coated tablet | Oral use |
| Greece | | Nassington LTD | Metogline | Vildagliptin/metformin | 50 mg/850 mg | Film-coated tablet | Oral use |
| Greece | | Nassington LTD | Metogline | Vildagliptin/metformin | 50 mg/1 000  mg | Film-coated tablet | Oral use |
| Greece | | Nassington LTD | PERIVALE | Sitagliptin/metformin | 50 mg/850 mg | Film-coated tablet | Oral use |
| Greece | | Nassington LTD | PERIVALE | Sitagliptin/metformin | 50 mg/1 000  mg | Film-coated tablet | Oral use |
| Greece | | Verisfield AE | Toogluc | Sitagliptin/metformin | 50 mg/850 mg | Film-coated tablet | Oral use |
| Greece | | Verisfield AE | Toogluc | Sitagliptin/metformin | 50 mg/1 000  mg | Film-coated tablet | Oral use |
| Hungary | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Hungary | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Hungary | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Hungary | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Hungary | | STADA Arzneimittel AG | Dolostad 200 mg/500 mg lágy kapszula | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Hungary | | STADA Arzneimittel AG | Dolostad 200 mg/500 mg lágy kapszula | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Iceland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Iceland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Iceland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Ireland | Bluefish Pharmaceuticals AB | | Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets | Amoxicillin/ clavulanic acid | 500 mg/125 mg | Film-coated tablet | Oral use |
| Ireland | McDermott Laboratories Ltd | | Atorvastatin Mylan 10 mg film-coated tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Ireland | McDermott Laboratories Ltd | | Atorvastatin Mylan 20 mg film-coated tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Ireland | McDermott Laboratories Ltd | | Atorvastatin Mylan 40 mg film-coated tablets | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Ireland | McDermott Laboratories Ltd | | Atorvastatin Mylan 80 mg film-coated tablets | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Ireland | Pinewood Laboratories Limited | | Atorvastatin 10 mg Film-Coated Tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Ireland | Pinewood Laboratories Limited | | Atorvastatin 20 mg Film-Coated Tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Ireland | Pinewood Laboratories Limited | | Atorvastatin 40 mg Film-Coated Tablets | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Ireland | Pinewood Laboratories Limited | | Atorvastatin 80 mg Film-Coated Tablets | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Ireland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Ireland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Ireland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Ireland | | Clonmel Healthcare Ltd | Easofen Cold & Flu | Ibuprofen/pseudoephedrine | 200 mg /20 mg | Capsule, soft | Oral use |
| Ireland | Clonmel Healthcare Ltd, | | Paralief 500 mg soft capsules | Paracetamol | 500 mg | Capsule, soft | Oral use |
| Ireland | | Theramex Ireland Limited | Ovalute | Progesterone | 100 mg | Capsule, soft | Oral use |
| Ireland | | Theramex Ireland Limited | Ovalute | Progesterone | 200 mg | Capsule, soft | Oral use |
| Italy | Stewart Italia S.r.l. | | Stemox | Amoxicillin/ clavulanic acid | 400 mg/5 ml + 57 mg/5 ml | Powder for oral suspension | Oral use |
| Italy | Mylan S.p.A. | | Atorvastatina Mylan Generics Italia | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | Atorvastatina Mylan Generics Italia | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | Atorvastatina Mylan Generics Italia | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | Atorvastatina Mylan Generics Italia | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | Efavirenz Mylan | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| Italy | | Tillomed Pharma Gmbh | Paliperidone Tillomed | Paliperidone | 3 mg | Prolonged-release tablet | Oral use |
| Italy | | Tillomed Pharma Gmbh | Paliperidone Tillomed | Paliperidone | 6 mg | Prolonged-release tablet | Oral use |
| Italy | | Tillomed Pharma Gmbh | Paliperidone Tillomed | Paliperidone | 9 mg | Prolonged-release tablet | Oral use |
| Italy | Mylan S.p.A. | | Pioglitazone Mylan | Pioglitazone | 15 mg | Tablet | Oral use |
| Italy | Mylan S.p.A. | | Pioglitazone Mylan | Pioglitazone | 30 mg | Tablet | Oral use |
| Italy | Mylan S.p.A. | | Zolmitriptan Mylan Generics | Zolmitriptan | 2,5  mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | Zolmitriptan Mylan Generics | Zolmitriptan | 5 mg | Film-coated tablet | Oral use |
| Luxembourg | JOHNSON & JOHNSON CONSUMER N.V./S.A. | | Bronchosedal Dextromethorphan Unidose 15 mg oral solution en sachet | Dextromethorphan | 15 mg/5 ml | Oral solution in sachet | Oral use |
| Luxembourg | | PharmaMatch B.V. | Progesteron PharmaMatch 100 mg Weichkapseln | Progesterone | 100 mg | Capsule, soft | Oral use |
| Luxembourg | | PharmaMatch B.V. | Progesteron PharmaMatch 200 mg Weichkapseln | Progesterone | 200 mg | Capsule, soft | Oral use |
| Luxembourg | Micro Labs GmbH | | Rosuvastatin Micro Labs 10 mg Filmtabletten | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| Luxembourg | Micro Labs GmbH | | Rosuvastatin Micro Labs 20 mg Filmtabletten | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| Luxembourg | Micro Labs GmbH | | Rosuvastatin Micro Labs 40 mg Filmtabletten | Rosuvastatin | 40 mg | Film-coated tablet | Oral use |
| Luxembourg | Mylan bvba/sprl | | Zolmitriptan ODIS Mylan 2,5  mg comprimé orodispersible | Zolmitriptan | 2,5  mg | Orodispersible tablet | Oral use |
| Malta | RIA Generics Ireland Limited | | Nefopam Hydrochloride 30 mg film-coated tablets | Nefopam | 30 mg | Film-coated tablet | Oral use |
| Norway | Orifarm Generics A/S | | Alfacalcidol ‘Orifarm’ | Alfacalcidol | 0,25 mcg | Capsule, soft | Oral use |
| Norway | Orifarm Generics A/S | | Alfacalcidol ‘Orifarm’ | Alfacalcidol | 0,5 mcg | Capsule, soft | Oral use |
| Norway | Orifarm Generics A/S | | Alfacalcidol ‘Orifarm’ | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Norway | Pensa Pharma AB | | Atorvastatin Pensa | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Norway | Pensa Pharma AB | | Atorvastatin Pensa | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Norway | Pensa Pharma AB | | Atorvastatin Pensa | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Norway | Pensa Pharma AB | | Atorvastatin Pensa | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Norway | 2care4 Generics Aps | | Carexarit | Clonidine | 25 mcg | Coated tablet | Oral use |
| Norway | Aristo Pharma GmbH | | Kagitz | Quetiapine | 50 mg | Prolonged-release tablet | Oral use |
| Norway | Aristo Pharma GmbH | | Kagitz | Quetiapine | 300 mg | Prolonged-release tablet | Oral use |
| Norway | Aristo Pharma GmbH | | Kagitz | Quetiapine | 400 mg | Prolonged-release tablet | Oral use |
| Poland | Bluefish Pharmaceuticals AB | | Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets | Amoxicillin/ clavulanic acid | 500 mg/125 mg | Film-coated tablet | Oral use |
| Poland | Mylan Ireland Limited | | Atorvagen | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Poland | Mylan Ireland Limited | | Atorvagen | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Poland | Mylan Ireland Limited | | Atorvagen | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Poland | Artespharm Sp. z o.o. | | Atostat | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Poland | Artespharm Sp. z o.o. | | Atostat | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Poland | Artespharm Sp. z o.o. | | Atostat | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Poland | Artespharm Sp. z o.o. | | Atostat | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Poland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Poland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Poland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Poland | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Poland | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Poland | US Pharmacia Sp. z o.o. | | Ibuprom Ultramax Sprint | Ibuprofen | 600 mg | Capsule, soft | Oral use |
| Poland | US Pharmacia Sp. z o.o. | | Ibuprom Zatoki Sprint | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Poland | | Synoptis Pharma Sp. z o.o. | Ifedrin ZATOKI APTEO MED | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Portugal | Laboratórios Basi — Indústria Farmacêutica, S.A | | Amoxicilina + Ácido Clavulânico Basi | Amoxicillin/ clavulanic acid | 250 mg/5 ml +62,5  mg/5 ml | Powder for oral suspension | Oral use |
| Portugal | Laboratórios Basi — Indústria Farmacêutica, S.A | | Amoxicilina + Ácido Clavulânico Basi | Amoxicillin/ clavulanic acid | 400 mg/5 ml + 57 mg/5 ml | Powder for oral suspension | Oral use |
| Portugal | Mylan Lda | | Atorvastatine Mylan | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Portugal | Mylan Lda | | Atorvastatine Mylan | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Portugal | Mylan Lda | | Atorvastatine Mylan | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Portugal | Mylan Lda | | Atorvastatine Mylan | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Portugal | Mylan Lda | | Efavirenz Mylan | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| Portugal | Abdi Farma Unipessoal Limitada | | Etolyn | Etodolac | 600 mg | Prolonged-release tablet | Oral use |
| Portugal | STADA Lda. | | Pramolix 500 mg cápsula mole | Paracetamol | 500 mg | Capsule, soft | Oral use |
| Portugal | Laboratórios Azevedos — Indústria Farmacêutica, S.A. | | Algik Gripe | Paracetamol/pseudoephedrine | 500 mg/30 mg | Capsule, soft | Oral use |
| Portugal | Mylan, Lda. | | Pioglitazona Mylan | Pioglitazone | 15 mg | Tablet | Oral use |
| Portugal | Mylan, Lda. | | Pioglitazona Mylan | Pioglitazone | 30 mg | Tablet | Oral use |
| Portugal | Mylan, Lda. | | Pioglitazona Mylan | Pioglitazone | 45 mg | Tablet | Oral use |
| Portugal | Alter, S.A. | | Rosuvastatina + Ezetimiba Alter | Rosuvastatin/ezetimibe | 5 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Alter, S.A. | | Rosuvastatina + Ezetimiba Alter | Rosuvastatin/ezetimibe | 10 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Alter, S.A. | | Rosuvastatina + Ezetimiba Alter | Rosuvastatin/ezetimibe | 20 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Alter, S.A. | | Rosuvastatina + Ezetimiba Alter | Rosuvastatin/ezetimibe | 40 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. | | Rosuvastatina + Ezetimiba Bistenibe | Rosuvastatin/ezetimibe | 5 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. | | Rosuvastatina + Ezetimiba Bistenibe | Rosuvastatin/ezetimibe | 10 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. | | Rosuvastatina + Ezetimiba Bistenibe | Rosuvastatin/ezetimibe | 20 mg/10 mg | Film-coated tablet | Oral use |
| Portugal | Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. | | Rosuvastatina + Ezetimiba Bistenibe | Rosuvastatin/ezetimibe | 40 mg/10 mg | Film-coated tablet | Oral use |
| Romania | S.C. Sandoz SRL | | ALFACALCIDOL SANDOZ 0,25 μg | Alfacalcidol | 0,25  mg | Capsule, soft | Oral use |
| Romania | S.C. Sandoz SRL | | ALFACALCIDOL SANDOZ 0,5 μg | Alfacalcidol | 0,5  mg | Capsule, soft | Oral use |
| Romania | | Strides Pharma (Cyprus) Limited | Ibuprofen STRIDES | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Romania | | Strides Pharma (Cyprus) Limited | Ibuprofen STRIDES | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Romania | | Strides Pharma (Cyprus) Limited | Ibuprofen STRIDES | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Romania | | Strides Pharma (Cyprus) Limited | Ibuprofen STRIDES | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Romania | | STADA Arzneimittel AG | IBUPROFEN/ PARACETAMOL 200 mg/500 mg | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Romania | | PharmaMatch B.V. | Buprofess raceala si Gripa | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| Slovakia | Sandoz Pharmaceuticals d.d. | | Alfakalcidol SANDOZ 1 mikrogram mäkké kapsuly | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Slovakia | Mylan Ireland Limited | | Atorvastatine Mylan | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Slovakia | Mylan Ireland Limited | | Atorvastatine Mylan | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Slovakia | | STADA Arzneimittel AG | Ibumol | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Slovakia | STADA Arzneimittel AG | | Parastad mäkké kapsuly | Paracetamol | 500 mg | Capsule, soft | Oral use |
| Slovenia | Mylan Ireland Limited | | Atorvastatin Mylan | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Slovenia | Mylan Ireland Limited | | Atorvastatin Mylan | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Slovenia | Mylan Ireland Limited | | Atorvastatin Mylan | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Slovenia | | STADA Arzneimittel AG | Ibumol | Ibuprofen/paracetamol | 200 mg/500 mg | Capsule, soft | Oral use |
| Spain | Mylan Pharmaceuticals, S.L. | | ATORVASTATINA MYLAN 10 mg comprimidos recubiertos con película EFG | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Spain | Mylan Pharmaceuticals, S.L. | | ATORVASTATINA MYLAN 20 mg comprimidos recubiertos con película EFG | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Spain | Mylan Pharmaceuticals, S.L. | | ATORVASTATINA MYLAN 40 mg comprimidos recubiertos con película EFG | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Spain | Mylan Pharmaceuticals, S.L. | | ATORVASTATINA MYLAN 80 mg comprimidos recubiertos con película EFG | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Spain | Tarbis Farma, S.L. | | ATORVASTATINA TARBIS FARMA 10 mg comprimidos recubiertos con película EFG | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Spain | Tarbis Farma, S.L. | | ATORVASTATINA TARBIS FARMA 20 mg comprimidos recubiertos con película EFG | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Spain | Tarbis Farma, S.L. | | ATORVASTATINA TARBIS FARMA 40 mg comprimidos recubiertos con película EFG | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Spain | Tarbis Farma, S.L. | | ATORVASTATINA TARBIS FARMA 80 mg comprimidos recubiertos con película EFG | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Spain | Johnson and Johnson, S.A. | | INISTON TUSIV 15 mg solución oral en sobre | Dextromethorphan | 15 mg/5 ml | Oral solution in sachet | Oral use |
| Spain | Mylan Pharmaceutica LS, S.L. | | EFAVIRENZ MYLAN 600 mg comprimidos recubiertos con película EFG | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| Spain | | Fair-med Healthcare GmbH | IBUPROFEN FMH 200 mg comprimidos recubiertos con película EFG | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Spain | | Fair-med Healthcare GmbH | IBUPROFEN FMH 400 mg comprimidos recubiertos con película EFG | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Spain | | Fair-med Healthcare GmbH | IBUPROFEN FMH 600 mg comprimidos recubiertos con película EFG | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Spain | | Fair-med Healthcare GmbH | IBUPROFEN FMH 800 mg comprimidos recubiertos con película EFG | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Spain | | Laboratorios Tillomed Spain S.L.U. | PALIPERIDONA TILLOMED 3 mg comprimidos de liberación controlada | Paliperidone | 3 mg | Prolonged-release tablet | Oral use |
| Spain | | Laboratorios Tillomed Spain S.L.U. | PALIPERIDONA TILLOMED 6 mg comprimidos de liberación controlada | Paliperidone | 6 mg | Prolonged-release tablet | Oral use |
| Spain | | Laboratorios Tillomed Spain S.L.U. | PALIPERIDONA TILLOMED 9 mg comprimidos de liberación controlada | Paliperidone | 9 mg | Prolonged-release tablet | Oral use |
| Spain | | Theramex Ireland Limited | OVALUTE 100 mg cápsulas blandas | Progesterone | 100 mg | Capsule, soft | Oral use |
| Spain | Aurovitas Spain, S.A.U. | | TRAMADOL/PARACETAMOL AUROVITAS SPAIN 37,5  mg/325 mg comprimidos recubiertos con película EFG | Tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Sweden | Orifarm Generics A/S | | Alfacalcidol Orifarm | Alfacalcidol | 0,25 mcg | Capsule, soft | Oral use |
| Sweden | Orifarm Generics A/S | | Alfacalcidol Orifarm | Alfacalcidol | 0,5 mcg | Capsule, soft | Oral use |
| Sweden | Orifarm Generics A/S | | Alfacalcidol Orifarm | Alfacalcidol | 1 mcg | Capsule, soft | Oral use |
| Sweden | Mylan AB | | Atorvastatin Mylan | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Sweden | Mylan AB | | Atorvastatin Mylan | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Sweden | Mylan AB | | Atorvastatin Mylan | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Sweden | Mylan AB | | Atorvastatin Mylan | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Sweden | Amarox Pharma B.V. | | Atorvastatin Amarox | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| Sweden | Amarox Pharma B.V. | | Atorvastatin Amarox | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| Sweden | Amarox Pharma B.V. | | Atorvastatin Amarox | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| Sweden | Amarox Pharma B.V. | | Atorvastatin Amarox | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| Sweden | Sandoz A/S | | Flucloxacillin Sandoz | Flucloxacillin | 500 mg | Film-coated tablet | Oral use |
| Sweden | Sandoz A/S | | Flucloxacillin Sandoz | Flucloxacillin | 750 mg | Film-coated tablet | Oral use |
| Sweden | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Sweden | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Sweden | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Sweden | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| Sweden | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Sweden | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Sweden | Brillpharma (Ireland) Limited | | Ibuprofen Bril | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Sweden | Brillpharma (Ireland) Limited | | Ibuprofen BrillPharma | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Sweden | Brillpharma (Ireland) Limited | | Ibuprofen BrillPharma | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Sweden | Brillpharma (Ireland) Limited | | Ibuprofen BrillPharma | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Sweden | Orifarm Generics A/S | | Isonova | Isosorbide mononitrate | 30 mg | Prolonged-release tablet | Oral use |
| Sweden | Orifarm Generics A/S | | Isonova | Isosorbide mononitrate | 60 mg | Prolonged-release tablet | Oral use |
| Sweden | Aristo Pharma GmbH | | Kagitz | Quetiapine | 50 mg | Prolonged-release tablet | Oral use |
| Sweden | Aristo Pharma GmbH | | Kagitz | Quetiapine | 300 mg | Prolonged-release tablet | Oral use |
| Sweden | Aristo Pharma GmbH | | Kagitz | Quetiapine | 400 mg | Prolonged-release tablet | Oral use |
| The Netherlands | Mylan B.V. | | Atorvastatine Mylan 10 mg, filmomhulde tabletten | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| The Netherlands | Mylan B.V. | | Atorvastatine Mylan 20 mg, filmomhulde tabletten | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| The Netherlands | Mylan B.V. | | Atorvastatine Mylan 40 mg, filmomhulde tabletten | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| The Netherlands | Mylan B.V. | | Atorvastatine Mylan 80 mg, filmomhulde tabletten | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| The Netherlands | Amarox Pharma B.V. | | Atorvastatine Amarox 10 mg filmomhulde tabletten | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| The Netherlands | Amarox Pharma B.V. | | Atorvastatine Amarox 20 mg filmomhulde tabletten | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| The Netherlands | Amarox Pharma B.V. | | Atorvastatine Amarox 40 mg filmomhulde tabletten | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| The Netherlands | Amarox Pharma B.V. | | Atorvastatine Amarox 80 mg filmomhulde tabletten | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Clobazam Sandoz 10 mg, tabletten | Clobazam | 10 mg | Tablet | Oral use |
| The Netherlands | TioFarma B.V. | | Clobazam Tiofarma 10 mg, tabletten | Clobazam | 10 mg | Tablet | Oral use |
| The Netherlands | TioFarma B.V. | | Clobazam Tiofarma 20 mg, tabletten | Clobazam | 20 mg | Tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Clonazepam Sandoz 0,5  mg, tabletten | Clonazepam | 0,5  mg | Tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Clonazepam Sandoz 2 mg, tabletten | Clonazepam | 2 mg | Tablet | Oral use |
| The Netherlands | TioFarma B.V. | | Clonazepam Tiofarma 0,5  mg, tabletten | Clonazepam | 0,5  mg | Tablet | Oral use |
| The Netherlands | TioFarma B.V. | | Clonazepam Tiofarma 2 mg, tabletten | Clonazepam | 2 mg | Tablet | Oral use |
| The Netherlands | Mylan B.V. | | Efavirenz Mylan 600 mg, filmomhulde tabletten | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| The Netherlands | Tillomed Pharma GmbH | | Ezetimibe/Simvastatine Tillomed 10 mg/10 mg, tabletten | Ezetimibe/simvastatin | 10 mg/10 mg | Tablet | Oral use |
| The Netherlands | Tillomed Pharma GmbH | | Ezetimibe/Simvastatine Tillomed 10 mg/20 mg, tabletten | Ezetimibe/simvastatin | 10 mg/20 mg | Tablet | Oral use |
| The Netherlands | Tillomed Pharma GmbH | | Ezetimibe/Simvastatine Tillomed 10 mg/40 mg, tabletten | Ezetimibe/simvastatin | 10 mg/40 mg | Tablet | Oral use |
| The Netherlands | Tillomed Pharma GmbH | | Ezetimibe/Simvastatine Tillomed 10 mg/80 mg, tabletten | Ezetimibe/simvastatin | 10 mg/80 mg | Tablet | Oral use |
| The Netherlands | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 200 mg, filmomhulde tabletten | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| The Netherlands | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 200 mg, filmomhulde tabletten | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| The Netherlands | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 200 mg, filmomhulde tabletten | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| The Netherlands | | Strides Pharma (Cyprus) Limited | Ibuprofen Strides 200 mg, filmomhulde tabletten | Ibuprofen | 800 mg | Film-coated tablet | Oral use |
| The Netherlands | RIA Generics Limited | | Nortriptyline RIA 10 mg tabletten | Nortriptyline | 10 mg | Tablet | Oral use |
| The Netherlands | RIA Generics Limited | | Nortriptyline RIA 25 mg tabletten | Nortriptyline | 25 mg | Tablet | Oral use |
| The Netherlands | | Tillomed Pharma GmbH | Paliperidon Tillomed 3 mg, tabletten met verlengde afgifte | Paliperidone | 3 mg | Prolonged-release tablet | Oral use |
| The Netherlands | | Tillomed Pharma GmbH | Paliperidon Tillomed 6 mg, tabletten met verlengde afgifte | Paliperidone | 6 mg | Prolonged-release tablet | Oral use |
| The Netherlands | | Tillomed Pharma GmbH | Paliperidon Tillomed 9 mg, tabletten met verlengde afgifte | Paliperidone | 9 mg | Prolonged-release tablet | Oral use |
| The Netherlands | Healthypharm B.V. | | Paracetamol liquid caps HTP 500 mg, zachte capsules | Paracetamol | 500 mg | Capsule, soft | Oral use |
| The Netherlands | MAE Holding B.V. | | Paracetamol Linn 500 mg liquid caps, zachte capsules | Paracetamol | 500 mg | Capsule, soft | Oral use |
| The Netherlands | | Socium Pharma B.V. | Paracetamol/Ibuprofen Socium 500/200 mg zachte capsules | Paracetamol/ibuprofen | 500 mg / 200 mg | Capsule, soft | Oral use |
| The Netherlands | | Theramex Ireland Limited | Ovalute 100 mg, zachte capsule | Progesterone | 100 mg | Capsule, soft | Oral use |
| The Netherlands | | Theramex Ireland Limited | Ovalute 200 mg, zachte capsule | Progesterone | 200 mg | Capsule, soft | Oral use |
| The Netherlands | RIA Generics Limited | | Sertraline RIA 50 mg, filmomhulde tabletten | Sertraline | 50 mg | Film-coated tablet | Oral use |
| The Netherlands | RIA Generics Limited | | Sertraline RIA 100 mg, filmomhulde tabletten | Sertraline | 100 mg | Film-coated tablet | Oral use |
| The Netherlands | Mylan B.V. | | Zolmitriptan Mylan 2,5  mg, orodispergeerbare tabletten | Zolmitriptan | 2,5  mg | Orodispersible tablet | Oral use |
| The Netherlands | Mylan B.V. | | Zolmitriptan Mylan 5 mg, orodispergeerbare tabletten | Zolmitriptan | 5 mg | Orodispersible tablet | Oral use |
| United Kingdom (Northern Ireland) | Strandhaven Limited | | Amlodipine 5 mg Tablets | Amlodipine | 5 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Strandhaven Limited | | Amlodipine 10 mg Tablets | Amlodipine | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Wockhardt UK Limited | | Amlodipine 5 mg Tablets | Amlodipine | 5 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Wockhardt UK Limited | | Amlodipine 10 mg Tablets | Amlodipine | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Accord Healthcare Limited | | Amoxicillin 250 mg Capsules | Amoxicillin | 250 mg | Capsule, hard | Oral use |
| United Kingdom (Northern Ireland) | Accord Healthcare Limited | | Amoxicillin 500 mg Capsules | Amoxicillin | 500 mg | Capsule, hard | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Amoxicillin 250 mg Capsules | Amoxicillin | 250 mg | Capsule, hard | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Amoxicillin 500 mg Capsules | Amoxicillin | 500 mg | Capsule, hard | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Co-Amoxiclav 250/62.5 mg Powder for Oral Suspension | Amoxicillin/ clavulanic acid | 250 mg/62,5  mg | Powder for oral suspension | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Co-Amoxiclav 457/5 ml Suspension | Amoxicillin/ clavulanic acid | 457 mg/5 ml | Powder for oral suspension | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Co-Amoxiclav 500/125 mg Tablets | Amoxicillin/ clavulanic acid | 500 mg/125 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Ltd | | Atorvastatine Mylan | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Ltd | | Atorvastatine Mylan | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Ltd | | Atorvastatine Mylan | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Ltd | | Atorvastatine Mylan | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Wockhardt UK Limited | | Atorvastatin 80 mg film-coated Tablets | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Wockhardt UK Limited | | Atorvastatin 10 mg film-coated Tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Wockhardt UK Limited | | Atorvastatin 20 mg film-coated Tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Wockhardt UK Limited | | Atorvastatin 40 mg film-coated Tablets | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Amarox Limited | | Atorvastatin 10 mg film-coated Tablets | Atorvastatin | 10 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Amarox Limited | | Atorvastatin 20 mg film-coated Tablets | Atorvastatin | 20 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Amarox Limited | | Atorvastatin 40 mg film-coated Tablets | Atorvastatin | 40 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Amarox Limited | | Atorvastatin 80 mg film-coated Tablets | Atorvastatin | 80 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Morningside Healthcare Limited | | Clonidine hydrochloride 25 microgram Tablets | Clonidine | 25 mcg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Limited | | Efavirenz 600 mg film-coated Tablets | Efavirenz | 600 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Ethambutol 100 mg film-coated Tablets | Ethambutol | 100 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Ethambutol 400 mg film-coated Tablets | Ethambutol | 400 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Abdi Farma Unipessoal Limitada | | Etolyn 600 mg Prolonged-Release Tablets | Etodolac | 600 mg | Prolonged-release tablet | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Flucloxacillin 250 mg Capsules | Flucloxacillin | 250 mg | Capsule, hard | Oral use |
| United Kingdom (Northern Ireland) | Medreich PLC | | Flucloxacillin 500 mg Capsules | Flucloxacillin | 500 mg | Capsule, hard | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Gliclazide 30 mg Prolonged-Release Tablets | Gliclazide | 30 mg | Prolonged-release tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Gliclazide 40 mg Prolonged-Release Tablets | Gliclazide | 40 mg | Prolonged-release tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Gliclazide 60 mg Prolonged-Release Tablets | Gliclazide | 60 mg | Prolonged-release tablet | Oral use |
| United Kingdom (Northern Ireland) | | Blackrock Pharmaceuticals Limited | Hydrocortisone 10 mg Tablets | Hydrocortisone | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | | Blackrock Pharmaceuticals Limited | Hydrocortisone 20 mg Tablets | Hydrocortisone | 20 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Silicon Pharma Limited | | Hydrocortisone 10 mg Tablets | Hydrocortisone | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Silicon Pharma Limited | | Hydrocortisone 20 mg Tablets | Hydrocortisone | 20 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | | Strides Pharma UK Limited | Ibuprofen 200 mg film-coated Tablets | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | | Strides Pharma UK Limited | Ibuprofen 400 mg film-coated Tablets | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | | Strides Pharma UK Limited | Ibuprofen 600 mg film-coated Tablets | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | | Socium Pharma B.V. | Ibuprofen/Pseudoephadrine HCl 200/30 mg Capsules, soft | Ibuprofen/pseudoephedrine | 200 mg/30 mg | Capsule, soft | Oral use |
| United Kingdom (Northern Ireland) | | Strides Pharma UK Limited | Liothyronine sodium 5 microgram Tablets | Liothyronine | 5 mcg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | | Strides Pharma UK Limited | Liothyronine sodium 20 microgram Tablets | Liothyronine | 20 mcg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Zentiva Pharma UK Limited | | Memantine hydrochloride 5 mg + 10 mg + 15 mg + 20 mg Soluble Tablets | Memantine | 5 mg + 10 mg + 15 mg + 20 mg | Soluble tablet | Oral use |
| United Kingdom (Northern Ireland) | Zentiva Pharma UK Limited | | Memantine hydrochloride 10 mg Soluble Tablets | Memantine | 10 mg | Soluble tablet | Oral use |
| United Kingdom (Northern Ireland) | Zentiva Pharma UK Limited | | Memantine hydrochloride 20 mg Soluble Tablets | Memantine | 20 mg | Soluble tablet | Oral use |
| United Kingdom (Northern Ireland) | Colonis Pharma Limited | | Metformin Colonis 500mg/5ml Oral Solution | Metformin | 500 mg | Oral solution | Oral use |
| United Kingdom (Northern Ireland) | Colonis Pharma Limited | | Metformin Colonis 850mg/5ml Oral Solution | Metformin | 850 mg | Oral solution | Oral use |
| United Kingdom (Northern Ireland) | Colonis Pharma Limited | | Metformin Colonis 1 000  mg/5ml Oral Solution | Metformin | 1 000  mg/5 ml | Oral solution | Oral use |
| United Kingdom (Northern Ireland) | Mercury Pharmaceuticals Limited | | Nebivolol 2.5 mg Tablets | Nebivolol | 2,5  mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Mercury Pharmaceuticals Limited | | Nebivolol 5 mg Tablets | Nebivolol | 5 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Nefopam hydrochloride 30 mg film-coated Tablets | Nefopam | 30 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Nefopam hydrochloride 30 mg film-coated Tablets | Nefopam | 30 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Zentiva Pharma UK Limited | | Nevirapine Amneal 400 mg Prolonged-Release Tablets | Nevirapine | 400 mg | Prolonged-Release Tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Nortriptyline 10 mg Tablets | Nortriptyline | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Nortriptyline 25 mg Tablets | Nortriptyline | 25 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Nortriptyline 10 mg Tablets | Nortriptyline | 10 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Nortriptyline 25 mg Tablets | Nortriptyline | 25 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | | Pharmamatch B.V. | Paracetamol 500 mg Capsules, soft | Paracetamol | 500 mg | Capsule, soft | Oral use |
| United Kingdom (Northern Ireland) | | Interdos Pharma B.V. | Paracetamol/Ibuprofen interdos 500/200 mg Caspules, soft | Paracetamol/Ibuprofen | 500 mg / 200 mg | Capsule, soft | Oral use |
| United Kingdom (Northern Ireland) | | Pharmamatch B.V. | Paracetamol/Ibuprofen 500/200 mg Caspules, soft | Paracetamol/Ibuprofen | 500 mg / 200 mg | Capsule, soft | Oral use |
| United Kingdom (Northern Ireland) | Generics Limited | | Pioglitazone 15 mg Tablets | Pioglitazone | 15 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Limited | | Pioglitazone 30 mg Tablets | Pioglitazone | 30 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Limited | | Pioglitazone 45 mg Tablets | Pioglitazone | 45 mg | Tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Rosuvastatin 10 mg film-coated Tablets | Rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Rosuvastatin 20 mg film-coated Tablets | Rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Brown & Burk UK Limited | | Rosuvastatin 40 mg film-coated Tablets | Rosuvastatin | 40 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Sertraline 50 mg film-coated Tablets | Sertraline | 50 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | RIA Generics Limited | | Sertraline 100 mg film-coated Tablets | Sertraline | 100 mg | Film-coated tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Limited | | Zolmitriptan 2.5 mg Orodispersible Tablets | Zolmitriptan | 2,5  mg | Orodispersible tablet | Oral use |
| United Kingdom (Northern Ireland) | Generics Limited | | Zolmitriptan 5 mg Orodispersible Tablets | Zolmitriptan | 5 mg | Orodispersible tablet | Oral use |
| United Kingdom (Northern Ireland) | Athlone Pharmaceuticals Limited | | Zopiclone 7.5 mg Tablets | Zopiclone | 7,5  mg | Tablet | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

Invented name

INN

Strength

Pharmaceutical form

Route of administration

Austria

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 200 mg Filmtabletten

Ibuprofen

200 mg

Film-coated tablet

Oral use

Austria

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 400 mg

Ibuprofen

400 mg

Film-coated tablet

Oral use

Austria

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 600 mg

Ibuprofen

600 mg

Film-coated tablet

Oral use

Austria

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 800 mg

Ibuprofen

800 mg

Film-coated tablet

Oral use

Austria

Fair-med Healthcare GmbH

Ibuprofen FMH 200 mg Filmtabletten

Ibuprofen

200 mg

Film-coated tablet

Oral use

Austria

Fair-med Healthcare GmbH

Ibuprofen FMH 400 mg Filmtabletten

Ibuprofen

400 mg

Film-coated tablet

Oral use

Austria

Fair-med Healthcare GmbH

Ibuprofen FMH 600 mg Filmtabletten

Ibuprofen

600 mg

Film-coated tablet

Oral use

Austria

Fair-med Healthcare GmbH

Ibuprofen FMH 800 mg Filmtabletten

Ibuprofen

800 mg

Film-coated tablet

Oral use

Austria

Aziende Chimiche Riunite Angelini Francesco S.p.A

BoxaGrippal 200 mg/30 mg Weichkapseln

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Atorvastatine Mylan 10 mg filmomhulde tabletten

Atorvastatin

10 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Atorvastatine Mylan 20 mg filmomhulde tabletten

Atorvastatin

20 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Atorvastatine Mylan 40 mg filmomhulde tabletten

Atorvastatin

40 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Atorvastatine Mylan 80 mg filmomhulde tabletten

Atorvastatin

80 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

AtorvastaMylan 10 mg filmomhulde tabletten

Atorvastatin

10 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

AtorvastaMylan 20 mg filmomhulde tabletten

Atorvastatin

20 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

AtorvastaMylan 40 mg filmomhulde tabletten

Atorvastatin

40 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

AtorvastaMylan 80 mg filmomhulde tabletten

Atorvastatin

80 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Mylanatorvastigen 10 mg [Film-coated tablet]

Atorvastatin

10 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Mylanatorvastigen 20 mg [Film-coated tablet]

Atorvastatin

20 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Mylanatorvastigen 40 mg [Film-coated tablet]

Atorvastatin

40 mg

Film-coated tablet

Oral use

Belgium

Mylan S.P.R.L.-B.V.B.A.

Mylanatorvastigen 80 mg [Film-coated tablet]

Atorvastatin

80 mg

Film-coated tablet

Oral use

Belgium

JOHNSON & JOHNSON CONSUMER N.V./S.A.

Bronchosedal Dextromethorphan Unidose 15 mg oral solution in sachet

Dextromethorphan

15 mg/5 ml

Oral solution in sachet

Oral use

Belgium

Mylan bvba/sprl

Efavirenz Mylan

Efavirenz

600 mg

Film-coated tablet

Oral use

Belgium

Tillomed Pharma GmbH

Paliperidon Tillomed 3 mg, tabletten met verlengde afgifte

Paliperidone

3 mg

Prolonged-release tablet

Oral use

Belgium

Tillomed Pharma GmbH

Paliperidon Tillomed 6 mg, tabletten met verlengde afgifte

Paliperidone

6 mg

Prolonged-release tablet

Oral use

Belgium

Tillomed Pharma GmbH

Paliperidon Tillomed 9 mg, tabletten met verlengde afgifte

Paliperidone

9 mg

Prolonged-release tablet

Oral use

Belgium

Theramex Ireland Limited

Ovalute 100 mg, zachte capsule

Progesterone

100 mg

Capsule, soft

Oral use

Belgium

Theramex Ireland Limited

Ovalute 200 mg, zachte capsule

Progesterone

200 mg

Capsule, soft

Oral use

Belgium

Mylan bvba/sprl

Zolmitriptan ODIS Mylan

Zolmitriptan

2,5  mg

Orodispersible tablet

Oral use

Belgium

Mylan bvba/sprl

Zolmitriptan ODIS Mylan

Zolmitriptan

5 mg

Orodispersible tablet

Oral use

Bulgaria

Mylan Ireland Limited

Atorgen 10 mg film — coated tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

Bulgaria

Mylan Ireland Limited

Atorgen 20 mg film — coated tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

Bulgaria

STADA Arzneimittel AG

Parabol

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Bulgaria

STADA Arzneimittel AG

Grippostad StopCold

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Croatia

STADA Arzneimittel AG

Combodolor 200 mg/500 mg meke kapsule

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Cyprus

Generics Pharma Hellas Ltd

Atorvastatin Generics 10 mg film-coated tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

Cyprus

Generics Pharma Hellas Ltd

Atorvastatin Generics 20 mg film-coated tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

Cyprus

Generics Pharma Hellas Ltd

Atorvastatin Generics 40 mg film-coated tablets

Atorvastatin

40 mg

Film-coated tablet

Oral use

Cyprus

Hellas Ltd

Cencipral Tablet, Film Coated 30Mg

Cinacalcet

30 mg

Film-coated tablet

Oral use

Cyprus

Remedica LTD

Cencipral Tablet, Film Coated 60Mg

Cinacalcet

60 mg

Film-coated tablet

Oral use

Cyprus

Remedica LTD

Cencipral Tablet, Film Coated 90Mg

Cinacalcet

90 mg

Film-coated tablet

Oral use

Cyprus

Nassington LTD

Zircos Tablet, Film Coated 5Mg

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Cyprus

Nassington LTD

Zircos Tablet, Film Coated 10Mg

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Cyprus

Nassington LTD

Zircos Tablet, Film Coated 20Mg

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Czech Republic

Mylan Ireland Limited

Atorvastatin Mylan 10 mg potahované tablety

Atorvastatin

10 mg

Film-coated tablet

Oral use

Czech Republic

Mylan Ireland Limited

Atorvastatin Mylan 20 mg potahované tablety

Atorvastatin

20 mg

Film-coated tablet

Oral use

Czech Republic

Mylan Ireland Limited

Atorvastatin Mylan 40 mg potahované tablety

Atorvastatin

40 mg

Film-coated tablet

Oral use

Czech Republic

Strides Pharma (Cyprus) Limited

IBUPROFEN STRIDES

Ibuprofen

200 mg

Film-coated tablet

Oral use

Czech Republic

Strides Pharma (Cyprus) Limited

IBUPROFEN STRIDES

Ibuprofen

400 mg

Film-coated tablet

Oral use

Czech Republic

Strides Pharma (Cyprus) Limited

IBUPROFEN STRIDES

Ibuprofen

600 mg

Film-coated tablet

Oral use

Czech Republic

Strides Pharma (Cyprus) Limited

IBUPROFEN STRIDES

Ibuprofen

800 mg

Film-coated tablet

Oral use

Czech Republic

PharmConsul s.r.o.

Brumet (previously Ibuber)

Ibuprofen

400 mg

Capsule, soft

Oral use

Czech Republic

PharmConsul s.r.o.

Ibamed (previously Ibuprofen Pharmconsul)

Ibuprofen

400 mg

Capsule, soft

Oral use

Czech Republic

PharmConsul s.r.o.

Ibivil (previously Ibunex)

Ibuprofen

400 mg

Capsule, soft

Oral use

Czech Republic

STADA Arzneimittel AG

STADALGEN

Paracetamol/ibuprofen

200 mg/500 mg

Capsule, soft

Oral use

Czech Republic

Actavis Group PTC ehf.

FOXIS

Tramadol/paracetamol

37,5  mg/325 mg

film-coated tablet

oral use

Czech republic

Mylan Ireland Limited

PIOGLITAZON MYLAN

Pioglitazone

15 mg

Tablet

Oral use

Czech republic

Mylan Ireland Limited

PIOGLITAZON MYLAN

Pioglitazone

30 mg

Tablet

Oral use

Denmark

Orifarm Generics A/S

Alfacalcidol ‘Orifarm’

Alfacalcidol

0,25 mcg

Capsule, soft

Oral use

Denmark

Orifarm Generics A/S

Alfacalcidol ‘Orifarm’

Alfacalcidol

0,5 mcg

Capsule, soft

Oral use

Denmark

Orifarm Generics A/S

Alfacalcidol ‘Orifarm’

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Denmark

Mylan AB

Atorvastatin ‘Mylan’

Atorvastatin

10 mg

Film-coated tablet

Oral use

Denmark

Mylan AB

Atorvastatin ‘Mylan’

Atorvastatin

20 mg

Film-coated tablet

Oral use

Denmark

Mylan AB

Atorvastatin ‘Mylan’

Atorvastatin

40 mg

Film-coated tablet

Oral use

Denmark

Mylan AB

Atorvastatin ‘Mylan’

Atorvastatin

80 mg

Film-coated tablet

Oral use

Denmark

Amarox Pharma B.V.

Atorvastatin ‘Amarox’

Atorvastatin

10 mg

Film-coated tablet

Oral use

Denmark

Amarox Pharma B.V.

Atorvastatin ‘Amarox’

Atorvastatin

20 mg

Film-coated tablet

Oral use

Denmark

Amarox Pharma B.V.

Atorvastatin ‘Amarox’

Atorvastatin

40 mg

Film-coated tablet

Oral use

Denmark

Amarox Pharma B.V.

Atorvastatin ‘Amarox’

Atorvastatin

80 mg

Film-coated tablet

Oral use

Denmark

2care4 Generics Aps

Carexarit

Clonidine

25 mcg

Coated tablet

Oral use

Denmark

Strides Pharma (Cyprus) Limited

Ibuprofen ‘Strides’

Ibuprofen

200 mg

Film-coated tablet

Oral use

Denmark

Strides Pharma (Cyprus) Limited

Ibuprofen ‘Strides’

Ibuprofen

400 mg

Film-coated tablet

Oral use

Denmark

Strides Pharma (Cyprus) Limited

Ibuprofen ‘Strides’

Ibuprofen

600 mg

Film-coated tablet

Oral use

Denmark

Strides Pharma (Cyprus) Limited

Ibuprofen ‘Strides’

Ibuprofen

800 mg

Film-coated tablet

Oral use

Denmark

Bristol Laboratories Ltd.

Ibuprofen ‘Bril’

Ibuprofen

200 mg

Film-coated tablet

Oral use

Denmark

Bristol Laboratories Ltd.

Ibuprofen ‘Bril’

Ibuprofen

400 mg

Film-coated tablet

Oral use

Denmark

Bristol Laboratories Ltd.

Ibuprofen ‘Bril’

Ibuprofen

600 mg

Film-coated tablet

Oral use

Denmark

Orifarm Generics A/S

Farmidur

Isosorbide mononitrate

30 mg

Prolonged-release tablet

Oral use

Denmark

Aristo Pharma GmbH

Kagitz

Quetiapine

50 mg

Prolonged-release tablet

Oral use

Denmark

Aristo Pharma GmbH

Kagitz

Quetiapine

300 mg

Prolonged-release tablet

Oral use

Denmark

Aristo Pharma GmbH

Kagitz

Quetiapine

400 mg

Prolonged-release tablet

Oral use

Finland

Orifarm Generics A/S

Alfacalcidol Orifarm

Alfacalcidol

0,25 mcg

Capsule, soft

Oral use

Finland

Orifarm Generics A/S

Alfacalcidol Orifarm

Alfacalcidol

0,5 mcg

Capsule, soft

Oral use

Finland

Orifarm Generics A/S

Alfacalcidol Orifarm

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Finland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

200 mg

Film-coated tablet

Oral use

Finland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

400 mg

Film-coated tablet

Oral use

Finland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

600 mg

Film-coated tablet

Oral use

Finland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

800 mg

Film-coated tablet

Oral use

Finland

Fair-med Healthcare GmbH

Ibuprofen Fmh

Ibuprofen

200 mg

Film-coated tablet

Oral use

Finland

Fair-med Healthcare GmbH

Ibuprofen Fmh

Ibuprofen

400 mg

Film-coated tablet

Oral use

Finland

Fair-med Healthcare GmbH

Ibuprofen Fmh

Ibuprofen

600 mg

Film-coated tablet

Oral use

Finland

Fair-med Healthcare GmbH

Ibuprofen Fmh

Ibuprofen

800 mg

Film-coated tablet

Oral use

France

Viatris Santé

Atorvastatine Viatris 10mg, comprimé pelliculé

Atorvastatin

10 mg

Film-coated tablet

Oral use

France

Viatris Santé

Atorvastatine Viatris 20mg, comprimé pelliculé

Atorvastatin

20 mg

Film-coated tablet

Oral use

France

Viatris Santé

Atorvastatine Viatris 40mg, comprimé pelliculé

Atorvastatin

40 mg

Film-coated tablet

Oral use

France

Viatris Santé

Atorvastatine Viatris 80mg, comprimé pelliculé

Atorvastatin

80 mg

Film-coated tablet

Oral use

France

Mylan SAS

EFAVIRENZ MYLAN 600 mg, comprimé pelliculé

Efavirenz

600 mg

Film-coated tablet

Oral use

France

Fair-Med Healthcare GmbH

IBUPROFÈNE FMH 200 mg, comprimé pelliculé

Ibuprofen

200 mg

Film-coated tablet

Oral use

France

Fair-Med Healthcare GmbH

IBUPROFÈNE FMH 400 mg, comprimé pelliculé

Ibuprofen

400 mg

Film-coated tablet

Oral use

France

Fair-Med Healthcare GmbH

IBUPROFÈNE FMH 600 mg, comprimé pelliculé

Ibuprofen

600 mg

Film-coated tablet

Oral use

France

Fair-Med Healthcare GmbH

IBUPROFÈNE FMH 800 mg, comprimé pelliculé

Ibuprofen

800 mg

Film-coated tablet

Oral use

France

Theramex Ireland Limited

OVALUTE 100 mg, capsule molle

Progesterone

100 mg

Capsule, soft

Oral use

France

Theramex Ireland Limited

OVALUTE 200 mg, capsule molle

Progesterone

200 mg

Capsule, soft

Oral use

France

Mylan SAS

ZOLMITRIPTAN MYLAN 2,5  mg, comprimé pelliculé

Zolmitriptan

2,5  mg

Film-coated tablet

Oral use

France

Mylan SAS

ZOLMITRIPTAN MYLAN 2,5  mg, comprimé orodispersible

Zolmitriptan

2,5  mg

Orodispersible tablet

Oral use

Germany

1 A Pharma GmbH

Alfacalcidol — 1 A Pharma 0,25 mcg Weichkapseln

Alfacalcidol

0,25 mcg

Capsule, soft

Oral use

Germany

1 A Pharma GmbH

Alfacalcidol — 1 A Pharma 0,5 mcg Weichkapseln

Alfacalcidol

0,5 mcg

Capsule, soft

Oral use

Germany

1 A Pharma GmbH

Alfacalcidol — 1 A Pharma 1 mcg Weichkapseln

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Germany

Hexal AG

Alfacalcidol HEXAL 0.25 mcg Weichkapseln

Alfacalcidol

0,25 mcg

Capsule, soft

Oral use

Germany

Hexal AG

Alfacalcidol HEXAL 0.5 mcg Weichkapseln

Alfacalcidol

0,5 mcg

Capsule, soft

Oral use

Germany

Hexal AG

Alfacalcidol HEXAL 1 mcg Weichkapseln

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Germany

Amarox Pharma B.V.

Atorvastatin Amarox 10 mg Filmtabletten

Atorvastatin

10 mg

Film-coated tablet

Oral use

Germany

Amarox Pharma B.V.

Atorvastatin Amarox 20 mg Filmtabletten

Atorvastatin

20 mg

Film-coated tablet

Oral use

Germany

Amarox Pharma B.V.

Atorvastatin Amarox 40 mg Filmtabletten

Atorvastatin

40 mg

Film-coated tablet

Oral use

Germany

Amarox Pharma B.V.

Atorvastatin Amarox 80 mg Filmtabletten

Atorvastatin

80 mg

Film-coated tablet

Oral use

Germany

Tillomed Pharma GmbH

Ezetimib/Simvastatin Tillomed 10 mg/ 10 mg Tabletten

Ezetimibe/simvastatin

10 mg/10 mg

Tablet

Oral use

Germany

Tillomed Pharma GmbH

Ezetimib/Simvastatin Tillomed 10 mg/ 20 mg Tabletten

Ezetimibe/simvastatin

10 mg/20 mg

Tablet

Oral use

Germany

Tillomed Pharma GmbH

Ezetimib/Simvastatin Tillomed 10 mg/ 40 mg Tabletten

Ezetimibe/simvastatin

10 mg/40 mg

Tablet

Oral use

Germany

Tillomed Pharma GmbH

Ezetimib/Simvastatin Tillomed 10 mg/ 80 mg Tabletten

Ezetimibe/simvastatin

10 mg/80 mg

Tablet

Oral use

Germany

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 200 mg Filmtabletten

Ibuprofen

200 mg

Film-coated tablet

Oral use

Germany

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 400 mg Filmtabletten

Ibuprofen

400 mg

Film-coated tablet

Oral use

Germany

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 600 mg Filmtabletten

Ibuprofen

600 mg

Film-coated tablet

Oral use

Germany

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 800 mg Filmtabletten

Ibuprofen

800 mg

Film-coated tablet

Oral use

Germany

Fair-Med Healthcare GmbH

Ibuprofen FMH 200 mg Filmtabletten

Ibuprofen

200 mg

Film-coated tablet

Oral use

Germany

Fair-Med Healthcare GmbH

Ibuprofen FMH 400 mg Filmtabletten

Ibuprofen

400 mg

Film-coated tablet

Oral use

Germany

Fair-Med Healthcare GmbH

Ibuprofen FMH 600 mg Filmtabletten

Ibuprofen

600 mg

Film-coated tablet

Oral use

Germany

Fair-Med Healthcare GmbH

Ibuprofen FMH 800 mg Filmtabletten

Ibuprofen

800 mg

Film-coated tablet

Oral use

Germany

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

200 mg

Film-coated tablet

Oral use

Germany

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

400 mg

Film-coated tablet

Oral use

Germany

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

600 mg

Film-coated tablet

Oral use

Germany

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.P.A.

BoxaGrippal 200 mg/30 mg Weichkapseln

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Germany

PharmaMatch B.V.

Ibuprofen 200 mg/ Pseudoephedrine 30 mg Kapsel

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Germany

Infectopharm Arzneimittel und Consilium GmbH

MetfoLiquid Geriasan 1 000  mg/5 ml, Lösung zum Einnehmen

Metformin

1 000  mg/5 ml

Oral solution

Oral use

Germany

Tillomed Pharma GmbH

Oxybutyninhydrochlorid Creative 2,5  mg Tabletten

Oxybutynin

2,5  mg

Tablet

Oral use

Germany

Tillomed Pharma GmbH

Oxybutyninhydrochlorid Creative 5 mg Tabletten

Oxybutynin

5 mg

Tablet

Oral use

Germany

PharmaMatch B.V.

Progesteron PharmaMatch 100 mg Weichkapseln

Progesterone

100 mg

Capsule, soft

Oral use

Germany

PharmaMatch B.V.

Progesteron PharmaMatch 200 mg Weichkapseln

Progesterone

200 mg

Capsule, soft

Oral use

Germany

Theramex Ireland Limited

Ovalute 100 mg Weichkapseln

Progesterone

100 mg

Capsule, soft

Oral use

Germany

Theramex Ireland Limited

Ovalute 200 mg Weichkapseln

Progesterone

200 mg

Capsule, soft

Oral use

Germany

Micro Labs GmbH

Rosuvastatin Micro Labs 10 mg Filmtabletten

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Rosuvastatin Micro Labs 20 mg Filmtabletten

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Rosuvastatin Micro Labs 40 mg Filmtabletten

Rosuvastatin

40 mg

Film-coated tablet

Oral use

Germany

Mylan Germany GmbH

Zolmitriptan dura Filmtabletten

Zolmitriptan

2,5  mg

Film-coated tablet

Oral use

Germany

Mylan Germany GmbH

Zolmitriptan dura Filmtabletten

Zolmitriptan

5 mg

Film-coated tablet

Oral use

Germany

Mylan Germany GmbH

Zolmitriptan dura Schmelztabletten

Zolmitriptan

2,5  mg

Orodispersible tablet

Oral use

Germany

Mylan Germany GmbH

Zolmitriptan dura Schmelztabletten

Zolmitriptan

5 mg

Orodispersible tablet

Oral use

Greece

Mylan Ireland Limited

Atorvastatin/Mylan Film-coated Tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

Greece

Mylan Ireland Limited

Atorvastatin/Mylan Film-coated Tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

Greece

Mylan Ireland Limited

Atorvastatin/Mylan Film-coated Tablets

Atorvastatin

40 mg

Film-coated tablet

Oral use

Greece

Bennet Pharmaceutica L A.E.

Memaben

Memantine

5 mg + 10 mg + 15 mg + 20 mg

Soluble tablet

Oral use

Greece

Bennet Pharmaceutica L A.E.

Memaben

Memantine

10 mg

Soluble tablet

Oral use

Greece

Bennet Pharmaceutica L A.E.

Memaben

Memantine

20 mg

Soluble tablet

Oral use

Greece

Vita Longa I.K.E. (Vita Longa P.C.)

Lycis

Metformin

1 000  mg/5 ml

Oral solution

Oral use

Greece

Tillomed Pharma GmbH

Paliperidone Tillomed

Paliperidone

3 mg

Prolonged-release tablet

Oral use

Greece

Tillomed Pharma GmbH

Paliperidone Tillomed

Paliperidone

6 mg

Prolonged-release tablet

Oral use

Greece

Tillomed Pharma GmbH

Paliperidone Tillomed

Paliperidone

9 mg

Prolonged-release tablet

Oral use

Greece

Nassington LTD

Rosupose

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Rosupose

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Rosupose

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Greece

Medicair Bioscience Laboratories CY LTD

Rosuvanox

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Greece

Medicair Bioscience Laboratories CY LTD

Rosuvanox

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Greece

Medicair Bioscience Laboratories CY LTD

Rosuvanox

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Greece

VELKA Hellas A.E.B.E.

Rosuvastatin/Velka

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Greece

VELKA Hellas A.E.B.E.

Rosuvastatin/Velka

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Greece

VELKA Hellas A.E.B.E.

Rosuvastatin/Velka

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Greece

Lavipharm AE

Rovastine

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Greece

Lavipharm AE

Rovastine

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Greece

Lavipharm AE

Rovastine

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Greece

Rafarm A.E.B.E

Zircos

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Greece

Rafarm A.E.B.E

Zircos

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Greece

Rafarm A.E.B.E

Zircos

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Zolvara

Rosuvastatin

5 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Zolvara

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Zolvara

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Mesi-2

Sitagliptin/metformin

50 mg/850 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Mesi-2

Sitagliptin/metformin

50 mg/1 000  mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Metogline

Vildagliptin/metformin

50 mg/850 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

Metogline

Vildagliptin/metformin

50 mg/1 000  mg

Film-coated tablet

Oral use

Greece

Nassington LTD

PERIVALE

Sitagliptin/metformin

50 mg/850 mg

Film-coated tablet

Oral use

Greece

Nassington LTD

PERIVALE

Sitagliptin/metformin

50 mg/1 000  mg

Film-coated tablet

Oral use

Greece

Verisfield AE

Toogluc

Sitagliptin/metformin

50 mg/850 mg

Film-coated tablet

Oral use

Greece

Verisfield AE

Toogluc

Sitagliptin/metformin

50 mg/1 000  mg

Film-coated tablet

Oral use

Hungary

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

200 mg

Film-coated tablet

Oral use

Hungary

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

400 mg

Film-coated tablet

Oral use

Hungary

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

600 mg

Film-coated tablet

Oral use

Hungary

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

800 mg

Film-coated tablet

Oral use

Hungary

STADA Arzneimittel AG

Dolostad 200 mg/500 mg lágy kapszula

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Hungary

STADA Arzneimittel AG

Dolostad 200 mg/500 mg lágy kapszula

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Iceland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

200 mg

Film-coated tablet

Oral use

Iceland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

400 mg

Film-coated tablet

Oral use

Iceland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

600 mg

Film-coated tablet

Oral use

Ireland

Bluefish Pharmaceuticals AB

Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets

Amoxicillin/ clavulanic acid

500 mg/125 mg

Film-coated tablet

Oral use

Ireland

McDermott Laboratories Ltd

Atorvastatin Mylan 10 mg film-coated tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

Ireland

McDermott Laboratories Ltd

Atorvastatin Mylan 20 mg film-coated tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

Ireland

McDermott Laboratories Ltd

Atorvastatin Mylan 40 mg film-coated tablets

Atorvastatin

40 mg

Film-coated tablet

Oral use

Ireland

McDermott Laboratories Ltd

Atorvastatin Mylan 80 mg film-coated tablets

Atorvastatin

80 mg

Film-coated tablet

Oral use

Ireland

Pinewood Laboratories Limited

Atorvastatin 10 mg Film-Coated Tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

Ireland

Pinewood Laboratories Limited

Atorvastatin 20 mg Film-Coated Tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

Ireland

Pinewood Laboratories Limited

Atorvastatin 40 mg Film-Coated Tablets

Atorvastatin

40 mg

Film-coated tablet

Oral use

Ireland

Pinewood Laboratories Limited

Atorvastatin 80 mg Film-Coated Tablets

Atorvastatin

80 mg

Film-coated tablet

Oral use

Ireland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

200 mg

Film-coated tablet

Oral use

Ireland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

400 mg

Film-coated tablet

Oral use

Ireland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

600 mg

Film-coated tablet

Oral use

Ireland

Clonmel Healthcare Ltd

Easofen Cold & Flu

Ibuprofen/pseudoephedrine

200 mg /20 mg

Capsule, soft

Oral use

Ireland

Clonmel Healthcare Ltd,

Paralief 500 mg soft capsules

Paracetamol

500 mg

Capsule, soft

Oral use

Ireland

Theramex Ireland Limited

Ovalute

Progesterone

100 mg

Capsule, soft

Oral use

Ireland

Theramex Ireland Limited

Ovalute

Progesterone

200 mg

Capsule, soft

Oral use

Italy

Stewart Italia S.r.l.

Stemox

Amoxicillin/ clavulanic acid

400 mg/5 ml + 57 mg/5 ml

Powder for oral suspension

Oral use

Italy

Mylan S.p.A.

Atorvastatina Mylan Generics Italia

Atorvastatin

10 mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

Atorvastatina Mylan Generics Italia

Atorvastatin

20 mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

Atorvastatina Mylan Generics Italia

Atorvastatin

40 mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

Atorvastatina Mylan Generics Italia

Atorvastatin

80 mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

Efavirenz Mylan

Efavirenz

600 mg

Film-coated tablet

Oral use

Italy

Tillomed Pharma Gmbh

Paliperidone Tillomed

Paliperidone

3 mg

Prolonged-release tablet

Oral use

Italy

Tillomed Pharma Gmbh

Paliperidone Tillomed

Paliperidone

6 mg

Prolonged-release tablet

Oral use

Italy

Tillomed Pharma Gmbh

Paliperidone Tillomed

Paliperidone

9 mg

Prolonged-release tablet

Oral use

Italy

Mylan S.p.A.

Pioglitazone Mylan

Pioglitazone

15 mg

Tablet

Oral use

Italy

Mylan S.p.A.

Pioglitazone Mylan

Pioglitazone

30 mg

Tablet

Oral use

Italy

Mylan S.p.A.

Zolmitriptan Mylan Generics

Zolmitriptan

2,5  mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

Zolmitriptan Mylan Generics

Zolmitriptan

5 mg

Film-coated tablet

Oral use

Luxembourg

JOHNSON & JOHNSON CONSUMER N.V./S.A.

Bronchosedal Dextromethorphan Unidose 15 mg oral solution en sachet

Dextromethorphan

15 mg/5 ml

Oral solution in sachet

Oral use

Luxembourg

PharmaMatch B.V.

Progesteron PharmaMatch 100 mg Weichkapseln

Progesterone

100 mg

Capsule, soft

Oral use

Luxembourg

PharmaMatch B.V.

Progesteron PharmaMatch 200 mg Weichkapseln

Progesterone

200 mg

Capsule, soft

Oral use

Luxembourg

Micro Labs GmbH

Rosuvastatin Micro Labs 10 mg Filmtabletten

Rosuvastatin

10 mg

Film-coated tablet

Oral use

Luxembourg

Micro Labs GmbH

Rosuvastatin Micro Labs 20 mg Filmtabletten

Rosuvastatin

20 mg

Film-coated tablet

Oral use

Luxembourg

Micro Labs GmbH

Rosuvastatin Micro Labs 40 mg Filmtabletten

Rosuvastatin

40 mg

Film-coated tablet

Oral use

Luxembourg

Mylan bvba/sprl

Zolmitriptan ODIS Mylan 2,5  mg comprimé orodispersible

Zolmitriptan

2,5  mg

Orodispersible tablet

Oral use

Malta

RIA Generics Ireland Limited

Nefopam Hydrochloride 30 mg film-coated tablets

Nefopam

30 mg

Film-coated tablet

Oral use

Norway

Orifarm Generics A/S

Alfacalcidol ‘Orifarm’

Alfacalcidol

0,25 mcg

Capsule, soft

Oral use

Norway

Orifarm Generics A/S

Alfacalcidol ‘Orifarm’

Alfacalcidol

0,5 mcg

Capsule, soft

Oral use

Norway

Orifarm Generics A/S

Alfacalcidol ‘Orifarm’

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Norway

Pensa Pharma AB

Atorvastatin Pensa

Atorvastatin

10 mg

Film-coated tablet

Oral use

Norway

Pensa Pharma AB

Atorvastatin Pensa

Atorvastatin

20 mg

Film-coated tablet

Oral use

Norway

Pensa Pharma AB

Atorvastatin Pensa

Atorvastatin

40 mg

Film-coated tablet

Oral use

Norway

Pensa Pharma AB

Atorvastatin Pensa

Atorvastatin

80 mg

Film-coated tablet

Oral use

Norway

2care4 Generics Aps

Carexarit

Clonidine

25 mcg

Coated tablet

Oral use

Norway

Aristo Pharma GmbH

Kagitz

Quetiapine

50 mg

Prolonged-release tablet

Oral use

Norway

Aristo Pharma GmbH

Kagitz

Quetiapine

300 mg

Prolonged-release tablet

Oral use

Norway

Aristo Pharma GmbH

Kagitz

Quetiapine

400 mg

Prolonged-release tablet

Oral use

Poland

Bluefish Pharmaceuticals AB

Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets

Amoxicillin/ clavulanic acid

500 mg/125 mg

Film-coated tablet

Oral use

Poland

Mylan Ireland Limited

Atorvagen

Atorvastatin

10 mg

Film-coated tablet

Oral use

Poland

Mylan Ireland Limited

Atorvagen

Atorvastatin

20 mg

Film-coated tablet

Oral use

Poland

Mylan Ireland Limited

Atorvagen

Atorvastatin

40 mg

Film-coated tablet

Oral use

Poland

Artespharm Sp. z o.o.

Atostat

Atorvastatin

10 mg

Film-coated tablet

Oral use

Poland

Artespharm Sp. z o.o.

Atostat

Atorvastatin

20 mg

Film-coated tablet

Oral use

Poland

Artespharm Sp. z o.o.

Atostat

Atorvastatin

40 mg

Film-coated tablet

Oral use

Poland

Artespharm Sp. z o.o.

Atostat

Atorvastatin

80 mg

Film-coated tablet

Oral use

Poland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

200 mg

Film-coated tablet

Oral use

Poland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

400 mg

Film-coated tablet

Oral use

Poland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

600 mg

Film-coated tablet

Oral use

Poland

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

800 mg

Film-coated tablet

Oral use

Poland

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

200 mg

Film-coated tablet

Oral use

Poland

US Pharmacia Sp. z o.o.

Ibuprom Ultramax Sprint

Ibuprofen

600 mg

Capsule, soft

Oral use

Poland

US Pharmacia Sp. z o.o.

Ibuprom Zatoki Sprint

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Poland

Synoptis Pharma Sp. z o.o.

Ifedrin ZATOKI APTEO MED

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Portugal

Laboratórios Basi — Indústria Farmacêutica, S.A

Amoxicilina + Ácido Clavulânico Basi

Amoxicillin/ clavulanic acid

250 mg/5 ml +62,5  mg/5 ml

Powder for oral suspension

Oral use

Portugal

Laboratórios Basi — Indústria Farmacêutica, S.A

Amoxicilina + Ácido Clavulânico Basi

Amoxicillin/ clavulanic acid

400 mg/5 ml + 57 mg/5 ml

Powder for oral suspension

Oral use

Portugal

Mylan Lda

Atorvastatine Mylan

Atorvastatin

10 mg

Film-coated tablet

Oral use

Portugal

Mylan Lda

Atorvastatine Mylan

Atorvastatin

20 mg

Film-coated tablet

Oral use

Portugal

Mylan Lda

Atorvastatine Mylan

Atorvastatin

40 mg

Film-coated tablet

Oral use

Portugal

Mylan Lda

Atorvastatine Mylan

Atorvastatin

80 mg

Film-coated tablet

Oral use

Portugal

Mylan Lda

Efavirenz Mylan

Efavirenz

600 mg

Film-coated tablet

Oral use

Portugal

Abdi Farma Unipessoal Limitada

Etolyn

Etodolac

600 mg

Prolonged-release tablet

Oral use

Portugal

STADA Lda.

Pramolix 500 mg cápsula mole

Paracetamol

500 mg

Capsule, soft

Oral use

Portugal

Laboratórios Azevedos — Indústria Farmacêutica, S.A.

Algik Gripe

Paracetamol/pseudoephedrine

500 mg/30 mg

Capsule, soft

Oral use

Portugal

Mylan, Lda.

Pioglitazona Mylan

Pioglitazone

15 mg

Tablet

Oral use

Portugal

Mylan, Lda.

Pioglitazona Mylan

Pioglitazone

30 mg

Tablet

Oral use

Portugal

Mylan, Lda.

Pioglitazona Mylan

Pioglitazone

45 mg

Tablet

Oral use

Portugal

Alter, S.A.

Rosuvastatina + Ezetimiba Alter

Rosuvastatin/ezetimibe

5 mg/10 mg

Film-coated tablet

Oral use

Portugal

Alter, S.A.

Rosuvastatina + Ezetimiba Alter

Rosuvastatin/ezetimibe

10 mg/10 mg

Film-coated tablet

Oral use

Portugal

Alter, S.A.

Rosuvastatina + Ezetimiba Alter

Rosuvastatin/ezetimibe

20 mg/10 mg

Film-coated tablet

Oral use

Portugal

Alter, S.A.

Rosuvastatina + Ezetimiba Alter

Rosuvastatin/ezetimibe

40 mg/10 mg

Film-coated tablet

Oral use

Portugal

Farmalter — Produtos Farmacêuticos e Dietéticos, Lda.

Rosuvastatina + Ezetimiba Bistenibe

Rosuvastatin/ezetimibe

5 mg/10 mg

Film-coated tablet

Oral use

Portugal

Farmalter — Produtos Farmacêuticos e Dietéticos, Lda.

Rosuvastatina + Ezetimiba Bistenibe

Rosuvastatin/ezetimibe

10 mg/10 mg

Film-coated tablet

Oral use

Portugal

Farmalter — Produtos Farmacêuticos e Dietéticos, Lda.

Rosuvastatina + Ezetimiba Bistenibe

Rosuvastatin/ezetimibe

20 mg/10 mg

Film-coated tablet

Oral use

Portugal

Farmalter — Produtos Farmacêuticos e Dietéticos, Lda.

Rosuvastatina + Ezetimiba Bistenibe

Rosuvastatin/ezetimibe

40 mg/10 mg

Film-coated tablet

Oral use

Romania

S.C. Sandoz SRL

ALFACALCIDOL SANDOZ 0,25 μg

Alfacalcidol

0,25  mg

Capsule, soft

Oral use

Romania

S.C. Sandoz SRL

ALFACALCIDOL SANDOZ 0,5 μg

Alfacalcidol

0,5  mg

Capsule, soft

Oral use

Romania

Strides Pharma (Cyprus) Limited

Ibuprofen STRIDES

Ibuprofen

200 mg

Film-coated tablet

Oral use

Romania

Strides Pharma (Cyprus) Limited

Ibuprofen STRIDES

Ibuprofen

400 mg

Film-coated tablet

Oral use

Romania

Strides Pharma (Cyprus) Limited

Ibuprofen STRIDES

Ibuprofen

600 mg

Film-coated tablet

Oral use

Romania

Strides Pharma (Cyprus) Limited

Ibuprofen STRIDES

Ibuprofen

800 mg

Film-coated tablet

Oral use

Romania

STADA Arzneimittel AG

IBUPROFEN/ PARACETAMOL 200 mg/500 mg

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Romania

PharmaMatch B.V.

Buprofess raceala si Gripa

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

Slovakia

Sandoz Pharmaceuticals d.d.

Alfakalcidol SANDOZ 1 mikrogram mäkké kapsuly

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Slovakia

Mylan Ireland Limited

Atorvastatine Mylan

Atorvastatin

20 mg

Film-coated tablet

Oral use

Slovakia

Mylan Ireland Limited

Atorvastatine Mylan

Atorvastatin

40 mg

Film-coated tablet

Oral use

Slovakia

STADA Arzneimittel AG

Ibumol

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Slovakia

STADA Arzneimittel AG

Parastad mäkké kapsuly

Paracetamol

500 mg

Capsule, soft

Oral use

Slovenia

Mylan Ireland Limited

Atorvastatin Mylan

Atorvastatin

10 mg

Film-coated tablet

Oral use

Slovenia

Mylan Ireland Limited

Atorvastatin Mylan

Atorvastatin

20 mg

Film-coated tablet

Oral use

Slovenia

Mylan Ireland Limited

Atorvastatin Mylan

Atorvastatin

40 mg

Film-coated tablet

Oral use

Slovenia

STADA Arzneimittel AG

Ibumol

Ibuprofen/paracetamol

200 mg/500 mg

Capsule, soft

Oral use

Spain

Mylan Pharmaceuticals, S.L.

ATORVASTATINA MYLAN 10 mg comprimidos recubiertos con película EFG

Atorvastatin

10 mg

Film-coated tablet

Oral use

Spain

Mylan Pharmaceuticals, S.L.

ATORVASTATINA MYLAN 20 mg comprimidos recubiertos con película EFG

Atorvastatin

20 mg

Film-coated tablet

Oral use

Spain

Mylan Pharmaceuticals, S.L.

ATORVASTATINA MYLAN 40 mg comprimidos recubiertos con película EFG

Atorvastatin

40 mg

Film-coated tablet

Oral use

Spain

Mylan Pharmaceuticals, S.L.

ATORVASTATINA MYLAN 80 mg comprimidos recubiertos con película EFG

Atorvastatin

80 mg

Film-coated tablet

Oral use

Spain

Tarbis Farma, S.L.

ATORVASTATINA TARBIS FARMA 10 mg comprimidos recubiertos con película EFG

Atorvastatin

10 mg

Film-coated tablet

Oral use

Spain

Tarbis Farma, S.L.

ATORVASTATINA TARBIS FARMA 20 mg comprimidos recubiertos con película EFG

Atorvastatin

20 mg

Film-coated tablet

Oral use

Spain

Tarbis Farma, S.L.

ATORVASTATINA TARBIS FARMA 40 mg comprimidos recubiertos con película EFG

Atorvastatin

40 mg

Film-coated tablet

Oral use

Spain

Tarbis Farma, S.L.

ATORVASTATINA TARBIS FARMA 80 mg comprimidos recubiertos con película EFG

Atorvastatin

80 mg

Film-coated tablet

Oral use

Spain

Johnson and Johnson, S.A.

INISTON TUSIV 15 mg solución oral en sobre

Dextromethorphan

15 mg/5 ml

Oral solution in sachet

Oral use

Spain

Mylan Pharmaceutica LS, S.L.

EFAVIRENZ MYLAN 600 mg comprimidos recubiertos con película EFG

Efavirenz

600 mg

Film-coated tablet

Oral use

Spain

Fair-med Healthcare GmbH

IBUPROFEN FMH 200 mg comprimidos recubiertos con película EFG

Ibuprofen

200 mg

Film-coated tablet

Oral use

Spain

Fair-med Healthcare GmbH

IBUPROFEN FMH 400 mg comprimidos recubiertos con película EFG

Ibuprofen

400 mg

Film-coated tablet

Oral use

Spain

Fair-med Healthcare GmbH

IBUPROFEN FMH 600 mg comprimidos recubiertos con película EFG

Ibuprofen

600 mg

Film-coated tablet

Oral use

Spain

Fair-med Healthcare GmbH

IBUPROFEN FMH 800 mg comprimidos recubiertos con película EFG

Ibuprofen

800 mg

Film-coated tablet

Oral use

Spain

Laboratorios Tillomed Spain S.L.U.

PALIPERIDONA TILLOMED 3 mg comprimidos de liberación controlada

Paliperidone

3 mg

Prolonged-release tablet

Oral use

Spain

Laboratorios Tillomed Spain S.L.U.

PALIPERIDONA TILLOMED 6 mg comprimidos de liberación controlada

Paliperidone

6 mg

Prolonged-release tablet

Oral use

Spain

Laboratorios Tillomed Spain S.L.U.

PALIPERIDONA TILLOMED 9 mg comprimidos de liberación controlada

Paliperidone

9 mg

Prolonged-release tablet

Oral use

Spain

Theramex Ireland Limited

OVALUTE 100 mg cápsulas blandas

Progesterone

100 mg

Capsule, soft

Oral use

Spain

Aurovitas Spain, S.A.U.

TRAMADOL/PARACETAMOL AUROVITAS SPAIN 37,5  mg/325 mg comprimidos recubiertos con película EFG

Tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Sweden

Orifarm Generics A/S

Alfacalcidol Orifarm

Alfacalcidol

0,25 mcg

Capsule, soft

Oral use

Sweden

Orifarm Generics A/S

Alfacalcidol Orifarm

Alfacalcidol

0,5 mcg

Capsule, soft

Oral use

Sweden

Orifarm Generics A/S

Alfacalcidol Orifarm

Alfacalcidol

1 mcg

Capsule, soft

Oral use

Sweden

Mylan AB

Atorvastatin Mylan

Atorvastatin

10 mg

Film-coated tablet

Oral use

Sweden

Mylan AB

Atorvastatin Mylan

Atorvastatin

20 mg

Film-coated tablet

Oral use

Sweden

Mylan AB

Atorvastatin Mylan

Atorvastatin

40 mg

Film-coated tablet

Oral use

Sweden

Mylan AB

Atorvastatin Mylan

Atorvastatin

80 mg

Film-coated tablet

Oral use

Sweden

Amarox Pharma B.V.

Atorvastatin Amarox

Atorvastatin

10 mg

Film-coated tablet

Oral use

Sweden

Amarox Pharma B.V.

Atorvastatin Amarox

Atorvastatin

20 mg

Film-coated tablet

Oral use

Sweden

Amarox Pharma B.V.

Atorvastatin Amarox

Atorvastatin

40 mg

Film-coated tablet

Oral use

Sweden

Amarox Pharma B.V.

Atorvastatin Amarox

Atorvastatin

80 mg

Film-coated tablet

Oral use

Sweden

Sandoz A/S

Flucloxacillin Sandoz

Flucloxacillin

500 mg

Film-coated tablet

Oral use

Sweden

Sandoz A/S

Flucloxacillin Sandoz

Flucloxacillin

750 mg

Film-coated tablet

Oral use

Sweden

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

200 mg

Film-coated tablet

Oral use

Sweden

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

400 mg

Film-coated tablet

Oral use

Sweden

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

600 mg

Film-coated tablet

Oral use

Sweden

Strides Pharma (Cyprus) Limited

Ibuprofen Strides

Ibuprofen

800 mg

Film-coated tablet

Oral use

Sweden

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

200 mg

Film-coated tablet

Oral use

Sweden

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

400 mg

Film-coated tablet

Oral use

Sweden

Brillpharma (Ireland) Limited

Ibuprofen Bril

Ibuprofen

600 mg

Film-coated tablet

Oral use

Sweden

Brillpharma (Ireland) Limited

Ibuprofen BrillPharma

Ibuprofen

200 mg

Film-coated tablet

Oral use

Sweden

Brillpharma (Ireland) Limited

Ibuprofen BrillPharma

Ibuprofen

400 mg

Film-coated tablet

Oral use

Sweden

Brillpharma (Ireland) Limited

Ibuprofen BrillPharma

Ibuprofen

600 mg

Film-coated tablet

Oral use

Sweden

Orifarm Generics A/S

Isonova

Isosorbide mononitrate

30 mg

Prolonged-release tablet

Oral use

Sweden

Orifarm Generics A/S

Isonova

Isosorbide mononitrate

60 mg

Prolonged-release tablet

Oral use

Sweden

Aristo Pharma GmbH

Kagitz

Quetiapine

50 mg

Prolonged-release tablet

Oral use

Sweden

Aristo Pharma GmbH

Kagitz

Quetiapine

300 mg

Prolonged-release tablet

Oral use

Sweden

Aristo Pharma GmbH

Kagitz

Quetiapine

400 mg

Prolonged-release tablet

Oral use

The Netherlands

Mylan B.V.

Atorvastatine Mylan 10 mg, filmomhulde tabletten

Atorvastatin

10 mg

Film-coated tablet

Oral use

The Netherlands

Mylan B.V.

Atorvastatine Mylan 20 mg, filmomhulde tabletten

Atorvastatin

20 mg

Film-coated tablet

Oral use

The Netherlands

Mylan B.V.

Atorvastatine Mylan 40 mg, filmomhulde tabletten

Atorvastatin

40 mg

Film-coated tablet

Oral use

The Netherlands

Mylan B.V.

Atorvastatine Mylan 80 mg, filmomhulde tabletten

Atorvastatin

80 mg

Film-coated tablet

Oral use

The Netherlands

Amarox Pharma B.V.

Atorvastatine Amarox 10 mg filmomhulde tabletten

Atorvastatin

10 mg

Film-coated tablet

Oral use

The Netherlands

Amarox Pharma B.V.

Atorvastatine Amarox 20 mg filmomhulde tabletten

Atorvastatin

20 mg

Film-coated tablet

Oral use

The Netherlands

Amarox Pharma B.V.

Atorvastatine Amarox 40 mg filmomhulde tabletten

Atorvastatin

40 mg

Film-coated tablet

Oral use

The Netherlands

Amarox Pharma B.V.

Atorvastatine Amarox 80 mg filmomhulde tabletten

Atorvastatin

80 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Clobazam Sandoz 10 mg, tabletten

Clobazam

10 mg

Tablet

Oral use

The Netherlands

TioFarma B.V.

Clobazam Tiofarma 10 mg, tabletten

Clobazam

10 mg

Tablet

Oral use

The Netherlands

TioFarma B.V.

Clobazam Tiofarma 20 mg, tabletten

Clobazam

20 mg

Tablet

Oral use

The Netherlands

Sandoz B.V.

Clonazepam Sandoz 0,5  mg, tabletten

Clonazepam

0,5  mg

Tablet

Oral use

The Netherlands

Sandoz B.V.

Clonazepam Sandoz 2 mg, tabletten

Clonazepam

2 mg

Tablet

Oral use

The Netherlands

TioFarma B.V.

Clonazepam Tiofarma 0,5  mg, tabletten

Clonazepam

0,5  mg

Tablet

Oral use

The Netherlands

TioFarma B.V.

Clonazepam Tiofarma 2 mg, tabletten

Clonazepam

2 mg

Tablet

Oral use

The Netherlands

Mylan B.V.

Efavirenz Mylan 600 mg, filmomhulde tabletten

Efavirenz

600 mg

Film-coated tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Ezetimibe/Simvastatine Tillomed 10 mg/10 mg, tabletten

Ezetimibe/simvastatin

10 mg/10 mg

Tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Ezetimibe/Simvastatine Tillomed 10 mg/20 mg, tabletten

Ezetimibe/simvastatin

10 mg/20 mg

Tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Ezetimibe/Simvastatine Tillomed 10 mg/40 mg, tabletten

Ezetimibe/simvastatin

10 mg/40 mg

Tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Ezetimibe/Simvastatine Tillomed 10 mg/80 mg, tabletten

Ezetimibe/simvastatin

10 mg/80 mg

Tablet

Oral use

The Netherlands

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 200 mg, filmomhulde tabletten

Ibuprofen

200 mg

Film-coated tablet

Oral use

The Netherlands

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 200 mg, filmomhulde tabletten

Ibuprofen

400 mg

Film-coated tablet

Oral use

The Netherlands

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 200 mg, filmomhulde tabletten

Ibuprofen

600 mg

Film-coated tablet

Oral use

The Netherlands

Strides Pharma (Cyprus) Limited

Ibuprofen Strides 200 mg, filmomhulde tabletten

Ibuprofen

800 mg

Film-coated tablet

Oral use

The Netherlands

RIA Generics Limited

Nortriptyline RIA 10 mg tabletten

Nortriptyline

10 mg

Tablet

Oral use

The Netherlands

RIA Generics Limited

Nortriptyline RIA 25 mg tabletten

Nortriptyline

25 mg

Tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Paliperidon Tillomed 3 mg, tabletten met verlengde afgifte

Paliperidone

3 mg

Prolonged-release tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Paliperidon Tillomed 6 mg, tabletten met verlengde afgifte

Paliperidone

6 mg

Prolonged-release tablet

Oral use

The Netherlands

Tillomed Pharma GmbH

Paliperidon Tillomed 9 mg, tabletten met verlengde afgifte

Paliperidone

9 mg

Prolonged-release tablet

Oral use

The Netherlands

Healthypharm B.V.

Paracetamol liquid caps HTP 500 mg, zachte capsules

Paracetamol

500 mg

Capsule, soft

Oral use

The Netherlands

MAE Holding B.V.

Paracetamol Linn 500 mg liquid caps, zachte capsules

Paracetamol

500 mg

Capsule, soft

Oral use

The Netherlands

Socium Pharma B.V.

Paracetamol/Ibuprofen Socium 500/200 mg zachte capsules

Paracetamol/ibuprofen

500 mg / 200 mg

Capsule, soft

Oral use

The Netherlands

Theramex Ireland Limited

Ovalute 100 mg, zachte capsule

Progesterone

100 mg

Capsule, soft

Oral use

The Netherlands

Theramex Ireland Limited

Ovalute 200 mg, zachte capsule

Progesterone

200 mg

Capsule, soft

Oral use

The Netherlands

RIA Generics Limited

Sertraline RIA 50 mg, filmomhulde tabletten

Sertraline

50 mg

Film-coated tablet

Oral use

The Netherlands

RIA Generics Limited

Sertraline RIA 100 mg, filmomhulde tabletten

Sertraline

100 mg

Film-coated tablet

Oral use

The Netherlands

Mylan B.V.

Zolmitriptan Mylan 2,5  mg, orodispergeerbare tabletten

Zolmitriptan

2,5  mg

Orodispersible tablet

Oral use

The Netherlands

Mylan B.V.

Zolmitriptan Mylan 5 mg, orodispergeerbare tabletten

Zolmitriptan

5 mg

Orodispersible tablet

Oral use

United Kingdom (Northern Ireland)

Strandhaven Limited

Amlodipine 5 mg Tablets

Amlodipine

5 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Strandhaven Limited

Amlodipine 10 mg Tablets

Amlodipine

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Wockhardt UK Limited

Amlodipine 5 mg Tablets

Amlodipine

5 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Wockhardt UK Limited

Amlodipine 10 mg Tablets

Amlodipine

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Accord Healthcare Limited

Amoxicillin 250 mg Capsules

Amoxicillin

250 mg

Capsule, hard

Oral use

United Kingdom (Northern Ireland)

Accord Healthcare Limited

Amoxicillin 500 mg Capsules

Amoxicillin

500 mg

Capsule, hard

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Amoxicillin 250 mg Capsules

Amoxicillin

250 mg

Capsule, hard

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Amoxicillin 500 mg Capsules

Amoxicillin

500 mg

Capsule, hard

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Co-Amoxiclav 250/62.5 mg Powder for Oral Suspension

Amoxicillin/ clavulanic acid

250 mg/62,5  mg

Powder for oral suspension

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Co-Amoxiclav 457/5 ml Suspension

Amoxicillin/ clavulanic acid

457 mg/5 ml

Powder for oral suspension

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Co-Amoxiclav 500/125 mg Tablets

Amoxicillin/ clavulanic acid

500 mg/125 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Generics Ltd

Atorvastatine Mylan

Atorvastatin

10 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Generics Ltd

Atorvastatine Mylan

Atorvastatin

20 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Generics Ltd

Atorvastatine Mylan

Atorvastatin

40 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Generics Ltd

Atorvastatine Mylan

Atorvastatin

80 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Wockhardt UK Limited

Atorvastatin 80 mg film-coated Tablets

Atorvastatin

80 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Wockhardt UK Limited

Atorvastatin 10 mg film-coated Tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Wockhardt UK Limited

Atorvastatin 20 mg film-coated Tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Wockhardt UK Limited

Atorvastatin 40 mg film-coated Tablets

Atorvastatin

40 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Amarox Limited

Atorvastatin 10 mg film-coated Tablets

Atorvastatin

10 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Amarox Limited

Atorvastatin 20 mg film-coated Tablets

Atorvastatin

20 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Amarox Limited

Atorvastatin 40 mg film-coated Tablets

Atorvastatin

40 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Amarox Limited

Atorvastatin 80 mg film-coated Tablets

Atorvastatin

80 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Morningside Healthcare Limited

Clonidine hydrochloride 25 microgram Tablets

Clonidine

25 mcg

Tablet

Oral use

United Kingdom (Northern Ireland)

Generics Limited

Efavirenz 600 mg film-coated Tablets

Efavirenz

600 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Ethambutol 100 mg film-coated Tablets

Ethambutol

100 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Ethambutol 400 mg film-coated Tablets

Ethambutol

400 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Abdi Farma Unipessoal Limitada

Etolyn 600 mg Prolonged-Release Tablets

Etodolac

600 mg

Prolonged-release tablet

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Flucloxacillin 250 mg Capsules

Flucloxacillin

250 mg

Capsule, hard

Oral use

United Kingdom (Northern Ireland)

Medreich PLC

Flucloxacillin 500 mg Capsules

Flucloxacillin

500 mg

Capsule, hard

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Gliclazide 30 mg Prolonged-Release Tablets

Gliclazide

30 mg

Prolonged-release tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Gliclazide 40 mg Prolonged-Release Tablets

Gliclazide

40 mg

Prolonged-release tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Gliclazide 60 mg Prolonged-Release Tablets

Gliclazide

60 mg

Prolonged-release tablet

Oral use

United Kingdom (Northern Ireland)

Blackrock Pharmaceuticals Limited

Hydrocortisone 10 mg Tablets

Hydrocortisone

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Blackrock Pharmaceuticals Limited

Hydrocortisone 20 mg Tablets

Hydrocortisone

20 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Silicon Pharma Limited

Hydrocortisone 10 mg Tablets

Hydrocortisone

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Silicon Pharma Limited

Hydrocortisone 20 mg Tablets

Hydrocortisone

20 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Strides Pharma UK Limited

Ibuprofen 200 mg film-coated Tablets

Ibuprofen

200 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Strides Pharma UK Limited

Ibuprofen 400 mg film-coated Tablets

Ibuprofen

400 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Strides Pharma UK Limited

Ibuprofen 600 mg film-coated Tablets

Ibuprofen

600 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Socium Pharma B.V.

Ibuprofen/Pseudoephadrine HCl 200/30 mg Capsules, soft

Ibuprofen/pseudoephedrine

200 mg/30 mg

Capsule, soft

Oral use

United Kingdom (Northern Ireland)

Strides Pharma UK Limited

Liothyronine sodium 5 microgram Tablets

Liothyronine

5 mcg

Tablet

Oral use

United Kingdom (Northern Ireland)

Strides Pharma UK Limited

Liothyronine sodium 20 microgram Tablets

Liothyronine

20 mcg

Tablet

Oral use

United Kingdom (Northern Ireland)

Zentiva Pharma UK Limited

Memantine hydrochloride 5 mg + 10 mg + 15 mg + 20 mg Soluble Tablets

Memantine

5 mg + 10 mg + 15 mg + 20 mg

Soluble tablet

Oral use

United Kingdom (Northern Ireland)

Zentiva Pharma UK Limited

Memantine hydrochloride 10 mg Soluble Tablets

Memantine

10 mg

Soluble tablet

Oral use

United Kingdom (Northern Ireland)

Zentiva Pharma UK Limited

Memantine hydrochloride 20 mg Soluble Tablets

Memantine

20 mg

Soluble tablet

Oral use

United Kingdom (Northern Ireland)

Colonis Pharma Limited

Metformin Colonis 500mg/5ml Oral Solution

Metformin

500 mg

Oral solution

Oral use

United Kingdom (Northern Ireland)

Colonis Pharma Limited

Metformin Colonis 850mg/5ml Oral Solution

Metformin

850 mg

Oral solution

Oral use

United Kingdom (Northern Ireland)

Colonis Pharma Limited

Metformin Colonis 1 000  mg/5ml Oral Solution

Metformin

1 000  mg/5 ml

Oral solution

Oral use

United Kingdom (Northern Ireland)

Mercury Pharmaceuticals Limited

Nebivolol 2.5 mg Tablets

Nebivolol

2,5  mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Mercury Pharmaceuticals Limited

Nebivolol 5 mg Tablets

Nebivolol

5 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Nefopam hydrochloride 30 mg film-coated Tablets

Nefopam

30 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Nefopam hydrochloride 30 mg film-coated Tablets

Nefopam

30 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Zentiva Pharma UK Limited

Nevirapine Amneal 400 mg Prolonged-Release Tablets

Nevirapine

400 mg

Prolonged-Release Tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Nortriptyline 10 mg Tablets

Nortriptyline

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Nortriptyline 25 mg Tablets

Nortriptyline

25 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Nortriptyline 10 mg Tablets

Nortriptyline

10 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Nortriptyline 25 mg Tablets

Nortriptyline

25 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Pharmamatch B.V.

Paracetamol 500 mg Capsules, soft

Paracetamol

500 mg

Capsule, soft

Oral use

United Kingdom (Northern Ireland)

Interdos Pharma B.V.

Paracetamol/Ibuprofen interdos 500/200 mg Caspules, soft

Paracetamol/Ibuprofen

500 mg / 200 mg

Capsule, soft

Oral use

United Kingdom (Northern Ireland)

Pharmamatch B.V.

Paracetamol/Ibuprofen 500/200 mg Caspules, soft

Paracetamol/Ibuprofen

500 mg / 200 mg

Capsule, soft

Oral use

United Kingdom (Northern Ireland)

Generics Limited

Pioglitazone 15 mg Tablets

Pioglitazone

15 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Generics Limited

Pioglitazone 30 mg Tablets

Pioglitazone

30 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Generics Limited

Pioglitazone 45 mg Tablets

Pioglitazone

45 mg

Tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Rosuvastatin 10 mg film-coated Tablets

Rosuvastatin

10 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Rosuvastatin 20 mg film-coated Tablets

Rosuvastatin

20 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Brown & Burk UK Limited

Rosuvastatin 40 mg film-coated Tablets

Rosuvastatin

40 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Sertraline 50 mg film-coated Tablets

Sertraline

50 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

RIA Generics Limited

Sertraline 100 mg film-coated Tablets

Sertraline

100 mg

Film-coated tablet

Oral use

United Kingdom (Northern Ireland)

Generics Limited

Zolmitriptan 2.5 mg Orodispersible Tablets

Zolmitriptan

2,5  mg

Orodispersible tablet

Oral use

United Kingdom (Northern Ireland)

Generics Limited

Zolmitriptan 5 mg Orodispersible Tablets

Zolmitriptan

5 mg

Orodispersible tablet

Oral use

United Kingdom (Northern Ireland)

Athlone Pharmaceuticals Limited

Zopiclone 7.5 mg Tablets

Zopiclone

7,5  mg

Tablet

Oral use

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