# Official Journal C 311/2013

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2013.311.eng |
| --- | --- |
| Official Journal
  of the European Union | C 311 |
| | |
| English edition | Information and Notices | Volume 5625 October 2013 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2013.311.eng

Official Journal

of the European Union

C 311

English edition

Information and Notices

Volume 5625 October 2013

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2013/C 311/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2013/C 311/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2013/C 311/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2013/C 311/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

8

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.10.2013 | EN | Official Journal of the European Union | C 311/1 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

C 311/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

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

2013/C 311/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.9.2013 | Procysbi | mercaptamine (cysteamine bitartrate) | Raptor Pharmaceuticals Europe BV |
| Naritaweg 165, NL-1043 BW Amsterdam, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.9.2013

Procysbi

mercaptamine (cysteamine bitartrate)

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/13/861

Gastro-resistant capsule, hard

A16AA04

10.9.2013

6.9.2013

Provenge

Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T)

| Dendreon UK Limited |
| --- |
| 41 Chalton Street, London NW1 1JD, United Kingdom |

Dendreon UK Limited

41 Chalton Street, London NW1 1JD, United Kingdom

EU/1/13/867

Dispersion for infusion

L03AX17

10.9.2013

10.9.2013

Inflectra

Infliximab

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/13/854

powder for concentrate for solution for infusion

L04AB02

12.9.2013

10.9.2013

Remsima

Infliximab

| Celltrion Healthcare Hungary Kft. |
| --- |
| Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország

EU/1/13/853

powder for concentrate for solution for infusion

L04AB02

12.9.2013

12.9.2013

Lemtrada

Alemtuzumab

| Genzyme Therapeutics Ltd |
| --- |
| 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom |

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

Concentrate for solution for infusion

Pending

16.9.2013

12.9.2013

Orphacol

Cholic acid

| Laboratoires CTRS (Cell Therapies Research & Services) |
| --- |
| 69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France |

Laboratoires CTRS (Cell Therapies Research & Services)

69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France

EU/1/13/870

Capsule, hard

A05AA03

16.9.2013

19.9.2013

Incresync

alogliptin / pioglitazone

| Takeda Pharma A/S |
| --- |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark |

Takeda Pharma A/S

PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/13/842

Film-coated tablet

A10BD09

23.9.2013

19.9.2013

Tybost

cobicistat

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/872

Film-coated tablet

V03AX03

23.9.2013

19.9.2013

Ultibro Breezhaler

indacaterol/glycopyrronium bromide

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/13/862

Inhalation powder, hard capsule

R03AL04

23.9.2013

19.9.2013

Vipdomet

alogliptin / metformin

| Takeda Pharma A/S |
| --- |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark |

Takeda Pharma A/S

PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/13/843

Film-coated tablet

A10BD13

23.9.2013

19.9.2013

Vipidia

alogliptin

| Takeda Pharma A/S |
| --- |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark |

Takeda Pharma A/S

PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/13/844

Film-coated tablet

A10BH04

23.9.2013

19.9.2013

Xoterna Breezhaler

indacaterol/glycopyrronium bromide

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/13/863

Inhalation powder, hard capsule

R03AL04

23.9.2013

25.9.2013

EVARREST

Human fibrinogen/Human thrombin

| Omrix Biopharmaceuticals N.V. |
| --- |
| Leonardo Da Vincilaan 15, B-1831 Diegem, België |

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/13/868

Sealant matrix

B02BC30

27.9.2013

25.9.2013

Giotrif

afatinib

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

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/13/879

Film-coated tablet

L01XE13

27.9.2013

25.9.2013

Imatinib Medac

Imatinib

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstr. 6, D-22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/13/876

Capsule, hard

L01XE01

27.9.2013

27.9.2013

Ovaleap

Follitropin alfa

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/13/871

Solution for injection

G03GA05

1.10.2013

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.9.2013 | Labazenit | LABORATOIRES SMB SA |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.9.2013

Labazenit

LABORATOIRES SMB SA

26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België

—

10.9.2013

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Neulasta | Amgen Europe B.V. |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2013

Neulasta

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227

5.9.2013

3.9.2013

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

5.9.2013

3.9.2013

Vibativ

| Clinigen Healthcare Limited |
| --- |
| Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/11/705

5.9.2013

3.9.2013

Victrelis

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/11/704

5.9.2013

3.9.2013

Xeplion

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/672

5.9.2013

5.9.2013

Mepact

| Takeda France SAS |
| --- |
| Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France |

Takeda France SAS

Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France

EU/1/08/502

9.9.2013

9.9.2013

IDflu

| Sanofi Pasteur SA |
| --- |
| 2 avenue Pont Pasteur, F-69007 Lyon, France |

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

10.9.2013

9.9.2013

Intanza

| Sanofi Pasteur MSD, SNC |
| --- |
| 8 rue Jonas Salk, F-69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk, F-69007 Lyon, France

EU/1/08/505

10.9.2013

12.9.2013

Cystagon

| Orphan Europe S.A.R.L. |
| --- |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |

Orphan Europe S.A.R.L.

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

EU/1/97/039

16.9.2013

12.9.2013

Puregon

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/96/008

16.9.2013

19.9.2013

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/06/365

23.9.2013

19.9.2013

Elonva

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/09/609

23.9.2013

19.9.2013

Insuman

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

23.9.2013

19.9.2013

NexoBrid

| MediWound Germany GmbH |
| --- |
| Eisenstr. 5, D-65428 Ruesselsheim, Deutschland |

MediWound Germany GmbH

Eisenstr. 5, D-65428 Ruesselsheim, Deutschland

EU/1/12/803

23.9.2013

19.9.2013

Orgalutran

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/00/130

23.9.2013

19.9.2013

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

23.9.2013

19.9.2013

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

23.9.2013

19.9.2013

Revolade

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

EU/1/10/612

23.9.2013

19.9.2013

Savene

| Norgine B.V. |
| --- |
| Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland |

Norgine B.V.

Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland

EU/1/06/350

23.9.2013

19.9.2013

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

23.9.2013

19.9.2013

Stelara

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

23.9.2013

24.9.2013

Intanza

| Sanofi Pasteur MSD, SNC |
| --- |
| 8 rue Jonas Salk, F-69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8 rue Jonas Salk, F-69007 Lyon, France

EU/1/08/505

26.9.2013

24.9.2013

TOBI Podhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/10/652

26.9.2013

25.9.2013

IDflu

| Sanofi Pasteur SA |
| --- |
| 2 avenue Pont Pasteur, F-69007 Lyon, France |

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

27.9.2013

25.9.2013

Multaq

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

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/09/591

27.9.2013

25.9.2013

Resolor

| Shire Pharmaceuticals Ireland Limited |
| --- |
| 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/09/581

27.9.2013

25.9.2013

RoActemra

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/08/492

30.9.2013

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Rasitrio | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2013

Rasitrio

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/730

5.9.2013

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.9.2013 | Apoquel | Oclacitinib maleate | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

12.9.2013

Apoquel

Oclacitinib maleate

Zoetis Belgium S.A.

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

EU/2/13/154

Film-coated tablet

QD11AH90

16.9.2013

19.9.2013

Trifexis

Spinosad / Milbemycin oxime

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |

Eli Lilly and Company Ltd

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

EU/2/13/155

Chewable tablet

QP54AB51

23.9.2013

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 12.9.2013 | Equip WNV | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

12.9.2013

Equip WNV

Zoetis Belgium S.A.

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

EU/2/08/086

16.9.2013

13.9.2013

Zulvac 8 Bovis

| 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/2/09/105

17.9.2013

13.9.2013

Zulvac 8 Ovis

| 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/2/09/104

17.9.2013

24.9.2013

Masivet

| AB Science S.A. |
| --- |
| 3 avenue George V, F-75008 Paris, France |

AB Science S.A.

3 avenue George V, F-75008 Paris, France

EU/2/08/087

26.9.2013

25.9.2013

Melovem

Dopharma Research B.V.

Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland

EU/2/09/098

27.9.2013

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 19.9.2013 | Netvax | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

19.9.2013

Netvax

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/09/093

23.9.2013

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK-LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK-LONDON E14 4H

---

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

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

---

| 25.10.2013 | EN | Official Journal of the European Union | C 311/8 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

C 311/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

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

2013/C 311/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 5.9.2013 | Okrido | See Annex I | See Annex I | 6.9.2013 |
| 24.9.2013 | Deltanil | See Annex II | See Annex II | 26.9.2013 |
| 13.9.2013 | Iron | See Annex III | See Annex III | 16.9.2013 |
| 18.9.2013 | Aprotinin | See Annex IV | See Annex IV | 19.9.2013 |
| 25.9.2013 | Cydectin | See Annex V | See Annex V | 26.9.2013 |
| 12.9.2013 | Targocid | See Annex VI | See Annex VI | 13.9.2013 |
| 5.9.2013 | Flupirtine | See Annex VII | See Annex VII | 6.9.2013 |
| 6.9.2013 | Doramectin | See Annex VIII | See Annex VIII | 9.9.2013 |
| 25.9.2013 | Diclofenac | See Annex IX | See Annex IX | 26.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | See Annex X | See Annex X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | See Annex XI | See Annex XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | See Annex XII | See Annex XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | See Annex XIII | See Annex XIII | 30.9.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

5.9.2013

Okrido

See Annex I

See Annex I

6.9.2013

24.9.2013

Deltanil

See Annex II

See Annex II

26.9.2013

13.9.2013

Iron

See Annex III

See Annex III

16.9.2013

18.9.2013

Aprotinin

See Annex IV

See Annex IV

19.9.2013

25.9.2013

Cydectin

See Annex V

See Annex V

26.9.2013

12.9.2013

Targocid

See Annex VI

See Annex VI

13.9.2013

5.9.2013

Flupirtine

See Annex VII

See Annex VII

6.9.2013

6.9.2013

Doramectin

See Annex VIII

See Annex VIII

9.9.2013

25.9.2013

Diclofenac

See Annex IX

See Annex IX

26.9.2013

27.9.2013

Ergot derivatives (dihydroergocristine)

See Annex X

See Annex X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

See Annex XI

See Annex XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

See Annex XII

See Annex XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

See Annex XIII

See Annex XIII

30.9.2013

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | See Annex X | See Annex X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | See Annex XI | See Annex XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | See Annex XII | See Annex XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | See Annex XIII | See Annex XIII | 30.9.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

27.9.2013

Ergot derivatives (dihydroergocristine)

See Annex X

See Annex X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

See Annex XI

See Annex XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

See Annex XII

See Annex XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

See Annex XIII

See Annex XIII

30.9.2013

—   Lift of suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 18.9.2013 | Aprotinin | See Annex IV | See Annex IV | 19.9.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.9.2013

Aprotinin

See Annex IV

See Annex IV

19.9.2013

---

(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Applicant | Invented name / Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Germany | | Pharmapol Arzneimittelvertrieb-GmbH, |
| Kaddenbusch 11, 25578 Daegeling, |
| Germany |

Member State

EU/EEA

Marketing authorisation holder

Applicant

Invented name / Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Germany

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Oral Solution

Oral use

Netherlands

| Pharmapol Arzneimittelvertrieb-GmbH, |
| --- |
| Kaddenbusch 11, 25578 Daegeling, |
| Germany |

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Oral Solution

Oral use

United Kingdom

| Pharmapol Arzneimittelvertrieb-GmbH, |
| --- |
| Kaddenbusch 11, 25578 Daegeling, |
| Germany |

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Oral Solution

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State EU/EEA | Applicant | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Virbac |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Member State EU/EEA

Applicant

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Belgium

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Solution pour-on pour bovins et ovins

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Belgium

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Bulgaria

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Делтанил 10 мг/мл пур он разтвор, предназначен за говеда и овце.

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Cyprus

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Czech Republic

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml pour-on roztok pro aplikaci na kůži skotu a ovcí

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Denmark

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on opløsning til kvæg og får

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Estonia

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, kriipsususpensioon veistele ja lammastele

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

France

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Solution pour-on pour bovins et ovins

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

France

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Germany

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Germany

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Lösung zum Auftropfen für Rinder

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Greece

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Hungary

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on szarvasmarha és juh részére

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Iceland

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml áhella, lausn fyrir nautgripi og sauöfé

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Ireland

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Solution for cattle and sheep

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Italy

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml soluzione Pour-on per bovini ed ovini

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Latvia

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, šķīdums uzliešanai uz muguras liellopiem un aitām

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Lithuania

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, užpilamasis tirpalas galvijams ir avims

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Luxembourg

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Solution pour-on pour bovins et ovins

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

The Netherlands

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Oplossing voor runderen en schapen

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

The Netherlands

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Oplossing voor runderen

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Poland

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10mg/ml, roztwór do polewania dla bydła i owiec

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Portugal

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml solução Spot- on para bovinos e ovinos

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Romania

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml soluție pour-on pentru bovine și ovine

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Slovakia

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

DELTANIL 10 mg/ml Pour-on roztok pre hovädzí dobytok a ovce

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Slovenia

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml raztopina za kožni poliv za govedo in ovce

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Spain

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml solución pour-on para bovino y ovino

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

United Kingdom

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Solution for cattle and sheep

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

United Kingdom

| Virbac |
| --- |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Solution for cattle

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pharmacosmos A/S |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Austria

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

Austria

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| DE-58638 Iserlohn |
| Germany |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Injektions- oder Infusionslösung

100 mg/ml

Solution for injection/infusion

Intravenous use

Austria

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml - Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

Injectafer

50 mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

| Pharmalog AG, |
| --- |
| 33 Cherni vrah blvd., |
| 1421 Sofia |
| Bulgaria |

Pharmalog AG,

33 Cherni vrah blvd.,

1421 Sofia

Bulgaria

Iron sucrose complex

Idafer

20 mg/ml

Solution for injection

Intravenous use

Bulgaria

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection

Intravenous use

Bulgaria

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

| The Star Medicines Importers & co ltd, |
| --- |
| 9A Loukis Akritas Street, |
| P.O.box 50151, |
| 3601 Lemesos, |
| Cyprus |

The Star Medicines Importers & co ltd,

9A Loukis Akritas Street,

P.O.box 50151,

3601 Lemesos,

Cyprus

Iron sucrose complex

VENOFER INJECTION 100 MG IRON/5 ML

100 mg/5 ml

Solution for injection

Intravenous use

Cyprus

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML

20 mg/ml

Solution for injection/infusion

Intravenous use

Czech Republic

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Czech Republic

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

| PHARMABIDE LTD |
| --- |
| 20, Lakonias str, 15234 Halandri |
| Athens - |
| Greece |

PHARMABIDE LTD

20, Lakonias str, 15234 Halandri

Athens -

Greece

Iron sucrose complex

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

| Orion Corporation, |
| --- |
| Orionintie 1, |
| FI-02200 Espoo, |
| Finland |

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

FERION 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

| Sanofi-Aventis, s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

Sanofi-Aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

sodium ferric gluconate complex

FERRLECIT

12,5 mg/ml

Solution for injection

Intravenous use

Czech Republic

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

| Orion Corporation, |
| --- |
| Orionintie 1, |
| FI-02200 Espoo, |
| Finland |

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Jerndextran "Pharmacosmos"

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer

100 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

| Orion Corporation, |
| --- |
| Orionintie 1, |
| FI-02200 Espoo, |
| Finland |

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Estonia

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Estonia

| Lek Pharmaceuticals d.d. |
| --- |
| Verovškova 57 |
| 1526 Ljubljana |
| Slovenia |

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Iron (III)-hydroxide dextran complex

Ferrum Lek

50 mg/ml

Solution for injection

Intramuscular use

Finland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

| Alternova A/S |
| --- |
| Lodshusvej 11 |
| 4230 Skaelskoer |
| Denmark |

Alternova A/S

Lodshusvej 11

4230 Skaelskoer

Denmark

Iron sucrose complex

Venotrix

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Finland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

France

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

FERINJECT 50 mg/ml, solution injectable/pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml, solution injectable

20 mg/ml

Solution for injection

Intravenous use

France

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

FERRISAT 50 mg/ml, solution injectable ou pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

| Pharmaki Generics Ltd |
| --- |
| 5 Bourlet Close |
| W1W 7BL London |
| United Kingdom |

Pharmaki Generics Ltd

5 Bourlet Close

W1W 7BL London

United Kingdom

Iron sucrose complex

FER ACTAVIS 100 mg/5 ml, solution injectable

100 mg/5 ml

Solution for injection

Intravenous use

France

| IBD3 Pharma Consulting |
| --- |
| Immeuble l'Orient |
| 10, place Charles Béraudier |
| 69003 Lyon |
| France |

IBD3 Pharma Consulting

Immeuble l'Orient

10, place Charles Béraudier

69003 Lyon

France

Iron sucrose complex

FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

| Mylan SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

Iron sucrose complex

FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Iron sucrose complex

FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| FRANCE |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

FRANCE

Iron sucrose complex

FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)

100 mg/5 ml

Solution for injection

Intravenous use

Germany

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung/ Konzentrat zur Herstellung einer Infusionslösung

1 709 mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| DE-58638 Iserlohn |
| Germany |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed

1 563 - 1 887 mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| DE-58638 Iserlohn |
| Germany |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Nefro-Fer

1 563 - 1 887 mg/5 ml

Solution for injection

Intravenous use

Germany

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Lösung zur Injektion/Infusion

377-465 mg/ml

Solution for injection/infusion

Intravenous use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50, |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

sodium ferric gluconate complex

Ferrlecit 40 mg

1 288,9 mg/3.2 ml

Solution for injection

Intravenous use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50, |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

sodium ferric gluconate complex

Ferrlecit 62,5 mg

2 013,9 mg/5 ml

Solution for injection

Intravenous use

Germany

| Pharmacosmos A/S |
| --- |
| Roervangsvei 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvei 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Germany

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose complex

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung

180 mg/ml

Solution for injection/infusion

Intravenous use

Germany

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg FR / ml Injektionslösung

2 700 mg/5ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Greece

| Medicus SA |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis 14452 |
| Greece |

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron sucrose complex

REOXYL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| Nea Erythrea 14671 |
| Greece |

Vianex S.A.

Tatoiou Street

Nea Erythrea 14671

Greece

Iron sucrose complex

INTRAFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Alapis ABEE |
| --- |
| Aftokratoros Nikolaou 2 |
| Athens 17671 |
| Greece |

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Iron sucrose complex

FAREMIO

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Intermed ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Iron sucrose complex

DEXTRIFER-S

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Demo ABEE |
| --- |
| 21ST Km National Highway |
| Athens-Lamia, 14565 |
| Greece |

Demo ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Iron (III) hydroxide dextran

COSMOFER

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

| Rafarm AEBE |
| --- |
| Korinthou 12, |
| N. Psychiko, 15451 |
| Greece |

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Iron sucrose complex

FERROVIN

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Nephrotech S.A. |
| --- |
| Parnithos 44 |
| Metamorfosi Attikis 14452 |
| Greece |

Nephrotech S.A.

Parnithos 44

Metamorfosi Attikis 14452

Greece

Iron sucrose complex

SUCRO-FER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Uni-Pharma Kleon Tseitis |
| --- |
| Pharmaceutical Laboratories |
| 14KM National Highway |
| Athens-Lamia |
| Kifissia 14564 |
| Greece |

Uni-Pharma Kleon Tseitis

Pharmaceutical Laboratories

14KM National Highway

Athens-Lamia

Kifissia 14564

Greece

Iron sucrose complex

HEMAFER-S

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

| Verisfield (UK) Ltd, U.K. |
| --- |
| 41 Chalton street |
| London, NW1 1JD |
| United Kingdom |

Verisfield (UK) Ltd, U.K.

41 Chalton street

London, NW1 1JD

United Kingdom

Iron sucrose complex

NEPHROFEROL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron sucrose complex

FERRINEMIA

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| Specifar AEBE |
| --- |
| 28th October Street 1 |
| Agia Barbara 12351 |
| Greece |

Specifar AEBE

28th October Street 1

Agia Barbara 12351

Greece

Iron sucrose complex

ALVOFER

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

| Alet Pharmaceuticals |
| --- |
| M. Alexander 121, |
| Agia Varvara, 12351 |
| Greece |

Alet Pharmaceuticals

M. Alexander 121,

Agia Varvara, 12351

Greece

Iron sucrose complex

SUCROVEN

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

| Target Pharma Ltd |
| --- |
| Menandrou 54 |
| Athens 10431 |
| Greece |

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Iron sucrose complex

IRONCROSE

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron(III)-hydroxide dextran complex

IRONATE

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

| Demo ABEE |
| --- |
| 21st km National Highway |
| Athens-Lamia, 14565 |
| Greece |

Demo ABEE

21st km National Highway

Athens-Lamia, 14565

Greece

Iron(III) isomaltoside complex

MONOFER

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

| Viofar EPE |
| --- |
| Ethnikis Antistaseos & Trifyllias, |
| Aharnai, 13671 |
| Greece |

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Iron sucrose complex

VENIRON

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

| Medicus SA |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis 14452 |
| Greece |

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron(III)-hydroxide dextran complex

IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Hungary

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

| Sanofi-Aventis Zrt |
| --- |
| Tó utca 1-5, |
| 1045 Budapest |
| Hungary |

Sanofi-Aventis Zrt

Tó utca 1-5,

1045 Budapest

Hungary

Sodium ferric gluconate complex

Ferrlecit

12,5 mg/ml

Solution for injection

Intravenous use

Iceland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Iceland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for infusion

Intravenous use

Iceland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Ireland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml solution for infusion and injection

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (ampoules)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (vials)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Ireland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex)

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial

20 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Intravenous use

Italy

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Italy

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERRO SACCARATO FME

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Italy

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Italy

| Sanofi-Aventis SPA |
| --- |
| Viale Luigi Bodio, 37/B |
| 20158 Milano |
| Italy |

Sanofi-Aventis SPA

Viale Luigi Bodio, 37/B

20158 Milano

Italy

sodium ferric gluconate complex

FERLIXIT

62,5 mg/5 ml

Oral solution or solution for infusion

Oral use

Intravenous use

Latvia

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Latvia

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Latvia

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Latvia

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Latvia

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Lithuania

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Lithuania

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Luxembourg

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Injectafer-50 mg/l

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer-50 mg/ml

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| DE-58638 Iserlohn |
| Germany |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Fermed-100 mg/5 ml

100 mg/5 ml

Solution for perfusion

Intravenous use

Luxembourg

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic-20 mg/ml

20 mg/ml

Solution for perfusion

Intravenous use

Malta

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Malta

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex.

Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Norway

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

| Orion Corporation, |
| --- |
| Orionintie 1, |
| FI-02200 Espoo, |
| Finland |

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Parenteral use

Norway

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Uniferon

200 mg/ml

Solution for injection

Parenteral use

Norway

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Poland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

Poland

| VIFOR France SA |
| --- |
| 123 Rue Jules Guesde |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Poland

| VIFOR France SA |
| --- |
| 123 Rue Jules Guesde |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Poland

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| 61346 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Iron(III) isomaltoside complex

Ferrum-Lek

50 mg/ml

Solution for injection

Intramuscular use

Poland

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Referen

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

| Vifor France, SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

| Combino Pharm Portugal, Unipessoal, Lda. |
| --- |
| Lagoas Park |
| Edifício 8 |
| Piso 0 2740-268 Porto Salvo |
| Portugal |

Combino Pharm Portugal, Unipessoal, Lda.

Lagoas Park

Edifício 8

Piso 0 2740-268 Porto Salvo

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Combino

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2, |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2,

Abrunheira

2710-089 Sintra

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Farmoz

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| Portugal |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Generis

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

| Laboratórios Normon, S.A. |
| --- |
| Rua Armando Villar, |
| Lote 42 1o Dto. Quinta das Patinhas, Cobre |
| 2750 - 777 Cascais |
| Portugal |

Laboratórios Normon, S.A.

Rua Armando Villar,

Lote 42 1o Dto. Quinta das Patinhas, Cobre

2750 - 777 Cascais

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Normon

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

| Vifor France, SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Portugal

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Monofar

100 mg/ml

Solution for injection/infusion

Intravenous use

Romania

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER®

20 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER 100 mg/ml

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg fer/ml

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Slovak Republic

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovak Republic

| Orion Corporation, |
| --- |
| Orionintie 1, |
| FI-02200 Espoo, |
| Finland |

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Slovenia

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovenia

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

carboxymaltose

Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovenia

| Lek farmacevtska družba d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| Slovenia |

Lek farmacevtska družba d.d.,

Verovškova 57,

1000 Ljubljana

Slovenia

Iron sucrose complex

Venofer 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

intramuscular use

Spain

| GUERBET B.P. |
| --- |
| 57400 ROISSY CdG |
| CEDEX F-95943 |
| France |

GUERBET B.P.

57400 ROISSY CdG

CEDEX F-95943

France

Iron sucrose complex

ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION

11,2 mg/ml

Concentrate for suspension for infusion

Intravenous use

Spain

| G.E.S. Genericos Espanoles Laboratorio |
| --- |
| S.A.Cólquide, 6 - Portal 2, 1 |
| Oficina F.Las Rozas |
| 28230 MADRID |
| Spain |

G.E.S. Genericos Espanoles Laboratorio

S.A.Cólquide, 6 - Portal 2, 1

Oficina F.Las Rozas

28230 MADRID

Spain

Iron sucrose complex

FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61346 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

| Laboratorios Normon S.A. |
| --- |
| Ronda de Valdecarrizo 6 |
| 28760 Tres Cantos |
| Madrid |
| Spain |

Laboratorios Normon S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos

Madrid

Spain

Iron sucrose complex

HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| DE-58638 Iserlohn |
| Germany |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FERMED 100 mg/ 5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Spain

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN

100 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Sweden

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer®

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer®

50 mg/ml

Solution for injection

Intravenous use

Sweden

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92200 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Sweden

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61346 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

| Orion Corporation, |
| --- |
| Orionintie 1, |
| FI-02200 Espoo, |
| Finland |

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer®

100 mg/ml

Solution for injection

Intravenous use

The Netherlands

| Pharmamatch B.V. |
| --- |
| Egelenburg 2 |
| Amsterdam GK - 1081 |
| The Netherlands |

Pharmamatch B.V.

Egelenburg 2

Amsterdam GK - 1081

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer 100 mg/ml oplossing voor injectie/infusie

100 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg ijzer/ ml, oplossing voor injectie/infusie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml oplossing voor infusie en injectie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Haarlem - 2031 GA |
| The Netherlands |

Pharmachemie B.V.

Haarlem - 2031 GA

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Diafer

50 mg/ml

Solution for injection

Intravenous use

United Kingdom

| Pharmacosmos A/S |
| --- |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

United Kingdom

| Fresenius Medical Care Nephrologica Deutschland GmbH |
| --- |
| Else-Kröner-Strasse 1 |
| 61352 Bad Homburg |
| Germany |

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

| VIFOR France SA |
| --- |
| 7-13 Boulevard Paul Emile Victor |
| 92521 Neuilly-sur-Seine |
| France |

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

---

ANNEX IV

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Aprotinin containing medicinal products with Marketing Authorisation in the European Union

| Member State
  (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Bayer Austria GmbH |
| Herbststraße 6-10 |
| A-1160 Wien |
| Austria |

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Austria

Trasylol 10 000 KIE/ml - Infusionsflasche

10 000 KIU/ml

solution for infusion

intravenous use

BE-Belgium

| Belgium Bayer S.A. |
| --- |
| 14, J.E. Mommaertslaan |
| B- 1831 Diegem |
| Belgium |

Belgium Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

Belgium

Trasylol

10 000 KIU/ml

solution for infusion

intravenous use

CZ - Czech Republic

| Chemical Works of Gedeon Richter Plc., |
| --- |
| HU-1103 Budapest, |
| Gyömrői út 19-21., |
| Hungary |

Chemical Works of Gedeon Richter Plc.,

HU-1103 Budapest,

Gyömrői út 19-21.,

Hungary

Gordox

10 ku/ml

solution for injection

intravenous use

CZ - Czech Republic

| Bayer Schering Pharma AG |
| --- |
| Mullerstrasse 178 |
| 13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Mullerstrasse 178

13353 Berlin

Germany

Trasylol 500 000 KIE

10 ku/ml

solution for infusion

intravenous use

DE - Germany

Bayer Pharma Aktiengesellschaft

registered business address:

| Müllerstr. 178 |
| --- |
| D-13353 Berlin |
| postal address: |
| D-13342 Berlin |

Müllerstr. 178

D-13353 Berlin

postal address:

D-13342 Berlin

Trasynin 0,5

70,0 mg /50 ml

solution for infusion

intravenous use

DE - Germany

Bayer Pharma Aktiengesellschaft

registered business address:

| Müllerstr. 178 |
| --- |
| D-13353 Berlin |
| postal address: |
| D-13342 Berlin |

Müllerstr. 178

D-13353 Berlin

postal address:

D-13342 Berlin

Trasynin 1,0

140,0 mg /100 ml

solution for infusion

intravenous use

DE - Germany

Bayer Pharma Aktiengesellschaft

registered business address:

| Müllerstr. 78 |
| --- |
| D-13353 Berlin |
| postal address: |
| D-13342 Berlin |

Müllerstr. 78

D-13353 Berlin

postal address:

D-13342 Berlin

Trasynin 2,0

280,0 mg /200 ml

solution for infusion

intravenous use

DE - Germany

| Bayer Vital GmbH |
| --- |
| D-51373 Leverkusen |

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 0,5

70,0 mg /50 ml

solution for infusion

intravenous use

DE - Germany

| Bayer Vital GmbH |
| --- |
| D-51373 Leverkusen |

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 1,0

140,0 mg /100 ml

solution for infusion

intravenous use

DE - Germany

| Bayer Vital GmbH |
| --- |
| D-51373 Leverkusen |

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 2,0

280,0 mg /200 ml

solution for infusion

intravenous use

DK - Denmark

| Bayer Schering Pharma AG, |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin, |
| Germany |

Bayer Schering Pharma AG,

Müllerstrasse 170-178,

DE-13342 Berlin,

Germany

Trasylol

10 000 KIE/ml

solution for injection

intravenous use

EL - Greece

| Bayer Hellas AG |
| --- |
| 18 - 20, Sorou Str. |
| 151 25, Marousi - Athens |

Bayer Hellas AG

18 - 20, Sorou Str.

151 25, Marousi - Athens

TRASYLOL

500 000 KIU/50ML

solution for infusion

intravenous use

ES - Spain

| QUIMICA FARMACEUTICA BAYER, S.L |
| --- |
| Av. Baix Llobregat, 3-5 |
| 08970 Sant Joan Despi |
| Barcelona - España |

QUIMICA FARMACEUTICA BAYER, S.L

Av. Baix Llobregat, 3-5

08970 Sant Joan Despi

Barcelona - España

TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA

10 000 K 10 000 KIU/ml IU/ml

solution for perfusion

intravenous use

FI - Finland

| Bayer HealthCare AG, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer HealthCare AG,

51368 Leverkusen,

Germany

TRASYLOL

10 000 KIU/ml

solution for injection/infusion

intravenous use

FR - France

| BAYER SANTE - 220, |
| --- |
| avenue de la recherche - 59120 LOOS |

BAYER SANTE - 220,

avenue de la recherche - 59120 LOOS

Trasylol

1 000 000 KUI/100 mL

solution for injection

intravenous use

FR - France

| BAYER SANTE - 220, |
| --- |
| avenue de la recherche - 59120 LOOS |

BAYER SANTE - 220,

avenue de la recherche - 59120 LOOS

Trasylol

2 000 000 KUI/200 mL

solution for injection

intravenous use

FR - France

| BAYER SANTE - 220, |
| --- |
| avenue de la recherche - 59120 LOOS |

BAYER SANTE - 220,

avenue de la recherche - 59120 LOOS

Trasylol

500 000 UIK/50 mL

solution for injection

intravenous use

HU - Hungary

| Richter Gedeon Nyrt. |
| --- |
| Gyömrői út 19-21. |
| 1103 Budapest, |
| Hungary |

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest,

Hungary

Gordox

100 000 KIU/10 ml

solution for injection

intravenous use

HU - Hungary

| Richter Gedeon Nyrt. |
| --- |
| Gyömrői út 19-21. |
| 1103 Budapest, |
| Hungary |

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest,

Hungary

Gordox

500 000 KIU/50 ml

solution for infusion

intravenous use

HU - Hungary

| Bayer Healthcare AG |
| --- |
| Kaiser-Wilhelm-Allee, Bldg. E39 |
| 51368 Leverkusen, |
| Germany |

Bayer Healthcare AG

Kaiser-Wilhelm-Allee, Bldg. E39

51368 Leverkusen,

Germany

Trasylol

500 000 KIU/50 ml

solution for infusion

intravenous use

LU - Luxembourg

| Bayer S.A. |
| --- |
| 14, J.E. Mommaertslaan |
| B- 1831 Diegem |

Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

TRASYLOL

50 000 U/50ml

solution for injection

intravenous use

LV - Latvia

| Gedeon Richter Ltd. |
| --- |
| Gyomroi ut 19-21 |
| Budapest HU-1103 |
| Hungary |

Gedeon Richter Ltd.

Gyomroi ut 19-21

Budapest HU-1103

Hungary

Gordox 10 000 KSV/ml šķīdums infūzijām

10 000 KIU/ml

solution for infusion

intravenous use

MT - Malta

| Bayer Plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| United Kingdom |

Bayer Plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

trading as Bayer Plc, Pharmaceutical division

TRASYLOL

10 000 KIU/ML

solution for infusion

intravenous use

NL - Netherlands

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| The Netherlands |

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Trasylol 500 000, oplossing voor infusie 10 000 KIE/ml

10 000 KIU/ml

solution for infusion

intravenous use

PL - Poland

| Bayer Pharma AG |
| --- |
| Berlin, D-13342 |
| Germany |

Bayer Pharma AG

Berlin, D-13342

Germany

Trasylol

555,6 Ph.Eur.u. (1 000 000 KIU)

solution for infusion

intravenous use

PL - Poland

| Bayer Pharma AG |
| --- |
| Berlin, D-13342 |
| Germany |

Bayer Pharma AG

Berlin, D-13342

Germany

Trasylol

1 111,1 Ph.Eur.u. (2 000 000 KIU)

solution for infusion

intravenous use

PL - Poland

| Bayer Pharma AG |
| --- |
| Berlin, D-13342 |
| Germany |

Bayer Pharma AG

Berlin, D-13342

Germany

Trasylol

277,8 j. Ph. Eur. (500 000 KIU)

solution for infusion

intravenous use

PT - Portugal

| Bayer Portugal, S.A. |
| --- |
| Rua Quinta do Pinheiro 5 |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Trasylol

500 000 U.I.C/50 ml

solution for infusion

intravenous use

PT - Portugal

| Bayer Portugal, S.A. |
| --- |
| Rua Quinta do Pinheiro 5 |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Trasylol 1 000 000 UIC

1 000 000 U.I.C/100 ml

solution for infusion

intravenous use

PT - Portugal

| Bayer Portugal, S.A. |
| --- |
| Rua Quinta do Pinheiro 5 |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Trasylol 2 000 000 UIC

2 000 000 U.I.C/200 ml

solution for infusion

Intravenous use

SE - Sweden

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-133 42 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-133 42 Berlin

Germany

Trasylol

10 000 KIE/ml

solution for injection/infusion

intravenous use

SK - Slovakia

| Richter Gedeon Nyrt., |
| --- |
| Budapest 10, |
| Pf. 27., H-1475 |
| Hungary |

Richter Gedeon Nyrt.,

Budapest 10,

Pf. 27., H-1475

Hungary

GORDOX

100 000 IU/10 ml

solution for injection

intravenous use

SL - Slovenia

| Bayer d.o.o., |
| --- |
| Bravničarjeva 13, |
| Ljubljana, |
| Slovenia |

Bayer d.o.o.,

Bravničarjeva 13,

Ljubljana,

Slovenia

TRASYLOL

10 000 KIU/ml

solution for injection and infusion

intravenous use

UK - United Kingdom

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury, |
| Berkshire RG14 1JA |
| UK |

Bayer plc

Bayer House

Strawberry Hill

Newbury,

Berkshire RG14 1JA

UK

Trasylol Solution

10,000 KIU/ML

solution for injection

intravenous use

UK - United Kingdom

| Nordic Pharma Limited, |
| --- |
| Abbey House, |
| 1650 Arlington Business Park, |
| Theale, Reading, |
| Berkshire RG7 4SA, |
| UK |

Nordic Pharma Limited,

Abbey House,

1650 Arlington Business Park,

Theale, Reading,

Berkshire RG7 4SA,

UK

Aprotinin 10,000 KIU/ml Injection

10,000 KIU/ml

solution for injection

intravenous use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corp. Austria G.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Austria |

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Pfizer Corp. Austria G.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austria

Cydectin TriclaMox 5 mg/ml + 200 mg/ml lösung zum aufgießen für Rinder

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Belgium

| Pfizer Animal Health s.a. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-la-Neuve |
| Belgium |

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy, Animal Health

Tietokuja 4

00330 Helsinki

Finland

Cydectin TriclaMox

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

France

| Pfizer Holding France |
| --- |
| 23-25 avenue du Docteur Lannelongue |
| F – 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 avenue du Docteur Lannelongue

F – 75668 Paris Cedex 14

France

Cydectine TriclaMox 5 mg/ml + 200 mg/ml Solution pour pour-on bovins

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Germany

| Pfizer GmbH |
| --- |
| Linkstraße 10 |
| 10785 Berlin |
| Germany |

Pfizer GmbH

Linkstraße 10

10785 Berlin

Germany

Cydectin® TriclaMox 5 mg/ml + 200 mg/ml Lösung zum Aufgießen für Rinder

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Greece

| Pfizer Hellas AE |
| --- |
| Mesogion Avenue 243 |
| 154 51 N. Psychiko |
| Athens |
| Greece |

Pfizer Hellas AE

Mesogion Avenue 243

154 51 N. Psychiko

Athens

Greece

Cydectin TriclaMox

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Ireland

| Pfizer Healthcare Ireland |
| --- |
| Ringaskiddy |
| Co Cork |
| Ireland |

Pfizer Healthcare Ireland

Ringaskiddy

Co Cork

Ireland

Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo 71 |
| 04100 Latina |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo 71

04100 Latina

Italy

Cydectin TriclaMox 5 mg/ml + 200 mg/ml soluzione Pour-on per bovini

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Luxembourg

| Pfizer Animal Health s.a. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-la-Neuve |
| Belgium |

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Portugal

| Laboratórios Pfizer, Lda |
| --- |
| Lagoas Park – Edíficio 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda

Lagoas Park – Edíficio 10

2740-271 Porto Salvo

Portugal

Cydectin TriclaMox 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 51, Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| Luksemburg |

Pfizer Luxembourg SARL

51, Avenue J.F.Kennedy

L-1855 Luxembourg

Luksemburg

Cydectin TriclaMox

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Spain

| Zoetis Spain, S.L. |
| --- |
| Avda. de Europa 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Zoetis Spain, S.L.

Avda. de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Cydectin Triclamox 5 mg/ml + 200 mg/ml Solución Pour-on para Bovino

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich CT13 9NJ

United Kingdom

Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

---

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder company name, address | Invented name Name | Strength | Pharmaceutical Form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | sanofi-aventis GmbH, |
| Leonard-Bernstein-Straße 10, |
| A-1220 Vienna, |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder company name, address

Invented name Name

Strength

Pharmaceutical Form

Route of administration

Content (concentration)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Austria

Targocid 100 mg Trockenstechampullen mit Lösungsmittel

100 mg

powder and solvent for solution for injection/ infusion and oral solution

intramuscular use, intravenous use, oral use

100 mg/1.5 ml

Austria

| sanofi-aventis GmbH, |
| --- |
| Leonard-Bernstein-Straße 10, |
| A-1220 Vienna, |
| Austria |

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Austria

Targocid 200 mg Trockenstechampullen mit Lösungsmittel

200 mg

powder and solvent for solution for injection/ infusion and oral solution

intramuscular use, intravenous use, oral use

200 mg/3 ml

Austria

| sanofi-aventis GmbH, |
| --- |
| Leonard-Bernstein-Straße 10, |
| A-1220 Vienna, |
| Austria |

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Austria

Targocid 400 mg Trockenstechampullen mit Lösungsmittel

400 mg

powder and solvent for solution for injection/ infusion and oral solution

intramuscular use, intravenous use, oral use

400 mg/3 ml

Belgium

| sanofi-aventis Belgium |
| --- |
| Culliganlaan 1C |
| 1831 Diegem, |
| Belgium |

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

Targocid 200 mg, poeder en oplosmiddel voor oplossing voor injectie

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Belgium

| sanofi-aventis Belgium |
| --- |
| Culliganlaan 1C |
| 1831 Diegem, |
| Belgium |

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

Targocid 400 mg, poeder en oplosmiddel voor oplossing voor injectie

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Bulgaria

| sanofi-aventis Bulgaria EOOD |
| --- |
| 1303 Sofia, |
| 103 Alexander Stamboliiski Blvd. fl.8., |
| Bulgaria |

sanofi-aventis Bulgaria EOOD

1303 Sofia,

103 Alexander Stamboliiski Blvd. fl.8.,

Bulgaria

TARGOCID 400mg powder and solvent for solution for injection/infusion

400 mg

powder and solvent for solution for injection/infusion

intramuscular use/intravenous use, oral use

400 mg/3 ml

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a, |
| 160 00 Praha 6, |
| Czech Republic |

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Czech Republic

Targocid 200 mg

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a, |
| 160 00 Praha 6, |
| Czech Republic |

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Czech Republic

Targocid 400 mg

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Denmark

| sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13, |
| 2970 Hoersholm, |
| Denmark |

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Denmark

Targocid

100 mg

powder for solution for injection

intramuscular use/intravenous use

100 mg/1.5 ml

Denmark

| sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13, |
| 2970 Hoersholm, |
| Denmark |

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Denmark

Targocid

200 mg

powder for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Denmark

| sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13, |
| 2970 Hoersholm, |
| Denmark |

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Denmark

Targocid

400 mg

powder for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| PL 22 |
| 00351 Helsinki, |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Finland

Targocid 200 mg injektio- ja infuusiokuiva-aine, liuosta varten

200 mg

powder for solution for injection/ infusion

intramuscular use/intravenous use

200 mg/3 ml

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| PL 22 |
| 00351 Helsinki, |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Finland

Targocid 400 mg injektio- ja infuusiokuiva-aine, liuosta varten

400 mg

powder for solution for injection/ infusion

intramuscular use/intravenous use

400 mg/3 ml

France

| sanofi-aventis France |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris, |
| France |

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

France

TARGOCID 100 mg, lyophilisat et solution pour usage parentéral

100 mg

powder and solvent for injection

intramuscular use/intravenous use

100 mg/1.5 ml

France

| sanofi-aventis France |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris, |
| France |

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

France

TARGOCID 200 mg, lyophilisat et solution pour usage parentéral

200 mg

powder and solvent for injection

intramuscular use/intravenous use

200 mg/3 ml

France

| sanofi-aventis France |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris, |
| France |

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

France

TARGOCID 400 mg, lyophilisat et solution pour usage parentéral

400 mg

powder and solvent for injection

intramuscular use/intravenous use

400 mg/3 ml

Germany

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt am Main, |
| Deutschland |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Targocid® 100 mg

100 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

100 mg/1.5 ml

Germany

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt am Main, |
| Deutschland |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Targocid® 200 mg

200 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

200 mg/3 ml

Germany

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt am Main, |
| Deutschland |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Targocid® 400 mg

400 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

400 mg/3 ml

Germany

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt am Main, |
| Deutschland |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Teicoplanin Sanofi-Aventis 100 mg

100 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

100 mg/1.5 ml

Germany

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt am Main, |
| Deutschland |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Teicoplanin Sanofi-Aventis 200 mg

200 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

200 mg/3 ml

Germany

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt am Main, |
| Deutschland |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Teicoplanin Sanofi-Aventis 400 mg

400 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

400 mg/3 ml

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| 14671 Nea Erythrea, |
| Greece |

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Greece

TARGOCID®

200 mg

Powder and solvent for injection or infusion

intramuscular use/intravenous use

200 mg/3 ml

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| 14671 Nea Erythrea, |
| Greece |

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Greece

TARGOCID®

400mg

Powder and solvent for injection or infusion

intramuscular use/intravenous use

400 mg/3 ml

Hungary

| sanofi-aventis Zrt. |
| --- |
| 1-5. Tó u., |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

Hungary

Targocid 200 mg por és oldószer oldatos injekcióhoz

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Hungary

| sanofi-aventis Zrt. |
| --- |
| 1-5. Tó u., |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

Hungary

Targocid 400 mg por és oldószer oldatos injekcióhoz

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Ireland

| sanofi-aventis Ireland Ltd., T/A Sanofi |
| --- |
| 18 Riverwalk |
| Citywest Business Campus, Dublin 24, |
| Ireland |

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

Ireland

Targocid 200mg Powder and Solvent for Solution for Injection

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Ireland

| sanofi-aventis Ireland Ltd., T/A Sanofi |
| --- |
| 18 Riverwalk |
| Citywest Business Campus, Dublin 24, |
| Ireland |

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

Ireland

Targocid 400mg Powder and Solvent for Solution for Injection

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Italy

| sanofi-aventis SPA |
| --- |
| Viale L. Bodio, 37/B – |
| 20158 Milano, |
| Italy |

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TARGOSID

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Italy

| sanofi-aventis SPA |
| --- |
| Viale L. Bodio, 37/B – |
| 20158 Milano, |
| Italy |

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TARGOSID

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Italy

| sanofi-aventis SPA |
| --- |
| Viale L. Bodio, 37/B – |
| 20158 Milano, |
| Italy |

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TEICOMID

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Italy

| sanofi-aventis SPA |
| --- |
| Viale L. Bodio, 37/B – |
| 20158 Milano, |
| Italy |

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TEICOMID

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Luxembourg

| sanofi-aventis Belgium |
| --- |
| Culliganlaan 1C |
| 1831 Diegem, |
| Belgium |

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

TARGOCID

200 mg

powder for injectable preparations

intramuscular use/intravenous use

200 mg/3 ml

Luxembourg

| sanofi-aventis Belgium |
| --- |
| Culliganlaan 1C |
| 1831 Diegem, |
| Belgium |

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

TARGOCID

400 mg

powder for injectable preparations

intramuscular use/intravenous use

400 mg/3 ml

Malta

| Sanofi-Aventis Malta Ltd. |
| --- |
| Triq Kan. K. Pirotta, |
| Birkirkara BKR1114, |
| Malta |

Sanofi-Aventis Malta Ltd.

Triq Kan. K. Pirotta,

Birkirkara BKR1114,

Malta

Targocid® 200 mg

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Netherlands

| sanofi-aventis Netherlands BV. |
| --- |
| Kampenringweg 45 D-E, |
| 2803 PE Gouda, |
| The Netherlands |

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The Netherlands

TARGOCID® 200

200 mg

powder for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Netherlands

| sanofi-aventis Netherlands BV. |
| --- |
| Kampenringweg 45 D-E, |
| 2803 PE Gouda, |
| The Netherlands |

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The Netherlands

TARGOCID® 400

400 mg

powder for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Norway

| sanofi-aventis Norge AS, |
| --- |
| Strandveien 15, |
| PO Box 133, 1325 Lysaker, |
| Norway |

sanofi-aventis Norge AS,

Strandveien 15,

PO Box 133, 1325 Lysaker,

Norway

TARGOCID®

400 mg

powder for solution for injection/infusion

intramuscular use/intravenous use

400 mg/3 ml

Poland

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| United Kingdom |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

United Kingdom

TARGOCID

200 mg

powder and solvent for solution for injection and infusion

intramuscular use/intravenous use

200 mg/3 ml

Poland

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| United Kingdom |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

United Kingdom

TARGOCID

400 mg

powder and solvent for solution for injection and infusion

intramuscular use/intravenous use

400 mg/3 ml

Portugal

| Sanofi - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Portugal

Targosid

200 mg/3 ml

powder and solvent for solution for injection or for infusion

intramuscular use/intravenous use

200 mg/3 ml

Portugal

| Sanofi - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Portugal

Targosid

400 mg/3 ml

powder and solvent for solution for injection or for infusion

intramuscular use/intravenous use

400 mg/3 ml

Romania

| Aventis Pharma Ltd. |
| --- |
| Trading as sanofi-aventis or Sanofi |
| One Onslow Street, |
| Guildford Surrey, |
| GU1 4YS, |
| United Kingdom |

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

United Kingdom

TARGOCID® 200 mg

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Romania

| Aventis Pharma Ltd. |
| --- |
| Trading as sanofi-aventis or Sanofi |
| One Onslow Street, |
| Guildford Surrey, |
| GU1 4YS, |
| United Kingdom |

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

United Kingdom

TARGOCID® 400 mg

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Slovak Republic

| sanofi-aventis Pharma |
| --- |
| Slovakia s.r.o Einsteinova 24, |
| 85101 Bratislava, |
| Slovak Republic |

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovak Republic

Targocid 200

200 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use, oral use

200 mg/3 ml

Slovak Republic

| sanofi-aventis Pharma |
| --- |
| Slovakia s.r.o Einsteinova 24, |
| 85101 Bratislava, |
| Slovak Republic |

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovak Republic

Targocid 400

400 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use, oral use

400 mg/3 ml

Slovenia

| sanofi-aventis d.o.o. |
| --- |
| Dunajska cesta 151 |
| 1000 Ljubljana |
| Slovenia |

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenia

Targocid 200 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

200 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

200 mg/3 ml

Slovenia

| sanofi-aventis d.o.o. |
| --- |
| Dunajska cesta 151 |
| 1000 Ljubljana |
| Slovenia |

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenia

Targocid 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

400 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

400 mg/3 ml

Spain

| Marion Merrell S.A. |
| --- |
| Martínez Villergas, 52 |
| 28027 Madrid |
| Spain |

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Spain

TARGOCID

200 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

200 mg/3 ml

Spain

| Marion Merrell S.A. |
| --- |
| Martínez Villergas, 52 |
| 28027 Madrid |
| Spain |

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Spain

TARGOCID

400 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

400 mg/3 ml

Sweden

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma, |
| Sweden |

sanofi-aventis AB

Box 14142

167 14 Bromma,

Sweden

Targocid

200 mg

Powder for injection-/infusion, solution

intramuscular use/intravenous use

200 mg/3 ml

Sweden

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma, |
| Sweden |

sanofi-aventis AB

Box 14142

167 14 Bromma,

Sweden

Targocid

400 mg

Powder for injection-/infusion, solution

intramuscular use/intravenous use

400 mg/3 ml

United Kingdom

| Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma) |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| United Kingdom |

Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

or trading as

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| United Kingdom |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

TARGOCID®

200 mg

powder for injection

intramuscular use/intravenous use

200 mg/3 ml

United Kingdom

| Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma) |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| United Kingdom |

Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

or trading as

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| United Kingdom |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

TARGOCID®

400 mg

powder for injection

intramuscular use/intravenous use

400 mg/3 ml

---

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Bulgaria | Zentiva k.s. |
| 130 U kabelovn |
| Prague 10237 |
| Czech Republic |

Member State

(in EEA)

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Bulgaria

Zentiva k.s.

130 U kabelovn

Prague 10237

Czech Republic

Flupizen

100 mg

capsule, hard

oral use

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

KATADOLON

100 mg

capsule, hard

oral use

Germany

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat AbZ 100 mg Kapseln

100 mg

capsule, hard

oral use

Germany

| Aliud Pharma GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| 89150 Laichingen |
| Germany |

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Flupirtinmaleat AL 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Awegal inject

164,5 mg / 3 ml

solution for injection

intramuscular use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon inject

164,5 mg / 3 ml

solution for injection

intramuscular use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon Kinderzäpfchen

75 mg

suppository

rectal use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon Zäpfchen

150 mg

suppository

rectal use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancopal Dolo

100 mg

capsule

oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancopal Dolo Suppositorien

150 mg

suppository

rectal use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon S long

400 mg

prolonged release tablet

oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon

100 mg

capsule, hard

oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancolong

400 mg

prolonged release tablet

oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon retard

400 mg

prolonged release tablet

oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Flupirtinmaleat Winthrop 400 mg Retardtabletten

400 mg

prolonged release tablet

oral use

Germany

| CT Arzneimittel GmmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat-CT 100 mg Hartkapsel

100 mg

capsule, hard

oral use

Germany

| CT Arzneimittel GmmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupin 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| 12277 Berlin |
| Germany |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Dolokadin einmal täglich

400 mg

prolonged release tablet

oral use

Germany

| Hormosan Pharma GmbH |
| --- |
| Wilhelmshöher Str. 106 |
| 60389 Frankfurt |
| Germany |

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Germany

Flupigamma 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Hormosan Pharma GmbH |
| --- |
| Wilhelmshöher Str. 106 |
| 60389 Frankfurt |
| Germany |

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Germany

Flupirtinmaleat-Hormosan 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Flupigil 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Flupigil 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Midas Pharma GmbH |
| --- |
| Rheinstr. 49 |
| 55218 Ingelheim |
| Germany |

Midas Pharma GmbH

Rheinstr. 49

55218 Ingelheim

Germany

Flupirtinmaleat Midas 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat-ratiopharm 100 mg Hartkapsel

100 mg

capsule, hard

oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Miflumal 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Vitapharma Generics GmbH |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg v. d. H. |
| Germany |

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupirtinmaleat Vitapharma 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Vitapharma Generics GmbH |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg v. d. H. |
| Germany |

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupivil 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Vitapharma Generics GmbH |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg v. d. H. |
| Germany |

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupirtinmaleat Viatris 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Brüningstr. 50 |
| 65926 Frankfurt am Main |
| Germany |

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Brüningstr. 50 |
| 65926 Frankfurt am Main |
| Germany |

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupimal 100 mg Hertkapseln

100 mg

capsule, hard

oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Brüningstr. 50 |
| 65926 Frankfurt am Main |
| Germany |

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupsadim 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Brüningstr. 50 |
| 65926 Frankfurt am Main |
| Germany |

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Miphaflumix 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Brüningstr. 50 |
| 65926 Frankfurt am Main |
| Germany |

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Fluporol 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Brüningstr. 50 |
| 65926 Frankfurt am Main |
| Germany |

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Hungary

| ZENTIVA k.s. |
| --- |
| Ul. kabelovny 130, Dolní Mecholupy |
| 10237 Prague 10 |
| Czeh Republic |

ZENTIVA k.s.

Ul. kabelovny 130, Dolní Mecholupy

10237 Prague 10

Czeh Republic

Flupizen 100 mg kemény kapszula

100 mg

capsule, hard

oral use

Italy

| MEDA PHARMA S.p.A., |
| --- |
| Viale Brenta 18, 20139 Milano |
| Italy |

MEDA PHARMA S.p.A.,

Viale Brenta 18, 20139 Milano

Italy

EFIRET

100 mg

capsule, hard

oral use

Latvia

| Teva Pharma B.V., |
| --- |
| Computerweg 10, |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.,

Computerweg 10,

3542 DR Utrecht

The Netherlands

Katadolon 100 mg hard capsules

100 mg

capsule, hard

oral use

Lithuania

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Katadolon

100 mg

capsule, hard

oral use

Poland

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| ul. Emilii Plater 53 |
| 00-113 Warsaw |
| Poland |

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poland

Katadolon

100 mg

capsule, hard

oral use

Portugal

| Midas Pharma GmbH |
| --- |
| Rheinstrasse, 49 |
| 55218 Ingelheim |
| Germany |

Midas Pharma GmbH

Rheinstrasse, 49

55218 Ingelheim

Germany

Flupirtina Midas

100 mg

capsule, hard

oral use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park, |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Flupirtina Winthrop

100 mg

capsule, hard

oral use

Portugal

| Meda Pharma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Cultural, 13 |
| 1749-066 Lisboa |
| Portugal |

Meda Pharma - Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Metanor

100 mg

capsule, hard

oral use

Romania

| Zentiva k.s. |
| --- |
| U Kabelovny 130, Dolní Měcholupy |
| 102 37, Praga 10, |
| Czech Republic |

Zentiva k.s.

U Kabelovny 130, Dolní Měcholupy

102 37, Praga 10,

Czech Republic

FLUPIZEN 100 mg

100 mg

capsule

oral use

Slovak Republic

| Zentiva k.s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

Flupizen 100 mg tvrdé kapsuly

100 mg

capsule, hard

oral use

Slovak Republic

| TEVA Pharmaceuticals Slovakia, s.r.o. |
| --- |
| Teslova 26 |
| 821 02 Bratislava |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia, s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Katadolon

100 mg

capsule, hard

oral use

---

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Applicant/marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Gesellschaft m.b.H. |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AUSTRIA |

Member State EU/EEA

Applicant/marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax 1 % - Injektionslösung für Rinder und Schafe

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Austria

| Pfizer Corporation Austria Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax S 10 mg/ml Injektionslösung für Schweine

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Austria

| Pfizer Corporation Austria Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax Pour-On 5 mg/ml Lösung für Rinder

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| Division Elanco Animal Health |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIUM |

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

DECTOMAX

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| Division Elanco Animal Health |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIUM |

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

DECTOMAX POUR-ON

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| Division Elanco Animal Health |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIUM |

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

DECTOMAX SOLUTION INJECTABLE POUR PORCS

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Bulgaria

| Pfizer S.A., |
| --- |
| Z.l. De Poce-sur-Cisse, B.P. 109 |
| 37401 Amboise Cedex, |
| FRANCE |

Pfizer S.A.,

Z.l. De Poce-sur-Cisse, B.P. 109

37401 Amboise Cedex,

FRANCE

Дектомакс 1 % инжективен разтвор

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Bulgaria

| BIOVET AD |
| --- |
| 39 Petar Rakov str. |
| Peshtera 4550 |
| BULGARIA |

BIOVET AD

39 Petar Rakov str.

Peshtera 4550

BULGARIA

Ендектовет 1 % инжекционен разтвор за говеда, овце и свине

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Cyprus

| PFIZER HELLAS AE |
| --- |
| 243 Av Mesogeion |
| 15451, Athens |
| GREECE |

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GREECE

DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Czech republic

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| CZECH REPUBLIC |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha

CZECH REPUBLIC

DECTOMAX 10 mg/ml injekční roztok

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Czech republic

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Prontax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Denmark

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Pour-On Vet.

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Denmark

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Vet.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Denmark

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous

Cattle

Estonia

| Pfizer Animal Health S.A., |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve, |
| BELGIUM |

Pfizer Animal Health S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

BELGIUM

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Estonia

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Prontax 10 mg/ml Solution for injection for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Finland

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

DECTOMAX vet 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, reindeer, pigs

Finland

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax 5 mg/ml kertavaleluliuos

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Finland

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

France

| Lilly France |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCE |

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCE

ZEARL

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

France

| Lilly France |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCE |

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCE

ZEARL POUR ON

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

France

| Lilly France |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCE |

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCE

ZEARL PORCS

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

France

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

France

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 10 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS ET PORCINS

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| GERMANY |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| GERMANY |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Dectomax Pour-On

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| GERMANY |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Dectomax-S Injektionslösung

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Greece

| PFIZER HELLAS AE |
| --- |
| 243 Av Mesogeion |
| 15451, Athens |
| GREECE |

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GREECE

DECTOMAX ing sol

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Hungary

| Pfizer Kft. |
| --- |
| Alkotás u. 53. |
| 1123 Budapest |
| HUNGARY |

Pfizer Kft.

Alkotás u. 53.

1123 Budapest

HUNGARY

Dectomax injekció A.U.V.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Iceland

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax, vet.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Iceland

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Iceland

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Zearl Pour-On Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Zearl 10 mg/ml Solution for Injection for Cattle and Sheep

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Zearl 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Ireland

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Dectomax 5 mg/ml Pour-On Solution for Cattle

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Ireland

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| ITALY |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

ITALY

DECTOMAX 10 mg/ml soluzione iniettabile per bovini, ovini e suini

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| ITALY |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

ITALY

DECTOMAX POUR ON 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Latvia

| Pfizer Animal Health S.A., |
| --- |
| Rue Laid Burniat, 1, |
| 1348 Louvain-la-Neuve, |
| BELGIUM |

Pfizer Animal Health S.A.,

Rue Laid Burniat, 1,

1348 Louvain-la-Neuve,

BELGIUM

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Latvia

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Lithuania

| Pfizer S.A., |
| --- |
| Z.l. De Poce-sur-Cisse, B.P. 109 |
| 37401 Amboise Cedex, |
| FRANCE |

Pfizer S.A.,

Z.l. De Poce-sur-Cisse, B.P. 109

37401 Amboise Cedex,

FRANCE

DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Lithuania

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 10 mg/ml, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

THE NETHERLANDS

Dectomax Pour-On Oplossing voor Rundvee 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

THE NETHERLANDS

DECTOMAX oplossing voor injectie 10 mg/ml voor rundvee, varkens en schapen

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Norway

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Pour-On vet

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Norway

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax vet

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Norway

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Norway

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Poland

| Pfizer Trading Polska s.p. z o.o. |
| --- |
| ul. Postępu 17 B |
| 02-676 Warszawa |
| POLAND |

Pfizer Trading Polska s.p. z o.o.

ul. Postępu 17 B

02-676 Warszawa

POLAND

Dectomax 10 mg/ml, roztwór do wstrzykiwań dla bydła, świń i owiec

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Portugal

| LABORATÓRIOS PFIZER, LDA. |
| --- |
| Lagoas Park - Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

PORTUGAL

Dectomax Pour-on

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Portugal

| LABORATÓRIOS PFIZER, LDA. |
| --- |
| Lagoas Park - Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

PORTUGAL

Dectomax solução injectável

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Romania

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

DECTOMAX

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Romania

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 10 mg/ml Injectable Solution for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Romania

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 5 mg/ml Pour On Solution for Cattle

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Slovakia

| Pfizer Luxemburg SARL, o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 811 09 Bratislava |
| SLOVAK REPUBLIC |

Pfizer Luxemburg SARL, o.z.

Pfizer AH

Pribinova 25

811 09 Bratislava

SLOVAK REPUBLIC

Dectomax 10 mg/ml injekčný roztok

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 51, Avenue J.F. Kennedy |
| L-1855 Luxembourg |
| LUXEMBOURG |

Pfizer Luxembourg SARL

51, Avenue J.F. Kennedy

L-1855 Luxembourg

LUXEMBOURG

DECTOMAX 10 mg/ml raztopina za injiciranje

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Spain

| PFIZER S.A. |
| --- |
| Avda. de Europa 20 B. |
| Parque Empresarial La Moraleja |
| 28108 - Alcobendas |
| Madrid |
| SPAIN |

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPAIN

DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Spain

| PFIZER S.A. |
| --- |
| Avda. de Europa 20 B. |
| Parque Empresarial La Moraleja |
| 28108 - Alcobendas |
| Madrid |
| SPAIN |

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPAIN

DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Spain

| PFIZER S.A. |
| --- |
| Avda. de Europa 20 B. |
| Parque Empresarial La Moraleja |
| 28108 - Alcobendas |
| Madrid |
| SPAIN |

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPAIN

DECTOMAX SOLUCION INYECTABLE

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Sweden

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax vet.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, reindeer

Sweden

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Suis vet.

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Sweden

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Sweden

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax pour-on vet.

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Sweden

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

United Kingdom

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Dectomax 10 mg/ml Solution for Injection for Cattle and Sheep

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

United Kingdom

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Dectomax 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

United Kingdom

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Dectomax Pour-on Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

---

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing authorisation holder | INN | Invented name | Strengths | Pharmaceutical forms | Routes of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H |
| Floridsdorfer Hauptstraße 1, |
| 1210 Vienna |
| Austria |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strengths

Pharmaceutical forms

Routes of administration

Austria

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

Diclofenac sodium

Misoprostol

Arthrotec forte - Manteltabletten

75 mg

0,2 mg

Coated tablet

Oral use

Austria

| Pfizer Corporation Austria Ges.m.b.H |
| --- |
| Floridsdorfer Hauptstraße 1, |
| 1210 Vienna |
| Austria |

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

Diclofenac sodium

Misoprostol

Arthrotec - Manteltabletten

50 mg

0,2 mg

Coated tablet

Oral use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Dedolor akut 75 mg – Kapseln

75 mg

Gastro-resistant capsule, hard

Oral use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Dedolor DRS 100 mg – Kapseln

100 mg

Capsule, hard

Oral use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat DRS 75 mg – Kapseln

75 mg

Capsule, hard

Oral use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 75 mg - Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 50 mg – Kapseln

50 mg

Capsule, hard

Oral use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 100 mg – Suppositorien

100 mg

Suppository

Rectal use

Austria

| Astellas Pharma GmbH |
| --- |
| Linzer Straße 221/E02 |
| 1140 Vienna |
| Austria |

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat retard 100 mg – Kapseln

100 mg

Capsule, hard

Oral use

Austria

| Hexal Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| Hexal Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal rapid 50 mg - lösbare Tabletten

50 mg

Soluble tablet

Oral use

Austria

| Hexal Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal retard 150 mg - Tabletten

150 mg

Prolonged-release tablet

Oral use

Austria

| Hexal Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal retard 75 mg - Tabletten

75 mg

Prolonged-release tablet

Oral use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 75 mg – Ampullen

75 mg/2 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 25 mg – Filmtabletten

25 mg

Film-coated tablet

Oral use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 50 mg – Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 100 mg – Zäpfchen

100 mg

Suppository

Rectal use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 50 mg – Zäpfchen

50 mg

Suppository

Rectal use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene retard 100 mg - Kapseln

100 mg

Capsule, hard

Oral use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene uno 150 mg - Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Austria

| 1A Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten

50 mg

Soluble tablet

Oral use

Austria

| Genericon Pharma Gesellschaft m.b.H. |
| --- |
| Hafnerstraße 211 |
| 8054 Graz |
| Austria |

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac Genericon 75 mg - Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

| Genericon Pharma Gesellschaft m.b.H. |
| --- |
| Hafnerstraße 211 |
| 8054 Graz |
| Austria |

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac "Genericon" 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| Genericon Pharma Gesellschaft m.b.H. |
| --- |
| Hafnerstraße 211 |
| 8054 Graz |
| Austria |

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac Genericon retard 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| S.MED Handels GmbH |
| --- |
| Zachgasse 1 |
| 1220 Vienna |
| Austria |

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" 25 mg-Filmtabletten

25 mg

Film-coated tablet

Oral use

Austria

| S.MED Handels GmbH |
| --- |
| Zachgasse 1 |
| 1220 Vienna |
| Austria |

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| S.MED Handels GmbH |
| --- |
| Zachgasse 1 |
| 1220 Vienna |
| Austria |

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

Diclofenac ”S.Med“ 75 mg/3 ml - Ampullen

75 mg/3 ml

Solution for injection

Intramuscular use

Austria

| S.MED Handels GmbH |
| --- |
| Zachgasse 1 |
| 1220 Vienna |
| Austria |

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" retard 100 mg - Tabletten

100 mg

Tablet

Oral use

Austria

| S.MED Handels GmbH |
| --- |
| Zachgasse 1 |
| 1220 Vienna |
| Austria |

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" retard 75 mg - Tabletten

75 mg

Tablet

Oral use

Austria

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclofenac G.L. 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| 1A Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac 1A Pharma retard 150 mg - Tabletten

150 mg

Prolonged-release tablet

Oral use

Austria

| 1A Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac 1A Pharma retard 75 mg - Tabletten

75 mg

Prolonged-release tablet

Oral use

Austria

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclofenac G.L. retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 75 mg – Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 50 mg – Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 150 mg - Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 75 mg - Retardtabletten

75 mg

Prolonged-release tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac "Sandoz" retard 100 mg – Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| Lannacher Heilmittel Ges.m.b.H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Diclo-B „Lannacher“-Kapseln

50 mg

Capsule, hard

Oral use

Austria

| Lannacher Heilmittel Ges.m.b.H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Diclo-B G.L.

50 mg

Capsule, hard

Oral use

Austria

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Vienna |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac sodium

Diclostad Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Vienna |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac Sodium

Diclostad 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Vienna |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac sodium

Diclostad retard 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclovit-Kapseln

50 mg

Capsule, hard

Oral use

Austria

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Dolpasse 75 mg – Infusionslösung

75 mg/250 ml

Solution for Infusion

Intravenous use

Austria

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Dolpasse retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse – Infusionslösung

75 mg/250 ml

30 mg/250 ml

Solution for Infusion

Intravenous use

Austria

| MERCK GesmbH |
| --- |
| Zimbagasse 5 |
| 1147 Vienna |
| Austria |

MERCK GesmbH

Zimbagasse 5

1147 Vienna

Austria

Diclofenac sodium

Neurofenac - Kapseln

50 mg

Capsule, hard

Oral use

Austria

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenac sodium

Tratul retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 25 mg - Filmtabletten

25 mg

Film-coated tablet

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 75 mg/3 ml - Injektionslösung

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 25 mg - Zäpfchen

25 mg

Suppository

Rectal use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 100 mg - Zäpfchen für Erwachsene

100 mg

Suppository

Rectal use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 50 mg - Zäpfchen für Erwachsene

50 mg

Suppository

Rectal use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenac Acid

Tratul 50 mg - Kapseln

50 mg

Gastro-resistant capsule, soft

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac Acid

Voltaren dispers - lösliche Tabletten

46,5 mg

Soluble tablet

Oral use

Austria

| ratiopharm Arzneimittel VertriebsGmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| 1140 Vienna |
| Austria |

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac potassium

Diclobene rapid 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac potassium

Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen

50 mg

Powder for oral solution

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| 1020 Vienna |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac potassium

Voltaren rapid 50 mg - Dragees

50 mg

Coated tablet

Oral use

Belgium

| Continental Pharma |
| --- |
| Rijksweg, 12 |
| B-2870 Puurs |
| Belgium |

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

ARTHROTEC 50

50 mg

0,2 mg

Modified-release tablet

Oral use

Belgium

| Continental Pharma |
| --- |
| Rijksweg, 12 |
| B-2870 Puurs |
| Belgium |

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

ARTHROTEC 75

75 mg

0,2 mg

Modified-release tablet

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac potassium

CATAFLAM 50 MG

50 mg

Coated tablet

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac potassium

CATAFLAM 50 MG

50 mg

Powder for oral solution

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac

CATAFLAM DISPERSIBLE

46,5 mg

Dispersible tablet

Oral use

Belgium

| APOTEX NV |
| --- |
| Av. du Bourg. Etienne Demunter 5, box 8 |
| 1090 Jette |
| Belgium |

APOTEX NV

Av. du Bourg. Etienne Demunter 5, box 8

1090 Jette

Belgium

Diclofenac sodium

DICLOFENAC APOTEX 100 MG

100 mg

Prolonged-release tablet

Oral use

Belgium

| APOTEX NV |
| --- |
| Av. du Bourg. Etienne Demunter 5, box 8 |
| 1090 Jette |
| Belgium |

APOTEX NV

Av. du Bourg. Etienne Demunter 5, box 8

1090 Jette

Belgium

Diclofenac sodium

DICLOFENAC APOTEX 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 100 MG

100 mg

Suppository

Rectal use

Belgium

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 25 MG

25 mg

Coated tablet

Oral use

Belgium

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 50 MG

50 mg

Coated tablet

Oral use

Belgium

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 75 MG

75 mg/3 ml

Solution for injection

Intramuscular use

Belgium

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG RETARD 100 MG

100 mg

Prolonged-release tablet

Oral use

Belgium

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG RETARD 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

| Mylan bvba |
| --- |
| Rozendal Businesspark |
| Terhulpsesteenweg 6A |
| B-1560 Hoeilaart |
| Belgium |

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

DICLOFENAC RETARD MYLAN 100 MG

100 mg

Prolonged-release tablet

Oral use

Belgium

| Mylan bvba |
| --- |
| Rozendal Businesspark |
| Terhulpsesteenweg 6A |
| B-1560 Hoeilaart |
| Belgium |

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

DICLOFENAC RETARD MYLAN 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ 50 MG

50 mg

Gastro-resistant tablet

Oral use

Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ 75 MG

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ RETARD 100 MG

100 mg

Modified-release tablet

Oral use

Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ RETARD 75 MG

75 mg

Modified-release tablet

Oral use

Belgium

| Teva Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 100

100 mg

Suppository

Rectal use

Belgium

| Teva Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 100 MG RETARD

100 mg

Prolonged-release tablet

Oral use

Belgium

| Teva Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 50 MG

50 mg

Gastro-resistant tablet

Oral use

Belgium

| Teva Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 75 MG / 3 ML

75 mg/3 ml

Solution for injection

Intramuscular use

Belgium

| Teva Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 75 MG RETARD

75 mg

Prolonged-release tablet

Oral use

Belgium

| Teva Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac potassium

DICLOFENAC-K-TEVA 50 MG COMPR

50 mg

Film-coated tablet

Oral use

Belgium

| RATIOPHARM BELGIUM S.A. |
| --- |
| Rue Saint-Lambert 141 |
| 1200 Woluwé-saint-lambert |
| Belgium |

RATIOPHARM BELGIUM S.A.

Rue Saint-Lambert 141

1200 Woluwé-saint-lambert

Belgium

Diclofenac sodium

DICLOFENAC-RATIOPHARM 50 MG GASTRO-

50 mg

Gastro-resistant tablet

Oral use

Belgium

| LABORATORIA QUALIPHAR N.V/S.A |
| --- |
| Rijksweg 9 |
| 2880 Bornem |
| Belgium |

LABORATORIA QUALIPHAR N.V/S.A

Rijksweg 9

2880 Bornem

Belgium

Diclofenac sodium

DICLOFENACUM NATRI QUALIPHAR 50 MG

50 mg

Gastro-resistant tablet

Oral use

Belgium

| SOCOBOM N.V. |
| --- |
| Louizalaan 149 box 24 |
| 1050 Ixelles |
| Belgium |

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

FLAMPHAR 50 MG

50 mg

Tablet

Oral use

Belgium

| Daiichi Sankyo Belgium SA |
| --- |
| Rue Fond Jean Pâques 5 |
| B-1348 Louvain-la-Neuve |
| Belgium |

Daiichi Sankyo Belgium SA

Rue Fond Jean Pâques 5

B-1348 Louvain-la-Neuve

Belgium

Diclofenac sodium

MOTIFENE 75 MG

75 mg

Modified-release capsule

Oral use

Belgium

| SOCOBOM N.V. |
| --- |
| Louizalaan 149 box 24 |
| 1050 Ixelles |
| Belgium |

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

POLYFLAM 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

| SOCOBOM N.V. |
| --- |
| Louizalaan 149 box 24 |
| 1050 Ixelles |
| Belgium |

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG

50 mg

Coated tablet

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 100

100 mg

Suppository

Rectal use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 25

25 mg

Gastro-resistant tablet

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 50

50 mg

Gastro-resistant tablet

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 75 MG/3 ML

75 mg/3 ml

Solution for injection

Intramuscular use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN RETARD 100

100 mg

Tablet

Oral use

Belgium

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan, 40, box 1 |
| 1800 Vilvoorde |
| Belgium |

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN RETARD 75 MG

75 mg

Tablet

Oral use

Belgium

| Novartis Consumer Health S.A. |
| --- |
| Medialaan, 40 |
| B-1800 Vilvoorde |
| Belgium |

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

Diclofenac potassium

VOLTATABS 12,5 MG(EX:ZYMAMED)

12,5 mg

Coated tablet

Oral use

Bulgaria

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Bulgaria

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac sodium

Diclofenac Duo

75 mg

Prolonged-release capsule, hard

Oral use

Bulgaria

| Tchaikapharma Highquality Medicines |
| --- |
| 1 G. M. Dimitrov Blvd. |
| Sofia 1172 |
| Bulgaria |

Tchaikapharma Highquality Medicines

1 G. M. Dimitrov Blvd.

Sofia 1172

Bulgaria

Diclofenac sodium

Diclofenac-Tchaikapharma

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Bulgaria

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg

Modified-release tablet

Oral use

Bulgaria

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

150 mg

Modified-release tablet

Oral use

Bulgaria

| Sopharma Pharmaceuticals |
| --- |
| 5 Lachezar Stanchev Str. |
| Sofia 1220 |
| Bulgaria |

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

Diclofenac sodium

Feloran

100 mg

Suppository

Rectal use

Bulgaria

| Actavis EAD |
| --- |
| 29 Atanas Dukov Str. |
| Sofia 1407 |
| Bulgaria |

Actavis EAD

29 Atanas Dukov Str.

Sofia 1407

Bulgaria

Diclofenac sodium

Feloran Actavis

100 mg

Prolonged-release tablet

Oral use

Bulgaria

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen SR

100 mg

Prolonged-release tablet

Oral use

Bulgaria

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen DUO

75 mg

Modified-release capsule, hard

Oral use

Bulgaria

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

75 mg/3 ml

Solution for injection

Intramuscular use

Bulgaria

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

100 mg

Suppository

Rectal use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Suppository

Rectal use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassium

Voltfast

50 mg

Powder for oral solution

Oral use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Bulgaria

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Dolo

12,5 mg

Capsule, soft

Oral use

Bulgaria

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Dolo

12,5 mg

Film-coated tablet

Oral use

Bulgaria

| Sopharma Pharmaceuticals |
| --- |
| 5 Lachezar Stanchev Str. |
| Sofia 1220 |
| Bulgaria |

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

Diclofenac sodium

Feloran

25 mg/ml

solution for injection

Intramuscular use, Intravenous use

Cyprus

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL SUPPOSITORY 100 MG

100 mg

Suppository

Rectal use

Cyprus

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL SUPPOSITORY 50 MG

50 mg

Suppository

Rectal use

Cyprus

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL GASTRO-RESISTANT TABLET 25 MG

25 mg

Tablet

Oral use

Cyprus

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL GASTRO-RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ARESTON TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

CATAFLAM ORAL DROPS 1,5 %

15 mg/ml

Oral drops, solution

Oral use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

CATAFLAM COATED TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| P.T.Hadjigeorgiou CO ltd, |
| --- |
| P.O.Box 53158 |
| 3301 Lemesos |
| Cyprus |

P.T.Hadjigeorgiou CO ltd,

P.O.Box 53158

3301 Lemesos

Cyprus

Diclofenac sodium

DICLAC INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75 MG

75 mg

Tablet

Oral use

Cyprus

| Medlink Pharmaceuticals ltd |
| --- |
| 30 Armenias Str. |
| P.O.Box 26576 |
| Strovolos |
| Cyprus |

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

Diclofenac sodium

DIFENE DUAL CAPSULE 100 MG

100 mg

Capsule

Oral use

Cyprus

| Medlink Pharmaceuticals ltd |
| --- |
| 30 Armenias Str. |
| P.O.Box 26576 |
| Strovolos |
| Cyprus |

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

Diclofenac sodium

DIFENE DUAL CAPSULE 75 MG

75 mg

Capsule

Oral use

Cyprus

| Interpak ltd |
| --- |
| Aharnon st |
| Industrial Estate |
| P.O. Box 51166 |
| 3502 Lemesos |
| Cyprus |

Interpak ltd

Aharnon st

Industrial Estate

P.O. Box 51166

3502 Lemesos

Cyprus

Diclofenac sodium

NERITAN GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Interpak ltd |
| --- |
| Aharnon st |
| Industrial Estate |
| P.O. Box 51166 |
| 3502 Lemesos |
| Cyprus |

Interpak ltd

Aharnon st

Industrial Estate

P.O. Box 51166

3502 Lemesos

Cyprus

Diclofenac sodium

NERITAN GASTRO RESISTANT TABLET 25 MG

25 mg

Tablet

Oral use

Cyprus

| Remedica ltd |
| --- |
| Aharnon str. |
| P.O. Box 51706 |
| Lemesos |
| Cyprus |

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN SUPPOSITORY 100 MG

100 mg

Suppository

Rectal use

Cyprus

| Remedica ltd |
| --- |
| Aharnon str. |
| P.O. Box 51706 |
| Lemesos |
| Cyprus |

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN SUSTAINED RELEASE TABLET 100 MG

100 mg

Tablet

Oral use

Cyprus

| Remedica ltd |
| --- |
| Aharnon str. |
| P.O. Box 51706 |
| Lemesos |
| Cyprus |

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN GASTRO RESISTANT TABLET 25 MG

25 mg

Tablet

Oral use

Cyprus

| Remedica ltd |
| --- |
| Aharnon str. |
| P.O. Box 51706 |
| Lemesos |
| Cyprus |

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Codal Synto ltd |
| --- |
| 33 Theklas Lysioti str. |
| P.O. Box 51785 |
| Lemesos |
| Cyprus |

Codal Synto ltd

33 Theklas Lysioti str.

P.O. Box 51785

Lemesos

Cyprus

Diclofenac sodium

TAKS INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

| Codal Synto ltd |
| --- |
| 33 Theklas Lysioti str. |
| P.O. Box 51785 |
| Lemesos |
| Cyprus |

Codal Synto ltd

33 Theklas Lysioti str.

P.O. Box 51785

Lemesos

Cyprus

Diclofenac sodium

TAKS GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SUPPOSITORY 100 MG

100 mg

Suppository

Rectal use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SUPPOSITORY 50 MG

50 mg

Suppository

Rectal use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN D DISPERSIBLE TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

| Novartis Hellas S.A.C.I. |
| --- |
| 12th km |
| National Road No1 |
| Metamorfosi Attiki |
| Athens |
| Greece |

Novartis Hellas S.A.C.I.

12th km

National Road No1

Metamorfosi Attiki

Athens

Greece

Diclofenac sodium

VOLTAREN DOLO FILM COATED TABLET 12,5 MG

12,5 mg

Tablet

Oral use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN FOR CHILDREN SUPPOSITORY 12,5 MG

12,5 mg

Suppository

Rectal use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN RETARD SUSTAINED RELEASE TABLET 100 MG

100 mg

Tablet

Oral use

Cyprus

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SR SUSTAINED RELEASE TABLET 75 MG

75 mg

Tablet

Oral use

Czech Republic

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum natricum

ALMIRAL

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum natricum

ALMIRAL 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenacum natricum

APO-DICLO SR 100

100 mg

Modified-release tablet

Oral use

Czech Republic

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenacum natricum

APO-DICLO 25 MG

25 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenacum natricum

APO-DICLO 50 MG

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum natricum

DICLOFENAC AL RETARD

100 mg

Prolonged-release tablet

Oral use

Czech Republic

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum natricum

DICLOFENAC AL 25

25 mg

Film-coated tablet

Oral use

Czech Republic

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum natricum

DICLOFENAC AL 50

50 mg

Film-coated tablet

Oral use

Czech Republic

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum natricum

DICLOFENAC DUO PHARMASWISS 75 MG

75 mg

Modified-release capsule, hard

Oral use

Czech Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM

25 mg/ml

Solution for injection

Intramuscular use

Czech Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM RETARD

100 mg

Prolonged-release tablet

Oral use

Czech Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM 100

100 mg

Suppository

Rectal use

Czech Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM 50

50 mg

Suppository

Rectal use

Czech Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

DICUNO 25 MG POTAHOVANÉ TABLETY

25 mg

Film-coated tablet

Oral use

Czech Republic

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

DICUNO 50 MG POTAHOVANÉ TABLETY

50 mg

Film-coated tablet

Oral use

Czech Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenacum natricum

DOLMINA INJ

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenacum natricum

DOLMINA 100 SR

100 mg

Prolonged-release tablet

Oral use

Czech Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenacum natricum

DOLMINA 50

50 mg

Film-coated tablet

Oral use

Czech Republic

| IBSA Slovakia s.r.o. |
| --- |
| Mytna 42 |
| 811 05 Bratislava |
| Slovak Republic |

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

Diclofenacum epolaminum

FLECTOR EP RAPID 50 MG

50 mg

Granules for oral solution

Oral use

Czech Republic

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestrasse 26 |
| Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

Diclofenacum natricum

MONOFLAM 100 MG

100 mg

Suppository

Rectal use

Czech Republic

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestrasse 26 |
| Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

Diclofenacum natricum

MONOFLAM 50 MG

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenacum natricum

MYOGIT 25

25 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenacum natricum

MYOGIT 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

NAKLOFEN DUO TOBOLKY

75 mg

Modified-release capsule, hard

Oral use

Czech Republic

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Czech Republic

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

OLFEN-100 SR

100 mg

Prolonged-release capsule, hard

Oral use

Czech Republic

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

OLFEN-50

50 mg

Film-coated tablet

Oral use

Czech Republic

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

OLFEN-75

37,5 mg/ml

Solution for injection

Intramuscular use

Czech Republic

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

UNO

150 mg

Prolonged-release tablet

Oral use

Czech Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 100 MG

100 mg

Suppository

Rectal use

Czech Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 100 RETARD

100 mg

Modified-release tablet

Oral use

Czech Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 25 MG

25 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 50 MG

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 75

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 75 RETARD

75 mg

Modified-release tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenacum natricum

VOLTAREN

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenacum natricum

VOLTAREN RETARD

100 mg

Prolonged-release tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenacum natricum

VOLTAREN 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN RAPID 50 MG TABLETY

50 mg

Coated tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN ACTIGO

12,5 mg

Film-coated tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN ACTIGO EXTRA

25 mg

Coated tablet

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN RAPID 12,5 MG

12,5 mg

Capsule, soft

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN RAPID 25 MG

25 mg

Capsule, soft

Oral use

Denmark

| PharmaCoDane ApS |
| --- |
| Marielundvej 46 A |
| DK-2730 Herlev |
| Denmark |

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

Diclofenac

Diclodan

50 mg

Suppository

Rectal use

Denmark

| PharmaCoDane ApS |
| --- |
| Marielundvej 46 A |
| DK-2730 Herlev |
| Denmark |

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

Diclofenac

Diclodan

100 mg

Suppository

Rectal use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Købenahvn S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon

100 mg

Suppository

Rectal use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Købenahvn S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon Rapid

50 mg

Film-coated tablet

Oral use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Købenahvn S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon Rapid

25 mg

Film-coated tablet

Oral use

Denmark

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac

Diklofenak "Mylan"

50 mg

Gastro-resistant tablet

Oral use

Denmark

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diklofenak "Orifarm"

25 mg

Gastro-resistant tablet

Oral use

Denmark

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diklofenak "Orifarm"

50 mg

Gastro-resistant tablet

Oral use

Denmark

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Modifenac

75 mg

Modified-release capsule

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

100 mg

Suppository

Rectal use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

25 mg/ml

Solution for injection

Intramuscular use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

50 mg

Suppository

Rectal use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Film-coated tablet

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Capsule, soft

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Tablet

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Rapid

50 mg

Tablet

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Retard

75 mg

Prolonged-release tablet

Oral use

Denmark

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac

Diclofenac "BMM Pharma"

50 mg

Gastro-resistant tablet

Oral use

Denmark

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac

Diclofenac "BMM Pharma"

25 mg

Gastro-resistant tablet

Oral use

Denmark

| Actavis Nordic A/S |
| --- |
| Ørnegårdsvej 16 |
| DK-2820 Gentofte |
| Denmark |

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Diclofenac Rapid "Actavis"

50 mg

Film-coated tablet

Oral use

Denmark

| Actavis Nordic A/S |
| --- |
| Ørnegårdsvej 16 |
| DK-2820 Gentofte |
| Denmark |

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Diclofenac Rapid "Actavis"

25 mg

Film-coated tablet

Oral use

Denmark

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diclofenac Rapid "Orifarm"

50 mg

Film-coated tablet

Oral use

Denmark

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diclofenac Rapid "Orifarm"

25 mg

Film-coated tablet

Oral use

Denmark

| Teva Denmark A/S |
| --- |
| Parallelvej 10-12 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10-12

DK-2800 Kongens Lyngby

Denmark

Diclofenac

Diclofenac Rapid "Teva"

50 mg

Film-coated tablet

Oral use

Denmark

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

50 mg

Gastro-resistant tablet

Oral use

Denmark

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

100 mg

Prolonged-release tablet

Oral use

Denmark

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

75 mg

Prolonged-release tablet

Oral use

Denmark

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

25 mg

Gastro-resistant tablet

Oral use

Denmark

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Diclopax

25 mg

Film-coated tablet

Oral use

Denmark

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Diclopax

50 mg

Film-coated tablet

Oral use

Denmark

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac

Diklotab

25 mg

Film-coated tablet

Oral use

Denmark

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac

Diklotab

50 mg

Film-coated tablet

Oral use

Denmark

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac

Eeze

25 mg

Film-coated tablet

Oral use

Denmark

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Fenacta

12,5 mg

Film-coated tablet

Oral use

Denmark

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

50 mg

Film-coated tablet

Oral use

Denmark

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

25 mg

Film-coated tablet

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac

Misoprostol

Arthrotec Forte

75 mg

0,2 mg

Tablet

Oral use

Estonia

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

DICLOBERL 75 MG/3 ML

25 mg/ml

Solution for injection

Intramuscular use

Estonia

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

DICLOBERL RETARD

100 mg

Prolonged-release capsule, hard

Oral use

Estonia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN 50 MG

50 mg

Gastro-resistant tablet

Oral use

Estonia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN

100 mg

Suppository

Rectal use

Estonia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN RETARD 100 MG

100 mg

Prolonged-release tablet

Oral use

Estonia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

50 mg

Gastro-resistant tablet

Oral use

Estonia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

50 mg

Suppository

Rectal use

Estonia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

25 mg/ml

Solution for injection

Intramuscular use

Estonia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN SR

100 mg

Prolonged-release tablet

Oral use

Estonia

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac

ALMIRAL

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Estonia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

OLFEN DEPOCAPS

100 mg

Prolonged-release capsule, hard

Oral use

Estonia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

OLFEN DEPOCAPS

75 mg

Prolonged-release tablet

Oral use

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

CATAFLAM

50 mg

Coated tablet

Oral use

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN

25 mg/ml

Solution for injection

Intramuscular use

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN RETARD

100 mg

Prolonged-release tablet

Oral use

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN AKTI

12,5 mg

Film-coated tablet

Oral use

Estonia

| Pfizer Enterprises SARL |
| --- |
| Round-Point du Kirchberg |
| 51, Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| Luxembourg |

Pfizer Enterprises SARL

Round-Point du Kirchberg

51, Avenue J.F.Kennedy

L-1855 Luxembourg

Luxembourg

Diclofenac

Misoprostol

ARTHROTEC

50 mg

0,2 mg

Modified-release tablet

Oral use

Estonia

| Pharmaswiss Eesti OÜ |
| --- |
| Tammsaare tee 47 |
| 11316 Tallinn |
| Estonia |

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

Estonia

Diclofenac

DICLORAPID

75 mg

Gastro-resistant capsule, hard

Oral use

Estonia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC- RATIOPHARM 50 MG

50 mg

Gastro-resistant tablet

Oral use

Estonia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 50 MG

50 mg

Suppository

Rectal use

Estonia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 100 MG

100 mg

Suppository

Rectal use

Estonia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 75 MG/2 ML

75 mg/2 ml

Solution for injection

Intramuscular use

Estonia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM UNO

150 mg

Modified-release tablet

Oral use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC 100

100 mg

Suppository

Rectal use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC

25 mg/ml

Solution for injection

Intramuscular use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC ID 75 MG

75 mg

Modified-release tablet

Oral use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC ID 150 MG

150 mg

Modified-release tablet

Oral use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC 100 MG

100 mg

Prolonged-release tablet

Oral use

Estonia

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

DICUNO

25 mg

Film-coated tablet

Oral use

Estonia

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

DICUNO

50 mg

Film-coated tablet

Oral use

Finland

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenacum kalium

Diclofenac Rapid Orifarm

50 mg

Film-coated tablet

oral use

Finland

| ratiopharm Oy |
| --- |
| P.O.Box 67 |
| 02631 Espoo |
| Finland |

ratiopharm Oy

P.O.Box 67

02631 Espoo

Finland

Diclofenacum kalium

Diclomex Rapid

50 mg

Film-coated tablet

oral use

Finland

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenacum kalium

Dicuno

25 mg

Film-coated tablet

oral use

Finland

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenacum kalium

Dicuno

50 mg

Film-coated tablet

oral use

Finland

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenacum kalium

Eeze

25 mg

Film-coated tablet

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum kalium

Voltaren Rapid

25 mg

Coated tablet

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum kalium

Voltaren Rapid

50 mg

Coated tablet

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum kalium

Voltfast

50 mg

Powder for oral solution

oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diclofenacum natricum

Misoprostolum

Arthrotec

50 mg

0,2 mg

Tablet

oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diclofenacum natricum

Misoprostolum

Arthrotec Forte

75 mg

0,2 mg

Prolonged-release tablet

oral use

Finland

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenacum natricum

Diclofenac BMM Pharma

25 mg

Gastro-resistant tablet

oral use

Finland

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenacum natricum

Diclofenac BMM Pharma

50 mg

Gastro-resistant tablet

oral use

Finland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclomex

25 mg

Gastro-resistant tablet

oral use

Finland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclomex

50 mg

Gastro-resistant tablet

oral use

Finland

| Oy Stada Pharma Ab |
| --- |
| P.O.Box 1310 |
| 00101 Helsinki |
| Finland |

Oy Stada Pharma Ab

P.O.Box 1310

00101 Helsinki

Finland

Diclofenacum natricum

Motifene Dual

75 mg

Prolonged-release capsule

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

100 mg

Suppository

rectal use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

25 mg

Gastro-resistant tablet

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

25 mg/ml

Solution for injection /concentrate for solution for infusion

Intramuscular use, Intravenous use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

50 mg

Gastro-resistant tablet

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren Retard

100 mg

Prolonged-release tablet

oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren Retard

75 mg

Prolonged-release tablet

oral use

France

| Laboratoires Genevrier |
| --- |
| 280, rue de Goa |
| Les Trois Moulins - Parc de Sophia Antipolis |
| 06600 Antibes |
| France |

Laboratoires Genevrier

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

Diclofenac epolamine

FLECTOR 25 mg, granulés pour solution buvable en sachet-dose

25 mg

Granules for oral solution

Oral use

France

| Laboratoires Genevrier |
| --- |
| 280, rue de Goa |
| Les Trois Moulins - Parc de Sophia Antipolis |
| 06600 Antibes |
| France |

Laboratoires Genevrier

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

Diclofenac epolamine

FLECTOR 50 mg, granulés pour solution buvable en sachet-dose

50 mg

Granules for oral solution

Oral use

France

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé

12,5 mg

Film-coated tablet

Oral use

France

| NOVARTIS SANTE FAMILIALE |
| --- |
| 14, boulevard Richelieu |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS SANTE FAMILIALE

14, boulevard Richelieu

92500 Rueil-Malmaison

France

Diclofenac potassium

VOLTARENDOLO 12,5 mg, comprimé enrobé

12,5 mg

Coated tablet

Oral use

France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

Diclofenac sodium

DICLOFENAC ARROW 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Diclofenac sodium

DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant

50 mg

Film-coated gastro-resistant tablet

Oral use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Diclofenac sodium

DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

CRISTERS

22 quai Gallieni

92150 Suresnes

France

Diclofenac sodium

DICLOFENAC CRISTERS 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Diclofenac sodium

DICLOFENAC EG 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Diclofenac sodium

DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant

25 mg

Gastro-resistant tablet

Oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Diclofenac sodium

DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Diclofenac sodium

DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant

50 mg

Gastro-resistant coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Diclofenac sodium

DICLOFENAC TEVA 25 mg, comprimé enrobé gastro-résistant

25 mg

Gastro-resistant coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Diclofenac sodium

DICLOFENAC TEVA 50 mg, comprimé enrobé gastro-résistant

50 mg

Gastro-resistant coated tablet

Oral use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 100 mg, suppositoire

100 mg

Suppository

Rectal use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 25 mg, comprimé gastro-résistant

25 mg

Gastro-resistant tablet

Oral use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 50 mg, comprimé enrobé gastro-résistant

50 mg

Gastro-resistant coated tablet

Oral use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 75 mg/3 ml, solution injectable

75 mg/3 ml

Solution for injection

Intramuscular use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE ENFANT, suppositoire

25 mg

Suppository

Rectal use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée

100 mg

Prolonged-release coated tablet

Oral use

France

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée

75 mg

Prolonged-release coated tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

Diclofenac sodium

Misoprostol

ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant

50 mg

0,2 mg

Gastro-resistant tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

Diclofenac sodium

Misoprostol

ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant

75 mg

0,2 mg

Gastro-resistant tablet

Oral use

France

| TEVA GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Diclofenac sodium

Xelaran Brausetablette 25 mg

25 mg

Effervescent tablet

oral use

Germany

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 100 retard - 1 A Pharma

100 mg

Prolonged-release tablet

Oral use

Germany

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 25 - 1 A Pharma

25 mg

Gastro-resistant tablet

Oral use

Germany

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 50 - 1 A Pharma

50 mg

Gastro-resistant tablet

Oral use

Germany

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 75 SL - 1 A Pharma

75 mg

Prolonged-release tablet

Oral use

Germany

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclofenac- 1 A Pharma 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclofenac- 1 A Pharma 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 25 mg Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 50 mg Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 50 mg Trinktabletten

50 mg

Dispersible tablet

Oral use

Germany

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclo Divido

75 mg

Prolonged-release capsule, hard

Oral use

Germany

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclo-Divido long

75 mg

Prolonged-release capsule, hard

Oral use

Germany

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclofenac-Actavis 100 mg

100 mg

Prolonged-release capsule

Oral use

Germany

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclofenac-Actavis 50 mg

50 mg

Gastro-resistant capsule

Oral use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac kalium

Diclo AL akut 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 100

100 mg

Suppository

Rectal use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 25

25 mg

Gastro-resistant tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 50 Supp.

50 mg

Suppository

Rectal use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL i.m.

75 mg

Solution for injection

Intramuscular use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL retard

100 mg

Prolonged-release tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac kalium

Diclofenac-Kalium AL 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina dual 75 Kaps

75 mg

Capsule

Oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina uno 100

100 mg

Capsule

Oral use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| 01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Xelaran Brausetablette 50 mg

50 mg

Effervescent tablet

Oral use

Germany

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 50 mg

Tabletten

50 mg

Gastro-resistent tablet

Oral use

Germany

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl N 75

75 mg

Solution for injection

Intramuscular use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclo dispers

50 mg

Dispersible tablet

Oral use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 100

100 mg

Suppository

Rectal use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 100 retard

100 mg

Prolonged-release tablet

Oral use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 25

25 mg

Gastro-resistant tablet

Oral use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Muehlstr. 50 |
| 66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 100 mg Retardtablette

100 mg

Prolonged-release tablet

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Muehlstr. 50 |
| 66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Muehlstr. 50 |
| 66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 75 mg SF Injektionslösung

75 mg

Solution for injection

Intramuscular use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 100 mg Supp.

100 mg

Suppository

Rectal use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 25 mg Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Trinktabletten

50 mg

Dispersible tablet

Oral use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Supp.

50 mg

Suppository

Rectal use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 75 mg/2 ml Ampullen

75 mg

Solution for injection

Intramuscular use

Germany

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac kalium

Diclo-CT akut 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Germany

| Denk Pharma GmbH & Co. KG |
| --- |
| Prinzregentenstr. 79 |
| 81675 München |
| Germany |

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Diclofenac sodium

Diclo-Denk 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Denk Pharma GmbH & Co. KG |
| --- |
| Prinzregentenstr. 79 |
| 81675 München |
| Germany |

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Diclofenac sodium

DICLO-DENK 100 mg RETARD

100 mg

Prolonged-release tablet

Oral use

Germany

| Dexcel Pharma GmbH |
| --- |
| Carl-Zeiss-Str. 2 |
| 63755 Alzenau |
| Germany |

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Diclofenac sodium

Diclofenac Atid 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| Dexcel Pharma GmbH |
| --- |
| Carl-Zeiss-Str. 2 |
| 63755 Alzenau |
| Germany |

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Diclofenac sodium

Diclofenac Atid retard

100 mg

Prolonged-release tablet

Oral use

Germany

| DOCPHARM Arzneimittelvertrieb GmbH & Co. |
| --- |
| Kommanditgesellschaft auf Aktien |
| Greschbachstr. 7 |
| 76229 Karlsruhe |
| Germany |

DOCPHARM Arzneimittelvertrieb GmbH & Co.

Kommanditgesellschaft auf Aktien

Greschbachstr. 7

76229 Karlsruhe

Germany

Diclofenac sodium

Diclafenac PB retard 100 mg

100 mg

Prolonged-release tablet

Oral use

Germany

| Dolorgiet GmbH & Co. KG |
| --- |
| Otto-von-Guericke-Str. 1 |
| 53757 Sankt Augustin |
| Germany |

Dolorgiet GmbH & Co. KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Diclofenac sodium

Dolgit-Diclo 100

100 mg

Prolonged-release tablet

Oral use

Germany

| Dolorgiet GmbH & Co. KG |
| --- |
| Otto-von-Guericke-Str. 1 |
| 53757 Sankt Augustin |
| Germany |

Dolorgiet GmbH & Co. KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Diclofenac sodium

Dolgit-Diclo 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 100

100 mg

Suppository

Rectal use

Germany

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 25

25 mg

Gastro-resistant tablet

Oral use

Germany

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| 12277 Berlin |
| Germany |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 100

100 mg

Suppository

Rectal use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| 12277 Berlin |
| Germany |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 50

50 mg

Suppository

Rectal use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| 12277 Berlin |
| Germany |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| 12277 Berlin |
| Germany |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 75 akut

75 mg

Modified-release capsule, hard

Oral use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| 12277 Berlin |
| Germany |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD retard

100 mg

Prolonged-release tablet

Oral use

Germany

| hameln pharma plus gmbh |
| --- |
| Langes Feld 13 |
| 31789 Hameln |
| Germany |

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

Diclofenac sodium

Diclo-Weimer

75 mg

Solution for injection

Intramuscular use

Germany

| Hermes Arzneimittel GmbH |
| --- |
| Georg-Kalb-Str. 5-8 |
| 82049 Großhesselohe |
| Germany |

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Diclofenac sodium

Diclofenac Natrium HERMES 25 mg Brausetabletten

25 mg

Effervescent tablet

Oral use

Germany

| Hermes Arzneimittel GmbH |
| --- |
| Georg-Kalb-Str. 5-8 |
| 82049 Großhesselohe |
| Germany |

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Diclofenac sodium

Diclofenac Natrium HERMES 50 mg Brausetabletten

50 mg

Effervescent tablet

Oral use

Germany

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 100 Heumann Supp.

100 mg

Suppository

Rectal use

Germany

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 100 retard Heumenn

100 mg

Prolonged-release tablet

Oral use

Germany

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 25 Heumenn

25 mg

Gastro-resistant tablet

Oral use

Germany

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 50 Heumann

50 mg

Gastro-resistant tablet

Oral use

Germany

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 50 Heumenn Supp.

50 mg

Suppository

Rectal use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg

Solution for injection

Intramuscular use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 150 mg ID

150 mg

Prolonged-release tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 25

25 mg

Gastro-resistant tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 75 mg ID

75 mg

Prolonged-release tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac Dispers

50 mg

dispersible tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac potassium

Diclac Dolo 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac potassium

Diclac Dolo 25 mg

25 mg

Coated tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac retard

100 mg

Prolonged-release tablet

Oral use

Germany

| HIKMA Farmaceutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca |
| 2705-906 Terrugem SNT |
| Portugal |

HIKMA Farmaceutica (Portugal), S.A.

Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca

2705-906 Terrugem SNT

Portugal

Diclofenac sodium

Diclofenac Hikma 75 mg

75 mg

Solution for injection

Intramuscular use

Germany

| Juta Pharma GmbH |
| --- |
| Gutenbergstr. 13 |
| 24941 Flensburg |
| Germany |

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

Diclofenac sodium

Jutafenac 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

| Kappler Pharma Consult GmbH |
| --- |
| Fonyoder Str. 18 |
| 89340 Leipheim |
| Germany |

Kappler Pharma Consult GmbH

Fonyoder Str. 18

89340 Leipheim

Germany

Diclofenac potassium

Diclofen Kalium KPC 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

| KSK-Pharma Vertriebs AG |
| --- |
| Finkenstr. 1 |
| 76327 Pfinztal-Berghausen |
| Germany |

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Diclofenac sodium

Diclo KSK 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Diclofenac sodium

Diclofenac MEDA 25 mg Brausetabletten

25 mg

Effervescent tablet

Oral use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Diclofenac sodium

Diclofenac MEDA 50 mg Brausetabletten

50 mg

Effervescent tablet

Oral use

Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac Mylan 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| 81379 München |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Diclofenac NCH 25 mg

25 mg

Coated tablet

Oral use

Germany

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| 81379 München |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Optalidon Zahnschmerz mit Diclofenac 25 mg

25 mg

Coated tablet

Oral use

Germany

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| 81379 München |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| 81379 München |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo 25 mg

25 mg

Coated tablet

Oral use

Germany

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| 81379 München |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo 25 mg

25 mg

Coated tablet

Oral use

Germany

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| 81379 München |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo Liquid 12,5 mg

12,5 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Codein phosphate hemihydrate

Combaren 50 mg/50 mg Filmtabletten

50 mg

50 mg

Film-coated tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 100 mg retard

100 mg

Prolonged-release tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 25 mg Zäpfchen

25 mg

Suppository

Rectal use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren Dispers

50 mg

Dispersible tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac potassium

Voltaren K Migräne 50 mg

50 mg

Coated tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Codeine phosphate hemihydrate

Voltaren Plus 50 mg/50 mg Filmtabletten

50 mg

50 mg

Film-coated tablet

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac colestyramin

Voltaren Resinat

140 mg

Capsule, hard

Oral use

Germany

| Pharmacia GmbH |
| --- |
| Linkstrasse 10 |
| 10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

Diclofenac sodium

Misoprostol

Arthotec

50 mg

0,2 mg

Coated tablet

Oral use

Germany

| Pharmacia GmbH |
| --- |
| Linkstrasse 10 |
| 10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

Diclofenac sodium

Misoprostol

Arthotec forte

75 mg

0,2 mg

Coated tablet

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 100 mg Retardkapseln

100 mg

Prolonged-release capsule

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg Disperstabletten

50 mg

Dispersible tablet

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg SL Retardkapseln

75 mg

Prolonged-release capsule

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg/2 ml Injektionslösung

75 mg/2 ml

Solution for injection

Intramuscular use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac-ratiopharm Lösung bei Migräne

50 mg/1 ml

Oral drops, solution

Oral use

Germany

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac-ratiopharm Schmerztabletten 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

| Rotexmedica GmbH Arzneimittelwerk |
| --- |
| Bunsenstr. 4 |
| 22946 Trittau |
| Germany |

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

22946 Trittau

Germany

Diclofenac sodium

Diclofenac SF-Rotexmedica

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz parenteral 75 mg Injektionslösung

75 mg

Solution for injection

Intramuscular use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz Uno 150 mg Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Germany

| sigapharm GmbH |
| --- |
| Temmlerstr. 2 |
| 35039 Marburg/Lahn |
| Germany |

sigapharm GmbH

Temmlerstr. 2

35039 Marburg/Lahn

Germany

Diclofenac sodium

Sigafenac 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac Stada 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA N 75 mg/3 ml Injektionslösung

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac potassium

Diclofenac-Kalium STADA 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac potassium

Diclofenac-Kalium STADA 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

| T & D Pharma GmbH |
| --- |
| Kleine Knopheide 4 |
| 32657 Lemgo |
| Germany |

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

Diclofenac sodium

Allvoran 100 mg Retard

100 mg

Prolonged-release tablet

Oral use

Germany

| T & D Pharma GmbH |
| --- |
| Kleine Knopheide 4 |
| 32657 Lemgo |
| Germany |

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

Diclofenac sodium

Allvoran SF

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran S 100 mg

100 mg

Suppository

Rectal use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran S 50 mg

50 mg

Suppository

Rectal use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran uno

100 mg

Prolonged-release tablet

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclo-Klinge 75 mg magensaftresistente Hartkapsel

75 mg

Prolonged-release capsule, hard

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclo-Klinge 75 mg spezial

75 mg

Prolonged-release capsule, hard

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac spezial 100 mg Klinge

100 mg

Prolonged-release capsule, hard

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac spezial 75 mg Klinge

75 mg

Prolonged-release capsule, hard

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler 25 mg Hartkapseln

25 mg

Gastro-resistant capsule, hard

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler SL 100 mg Retardkapseln

100 mg

Prolonged-release capsule

Oral use

Germany

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler SL 75 mg Retardkapseln

75 mg

Prolonged-release capsule

Oral use

Germany

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 75 mg/3 ml Injektionslösung

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

| TEVA GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Diclofenac sodium

Xelaran Brausetablette 25 mg

25 mg

Effervescent tablet

Oral use

Germany

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Diclotin 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Diclotin 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Germany

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

Diclowal 100 mg retard

100 mg

Prolonged-release tablet

Oral use

Germany

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL 50

50 mg

Gastro-resistant tablet

Oral use

Germany

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL 75 mg

75 mg

Solution for injection

Intramuscular use

Germany

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL Supp.

100 mg

Suppository

Rectal use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 100 mg

100 mg

Suppository

Rectal use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 50 mg

50 mg

Suppository

Rectal use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam retard N

100 mg

Prolonged-release capsule, hard

Oral use

Germany

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 100 mg

100 mg

Prolonged-release tablet

Oral use

Germany

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 50 mg

50 mg

Gastro-resistant tablet

Oral use

Greece

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| Dilou 9, Peristeri |
| Attikis, 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9, Peristeri

Attikis, 12134

Greece

Diclofenac sodium

BATAFIL

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| PHARMATHEN International S.A. Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A. Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| DEMO ABEE |
| --- |
| 21ST Km National Highway |
| Athens-Lamia, 14565 |
| Greece |

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| RAFARM AEBE |
| --- |
| Korinthou 12 |
| N. Psychiko, 15451 |
| Greece |

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Greece |

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| MEDICUS S.A |
| --- |
| Valaoritou 10 |
| Metamorfosi 14452 |
| Greece |

MEDICUS S.A

Valaoritou 10

Metamorfosi 14452

Greece

Diclofenac sodium

DIFEND

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

25 mg

Enteric film-coated tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

100 mg

Film-coated sustained release tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

75 mg

Film-coated sustained release tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Dispersible tablet

Oral use

Greece

| PHARMATHEN International S.A. Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A. Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| PHARMATHEN International S.A. Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A. Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| D.A.S.T. BIOTECH Pharmaceutical Ltd |
| --- |
| Larissis 10 |
| Pallini 15351 |
| Greece |

D.A.S.T. BIOTECH Pharmaceutical Ltd

Larissis 10

Pallini 15351

Greece

Diclofenac sodium

FLEFARMIN

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

100 mg

Film-coated sustained release tablet

Oral use

Greece

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| DEMO ABEE |
| --- |
| 21ST Km National Highway |
| Athens-Lamia, 14565 |
| Greece |

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| DEMO ABEE |
| --- |
| 21ST Km National Highway |
| Athens-Lamia, 14565 |
| Greece |

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| RAFARM AEBE |
| --- |
| Korinthou 12 |
| N. Psychiko, 15451 |
| Greece |

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

50 mg

Coated tablet

Oral use

Greece

| RAFARM AEBE |
| --- |
| Korinthou 12 |
| N. Psychiko, 15451 |
| Greece |

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

25 mg

Coated tablet

Oral use

Greece

| ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Greece |

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Greece |

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

| Pfizer Hellas A.E. |
| --- |
| Messoghion Ave. 243 |
| Neo Psychiko 15451 |
| Greece |

Pfizer Hellas A.E.

Messoghion Ave. 243

Neo Psychiko 15451

Greece

Diclofenac sodium

Misoprostol

ARTHROTEC

50 mg

0,2 mg

Controlled release tablet

Oral use

Greece

| PHARMANEL COMMERCE PHARMACEUTICAL S.A. |
| --- |
| Marathonos Avenue 106, Gerakas 15344 |
| Greece |

PHARMANEL COMMERCE PHARMACEUTICAL S.A.

Marathonos Avenue 106, Gerakas 15344

Greece

Diclofenac sodium

FENOCLOF

75 mg

Controlled release capsule

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN ACTI-GO

25 mg

Coated tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN ACTI-GO

50 mg

Coated tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN ACTI-GO

12,5 mg

Coated tablet

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN FAST

50 mg

Powder for oral solution

Oral use

Greece

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

Diclofenac sodium

DICLO DUO

75 mg

Controlled release capsule

Oral use

Greece

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

Diclofenac sodium

COUNTERFLAME

75 mg

Gastro-resistant capsule

Oral use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Suppository

Rectal use

Greece

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

100 mg

Suppository

Rectal use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

50 mg

Suppository

Rectal use

Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi |
| Attikis, 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

100 mg

Suppository

Rectal use

Greece

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

50 mg

Suppository

Rectal use

Greece

| RAFARM AEBE |
| --- |
| Korinthou 12 |
| N. Psychiko, 15451 |
| Greece |

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

50 mg

Suppository

Rectal use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM belsőleges szuszpenziós cseppek

15 mg/ml

Oral drops, suspension

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM 50 mg bevont tabletta

50 mg

Coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM-V 50 mg tabletta

50 mg

Tablet

Oral use

Hungary

| Sandoz Hungária Kft., |
| --- |
| Bartók Béla út 43.-47. |
| Budapest, 1114 |
| Hungary |

Sandoz Hungária Kft.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

Diclofenac

DICLAC 75 mg retard tabletta

75 mg

Prolonged-release tablet

Oral use

Hungary

| Sandoz Hungária Kft., |
| --- |
| Bartók Béla út 43.-47. |
| Budapest, 1114 |
| Hungary |

Sandoz Hungária Kft.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

Diclofenac

DICLAC 150 mg retard tabletta

150 mg

Prolonged-release tablet

Oral use

Hungary

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 50 mg végbélkúp

50 mg

Suppository

Rectal use

Hungary

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 50 mg gyomornedv-ellenálló filmtabletta

50 mg

Gastro-resistant film-coated tablet

Oral use

Hungary

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 100 mg végbélkúp

100 mg

Suppository

Rectal use

Hungary

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 75 mg/3 ml oldatos injekció

75 mg/3 ml

Solution for injection

Parenteral use,

Intramuscular use

Hungary

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac

DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula

75 mg

Capsule, hard

Oral use

Hungary

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| Bad Vilbel 61118 |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

Diclofenac

DICLOFENAC STADA 100 mg retard filmtabletta

100 mg

Prolonged-release film-coated tablet

Oral use

Hungary

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 25 mg filmtabletta

25 mg

Film-coated tablet

Oral use

Hungary

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 100 mg retard kemény kapszula

100 mg

Prolonged-release capsule, hard

Oral use

Hungary

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 50 mg filmtabletta

50 mg

Film-coated tablet

Oral use

Hungary

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM retard tabletta

150 mg

Prolonged-release tablet

Oral use

Hungary

| TEVA Gyógyszergyár zRt. |
| --- |
| Pallagi út 13 |
| Debrecen 4042 |
| Hungary |

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

Diclofenac

DICLOFENAC-TEVA 100 mg végbélkúp

100 mg

Suppository

Rectal use

Hungary

| PANNONPHARMA Gyógyszergyártó Kft. |
| --- |
| PannonPharma út 1. |
| Pécsvárad 7720 |
| Hungary |

PANNONPHARMA Gyógyszergyártó Kft.

PannonPharma út 1.

Pécsvárad 7720

Hungary

Diclofenac

DICLOMEL SR 100 mg retard tabletta

100 mg

Prolonged-release tablet

Oral use

Hungary

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

NEODOLPASSE oldatos infúzió

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Parenteral use,

Intravenous use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 100 mg retard filmtabletta

100 mg

Prolonged-release film-coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 25 mg gyomornedv-ellenálló filmtabletta

25 mg

Gastro-resistant film-coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 50 mg gyomornedv-ellenálló filmtabletta

50 mg

Gastro-resistant film-coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 50 mg végbélkúp

50 mg

Suppository

Rectal use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 75 mg retard filmtabletta

75 mg

Prolonged-release film-coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 75 mg/3 ml oldatos injekció

75 mg/3 ml

Solution for injection

Parenteral use; Intramuscular injection or intravenous infusion. Not applicable for bolus intravenous injection

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 12,5 mg filmtabletta

12,5 mg

Film-coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 12,5 mg lágy kapszula

12,5 mg

Capsule, soft

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 25 mg bevont tabletta

25 mg

Coated tablet

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac potassium

VOLTAREN DOLO 25 mg lágy kapszula

25 mg

Capsule, soft

Oral use

Hungary

| IBSA Pharma Információs és Szolgáltató Kft. |
| --- |
| Fodor u. 54/B. |
| Budapest 1124, |
| Hungary |

IBSA Pharma Információs és Szolgáltató Kft.

Fodor u. 54/B.

Budapest 1124,

Hungary

Diclofenac

FLECTOR RAPID 50 mg granulátum

50 mg

Granules

Oral use

Hungary

| TEVA Gyógyszergyár zRt. |
| --- |
| Pallagi út 13 |
| Debrecen 4042 |
| Hungary |

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

Diclofenac

FORTEDOL 50 mg filmtabletta

50 mg

Film-coated tablet

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenacum natrium

Misoprostolum

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenacum natrium

Misoprostolum

Arthrotec Forte

75 mg

0,2 mg

Tablet

Oral use

Iceland

| ratiopharm GmbH |
| --- |
| Graf-Arco Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco Strasse 3

89079 Ulm

Germany

Diclofenacum INN natríum

Diclomex

50 mg

Gastro-resistant tablet

Oral use

Iceland

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenacum natrium

Diklofenak Mylan

50 mg

Gastro-resistant tablet

Oral use

Iceland

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum natrium

Klofen L

100 mg

Prolonged-release capsule, hard

Oral use

Iceland

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum natrium

Modifenac

75 mg

Modified-release capsule, hard

Oral use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

100 mg

Suppository

Rectal use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

25 mg/ml

Solution for injection

Intramuscular use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

50 mg

Suppository

Rectal use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Dolo

12,5 mg

Film-coated tablet

Oral use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Dolo

12,5 mg

Capsule, soft

Oral use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Dolo

25 mg

Coated tablet

Oral use

Iceland

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Rapid

50 mg

Coated tablet

Oral use

Iceland

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum kalium

Vóstar-S

25 mg

Film-coated tablet

Oral use

Iceland

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum kalium

Vóstar-S

50 mg

Film-coated tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 25 mg Gastro-Resistant Tablets

25 mg

Gastro-resistant tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 50 mg Gastro-Resistant Tablets

50 mg

Gastro-resistant tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 12,5 mg Suppositories

12,5 mg

Suppository

Rectal use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 100 mg Suppositories

100 mg

Suppository

Rectal use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Ampoules 75 mg/3 ml, solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Retard 100 mg Film-coated Prolonged Release Tablets

100 mg

Film-coated prolonged release tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Retard 75 mg Film-coated Prolonged-release Tablets

75 mg

Film-coated prolonged release tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassium

Cataflam 25 mg Coated Tablets

25 mg

Coated tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassium

Cataflam 50 mg Coated Tablets

50 mg

Coated tablet

Oral use

Ireland

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassium

Voltfast Sachets 50 mg Powder for Oral Solution

50 mg

Powder for oral solution

Oral use

Ireland

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Diclofenac potassium NCH 12,5 mg Film-coated tablets

12,5 mg

Film-coated tablet

Oral use

Ireland

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Otriflu 12,5 mg Film-coated Tablets

12,5 mg

Film-coated tablet

Oral use

Ireland

| Pinewood Laboratories Ltd |
| --- |
| (T/A Pinewood Heathcare) Ballymacarbry |
| Clonmel, Co. Tipperary |
| Ireland |

Pinewood Laboratories Ltd

(T/A Pinewood Heathcare) Ballymacarbry

Clonmel, Co. Tipperary

Ireland

Diclofenac sodium

Diclo 75 mg prolonged release tablets.

75 mg

Prolonged-release tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 75 mg Prolonged -Release Tablets

75 mg

Prolonged-release tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac Retard 100 mg Prolonged-release Tablets

100 mg

Prolonged-release tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 25 mg Gastro-resistant Tablets

25 mg

Gastro-resistant tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 50 mg Gastro-resistant Tablets

50 mg

Gastro-resistant tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 100 mg Suppositories

100 mg

Suppository

Rectal use

Ireland

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 25 mg/ml Solution for Injection 3 ml Ampoule

25 mg

Solution for injection

Intramuscular use

Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Diclofenac sodium

Arthrotec 50 modified release tablets

50 mg

Modified-release tablet

Oral use

Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Diclofenac sodium

Arthrotec 75 modified-release tablets

75 mg

Modified-release tablet

Oral use

Ireland

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 25 mg Capsules

25 mg

Capsule

Oral use

Ireland

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 50 mg Capsules

50 mg

Capsule

Oral use

Ireland

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 75 mg Dual Release Capsules

75 mg

Dual release capsule

Oral use

Ireland

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 100 mg Dual Release Capsules

100 mg

Dual release capsule

Oral use

Ireland

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion

75 mg/3 ml

Solution for injection or concentrate for solution for infusion

Intramuscular use, Intravenous use

Ireland

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 100 mg Suppositories

100 mg

Suppository

Rectal use

Ireland

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Kyflam 50 mg Film Coated Tablet

50 mg

Film-coated tablet

Oral use

Ireland

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac Sodium

Misoprostol

Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets

50 mg

0,2 mg

Modified Release Tablet

Oral use

Ireland

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac Sodium

Misoprostol

Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets

75 mg

0,2 mg

Modified Release Tablet

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

50 mg

Soluble tablet

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

50 mg

Gastro-resistant tablet

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

75 mg

Prolonged-release tablet

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

100 mg

Prolonged-release tablet

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

100 mg

Suppository

Rectal use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Industria Farmaceutica Galenica Senese S.r.l. |
| --- |
| Via Cassia Nord |
| 351 Darvia - 53014 Siena |
| Italy |

Industria Farmaceutica Galenica Senese S.r.l.

Via Cassia Nord

351 Darvia - 53014 Siena

Italy

Diclofenac sodico

ALGOSENAC

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Bayer S.p.a. |
| --- |
| Viale Certosa, 130 |
| Milano - 20156 |
| Italy |

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

Diclofenac hydroxyethylpyrrolidine

BAIFENAC

50 mg

Granules

Oral use

Italy

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

Diclofenac sodico

DEALGIC

75 mg

Prolonged-release capsule, hard

Oral use

Italy

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

Diclofenac sodico

DEALGIC

100 mg

Prolonged-release capsule, hard

Oral use

Italy

| DAICHI SANKYO Italia S.p.a. |
| --- |
| Via Paolo Di Dono 73 |
| 00142, Rome |
| Italy |

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodico

DEFLAMAT

25 mg/ml

Solution for injection

Intramuscular use

Italy

| DAICHI SANKYO Italia S.p.a. |
| --- |
| Via Paolo Di Dono 73 |
| 00142, Rome |
| Italy |

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodico

DEFLAMAT

75 mg

Prolonged-release capsule, hard

Oral use

Italy

| DAICHI SANKYO Italia S.p.a. |
| --- |
| Via Paolo Di Dono 73 |
| 00142, Rome |
| Italy |

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodico

DEFLAMAT

100 mg

Prolonged-release capsule, hard

Oral use

Italy

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

Diclofenac sodico

DICLOFAN

100 mg

Prolonged-release tablet

Oral use

Italy

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

Diclofenac sodico

DICLOFAN

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodico

DICLOFENAC

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodico

DICLOFENAC

100 mg

Suppository

Rectal use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

50 mg

Suppository

Rectal use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

100 mg

Suppository

Rectal use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

25 mg

Tablet

Oral use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

50 mg

Tablet

Oral use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

100 mg

Prolonged-release tablet

Oral use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

150 mg

Prolonged-release capsule

Oral use

Italy

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

25 mg/ml

Oral drops, solution

Oral use

Italy

| Almus S.r.l. |
| --- |
| Via Cesarea, 11/10 |
| Genova - 16121 |
| Italy |

Almus S.r.l.

Via Cesarea, 11/10

Genova - 16121

Italy

Diclofenac sodico

DICLOFENAC ALMUS

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

100 mg

Suppository

Rectal use

Italy

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

50 mg

Gastro-resistant tablet

Oral use

Italy

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

25 mg

Gastro-resistant tablet

Oral use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC DOC

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC DOC GENERICI

75 mg

Prolonged-release tablet

Oral use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC DOC GENERICI

100 mg

Prolonged-release tablet

Oral use

Italy

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

50 mg

Gastro-resistant tablet

Oral use

Italy

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

100 mg

Prolonged-release tablet

Oral use

Italy

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

100 mg

Suppository

Rectal use

Italy

| Germed Pharma S.p.a. |
| --- |
| Via Cantu, 11, Balsamo |
| Milano, 20092 |
| Italy |

Germed Pharma S.p.a.

Via Cantu, 11, Balsamo

Milano, 20092

Italy

Diclofenac sodico

DICLOFENAC GERMED

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

100 mg

Suppository

Rectal use

Italy

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

50 mg

Gastro-resistant tablet

Oral use

Italy

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

25 mg

Gastro-resistant tablet

Oral use

Italy

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC MYLAN GENERICS

100 mg

Prolonged-release tablet

Oral use

Italy

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC MYLAN GENERICS

100 mg

Suppository

rectal use

Italy

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodico

DICLOFENAC SODICO

100 mg

Prolonged-release tablet

Oral use

Italy

| Biologici Italia Laboratories S.r.l. |
| --- |
| Via Serpero, 2 |
| Masate, Milano - 20060 |
| Italy |

Biologici Italia Laboratories S.r.l.

Via Serpero, 2

Masate, Milano - 20060

Italy

Diclofenac sodico

DICLOFENAC SODICO BIL

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

50 mg

Suppository

rectal use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

100 mg

Suppository

rectal use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

100 mg

Prolonged-release tablet

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

150 mg

Prolonged-release capsule, hard

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

50 mg

Granules

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

50 mg

Gastro-resistant tablet

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

25 mg/ml

Oral drops, solution

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

46,5 mg/ml

Oral drops, solution

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac hydroxyethylpyrrolidine

DIEP

25 mg

Gastro-resistant tablet

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac hydroxyethylpyrrolidine

DIEP

25 mg

Granules for oral suspension

Oral use

Italy

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac potassico

EMINOCS

50 mg

Oral drops, solution

Oral use

Italy

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodico

FENADOL

100 mg

Prolonged-release tablet

Oral use

Italy

| Wellington Street Development Pharma Limited |
| --- |
| 47 Oaklands Drive Rathgar |
| Dublin 6 |
| Ireland |

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

Diclofenac sodico

FENDER

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Wellington Street Development Pharma Limited |
| --- |
| 47 Oaklands Drive Rathgar |
| Dublin 6 |
| Ireland |

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

Diclofenac sodico

FENDER

100 mg

Prolonged-release tablet

Oral use

Italy

| Bayer S.p.a. |
| --- |
| Viale Certosa, 130 |
| Milano - 20156 |
| Italy |

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

Diclofenac hydroxyethylpyrrolidine

FLECTOR DOLORE

25 mg

Granules for oral solution

Oral use

Italy

| Menarini Industrie Farmaceutiche Riunite S.r.l. |
| --- |
| Via Sette Santi 3, |
| Firenze 50131- Italy |

Menarini Industrie Farmaceutiche Riunite S.r.l.

Via Sette Santi 3,

Firenze 50131- Italy

Diclofenac sodico

FLOGOFENAC

100 mg

Prolonged-release capsule, hard

Oral use

Italy

| FIDIA Farmaceutici S.p.a. |
| --- |
| Via Ponte della Fabbrica |
| 3/a, Abano Terme |
| Padova - 35031 |
| Italy |

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica

3/a, Abano Terme

Padova - 35031

Italy

Diclofenac potassico

ITAMIFAST

25 mg

Film-coated tablet

Oral use

Italy

| FIDIA Farmaceutici S.p.a. |
| --- |
| Via Ponte della Fabbrica |
| 3/a, Abano Terme |
| Padova - 35031 |
| Italy |

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica

3/a, Abano Terme

Padova - 35031

Italy

Diclofenac potassico

ITAMIFAST

50 mg

Film-coated tablet

Oral use

Italy

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

Diclofenac potassico

KAPPADI

25 mg

Film-coated tablet

Oral use

Italy

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

Diclofenac potassico

KAPPADI

50 mg

Film-coated tablet

Oral use

Italy

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodico

NOVAPIRINA

25 mg

Coated tablet

Oral use

Italy

| O. P. PHARMA S.r.l. |
| --- |
| Via Torino 51 |
| Milano - 20123 |
| Italy |

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

Diclofenac sodico

TRAULEN

100 mg

Film-coated tablet

Oral use

Italy

| O. P. PHARMA S.r.l. |
| --- |
| Via Torino 51 |
| Milano - 20123 |
| Italy |

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

Diclofenac sodico

TRAULEN

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodico

VOLTADVANCE

25 mg

Powder for oral solution

Oral use

Italy

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodico

VOLTADVANCE

25 mg

Film-coated tablet

Oral use

Italy

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassico

VOLTFAST

50 mg

Coated tablet

Oral use

Italy

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassico

VOLTFAST

25 mg

Coated tablet

Oral use

Italy

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassico

VOLTFAST

50 mg

Granules for oral solution

Oral use

Italy

| Altergon Italia S.r.l. |
| --- |
| Via Dell'Industria |
| Pietradefusi - 83030 Avellino |
| Italy |

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

Diclofenac

INFORCE

75 mg/ml

Solution for injection

Intramuscular use, Subcutaneous use

Italy

| Altergon Italia S.r.l. |
| --- |
| Via Dell'Industria |
| Pietradefusi - 83030 Avellino |
| Italy |

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

Diclofenac sodico

INDICAM

75 mg/ml

Solution for injection

Intramuscular use, Subcutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo 71 |
| Latina 04100 |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

MISOFENAC

50 mg

0,2 mg

Tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo 71 |
| Latina 04100 |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

MISOFENAC

75 mg

0,2 mg

Modified-release tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo 71 |
| Latina 04100 |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

ARTROTEC

50 mg

0,2 mg

Tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo 71 |
| Latina 04100 |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

ARTROTEC

75 mg

0,2 mg

Modified-release tablet

Oral use

Italy

| HEXAL AG S.p.a. |
| --- |
| Industriestrasse, 25, D-83607 |
| HOLZKIRCHEN |
| Germany |

HEXAL AG S.p.a.

Industriestrasse, 25, D-83607

HOLZKIRCHEN

Germany

Diclofenac sodico

DICLOFENAC HEXAL AG

100 mg

Prolonged-release tablet

oral use

Italy

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodico

DICLOFENAC RATIOPHARM

50 mg

Gastro-resistant tablet

oral use

Italy

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodico

DICLOFENAC RATIOPHARM

75 mg/3 ml

solution for injection

Intramuscular use

Latvia

| Cipla (UK) Ltd |
| --- |
| The Old Post House |
| Heath Road, Weybridge |
| Surrey KT138TS |
| United Kingdom |

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Profenac 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Latvia

| Cipla (UK) Ltd |
| --- |
| The Old Post House |
| Heath Road, Weybridge |
| Surrey KT138TS |
| United Kingdom |

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Profenac SR 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm 25 mg gastro-resistant tablets

25 mg

Gastro-resistant tablet

Oral use

Latvia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm uno 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Latvia

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm 75 mg/2 ml solution for injection

75 mg/2 ml

Solution for injection

Intramuscular use

Latvia

| Cipla (UK) Ltd |
| --- |
| The Old Post House |
| Heath Road, Weybridge |
| Surrey KT138TS |
| United Kingdom |

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Diclogen 50 mg suppositories

50 mg

Suppository

Rectal use

Latvia

| Cipla (UK) Ltd |
| --- |
| The Old Post House |
| Heath Road, Weybridge |
| Surrey KT138TS |
| United Kingdom |

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Diclogen 100 mg suppositories

100 mg

Suppository

Rectal use

Latvia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac 75 mg/3 ml solution for injection/infusion

75 mg/3 ml

Solution for injection and infusion

Intramuscular use, Intravenous use

Latvia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac 100 mg modified release tablets

100 mg

Modified-release tablet

Oral use

Latvia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac ID 75 mg modified release tablets

75 mg

Modified-release tablet

Oral use

Latvia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac ID 150 mg modified release tablets

150 mg

Modified-release tablet

Oral use

Latvia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Diclomelan retard 100 mg sustained-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Diclomelan 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Diclomelan 100 mg suppositories

100 mg

Suppository

Rectal use

Latvia

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Thiamini hydrochloridum

Pyridoxini hydrochloridum

Cyanocobalaminum

Diclovit hard capsules

50 mg

50 mg

50 mg

0,25 mg

Capsule, hard

Oral use

Latvia

| SIA Briz |
| --- |
| Rasas iela 5 |
| Riga, LV-1057 |
| Latvia |

SIA Briz

Rasas iela 5

Riga, LV-1057

Latvia

Diclofenacum natricum

Feloran 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Latvia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Lidocainum hydrochloridum

Olfen 75 mg/20 mg/2 ml solution for injection

75 mg/2 ml

20 mg/2 ml

Solution for injection

Intramuscular use

Latvia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Lactab 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Depocaps 100 mg prolonged-release capsules, hard

100 mg

Prolonged-release capsule, hard

Oral use

Latvia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Rectocaps 100 mg rectal capsules

100 mg

Rectal capsule

Rectal use

Latvia

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Depotabs 75 mg prolonged release tablets

75 mg

Prolonged-release tablet

Oral use

Latvia

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno 25 mg film-coated tablets

25 mg

Film-coated tablet

Oral use

Latvia

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno 50 mg film-coated tablets

50 mg

Film-coated tablet

Oral use

Latvia

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Latvia

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 100 mg suppositories

100 mg

Suppository

rectal use

Latvia

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl retard 100 mg prolonged release capsules

100 mg

Prolonged-release capsule

Oral use

Latvia

| Pharmaceutical Works POLPHARMA SA |
| --- |
| ul. Pelplińska 19 |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

Diclofenacum natricum

Majamil retard 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

| A/S “Olainfarm” |
| --- |
| Rupnicu iela 5 |
| Olaine, LV – 2114 |
| Latvia |

A/S “Olainfarm”

Rupnicu iela 5

Olaine, LV – 2114

Latvia

Diclofenac potassium

Dikloferol 50 mg coated tablets

50 mg

Coated tablet

Oral use

Latvia

| SIA PharmaSwiss Latvia |
| --- |
| Gertrudes iela 54 – 5 |
| Riga, LV 1011 |
| Latvia |

SIA PharmaSwiss Latvia

Gertrudes iela 54 – 5

Riga, LV 1011

Latvia

Diclofenacum natricum

Diclorapid 75 mg gastro-resistant capsules, hard

75 mg

Gastro-resistant capsule, hard

Oral use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassium

Voltaren Akti 12,5 mg film-coated tablets

12,5 mg

Film-coated tablet

Oral use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassium

Voltaren Akti 25 mg soft capsules

25 mg

Capsule, soft

Oral use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren Retard 100 mg modified-release film-coated tablets

100 mg

Modified-release tablet

Oral use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassium

Cataflam 50 mg film-coated tablets

50 mg

Film-coated tablet

Oral use

Latvia

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

Diclofenacum natricum

Diclofenac 50 mg suppositories

50 mg

Suppository

Rectal use

Latvia

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

Diclofenacum natricum

Diclofenac 100 mg suppositories

100 mg

Suppository

Rectal use

Latvia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen SR 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Latvia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum natricum

Almiral 25 mg/ml solution for injection and infusion

25 mg/ml

Solution for injection and infusion

Intramuscular use, Intravenous use

Latvia

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenacum natricum

Diclo CT 75 mg/2 ml solution for injection

75 mg/2 ml

Solution for injection

Intramuscular use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac

100 mg

Prolonged-release tablet

Oral use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac ID

75 mg

Modified-release tablet

Oral use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac ID

150 mg

Modified-release tablet

Oral use

Lithuania

| UAB „PharmaSwiss“ |
| --- |
| Šeimyniškių g. 21B |
| LT-09200, Vilnius |
| Lithuania |

UAB „PharmaSwiss“

Šeimyniškių g. 21B

LT-09200, Vilnius

Lithuania

Diclofenac

DicloRapid

75 mg

Gastro-resistant capsule, hard

Oral use

Lithuania

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

75 mg/3 ml

Solution for injection

Intramuscular use

Lithuania

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

50 mg

Gastro-resistant tablet

Oral use

Lithuania

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

100 mg

Suppository

Rectal use

Lithuania

| UAB „BERLIN CHEMIE MENARINI BALTIC“ |
| --- |
| Jasinskio g. 16 a, |
| 01112 Vilnius |
| Lithuania |

UAB „BERLIN CHEMIE MENARINI BALTIC“

Jasinskio g. 16 a,

01112 Vilnius

Lithuania

Diclofenac

Dicloberl retard

100 mg

Prolonged-release capsule, hard

Oral use

Lithuania

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

50 mg

Gastro-resistant tablet

Oral use

Lithuania

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

100 mg

Suppository

Rectal use

Lithuania

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

50 mg

Suppository

Rectal use

Lithuania

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

75 mg/2 ml

Solution for injection

Intramuscular use

Lithuania

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

100 mg

Prolonged-release capsule, hard

Oral use

Lithuania

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm uno

150 mg

Modified-release tablet

Oral use

Lithuania

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan

100 mg

Suppository

Rectal use

Lithuania

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan

50 mg

Gastro-resistant tablet

Oral use

Lithuania

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan retard

100 mg

Prolonged-release tablet

Oral use

Lithuania

| UAB Corpus Medica |
| --- |
| Sukilėlių pr. 61 |
| LT-49333 Kaunas |
| Lithuania |

UAB Corpus Medica

Sukilėlių pr. 61

LT-49333 Kaunas

Lithuania

Diclofenac

FELORAN

75 mg/3 ml

Solution for injection

Intramuscular use

Lithuania

| Actavis Nordic A/S |
| --- |
| Ørnegårdsvej 16 |
| DK-2820 Gentofte |
| Denmark |

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Feloran

100 mg

Prolonged-release tablet

Oral use

Lithuania

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

75 mg/3 ml

Solution for injection

Intramuscular use

Lithuania

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

50 mg

Gastro-resistant tablet

Oral use

Lithuania

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

50 mg

Suppository

Rectal use

Lithuania

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen SR

100 mg

Prolonged-release tablet

Oral use

Lithuania

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Depocaps

100 mg

Prolonged-release capsule, hard

Oral use

Lithuania

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Depotabs

75 mg

Prolonged-release tablet

Oral use

Lithuania

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Lactab

50 mg

Gastro-resistant coated tablet

Oral use

Lithuania

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Rectocaps

100 mg

Rectal capsule

Rectal use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren

100 mg

Suppository

Rectal use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

25 mg

Coated tablet

Oral use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

12,5 mg

Film-coated tablet

Oral use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

25 mg

Capsule, soft

Oral use

Lithuania

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Cataflam

50 mg

Coated tablet

Oral use

Lithuania

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

25 mg

Film-coated tablet

Oral use

Lithuania

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

50 mg

Film-coated tablet

Oral use

Lithuania

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Lidocaine

Olfen

75 mg/2 ml

20 mg/2 ml

Solution for injection

Intramuscular use

Lithuania

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Thiamine

Pyridoxine

Cyanocobalamin

Diclovit

50 mg

50 mg

50 mg

0,25 mg

Capsule, hard

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassium

Cataflam

50 mg

Coated tablet

Oral use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac retard 100

100 mg

Prolonged-release tablet

Oral use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 75 mg/3 ml Injektionslösung

75 mg

solution for injection

Intramuscular use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-100 Zäpfchen

100 mg

suppository

Rectal use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-25

25 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-50 Zäpfchen

50 mg

suppository

Rectal use

Luxembourg

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG-25

25 mg

Coated tablet

Oral use

Luxembourg

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG-50

50 mg

Coated tablet

Oral use

Luxembourg

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG retard 75

75 mg

Prolonged-release tablet

Oral use

Luxembourg

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG retard 100

100 mg

Prolonged-release tablet

Oral use

Luxembourg

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG 75 mg/3 ml solution injectable

75 mg

solution for injection

Intramuscular use, Intravenous use

Luxembourg

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG 100 suppositoire

100 mg

suppository

Rectal use

Luxembourg

| Mylan bvba |
| --- |
| Rozendal Businesspark |
| Terhulpsesteenweg 6A |
| B-1560 Hoeilaart |
| Belgium |

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

Diclofenac Mylan-75 Retard

75 mg

Prolonged-release tablet

Oral use

Luxembourg

| Mylan bvba |
| --- |
| Rozendal Businesspark |
| Terhulpsesteenweg 6A |
| B-1560 Hoeilaart |
| Belgium |

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

Diclofenac Mylan-100 Retard

100 mg

Prolonged-release tablet

Oral use

Luxembourg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-100 Zäpfchen

100 mg

suppository

Rectal use

Luxembourg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-25

25 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung

75 mg

solution for injection

Intramuscular use

Luxembourg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Retard Ratiopharm-100

100 mg

Prolonged-release capsule, hard

Oral use

Luxembourg

| Daiichi Sankyo Belgium SA |
| --- |
| Rue Fond Jean Pâques 5 |
| B-1348 Louvain-la-Neuve |
| Belgium |

Daiichi Sankyo Belgium SA

Rue Fond Jean Pâques 5

B-1348 Louvain-la-Neuve

Belgium

Diclofenac sodium

Motifene-75

75 mg

Modified- release capsule, hard

Oral use

Luxembourg

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

Diclofenac sodium

Polyflam-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

Diclofenac sodium

Polyflam-75

75 mg

Prolonged-release tablet

Oral use

Luxembourg

| Continental Pharma |
| --- |
| Rijksweg, 12 |
| B-2870 Puurs |
| Belgium |

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

Arthrotec-50

50 mg

0,2 mg

Modified-release capsule, hard

Oral use

Luxembourg

| Continental Pharma |
| --- |
| Rijksweg, 12 |
| B-2870 Puurs |
| Belgium |

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

Arthrotec-75

75 mg

0,2 mg

Modified-release capsule, hard

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-100 Zäpfchen

100 mg

suppository

Rectal use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-25

25 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren injekt

75 mg

solution for injection

Intramuscular use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac colestyramine

Voltaren resinat

145,6 mg

Capsule, hard

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren Retard-100

100 mg

Prolonged-release tablet

Oral use

Luxembourg

| Novartis Consumer Health S.A. |
| --- |
| Medialaan, 40 |
| B-1800 Vilvoorde |
| Belgium |

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

Diclofenac potassium

Voltatabs

12,5 mg

Coated tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

Cataflam

25 mg

Coated tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

Cataflam

50 mg

Coated tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

Catafast

50 mg

Powder for oral solution

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

12,5 mg

Suppository

Rectal use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Suppository

Rectal use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

100 mg

Suppository

Rectal use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

75 mg/3 ml

Solution for injection

Intramuscular use, intravenous use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Dispersible tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

75 mg

Modified-release tablet

Oral use

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

100 mg

Modified-release tablet

Oral use

Malta

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

Fenadol

100 mg

Suppository

Rectal use

Malta

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

Fenadol

100 mg

Modified-release tablet

Oral use

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac potassium

Areston

50 mg

Film-coated tablet

Oral use

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 25 mg tablets

25 mg

Gastro-resistant tablet

Oral use

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 50 mg tablets

50 mg

Gastro-resistant tablet

Oral use

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral injection

75 mg/3 ml

Solution for Injection or Infusion

Intramuscular use, intravenous use

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-75 Ampoules

75 mg/2 ml

Solution for injection

Intramuscular use

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-25 Lactab

25 mg

Film-coated, gastro-resistant tablet

Oral use

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-50 Lactab

50 mg

Film-coated, gastro-resistant tablet

Oral use

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-100 Rectocaps

100 mg

Suppository

Rectal use

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-75 SR Depotabs

75 mg

Modified-release tablet

Oral use

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-100 SR Depocaps

100 mg

Modified-release capsule

Oral use

Malta

| Remedica Ltd |
| --- |
| Limassol Industrial Estate |
| Aharnon Street |
| PO Box 51706 |
| CY-3508 Limassol |
| Cyprus |

Remedica Ltd

Limassol Industrial Estate

Aharnon Street

PO Box 51706

CY-3508 Limassol

Cyprus

Diclofenac sodium

Remethan 25 mg Tablets

25 mg

Gastro-resistant tablet

Oral use

Malta

| DEMO SA Pharmaceutical Industry |
| --- |
| 21st km National Road |
| Athens-Lamia 14568 |
| Athens |
| Greece |

DEMO SA Pharmaceutical Industry

21st km National Road

Athens-Lamia 14568

Athens

Greece

Diclofenac sodium

Urigon 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Norway

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassium

Diclofenackalium Orifarm

25 mg

Film-coated tablet

Oral use

Norway

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassium

Diclofenackalium Orifarm

50 mg

Film-coated tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

12,5 mg

Capsule, soft

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

25 mg

Capsule, soft

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

12,5 mg

Film-coated tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

25 mg

Coated tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Cataflam

12,5 mg

Coated tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Cataflam

50 mg

Coated tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Cataflam

50 mg

Powder for oral solution

Oral use

Norway

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

25 mg

Film-coated tablet

Oral use

Norway

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

50 mg

Film-coated tablet

Oral use

Norway

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Difenassium

25 mg

Film-coated tablet

Oral use

Norway

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Difenassium

50 mg

Film-coated tablet

Oral use

Norway

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac Actavis

12,5 mg

Film-coated tablet

Oral use

Norway

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac sodium

Modifenac

75 mg

Modified- release capsule, hard

Oral use

Norway

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

DiclofenacKalium ratiopharm

50 mg

Film-coated tablet

Oral use

Norway

| Pfizer AS |
| --- |
| Lilleakerveien 2B |
| 1324 Lysaker |
| Norway |

Pfizer AS

Lilleakerveien 2B

1324 Lysaker

Norway

Diclofenac sodium

Misoprostol

Arthrotec

50 mg

0,2 mg

Modified-release tablet

Oral use

Norway

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac ratiopharm

25 mg

Gastro-resistant tablet

Oral use

Norway

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac ratiopharm

50 mg

Gastro-resistant tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg/ml

Solution for infusion /Concentrate for solution for infusion

Parenteral use

Norway

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Gastro-resistant tablet

Oral use

Norway

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Gastro-resistant tablet

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg

Suppository

Rectal use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

50 mg

Suppository

Rectal use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

100 mg

Suppository

Rectal use

Poland

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Vostar

12,5 mg

Film-coated tablet

Oral use

Poland

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

Dicloreum

50 mg

Gastro-resistant film-coated tablet

Oral use

Poland

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

Dicloreum

25 mg/ml

Solution for injection

Intramuscular use

Poland

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

Dicloreum retard

100 mg

Prolonged-release capsule

Oral use

Poland

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl retard

100 mg

Prolonged-release capsule

Oral use

Poland

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 50

50 mg

Suppository

Rectal use

Poland

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

Diclofenacum natricum

Diclofenac GSK

50 mg

Suppository

Rectal use

Poland

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

Diclofenacum natricum

Diclofenac GSK

100 mg

Suppository

Rectal use

Poland

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen

25 mg/ml

Solution for injection

Intramuscular use

Poland

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen Duo

75 mg

Prolonged-release capsule

Oral use

Poland

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 100

100 mg

Rectal capsule

Rectal use

Poland

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 50

50 mg

Rectal capsule

Rectal use

Poland

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Lidocaini hydrochloridum

Olfen 75

37,5 mg/ml

10 mg/ml

Solution for injection

Intramuscular use

Poland

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 100 SR

100 mg

Prolonged-release capsule

Oral use

Poland

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 25

25 mg

Film-coated tablet

Oral use

Poland

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 50

50 mg

Film-coated tablet

Oral use

Poland

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Acti

12,5 mg

Film-coated tablet

Oral use

Poland

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Express

12,5 mg

Capsule, soft

Oral use

Poland

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Acti Forte

25 mg

Film-coated tablet

Oral use

Poland

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Express Forte

25 mg

Capsule, soft

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassium

Cataflam 50

50 mg

Film-coated tablet

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren SR 100

100 mg

Prolonged-release tablet

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren SR 75

75 mg

Prolonged-release tablet

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

50 mg

Suppository

Rectal use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

25 mg

Suppository

Rectal use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

100 mg

Suppository

Rectal use

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenacum

Misoprostolum

Arthrotec Forte

75 mg

0,2 mg

Tablet

Oral use

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenacum natricum

Misoprostolum

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Poland

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum natricum

DicloDuo

75 mg

Modified-release capsule

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio Retard 100

100 mg

Prolonged-release capsule

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 25

25 mg

Gastro-resistant tablet

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Lidocainum

Dicloratio

75 mg/2 ml

20 mg/2 ml

Solution for injection

Intramuscular use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 50

50 mg

Gastro-resistant tablet

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Olfen UNO

150 mg

Prolonged-release capsule

Oral use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 100

100 mg

Suppository

Rectal use

Poland

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 50

50 mg

Suppository

Rectal use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac

75 mg/3 ml

Solution for injection

Intramuscular use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 75 Duo

75 mg

Modified-release tablet

Oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 150 Duo

150 mg

Modified-release tablet

Oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 100

100 mg

Suppository

Rectal use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 50

50 mg

Suppository

Rectal use

Poland

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

25 mg

Film-coated tablet

Oral use

Poland

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

50 mg

Film-coated tablet

Oral use

Poland

| Warszawskie Zakłady Farmaceutyczne POLFA S.A. |
| --- |
| ul. Karolkowa 22/24 |
| Warszawa 01-207 |
| Poland |

Warszawskie Zakłady Farmaceutyczne POLFA S.A.

ul. Karolkowa 22/24

Warszawa 01-207

Poland

Diclofenacum natricum

Difadol

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Poland

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

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

Starogard Gdański 83-200

Poland

Diclofenacum natricum

Majamil prolongatum

100 mg

Prolonged-release capsule

Oral use

Poland

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

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

Starogard Gdański 83-200

Poland

Diclofenacum natricum

Majamil PPH

25 mg

Gastro-resistant tablet

Oral use

Poland

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

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

Starogard Gdański 83-200

Poland

Diclofenacum natricum

Majamil PPH

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Diclofenac

Misoprostol

Arthrotec 75

75 mg

0,2 mg

Modified-release tablet

Oral use

Portugal

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina

Portugal

Diclofenac

Diclofenac Alter 50 mg Comprimidos

50 mg

Coated tablet

Oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| Portugal |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Diclofenac

Diclofenac Generis 50 mg Comprimidos Revestidos

50 mg

Coated tablet

Oral use

Portugal

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

100 mg

Suppository

Rectal use

Portugal

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Campo de Besteiros |
| 3465-051 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Campo de Besteiros

3465-051 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal 75 mg/3 ml Solução injectável

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Portugal

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro Borges |
| Edíficio Arquiparque 1 |
| R/C Esqo |
| 1499-016 Algés |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro Borges

Edíficio Arquiparque 1

R/C Esqo

1499-016 Algés

Portugal

Diclofenac

Diclofenac Mylan

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Ratiopharm

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Ratiopharm 100 mg Supositórios

100 mg

Suppository

Rectal use

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Retard Ratiopharm

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura |
| Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura

Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Diclofenac

Diclofenac Sandoz 50 mg Comprimidos revestidos

50 mg

Coated tablet

Oral use

Portugal

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Dolacen

75 mg/2 ml

Solution for injection

Intramuscular use

Portugal

| Laboratório B. A. Farma, Lda. |
| --- |
| Rua Prof. Sousa da Câmara, 207 - 211 |
| 1074-803 Lisboa |
| Portugal |

Laboratório B. A. Farma, Lda.

Rua Prof. Sousa da Câmara, 207 - 211

1074-803 Lisboa

Portugal

Diclofenac

Dorcalor

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

75 mg/2 ml

Solution for injection

Intramuscular use

Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

100 mg

Suppository

Rectal use

Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V Retard

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Portugal

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

100 mg

Suppository

Rectal use

Portugal

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril Retard

100 mg

Prolonged-release tablet

Oral use

Portugal

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Confar - Consórcio Farmacêutico, Lda. |
| --- |
| Rua Félix Correia, 1-B |
| 1500-271 Lisboa |
| Portugal |

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex 25

25 mg

Coated tablet

Oral use

Portugal

| Confar - Consórcio Farmacêutico, Lda. |
| --- |
| Rua Félix Correia, 1-B |
| 1500-271 Lisboa |
| Portugal |

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex 50

50 mg

Coated tablet

Oral use

Portugal

| Confar - Consórcio Farmacêutico, Lda. |
| --- |
| Rua Félix Correia, 1-B |
| 1500-271 Lisboa |
| Portugal |

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex R

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

100 mg

Suppository

Rectal use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren 75

75 mg

Prolonged-release tablet

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Portugal

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Cataflam

50 mg

Coated tablet

Oral use

Portugal

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Otriflu

12,5 mg

Coated tablet

Oral use

Portugal

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 12,5

12,5 mg

Film-coated tablet

Oral use

Portugal

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 12,5

12,5 mg

Capsule, soft

Oral use

Portugal

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 25

25 mg

Capsule, soft

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren Rapid

50 mg

Coated tablet

Oral use

Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V Dispersivel

46,5 mg

Dispersible tablet

Oral use

Romania

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum

DICLOFENAC DUO PHARMASWISS 75 mg

75 mg

Prolonged-release capsule, hard

Oral use

Romania

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum

DICLOREUM 150 mg

150 mg

Prolonged-release capsule, hard

Oral use

Romania

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 50 mg

50 mg

Gastro-resistant capsule, soft

Oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca 400 632 |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOTARD® 100 mg

100 mg

Prolonged-release tablet

Oral use

Romania

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenacum

DICLAC® 75 ID

75 mg

Modified-release tablet

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® RETARD

100 mg

Prolonged-release tablet

Oral use

Romania

| STADA HEMOFARM S.R.L. |
| --- |
| Str. Zugrav Nedelcu nr. 3, Timișoara |
| Județul Timiș |
| România |

STADA HEMOFARM S.R.L.

Str. Zugrav Nedelcu nr. 3, Timișoara

Județul Timiș

România

Diclofenacum

REFEN® RETARD

100 mg

Prolonged-release tablet

Oral use

Romania

| S.C. AC HELCOR PHARMA SRL |
| --- |
| Str. Victor Babeș nr. 50 |
| Baia-Mare |
| Jud. Maramureș 430092 |
| România |

S.C. AC HELCOR PHARMA SRL

Str. Victor Babeș nr. 50

Baia-Mare

Jud. Maramureș 430092

România

Diclofenacum

DICLOFENAC 50 mg

50 mg

Gastro-resistant tablet

Oral use

Romania

| SC ANTIBIOTICE SA |
| --- |
| Str. Valea Lupului nr. 1 |
| 6600-Iași |
| România |

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

Diclofenacum

CLAFEN 50 mg

50 mg

Gastro-resistant tablet

Oral use

Romania

| FARAN LABORATORIES S.A. |
| --- |
| 17 km Athens-Lamia |
| Achaias și Trizinas |
| 145 64 Nea Kifisia |
| Greece |

FARAN LABORATORIES S.A.

17 km Athens-Lamia

Achaias și Trizinas

145 64 Nea Kifisia

Greece

Diclofenacum

RHEUMAVEK

25 mg

Gastro-resistant tablet

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® 50

50 mg

Gastro-resistant tablet

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® 25

25 mg

Gastro-resistant tablet

Oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca 400 632 |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOFENAC 50 mg

50 mg

Gastro-resistant tablet

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN RAPID®

50 mg

Coated tablet

Oral use

Romania

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Stefan Mihaileanu |
| nr. 31, sector 2; |
| Bucuresti |
| România |

S.C. ARENA GROUP S.A.

Str. Stefan Mihaileanu

nr. 31, sector 2;

Bucuresti

România

Diclofenacum

DICLOFENAC ARENA 50 mg

25 mg

Coated tablet

Oral use

Romania

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Stefan Mihaileanu |
| nr. 31, sector 2; |
| Bucuresti |
| România |

S.C. ARENA GROUP S.A.

Str. Stefan Mihaileanu

nr. 31, sector 2;

Bucuresti

România

Diclofenacum

DICLOFENAC ARENA 50 mg

50 mg

Coated tablet

Oral use

Romania

| S.C. MEDUMAN S.A. |
| --- |
| Str. Aleea Eroilor nr. 28 |
| Vișeu de Sus |
| Județul Maramureș 435700 |
| România |

S.C. MEDUMAN S.A.

Str. Aleea Eroilor nr. 28

Vișeu de Sus

Județul Maramureș 435700

România

Diclofenacum

N - DICLOFENAC

50 mg

Coated tablet

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Romania

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum

DICLOFENAC AL I.M.

75 mg/3 ml

Solution for injection

Intramuscular use

Romania

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL®

30 mg/ml

Solution for injection

Intramuscular use

Romania

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum

ALMIRAL

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca 400 632 |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOFENAC 75 mg

75 mg/3 ml

Solution for injection

Intramuscular use

Romania

| STADA HEMOFARM S.R.L. |
| --- |
| Str. Zugrav Nedelcu nr. 3, Timișoara |
| Județul Timiș |
| România |

STADA HEMOFARM S.R.L.

Str. Zugrav Nedelcu nr. 3, Timișoara

Județul Timiș

România

Diclofenacum

REFEN 75 mg

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Romania

| FARAN LABORATORIES S.A. |
| --- |
| 17 km Athens-Lamia |
| Achaias și Trizinas |
| 145 64 Nea Kifisia |
| Greece |

FARAN LABORATORIES S.A.

17 km Athens-Lamia

Achaias și Trizinas

145 64 Nea Kifisia

Greece

Diclofenacum

RHEUMAVEK

25 mg/ml

Solution for injection

Intramuscular use

Romania

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 120 mg

120 mg

Suppository

Rectal use

Romania

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 60 mg

60 mg

Suppository

Rectal use

Romania

| SC ANTIBIOTICE SA |
| --- |
| Str. Valea Lupului nr. 1 |
| 6600-Iași |
| România |

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

Diclofenacum

CLAFEN 100 mg

100 mg

Suppository

Rectal use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

100 mg

Suppository

Rectal use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

50 mg

Suppository

Rectal use

Romania

| S.C. MAGISTRA C&C S.R.L. |
| --- |
| B-dul Aurel Vlaicu nr. 82A |
| Constanța 900055 |
| România |

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82A

Constanța 900055

România

Diclofenacum

DICLOFENAC SODIC 100 mg

100 mg

Suppository

Rectal use

Romania

| S.C. MAGISTRA C&C S.R.L. |
| --- |
| B-dul Aurel Vlaicu nr. 82A |
| Constanța 900055 |
| România |

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82A

Constanța 900055

România

Diclofenacum

DICLOFENAC 100 mg

100 mg

Suppository

Rectal use

Romania

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Romania

| PFIZER EUROPE MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PFIZER EUROPE MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenacu

Misoprostolum

ARTHROTEC 75

75 mg

0,2 mg

Gastro –

resistant tablet

Oral use

Romania

| Lannacher Heilmittel Ges.m.b.H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Thiamine hydrochloride

Pyridoxine hydrochloride

Cyanocobalamin

TRATUL PLUS

50 mg

50 mg

50 mg

0,25 mg

Gastro –

resistant tablet

Oral use

Slovak Republic

| MEDOPHARM s.r.o., Lehárova 1808/11 |
| --- |
| 143 00, Praha 4 |
| Czech Republic |

MEDOPHARM s.r.o., Lehárova 1808/11

143 00, Praha 4

Czech Republic

Diclofenac

ALMIRAL

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Slovak Republic

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac

ALMIRAL 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac

Diclac retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 150 mg retard

150 mg

Prolonged-release tablet

Oral use

Slovak Republic

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 25 mg

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

Diclofenac AL 25

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

Diclofenac AL 50

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

diclofenac

Diclofenac AL retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac

Diclofenac Duo PharmaSwiss 75 mg

75 mg

Modified-release capsule

Oral use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 25 mg

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 50 mg

50 mg

Suppository

Rectal use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 100 mg

100 mg

Suppository

Rectal use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

diclofenac

DICLOREUM 75 mg

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 25 mg filmom obalené tablety

25 mg

Film-coated tablet

Oral use

Slovak Republic

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 50 mg filmom obalené tablety

50 mg

Film-coated tablet

Oral use

Slovak Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac

Dolmina 50

50 mg

Film-coated tablet

Oral use

Slovak Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac

DOLMINA INJ

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

| IBSA Slovakia s.r.o. |
| --- |
| Mytna 42 |
| 811 05 Bratislava |
| Slovak Republic |

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

Diclofenac

Flector EP Rapid 50 mg

50 mg

Granules

Oral use

Slovak Republic

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr. Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr. Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac

Myogit 50

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 100 mg

100 mg

Suppository

Rectal use

Slovak Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 100 retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 25 mg

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 75

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 75 retard

75 mg

Prolonged-release tablet

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 100

100 mg

Suppository

Rectal use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 50

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 75 mg/3 ml

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Actigo Extra 25 mg

25 mg

Coated tablet

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 12,5 mg

12,5 mg

Capsule, soft

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 25 mg

25 mg

Capsule, soft

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 50 mg

50 mg

Coated tablet

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid Sachets

50 mg

Powder for oral solution

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Retard 100

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren SR 75

75 mg

Prolonged-release tablet

Oral use

Slovak Republic

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenac

Misoprostol

ARTHROTEC FORTE

75 mg

0,2 mg

Film-coated tablet

Oral use

Slovak Republic

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac

Orphenadrine

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Slovenia

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| 1000 Ljubljana |
| Slovenia |

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

Diclofenac

Diclo Duo 75 mg trde gastrorezistentne kapsule

75 mg

Gastro-resistant capsule, hard

Oral use

Slovenia

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| 1000 Ljubljana |
| Slovenia |

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

Diclofenac

DicloJet 75 mg trde gastrorezistentne kapsule

75 mg

Gastro-resistant capsule, hard

Oral use

Slovenia

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 25 mg filmsko obložene tablete

25 mg

Film-coated tablet

Oral use

Slovenia

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 50 mg filmsko obložene tablete

50 mg

Film-coated tablet

Oral use

Slovenia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen 25 mg/ml raztopina za injiciranje

25 mg/ml

Solution for injection

Intramuscular use

Slovenia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diclofenac

Naklofen 50 mg gastrorezistentne tablete

50 mg

Gastro-resistant tablet

Oral use

Slovenia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen 50 mg svečke

50 mg

Suppository

Rectal use

Slovenia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen duo 75 mg trde kapsule

75 mg

Capsule, hard

Oral use

Slovenia

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen SR 100 mg tablete s podaljšanim sproščanjem

100 mg

Prolonged-release tablet

Oral use

Slovenia

| Medias International d.o.o. |
| --- |
| Leskoškova cesta 9D |
| 1000 Ljubljana |
| Slovenia |

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

Diclofenac

Neodolpasse 75 mg/30 mg raztopina za infundiranje

2,5 mg/ml

Solution for infusion

Intravenous use

Slovenia

| Pliva Ljubljana d.o.o. |
| --- |
| pot k sejmišču 35 |
| 1231 Ljubljana Črnuče |
| Slovenia |

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Olfen 100 mg trde kapsule s podaljšanim sproščanjem

100 mg

Prolonged-release capsule, hard

Oral use

Slovenia

| Pliva Ljubljana d.o.o. |
| --- |
| pot k sejmišču 35 |
| 1231 Ljubljana Črnuče |
| Slovenia |

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Voltaren 12,5 mg svečke

12,5 mg

Suppository

Rectal use

Slovenia

| Pliva Ljubljana d.o.o. |
| --- |
| pot k sejmišču 35 |
| 1231 Ljubljana Črnuče |
| Slovenia |

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Voltaren 25 mg svečke

25 mg

Suppository

Rectal use

Slovenia

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac

Voltaren Dolo 12,5 mg filmsko obložene tablete

12,5 mg

Film-coated tablet

Oral use

Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 100 mg supositorios

100 mg

Suppository

Rectal use

Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 50 mg comprimidos gastrorresistentes

50 mg

Gastro-resistant tablet

Oral use

Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

DOLO-VOLTAREN 50 mg comprimidos dispersables

50 mg

Orodispersible tablet

Oral use

Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN RETARD 75 mg comprimidos de liberación modificada

75 mg

Modified-release tablet

Oral use

Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN RETARD 100 mg comprimidos de liberación modificada

100 mg

Modified-release tablet

Oral use

Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 75 mg/3 ml solución inyectable

75 mg/3 ml

Solution for injection

Intramuscular use

Spain

| LABORATORIOS ALDO-UNION, S.A. |
| --- |
| Baronesa de Malda, 73 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

LABORATORIOS ALDO-UNION, S.A.

Baronesa de Malda, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO ALDO-UNION comprimidos EFG

50 mg

Tablet

Oral use

Spain

| BEXAL FARMACEUTICA, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda. Osa Mayor, 4 - Area B |
| 28023 Aravaca (Madrid) |
| Spain |

BEXAL FARMACEUTICA, S.A.

Centro Empresarial Osa Mayor

Avda. Osa Mayor, 4 - Area B

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| LABORATORIOS STADA, S.L |
| --- |
| Frederic Mompou, 5 |
| 08960 Sant Just Desvern (Barcelona) |
| Spain |

LABORATORIOS STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO RETARD STADA 100 mg comprimidos EFG

100 mg

Film-coated tablet

Oral use

Spain

| LABORATORIOS STADA, S.L |
| --- |
| Frederic Mompou, 5 |
| 08960 Sant Just Desvern (Barcelona) |
| Spain |

LABORATORIOS STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO STADA 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| LABORATORIOS NORMON, S.A. |
| --- |
| Ronda de Valdecarrizo, 6 |
| 28760 Tres Cantos (Madrid) |
| Spain |

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Diclofenac sodium

DICLOFENACO NORMON 50 mg comprimidos dispersables EFG

50 mg

Orodispersible tablet

Oral use

Spain

| LABORATORIOS NORMON, S.A. |
| --- |
| Ronda de Valdecarrizo, 6 |
| 28760 Tres Cantos (Madrid) |
| Spain |

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Diclofenac sodium

DICLOFENACO NORMON 50 mg comprimidos entéricos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN 50 mg comprimidos gastrorresistentes

50 mg

Gastro-resistant tablet

Oral use

Spain

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN RETARD 100 mg cápsulas duras de liberación prolongada

100 mg

Modified-release hard capsule

Oral use

Spain

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN DISPERSABLE comprimidos

50 mg

Orodispersible tablet

Oral use

Spain

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN supositorios

100 mg

Suppository

Rectal use

Spain

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN ampollas

75 mg/3 ml

Solution for injection

Intramuscular use

Spain

| SIGMA TAU ESPAÑA, S.A. |
| --- |
| Bolivia, 15 |
| Polígono Industrial Azque |
| 28806 Alcalá de Henares (Madrid) |
| Spain |

SIGMA TAU ESPAÑA, S.A.

Bolivia, 15

Polígono Industrial Azque

28806 Alcalá de Henares (Madrid)

Spain

Diclofenac sodium

LUASE 50 mg comprimidos

50 mg

Gastro-resistant tablet

Oral use

Spain

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 75 mg solución inyectable EFG

75 mg/3 ml

Solution for injection

Intramuscular use

Spain

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DI-RETARD 100 mg comprimidos de liberación modificada

100 mg

Modified-release tablet

Oral use

Spain

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 100 mg supositorios EFG

100 mg

Suppository

Rectal use

Spain

| RATIOPHARM ESPAÑA, S.A. |
| --- |
| Avda. de Burgos, 16 D |
| 5a planta |
| 28036 Madrid |
| Spain |

RATIOPHARM ESPAÑA, S.A.

Avda. de Burgos, 16 D

5a planta

28036 Madrid

Spain

Diclofenac sodium

DICLOFENACO RATIOPHARM 50 mg comprimidos

50 mg

Coated tablet

Oral use

Spain

| LABORATORIOS ALTER, S.A. |
| --- |
| Mateo Inurria, 30 |
| 28036 Madrid |
| Spain |

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Diclofenac sodium

DICLOFENACO ALTER 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| PENSA PHARMA, S.A.U. |
| --- |
| Jorge Comín (médico pediatra), 3-bajos |
| 46015 Valencia |
| Spain |

PENSA PHARMA, S.A.U.

Jorge Comín (médico pediatra), 3-bajos

46015 Valencia

Spain

Diclofenac sodium

DICLOFENACO PENSA 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| LABORATORIOS CINFA, S.A. |
| --- |
| Olaz-Chipi, 10 |
| Polígono Industrial Areta |
| 31620 Huarte-Pamplona (Navarra) |
| Spain |

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10

Polígono Industrial Areta

31620 Huarte-Pamplona (Navarra)

Spain

Diclofenac sodium

DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ 100 mg supositorios EFG

100 mg

Suppository

Rectal use

Spain

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG

100 mg

Modified-release tablet

Oral use

Spain

| LABORATORIOS RANBAXY, S.L. |
| --- |
| Passeig de Gracia, 9 |
| 08007 Barcelona |
| Spain |

LABORATORIOS RANBAXY, S.L.

Passeig de Gracia, 9

08007 Barcelona

Spain

Diclofenac sodium

DICLOFENACO MUNDOGEN 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| GERMED FARMACEUTICA, S.L. |
| --- |
| Chile, 8-2a planta. Oficina 203 |
| 28290 Las Matas (Madrid) |
| Spain |

GERMED FARMACEUTICA, S.L.

Chile, 8-2a planta. Oficina 203

28290 Las Matas (Madrid)

Spain

Diclofenac sodium

DICLOFENACO EDIGEN 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

| Pfizer S.L. |
| --- |
| Avda. de Europa, 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Pfizer S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Diclofenac sodium

Misoprostol

ARTROTEC

50 mg

0,2 mg

Film-coated tablet

Oral use

Spain

| Pfizer S.L. |
| --- |
| Avda. de Europa, 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Pfizer S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Diclofenac sodium

Misoprostol

NORMULEN

50 mg

0,2 mg

Film-coated tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg

Gastro-resistant tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

50 mg

Gastro-resistant tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

12,5 mg

Film-coated tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg/ml

Solution for injection

Parenteral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

25 mg

Coated tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

50 mg

Coated tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

12,5 mg

Capsule, soft

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

25 mg

Capsule, soft

Oral use

Sweden

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

25 mg

Gastro-resistant tablet

Oral use

Sweden

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Gastro-resistant tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Modified-release tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Diclofenac natrium

Misoprostol

Arthrotec forte

75 mg

0,2 mg

Modified-release tablet

Oral use

Sweden

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diklofenak Sandoz

25 mg

Gastro-resistant tablet

Oral use

Sweden

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diklofenak Sandoz

50 mg

Gastro-resistant tablet

Oral use

Sweden

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac T ratiopharm

25 mg

Film-coated tablet

Oral use

Sweden

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac T ratiopharm

50 mg

Film-coated tablet

Oral use

Sweden

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak Orifarm

25 mg

Gastro-resistant tablet

Oral use

Sweden

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak Orifarm

50 mg

Gastro-resistant tablet

Oral use

Sweden

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassium

Eeze

25 mg

Film-coated tablet

Oral use

Sweden

| Evolan Pharma AB |
| --- |
| Box: 120 |
| 182 12 Danderyd |
| Sweden |

Evolan Pharma AB

Box: 120

182 12 Danderyd

Sweden

Diclofenac potassium

Diklofenak T Evolan

50 mg

Film-coated tablet

Oral use

Sweden

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak T Orifarm

25 mg

Film-coated tablet

Oral use

Sweden

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak T Orifarm

50 mg

Film-coated tablet

Oral use

Sweden

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Diclofenac potassium

Diklofenak T Actavis

25 mg

Film-coated tablet

Oral use

Sweden

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Diclofenac potassium

Diklofenak T Actavis

50 mg

Film-coated tablet

Oral use

Sweden

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Gastro-resistant tablet

Oral use

Sweden

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Gastro-resistant tablet

Oral use

Sweden

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Diclofenac potassium

Instantin

50 mg

Powder for oral solution

Oral use

Sweden

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassium

Eezeneo

25 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Eezeneo

50 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Eeze

12,5 mg

Film-coated tablet

Oral use

Sweden

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

25 mg

Film-coated tablet

Oral use

Sweden

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

50 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklotab

25 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklotab

50 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklok

25 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklok

50 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Kappadi

25 mg

Film-coated tablet

Oral use

Sweden

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Kappadi

50 mg

Film-coated tablet

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

100 mg

Suppository

Rectal use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

50 mg

Suppository

Rectal use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg

Suppository

Rectal use

Sweden

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

100 mg

Suppository

Rectal use

Sweden

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Suppository

Rectal use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis Retard 75 mg, tabletten met gereguleerde afgifte

75 mg

Modified-release tablet

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 25 mg, zetpillen

25 mg

Suppository

Rectal use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac Kalium Actavis 12,5 mg, filmomhulde tabletten

12,5 mg

Film-coated tablet

Oral use

The Netherlands

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac potassium

Eminocs 50 mg/ml, drank

50 mg

Oral drops, solution

Oral use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex retard 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 25 mg, zetpillen

25 mg

Suppository

Rectal use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 25 mg/ml, oplossing voor injectie

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na zetpil CF 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na zetpil CF 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na retard CF 75 mg, tabletten met gereguleerde afgifte

75 mg

Modified-release tablet

Oral use

The Netherlands

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na retard CF 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar EC 25, maagsapresistente tabletten 25 mg

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar EC 50, maagsapresistente tabletten 50 mg

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar Retard 75, tabletten met gereguleerde afgifte 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar Retard 100, tabletten met gereguleerde afgifte 100 mg

100 mg

Modified-release tablet

Oral use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 25, zetpillen 25 mg

25 mg

Suppository

Rectal use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 50, zetpillen 50 mg

50 mg

Suppository

Rectal use

The Netherlands

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 100, zetpillen 100 mg

100 mg

Suppository

Rectal use

The Netherlands

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium Manston 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium Manston 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium retard Manston 100 mg, maagsapresistente tabletten

100 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Marel B.V. |
| --- |
| Archimedesweg 2 |
| 2333 CN Leiden |
| The Netherlands |

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Diclofenac potassium

Kruidvat Diclofenac kalium 12,5 mg, filmomhulde tabletten

12,5 mg

Film-coated tablet

Oral use

The Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinselaan 142 |
| 4818 CP Breda |
| The Netherlands |

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassium

Voltaren K 12,5 mg, filmomhulde tabletten

12,5 mg

Film-coated tablet

Oral use

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinselaan 142 |
| 4818 CP Breda |
| The Netherlands |

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassium

Voltaren K 25 mg, omhulde tabletten

25 mg

Coated tablet

Oral use

The Netherlands

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinselaan 142 |
| 4818 CP Breda |
| The Netherlands |

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassium

Otriflu, omhulde tabletten 12,5 mg

12,5 mg

Coated tablet

Oral use

The Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

The Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac potassium

Cataflam 50, omhulde tabletten 50 mg

50 mg

Coated tablet

Oral use

The Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren Retard 75 mg, tabletten met verlengde afgifte

75 mg

Prolonged-release tablet

Oral use

The Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle aan den IJssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

The Netherlands

Diclofenac sodium

Misoprostol

Arthrotec 50, tabletten

50 mg

Modified-release tablet

Oral use

The Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle aan den IJssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

The Netherlands

Diclofenac sodium

Misoprostol

Arthrotec 75, tabletten 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 PCH, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 PCH, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 PCH, zetpillen 25 mg

25 mg

Suppository

Rectal use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 PCH, zetpillen 50 mg

50 mg

Suppository

Rectal use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 PCH, zetpillen 100 mg

100 mg

Suppository

Rectal use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na retard 75 PCH, tabletten met gereguleerde afgifte 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na Retard 100 PCH tabletten met gereguleerde afgifte 100 mg

100 mg

Modified-release tablet

Oral use

The Netherlands

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenacnatrium Pharmacin 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenacnatrium Pharmacin 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

| ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na ratiopharm retard 75 mg, tabletten met gereguleerde afgifte

75 mg

Modified-release tablet

Oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz retard 75, tabletten met gereguleerde afgite 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg

100 mg

Modified-release tablet

Oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

The Netherlands

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

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 mg Teva, zetpilen

25 mg

Suppository

Rectal use

The Netherlands

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

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 mg Teva, zetpilen

50 mg

Suppository

Rectal use

The Netherlands

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

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 mg Teva, zetpilen

100 mg

Suppository

Rectal use

The Netherlands

| Wise Pharmaceuticals Ltd. |
| --- |
| Hamwells Business Park Unit No. 7, Hardicker Street |
| M19 2RB Manchester |
| United Kingdom |

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No. 7, Hardicker Street

M19 2RB Manchester

United Kingdom

Diclofenac sodium

Diclofenacnatrium 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

| Wise Pharmaceuticals Ltd. |
| --- |
| Hamwells Business Park Unit No. 7, Hardicker Street |
| M19 2RB Manchester |
| United Kingdom |

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No. 7, Hardicker Street

M19 2RB Manchester

United Kingdom

Diclofenac sodium

Diclofenacnatrium 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Voltarol Pain-Eze Extra Strength Tablets

25 mg

Coated tablet

Oral use

United Kingdom

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Voltarol Pain-Eze Tablets

12,5 mg

Coated tablet

Oral use

United Kingdom

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenac sodium

Arthrotec 50 Modified-Release tablets

50 mg

Modified-release tablet

Oral use

United Kingdom

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenac sodium

Arthrotec 75 Modified-Release tablets

75 mg

Modified-release tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Injection 75 mg/3 ml

75 mg

Solution for Injection

Intramuscular use, Intravenous use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac free acid

Voltarol Dispersible Tablets 50 mg

46,5 mg

Tablet for oral solution

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Retard Tablets 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol SR Tablets

75 mg

Modified-release tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 12,5 mg

12,5 mg

Suppository

Rectal use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 25 mg

25 mg

Suppository

Rectal use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 50 mg

50 mg

Suppository

Rectal use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 100 mg

100 mg

Suppository

Rectal use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Rapid Tablets 25 mg

25 mg

Coated tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Rapid Tablets 50 mg

50 mg

Coated tablet

Oral use

United Kingdom

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon EX32 8NS |
| United Kingdom |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon EX32 8NS

United Kingdom

Diclofenac sodium

Flamatak MR Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| E Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

E Sussex BN22 9AG

United Kingdom

Diclofenac sodium

Teva UK Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| E Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

E Sussex BN22 9AG

United Kingdom

Diclofenac sodium

Teva UK Diclofenac Sodium Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Chatfield Pharmaceuticals Limited |
| --- |
| Kramer Mews |
| London SW5 9JL |
| United Kingdom |

Chatfield Pharmaceuticals Limited

Kramer Mews

London SW5 9JL

United Kingdom

Diclofenac sodium

Chatfield Pharms Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Mercury Pharma International Limited |
| --- |
| 4045 Kingswood Road |
| City West Business Park |
| Co Dublin, Ireland |

Mercury Pharma International Limited

4045 Kingswood Road

City West Business Park

Co Dublin, Ireland

Diclofenac sodium

Antigen Diclofenac Sodium Injection 2,5 % w/v

75 mg

Solution for injection

Intramuscular use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Lagap Pharms Diclofenac Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Lagap Pharms Diclofenac Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan SR Modified Release Capsules 75 mg

75 mg

Modified-Release Capsule, Hard

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan XL Modified Release Capsules 100 mg

100 mg

Modified-Release Capsule, Hard

Oral use

United Kingdom

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Diclofenac sodium

Generics UK Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Diclofenac sodium

Generics UK Diclofenac Sodium Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Waymade Plc |
| --- |
| Regency House |
| Miles Gray Road |
| Basildon, Essex SS14 3RF |
| United Kingdom |

Waymade Plc

Regency House

Miles Gray Road

Basildon, Essex SS14 3RF

United Kingdom

Diclofenac sodium

Rheumatac Retard Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

| Daichi-Sankyo UK Limited |
| --- |
| Chiltern Place |
| Chalfont Park |
| Gerrards Cross |
| Buckinghamshire SL9 0BG |
| United Kingdom |

Daichi-Sankyo UK Limited

Chiltern Place

Chalfont Park

Gerrards Cross

Buckinghamshire SL9 0BG

United Kingdom

Diclofenac sodium

Motifene Capsules 75 mg

75 mg

Modified-release capsule

Oral use

United Kingdom

| Chiesi Limited |
| --- |
| Cheadle Royal Business Park |
| Highfield, Cheadle |
| Cheshire SK8 3GY |
| United Kingdom |

Chiesi Limited

Cheadle Royal Business Park

Highfield, Cheadle

Cheshire SK8 3GY

United Kingdom

Diclofenac sodium

Volsaid Retard Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

| Chiesi Limited |
| --- |
| Cheadle Royal Business Park |
| Highfield, Cheadle |
| Cheshire SK8 3GY |
| United Kingdom |

Chiesi Limited

Cheadle Royal Business Park

Highfield, Cheadle

Cheshire SK8 3GY

United Kingdom

Diclofenac sodium

Volsaid Retard Tablets 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Econac Suppositories 100 mg

100 mg

Suppository

Rectal use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Econac Injection 75 mg/3 ml

75 mg

Solution for injection

Intramuscular use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Solution for Injection 75 mg/3 ml

75 mg

Solution for injection

Intramuscular use, Intravenous use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Econac SR Prolonged Release Tablet 75 mg

75 mg

Prolonged-release tablet

Oral use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Econac XL Prolonged Release Tablet 100 mg

100 mg

Prolonged-release tablet

Oral use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Sodium Tablets 25 mg

25 mg

Tablet

Oral use

United Kingdom

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Sodium Tablets 75 mg

50 mg

Tablet

Oral use

United Kingdom

| Co-Pharma Limited |
| --- |
| Unit 4, Metro Centre |
| Tolpits Lane, Watford |
| Hertfordshire WD18 9SS |
| United Kingdom |

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire WD18 9SS

United Kingdom

Diclofenac sodium

Diclo-XL 100

100 mg

Modified-release tablet

Oral use

United Kingdom

| Co-Pharma Limited |
| --- |
| Unit 4, Metro Centre |
| Tolpits Lane, Watford |
| Hertfordshire WD18 9SS |
| United Kingdom |

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire WD18 9SS

United Kingdom

Diclofenac sodium

Diclo-SR 75

75 mg

Modified-release tablet

Oral use

United Kingdom

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Diclofenac Sodium Tablets 75 mg

75 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Bristol Laboratories Limited |
| --- |
| Unit 3, Canal side |
| Northbridge Road, Berkhamsted |
| Hertfordshire HP4 1EG |
| United Kingdom |

Bristol Laboratories Limited

Unit 3, Canal side

Northbridge Road, Berkhamsted

Hertfordshire HP4 1EG

United Kingdom

Diclofenac sodium

Volraman 25 mg Gastro-resistant tablets

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Bristol Laboratories Limited |
| --- |
| Unit 3, Canal side |
| Northbridge Road, Berkhamsted |
| Hertfordshire HP4 1EG |
| United Kingdom |

Bristol Laboratories Limited

Unit 3, Canal side

Northbridge Road, Berkhamsted

Hertfordshire HP4 1EG

United Kingdom

Diclofenac sodium

Volraman 50 mg Gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Focus Pharmaceuticals Limited |
| --- |
| Unit 5, Faraday court |
| First Avenue, Centrum 100 |
| Burton upon trent |
| Staffordshire, DE14 2WX |
| United Kingdom |

Focus Pharmaceuticals Limited

Unit 5, Faraday court

First Avenue, Centrum 100

Burton upon trent

Staffordshire, DE14 2WX

United Kingdom

Diclofenac potassium

Adacium Rapid 50 mg Tablets

50 mg

Film-coated tablet

Oral use

United Kingdom

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac sodium

Misoprostol

Misofen 50 mg/200 mcg modified released tablets

50 mg

0,2 mg

Modified-release tablet

Oral use

United Kingdom

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac sodium

Misoprostol

Misofen 75 mg/200 mcg modified released tablets

75 mg

0,2 mg

Modified-release tablet

Oral use

United Kingdom

| Crescent Pharma Limited |
| --- |
| Unit 3&4 |
| Quidhampton Business Units |
| Polhampton Lane, Overton |
| Hampshire, RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Unit 3&4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire, RG25 3ED

United Kingdom

Diclofenac

Crescent Pharma Diclofenac Tablets BP 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Crescent Pharma Limited |
| --- |
| Unit 3&4 |
| Quidhampton Business Units |
| Polhampton Lane, Overton |
| Hampshire, RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Unit 3&4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire, RG25 3ED

United Kingdom

Diclofenac

Crescent Pharma Diclofenac Tablets BP 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

| Therabel pharma UK Limited |
| --- |
| Compass House, vision Park |
| Chivers, Histon |
| Cambridge CB24 9AD |
| United Kingdom |

Therabel pharma UK Limited

Compass House, vision Park

Chivers, Histon

Cambridge CB24 9AD

United Kingdom

Diclofenac sodium

Dyloject 75 mg/2 ml solution for injection

75 mg/2 ml

solution for injection

Intramuscular use, Intravenous use

United Kingdom

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

Diclofenac sodium

Diclomax SR

75 mg

Modified-release capsule

Oral use

United Kingdom

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

Diclofenac sodium

Diclomax Retard

100 mg

Modified-release capsule

Oral use

United Kingdom

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Doble action pain relief

12,5 mg

Tablet

Oral use

United Kingdom

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac potassium 12,5 mg Tablets

12,5 mg

Tablet

Oral use

United Kingdom

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac potassium 25 mg Tablets

25 mg

Film-coated tablet

Oral use

United Kingdom

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac potassium 50 mg Tablets

50 mg

Film-coated tablet

Oral use

United Kingdom

| Chelonia Healthcare Limited |
| --- |
| Boumpoulinas 11 |
| 3rd, Nicosia |
| CY-1060 |
| Cyprus |

Chelonia Healthcare Limited

Boumpoulinas 11

3rd, Nicosia

CY-1060

Cyprus

Diclofenac sodium

Diclofenac sodium 25 mg Tablets

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

| RI Pharma Limited |
| --- |
| First floor, 6 St John's Court |
| Upper Fforest Way |
| Swansea Enterprise Park |
| Swansea SA6 8QQ |
| United Kingdom |

RI Pharma Limited

First floor, 6 St John's Court

Upper Fforest Way

Swansea Enterprise Park

Swansea SA6 8QQ

United Kingdom

Diclofenac sodium

Slofenac 75 mg SR

75 mg

Modified-release tablet

Oral use

United Kingdom

| RI Pharma Limited |
| --- |
| First floor, 6 St John's Court |
| Upper Fforest Way |
| Swansea Enterprise Park |
| Swansea SA6 8QQ |
| United Kingdom |

RI Pharma Limited

First floor, 6 St John's Court

Upper Fforest Way

Swansea Enterprise Park

Swansea SA6 8QQ

United Kingdom

Diclofenac sodium

Slofenac 100 mg SR

100 mg

Modified-release tablet

Oral use

United Kingdom

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

Diclofenac sodium

Enstar SR 75 mg Tablets

75 mg

Prolonged-release tablet

Oral use

United Kingdom

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

Diclofenac sodium

Enstar XL 100 mg Tablets

100 mg

Modified-release tablet

Oral use

United Kingdom

| Aptil Pharma limited |
| --- |
| 9th Floor |
| CP House |
| 97-107 Uxbridge Road |
| London W5 5TL |
| United Kingdom |

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassium

Diclofenac potassium 12,5 mg Tablets

12,5 mg

Film-coated tablet

Oral use

United Kingdom

| Aptil Pharma limited |
| --- |
| 9th Floor |
| CP House |
| 97-107 Uxbridge Road |
| London W5 5TL |
| United Kingdom |

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassium

Diclofenac potassium 25 mg Tablets

25 mg

Film-coated tablet

Oral use

United Kingdom

| Aptil Pharma limited |
| --- |
| 9th Floor |
| CP House |
| 97-107 Uxbridge Road |
| London W5 5TL |
| United Kingdom |

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassium

Diclofenac potassium 50 mg Tablets

50 mg

Film-coated tablet

Oral use

---

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State (in EEA) | Marketing Authorisaton Holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | WABOSAN |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Austria |

Member State (in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Austria

Ergomed retard - Kapseln

2.5 mg (1:1:1)

prolonged-release capsule, soft

oral use

Austria

| WABOSAN |
| --- |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Austria |

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Austria

Ergomed - Tropfen

1 mg/ml (1:1:1)

oral drops, solution

oral use

Czech Republic

| TEVA Czech Industries s.r.o. |
| --- |
| Ostravská 29 |
| 747 70 Opava-Komárov |
| Czech Republic |

TEVA Czech Industries s.r.o.

Ostravská 29

747 70 Opava-Komárov

Czech Republic

ERSILAN

1mg/ml

Oral drops, solution

oral use

France

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| France |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL FORT, comprimé

2.40 mg/19.20 mg

tablet

oral use

France

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| France |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL, comprimé

0.60 mg / 4.80 mg

tablet

oral use

France

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| France |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL, solution buvable en flacon

0.10 g / 0.80 g

oral solution

oral use

France

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| France |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL, solution injectable en ampoule

0.3125 mg /6.25 mg

solution for injection

IV/IM

Greece

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greece |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

3mg/cap

capsules, soft

oral use

Greece

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greece |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

6MG/SINGLE DOSE

powder for oral solution for single dose

oral use

Greece

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greece |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

6MG/TAB

tablet

oral use

Greece

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, |
| GLYFADA, 16674 |
| Greece |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150,

GLYFADA, 16674

Greece

ERGOFIL

6MG/TAB

tablet

oral use

Greece

| GENEPHARM A.E. |
| --- |
| 18TH Km MARATHONOS |
| AVENUE, PALLINI, |
| ATTIKIS, 15351 |
| Greece |

GENEPHARM A.E.

18TH Km MARATHONOS

AVENUE, PALLINI,

ATTIKIS, 15351

Greece

MEMOTIL / GENEPHARM

6MG/TAB

tablet

oral use

Greece

| ANTOR LTD |
| --- |
| P. MAVROMIHALI 1 |
| VRILISSIA 15235 |
| Greece |

ANTOR LTD

P. MAVROMIHALI 1

VRILISSIA 15235

Greece

THRIOLAN

6MG/TAB

tablet

oral use

Greece

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, |
| ARGYROUPOLI, 16452 |
| Greece |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22,

ARGYROUPOLI, 16452

Greece

FENITINA

6MG/TAB

tablet

oral use

Greece

| PHARMACEUTICAL INDUSTRY PROEL EPAM. |
| --- |
| G. KORONIS |
| DILOU 9, PERISTERI, |
| ATTIKIS, 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM.

G. KORONIS

DILOU 9, PERISTERI,

ATTIKIS, 12134

Greece

BEYTINA

6MG/TAB

tablet

oral use

Greece

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, |
| GERAKAS, 15344 |
| Greece |

FINIXFARM EPE

DERVENAKION 38 & SAHINI,

GERAKAS, 15344

Greece

CRISTIL

6MG/TAB

tablet

oral use

Greece

| S.J.A. PHARM O.E. |
| --- |
| ARKOLEON 11, KATO |
| PATISSIA, 10445 |
| Greece |

S.J.A. PHARM O.E.

ARKOLEON 11, KATO

PATISSIA, 10445

Greece

AGIOBITA

6MG/TAB

tablet

oral use

Luxembourg

| Pierre Fabre Médicaments |
| --- |
| 45, PLACE ABEL GANCE |
| F 92654 BOULOGNE |
| CEDEX |
| France |

Pierre Fabre Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE

CEDEX

France

Iskedyl Fort

2.40 mg/19.20 mg

tablets

oral use

Portugal

| Daiichi Sankyo |
| --- |
| Portugal,Lda. PRT |
| Lagoas Park, Edifício 11 |
| 2740-270 Porto Salvo |
| Portugal |

Daiichi Sankyo

Portugal,Lda. PRT

Lagoas Park, Edifício 11

2740-270 Porto Salvo

Portugal

Diertina

3 mg

Capsule hard

oral use

Spain

| LABORATORIOS DAVUR, S.L. |
| --- |
| Teide, 4 - planta baja Polígono Empresarial La Marina |
| 28703 San Sebastian de los Reyes (Madrid) |
| Spain |

LABORATORIOS DAVUR, S.L.

Teide, 4 - planta baja Polígono Empresarial La Marina

28703 San Sebastian de los Reyes (Madrid)

Spain

ERGODAVUR GOTAS

1 mg (monodose suchet)

oral drops, solution

oral use

Spain

| TORA LABORATORIES |
| --- |
| S.L. Ferraz 80, 5o |
| 28008 Madrid |
| Spain |

TORA LABORATORIES

S.L. Ferraz 80, 5o

28008 Madrid

Spain

DIERTINE FORTE

2 mg/ ml

oral drops, solution

oral use

---

ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing Authorisaton Holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| France | CHIESI |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| France |

Member State

(in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

CHIESI

11, avenue Dubonnet

92400 Courbevoie

France

VASOBRAL, comprimé sécable

4 mg/40 mg

tablet

oral use

France

| CHIESI |
| --- |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| France |

CHIESI

11, avenue Dubonnet

92400 Courbevoie

France

VASOBRAL, solution buvable en flacon

0,10 g/1 g per 100 ml

oral solution

oral use

---

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State (in EEA) | Marketing Authorisaton Holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Kwizda Pharma GmbH |
| Effingergasse 21 |
| 1160 Vienna |
| Austria |

Member State (in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 10 mg - Tabletten

10 mg

tablet

oral use

Austria

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Austria |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 20 mg - Filmtabletten

20 mg

film-coated tablet

oral use

Austria

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Austria |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 30 mg - Filmtabletten

30 mg

film-coated tablet

oral use

Austria

| Rösch & Handel |
| --- |
| Scheringgasse 2/Objekt 2 |
| 1140 Vienna |
| Austria |

Rösch & Handel

Scheringgasse 2/Objekt 2

1140 Vienna

Austria

Nicergin - Filmtabletten

30 mg

film-coated tablet

oral use

Austria

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Vienna |
| Austria |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Sermion 30 mg - Filmtabletten

30 mg

film-coated tablet

oral use

Bulgaria

| Pfizer Enterprises SARL |
| --- |
| Avenue J.F.Kennedy 51 |
| L-1855 |
| Luxembourg |

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luxembourg

Sermion

4 mg/4 ml

powder and solvent for solution for injection

intramuscular and intravenous use

Bulgaria

| Pfizer Enterprises SARL |
| --- |
| Avenue J.F.Kennedy 51 |
| L-1855 |
| Luxembourg |

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luxembourg

Sermion

30 mg

film-coated tablets

oral use

Czech Republic

| Pfizer, spol. s r.o., Praha |
| --- |
| Stroupežnického 17 |
| 150 00 Prague 5 |
| Czech Republic |

Pfizer, spol. s r.o., Praha

Stroupežnického 17

150 00 Prague 5

Czech Republic

SERMION

30 mg

Film-coated tablet

oral use

France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 10 mg, gélule

10 mg

capsule, hard

oral use

France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 5 mg, gélule

5 mg

capsule, hard

oral use

France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 5 mg, poudre pour solution pour perfusion

5 mg

powder for solution for infusion

intravenous use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

NICERGOLINE BIOGARAN 10 mg, gélule

10 mg

capsule, hard

oral use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

NICERGOLINE BIOGARAN 5 mg, gélule

5 mg

capsule, hard

oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

NICERGOLINE EG 10 mg, gélule

10 mg

capsule, hard

oral use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

NICERGOLINE EG 5 mg, gélule

5 mg

capsule, hard

oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE MYLAN 10 mg, gélule

10 mg

capsule, hard

oral use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE MYLAN 5 mg, gélule

5 mg

capsule, hard

oral use

France

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE QUALIMED 10 mg, gélule

10 mg

capsule, hard

oral use

France

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE QUALIMED 5 mg, gélule

5 mg

capsule, hard

oral use

France

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

NICERGOLINE TEVA 10 mg, gélule

10 mg

capsule, hard

oral use

France

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

NICERGOLINE TEVA 5 mg, gélule

5 mg

capsule, hard

oral use

Hungary

| Pfizer Kft. |
| --- |
| Alkotás u. 53., MOM Park F épület |
| 1123 Budapest |
| Hungary |

Pfizer Kft.

Alkotás u. 53., MOM Park F épület

1123 Budapest

Hungary

SERMION 30 mg filmtabletta

30 mg

film-coated tablet

oral use

Italy

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

10 mg/ml

powder and solvent per oral solution

oral use

Italy

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

5 mg

coated tablet

oral use

Italy

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

10 mg

coated tablet

oral use

Italy

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

30 mg

film coated tablet

oral use

Italy

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

30 mg

soluble tablet

oral use

Italy

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italy |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italy

NICERGOLINA ANGENERICO

10 mg/ml

powder and solvente per oral solution

oral use

Italy

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italy |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italy

NICERGOLINA ANGENERICO

30 mg

tablet

oral use

Italy

| Sandoz spa |
| --- |
| Largo Umberto Boccioni, |
| 1 21040 Origgio - Varese |
| Italy |

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italy

NICERGOLINA SANDOZ

30 mg

effervescent tablet

oral use

Italy

| Sandoz spa |
| --- |
| Largo Umberto Boccioni, |
| 1 21040 Origgio - Varese |
| Italy |

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italy

NICERGOLINA SANDOZ

30 mg

tablet

oral use

Italy

| EG spa |
| --- |
| Via Scarlatti Domenico, |
| 31 20124 Milano |
| Italy |

EG spa

Via Scarlatti Domenico,

31 20124 Milano

Italy

NICERGOLINA EG

30 mg

tablet

oral use

Latvia

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

10 mg

film-coated tablets

oral use

Latvia

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

30 mg

capsules, hard

oral use

Latvia

| Pfizer Italia S.r.l., |
| --- |
| Via Isonzo 71, |
| 04100 Latina, |
| Italy |

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italy

Sermion

5 mg

film-coated tablets

oral use

Latvia

| Pfizer Italia S.r.l., |
| --- |
| Via Isonzo 71, |
| 04100 Latina, |
| Italy |

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italy

Sermion

10 mg

film-coated tablets

oral use

Lithuania

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

4 mg

Powder and solvent for solution for injection

intramuscular use intravenous use

Lithuania

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT) |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT)

Italy

Sermion

5 mg

Coated tablet

oral use

Lithuania

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

10 mg

Coated tablet

oral use

Lithuania

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

30 mg

Film-coated tablet

oral use

Lithuania

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

30 mg

Capsule, hard

oral use

Lithuania

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

10 mg

Film-coated tablet

oral use

Poland

| Farmaceutyczna Spółdzielnia Pracy FILOFARM |
| --- |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poland |

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Nicergolin

10 mg

tablet

oral use

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| CT13 9 NJ Kent, Sandwich |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

CT13 9 NJ Kent, Sandwich

United Kingdom

Nicergolin

10 mg

coated tablet

oral use

Poland

| Pfizer Italia S.r.l. |
| --- |
| Borgo San Michele SS 156 Km 50 |
| Latina |
| Italy |

Pfizer Italia S.r.l.

Borgo San Michele SS 156 Km 50

Latina

Italy

Nicergolin

4 mg

powder and solvent for solution for injection

intramuscular use intravenous use

Portugal

| Laboratórios Pfizer, |
| --- |
| Lda. PRT Lagoas Park, |
| Edifício 10 Porto Salvo |
| Portugal |

Laboratórios Pfizer,

Lda. PRT Lagoas Park,

Edifício 10 Porto Salvo

Portugal

Sermion 30

30 mg

Film-coated tablet

oral use

Romania

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romania |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 5 mg

5 mg

Film – coated tablet

oral use

Romania

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romania |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 10 mg

10 mg

Film – coated tablet

oral use

Romania

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romania |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 30 mg

30 mg

Film – coated tablet

oral use

Romania

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 5 mg

5 mg

Film – coated tablet

oral use

Romania

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 10 mg

10 mg

Film – coated tablet

oral use

Romania

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 30 mg

30 mg

Film – coated tablet

oral use

Romania

| HEXAL AG |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Germany |

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 10

10 mg

Coated tablet

oral use

Romania

| Hexal AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Germany |

Hexal AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 15

15 mg

Modified – release capsule, hard

oral use

Romania

| HEXAL AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Germany |

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 30 UNO

30 mg

Modified – release capsule, hard

oral use

Spain

| PFIZER, S.L. |
| --- |
| Avenida de Europa, |
| 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) |
| Spain |

PFIZER, S.L.

Avenida de Europa,

20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)

Spain

SERMION 5 mg

5 mg

coated tablet

oral use

---

ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing Authorisaton Holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Boehringer Ingelheim |
| RCV GmbH & Co KG, |
| Dr. Boehringer-Gasse 5-11, |
| A-1121 Vienna |
| Austria |

Member State

(in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Boehringer Ingelheim

RCV GmbH & Co KG,

Dr. Boehringer-Gasse 5-11,

A-1121 Vienna

Austria

Effortil comp. - Tropfen

2 mg/ml, 10 mg/ml

oral drops, solution

oral use

Austria

| ratiopharm Arzneimittel |
| --- |
| Vertriebs-GmbH, |
| Albert-Schweitzer-Gasse 3, |
| A-1140 Vienna |
| Austria |

ratiopharm Arzneimittel

Vertriebs-GmbH,

Albert-Schweitzer-Gasse 3,

A-1140 Vienna

Austria

DHE "ratiopharm" 2,5 mg - Kapseln

2,5 mg

prolonged-release capsule, hard

oral use

Austria

| ratiopharm Arzneimittel |
| --- |
| Vertriebs-GmbH, |
| Albert-Schweitzer-Gasse 3, |
| A-1140 Vienna |
| Austria |

ratiopharm Arzneimittel

Vertriebs-GmbH,

Albert-Schweitzer-Gasse 3,

A-1140 Vienna

Austria

DHE "ratiopharm" 5 mg - Kapseln

5 mg

prolonged-release capsule, hard

oral use

Austria

Amdipharm Ltd.

3, Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot 2,5 mg - Tabletten

2,5 mg

tablet

oral use

Austria

| WABOSAN |
| --- |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, |
| A-1210 Vienna |
| Austria |

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1,

A-1210 Vienna

Austria

Ergovasan 2 mg/ml - Tropfen

2 mg/ml

oral drops, solution

oral use

Austria

| WABOSAN |
| --- |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, |
| A-1210 Vienna |
| Austria |

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1,

A-1210 Vienna

Austria

Ergovasan 2,5 mg retard - Kapseln

2,5 mg

prolonged-release capsule, hard

oral use

Austria

| WABOSAN |
| --- |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, |
| A-1210 Vienna |
| Austria |

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1,

A-1210 Vienna

Austria

Ergovasan 5 mg retard - Kapseln

5 mg

prolonged-release capsule, hard

oral use

Belgium

| Amdipharm Limited |
| --- |
| Burlington Road, 3 |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Burlington Road, 3

Dublin 4

Ireland

Dihydergot Forte

2,5 mg

Tablet

oral use

Belgium

| Laboratoires Belges |
| --- |
| PHARMACOBEL SA |
| Avenue de Scheut 46-50 |
| 1070 Brussels |
| Belgium |

Laboratoires Belges

PHARMACOBEL SA

Avenue de Scheut 46-50

1070 Brussels

Belgium

Dystonal

2,5 mg

Tablet

oral use

Finland

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

ORSTANORM

2,5 mg

tablet

oral use

France

| PIERRE FABRE |
| --- |
| MEDICAMENT |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| France |

PIERRE FABRE

MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

IKARAN L.P. 5 mg, comprimé à libération prolongée

5 mg

prolonged-release tablet

oral use

France

| PIERRE FABRE |
| --- |
| MEDICAMENT |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| France |

PIERRE FABRE

MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

IKARAN, solution buvable en gouttes

0.20 g /100 ml

oral drops, solution

oral use

France

| UCB PHARMA |
| --- |
| 420 Avenue Estienne d'Orves |
| Défense Ouest |
| 92700 Colombes |
| France |

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

France

SEGLOR 2 mg/ml, solution buvable en gouttes

2 mg/ml

oral solution

oral use

France

| UCB PHARMA |
| --- |
| 420 Avenue Estienne d'Orves |
| Défense Ouest |
| 92700 Colombes |
| France |

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

France

SEGLOR 5 mg, gélule

5 mg

hard capsule

oral use

France

| UCB PHARMA |
| --- |
| 420 Avenue Estienne d'Orves |
| Défense Ouest |
| 92700 Colombes |
| France |

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

France

SEGLOR LYOC 5 mg, lyophilisat oral

5 mg

oral lyophilisate

oral use

France

| Alfa Wasserman Pharma SAS |
| --- |
| 67 rue Anatole France, |
| 92300 Levallois Perret |
| France |

Alfa Wasserman Pharma SAS

67 rue Anatole France,

92300 Levallois Perret

France

TAMIK, capsule

3 mg

soft capsule

oral use

France

| AMDIPHARM |
| --- |
| Temple Chambers |
| 3, Burlington Road |
| DUBLIN 4 |
| IRELAND |

AMDIPHARM

Temple Chambers

3, Burlington Road

DUBLIN 4

IRELAND

DIHYDROERGOTAMINE AMDIPHARM 2 mg/ml, solution buvable

2 mg/ml

oral solution

oral use

France

| AMDIPHARM |
| --- |
| Temple Chambers |
| 3, Burlington Road |
| DUBLIN 4 |
| Ireland |

AMDIPHARM

Temple Chambers

3, Burlington Road

DUBLIN 4

Ireland

DIHYDROERGOTAMINE AMDIPHARM 3 mg, comprimé

3 mg

tablet

oral use

Germany

| Amdipharm Limited |
| --- |
| Temple Chamcers, 3 |
| Burlington Road |
| IRL-Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chamcers, 3

Burlington Road

IRL-Dublin 4

Ireland

Dihydergot plus Lösung zum Einnehmen

2 mg/ 1 ml

10 mg/ 1 ml

Solution

oral use

Germany

| Boehringer Ingelheim Pharma GmbH & Co.KG |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim |
| Germany |

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Germany

Effortil plus

0.2 g/ 100 ml

1 g/ 100 ml

Solution

oral use

Germany

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DET MS Tropflösung

2 mg/ 1 ml

Solution

oral use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Ergotam-CT 2,5mg Retardkapseln

2,5 mg

Prolonged-released capsule

oral use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Ergotam-CT 5,0mg Retardkapseln

5 mg

Prolonged-released capsule

oral use

Germany

| UCB Pharma GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |
| Germany |

UCB Pharma GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Germany

Agit depot sanol

5 mg

Prolonged-released capsule, hard

oral use

Germany

| Verla-Pharm Arzneimittel GmbH & Co.KG Hauptstr. 98 |
| --- |
| D-82327 Tutzing |
| Germany |

Verla-Pharm Arzneimittel GmbH & Co.KG Hauptstr. 98

D-82327 Tutzing

Germany

Verladyn

2 mg/ 1 ml

solution

oral use

Greece

| Amdipharm Ltd. |
| --- |
| 3 Burlington Road, |
| Temple Chambers, |
| Dublin 4 |
| Ireland |

Amdipharm Ltd.

3 Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot

2,5 mg

tablet

oral use

Italy

| Teofarma srl |
| --- |
| Via Fratelli Cervi, 8 |
| 27010 Valle Salimbene |
| Pavia |
| Italy |

Teofarma srl

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia

Italy

DIIDERGOT

2 mg/ml

oral solution

oral use

Italy

| Teofarma srl |
| --- |
| Via Fratelli Cervi, 8 |
| 27010 Valle Salimbene |
| Pavia |
| Italy |

Teofarma srl

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia

Italy

DIIDERGOT

3 mg

tablet

oral use

Italy

| Acarpia - Servicos |
| --- |
| Farmaceuticos LDA |
| Rua dos Murcas, 88 |
| Funchal Madeira - |
| Portugal |

Acarpia - Servicos

Farmaceuticos LDA

Rua dos Murcas, 88

Funchal Madeira -

Portugal

SEGLOR

5 mg

modified-releasecapsule, hard

oral use

Luxembourg

| Pierre Fabre |
| --- |
| Médicaments |
| 45, PLACE ABEL GANCE |
| F 92654 BOULOGNE CEDEX |
| France |

Pierre Fabre

Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE CEDEX

France

Ikaran

0.20 g /100 ml

oral solution

oral use

Luxembourg

| Pierre Fabre |
| --- |
| Médicaments |
| 45, PLACE ABEL GANCE |
| F 92654 BOULOGNE CEDEX |
| France |

Pierre Fabre

Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE CEDEX

France

Ikaran L.P.

5 mg

tablets

oral use

Poland

| Farmaceutyczna |
| --- |
| Spółdzielnia Pracy |
| FILOFARM |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poland |

Farmaceutyczna

Spółdzielnia Pracy

FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Dihydroergotaminum Filofarm

2 mg/g

oral solution

oral use

Poland

| Farmaceutyczna |
| --- |
| Spółdzielnia Pracy |
| FILOFARM |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poland |

Farmaceutyczna

Spółdzielnia Pracy

FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

DHE - tar

1 mg

tablet

oral use

Portugal

| Laboratórios Azevedos – |
| --- |
| Indústria Farmacêutica, |
| S.A. PRT |
| Edifícios Azevedos – |
| Estrada Nacional 117-2, Alfragide |
| 2614-504 Amadora |
| Portugal |

Laboratórios Azevedos –

Indústria Farmacêutica,

S.A. PRT

Edifícios Azevedos –

Estrada Nacional 117-2, Alfragide

2614-504 Amadora

Portugal

Seglor Retard

5 mg

Prolonged-release capsule, hard

oral use

Slovenia

| LEK farmacevtska |
| --- |
| družba d.d., |
| Verovskova 57, |
| SI-1526 Ljubljana, |
| Slovenia |

LEK farmacevtska

družba d.d.,

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

Ditamin 2,5 mg tablete

2,5 mg

tablet

oral use

Spain

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DIHYDERGOT COMPRIMIDOS

1 mg

tablet

oral use

Sweden

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

2,5 mg

Tablets

oral use

Sweden

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

5 mg

Tablets

oral use

---