# Službeni list C 311/2013

| | ISSN 1977-1088
  doi:10.3000/19771088.C_2013.311.hrv |
| --- | --- |
| Službeni list
  Europske unije | C 311 |
| | |
| Hrvatsko izdanje | Informacije i objave | 5625. listopada 2013. |

ISSN 1977-1088

doi:10.3000/19771088.C_2013.311.hrv

Službeni list

Europske unije

C 311

Hrvatsko izdanje

Informacije i objave

5625. listopada 2013.

---

| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2013/C 311/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2013/C 311/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 8 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2013/C 311/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2013/C 311/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

8

| HR | |
| --- | --- |

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 25.10.2013 | HR | Službeni list Europske unije | C 311/1 |
| --- | --- | --- | --- |

25.10.2013

HR

Službeni list Europske unije

C 311/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća
   (1)
  )

2013/C 311/01

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.9.2013 | Procysbi | merkaptamin (cisteaminditartarata) | Raptor Pharmaceuticals Europe BV |
| Naritaweg 165, NL-1043 BW Amsterdam, Nederland |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

6.9.2013

Procysbi

merkaptamin (cisteaminditartarata)

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/13/861

Želučanootporna tvrda kapsula

A16AA04

10.9.2013

6.9.2013

Provenge

Autologne mononuklearne stanice periferne krvi aktivirane PAP-GM-CSF-om (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

Disperzija za infuziju

L03AX17

10.9.2013

10.9.2013

Inflectra

infliksimab

| 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

Prašak za koncentrat za otopinu za infuziju

L04AB02

12.9.2013

10.9.2013

Remsima

infliksimab

| 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

Prašak za koncentrat za otopinu za infuziju

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

Koncentrat za otopinu za infuziju

Pending

16.9.2013

12.9.2013

Orphacol

Kolna kiselina

| 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

Kapsula, tvrda

A05AA03

16.9.2013

19.9.2013

Incresync

alogliptin / pioglitazon

| 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

Filmom obložena tableta

A10BD09

23.9.2013

19.9.2013

Tybost

kobicistat

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/872

Filmom obložena tableta

V03AX03

23.9.2013

19.9.2013

Ultibro Breezhaler

indakaterol/glikopironijev bromid

| 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

Prašak inhalata, tvrda kapsula

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

Filmom obložena tableta

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

Filmom obložena tableta

A10BH04

23.9.2013

19.9.2013

Xoterna Breezhaler

indakaterol/glikopironijev bromid

| 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

Prašak inhalata, tvrda kapsula

R03AL04

23.9.2013

25.9.2013

EVARREST

Ljudski fibrinogen / Ljudski trombin

| 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

matriks za tkivno ljepilo

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

Filmom obložena tableta

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

Kapsula, tvrda

L01XE01

27.9.2013

27.9.2013

Ovaleap

Folitropin 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

Otopina za injekciju

G03GA05

1.10.2013

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Odbijeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 6.9.2013 | Labazenit | LABORATOIRES SMB SA |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.9.2013

Labazenit

LABORATOIRES SMB SA

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

—

10.9.2013

—   Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Neulasta | Amgen Europe B.V. |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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

—   Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Rasitrio | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.9.2013

Rasitrio

Novartis Europharm Limited

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

EU/1/11/730

5.9.2013

Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća
   (2)
  ): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.9.2013 | Apoquel | oclacitinib maleata | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

12.9.2013

Apoquel

oclacitinib maleata

Zoetis Belgium S.A.

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

EU/2/13/154

Filmom obložena tableta

QD11AH90

16.9.2013

19.9.2013

Trifexis

Spinosad / Milbemicin oksim

| 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

Tablete za žvakanje

QP54AB51

23.9.2013

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 12.9.2013 | Equip WNV | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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

—   Povlačenje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 19.9.2013 | Netvax | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

19.9.2013

Netvax

Intervet International B.V.

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

EU/2/09/093

23.9.2013

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| 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)  SL L 136, 30.4.04, str. 1.

(2)  SL L 136, 30.4.04, str. 1.

---

| 25.10.2013 | HR | Službeni list Europske unije | C 311/8 |
| --- | --- | --- | --- |

25.10.2013

HR

Službeni list Europske unije

C 311/8

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ
   (1)
  ili člankom 38. Direktive 2001/82/EZ
   (2)
  )

2013/C 311/02

—   Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 05.9.2013 | Okrido | Vidi Prilog I | Vidi Prilog I | 06.9.2013 |
| 24.9.2013 | Deltanil | Vidi Prilog II | Vidi Prilog II | 26.9.2013 |
| 13.9.2013 | Iron | Vidi Prilog III | Vidi Prilog III | 16.9.2013 |
| 18.9.2013 | Aprotinin | Vidi Prilog IV | Vidi Prilog IV | 19.9.2013 |
| 25.9.2013 | Cydectin | Vidi Prilog V | Vidi Prilog V | 26.9.2013 |
| 12.9.2013 | Targocid | Vidi Prilog VI | Vidi Prilog VI | 13.9.2013 |
| 05.9.2013 | Flupirtine | Vidi Prilog VII | Vidi Prilog VII | 06.9.2013 |
| 06.9.2013 | Doramectin | Vidi Prilog VIII | Vidi Prilog VIII | 09.9.2013 |
| 25.9.2013 | Diclofenac | Vidi Prilog IX | Vidi Prilog IX | 26.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | Vidi Prilog X | Vidi Prilog X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | Vidi Prilog XI | Vidi Prilog XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | Vidi Prilog XII | Vidi Prilog XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | Vidi Prilog XIII | Vidi Prilog XIII | 30.9.2013 |

Datum odluke

Naziv(i) lijeka

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

05.9.2013

Okrido

Vidi Prilog I

Vidi Prilog I

06.9.2013

24.9.2013

Deltanil

Vidi Prilog II

Vidi Prilog II

26.9.2013

13.9.2013

Iron

Vidi Prilog III

Vidi Prilog III

16.9.2013

18.9.2013

Aprotinin

Vidi Prilog IV

Vidi Prilog IV

19.9.2013

25.9.2013

Cydectin

Vidi Prilog V

Vidi Prilog V

26.9.2013

12.9.2013

Targocid

Vidi Prilog VI

Vidi Prilog VI

13.9.2013

05.9.2013

Flupirtine

Vidi Prilog VII

Vidi Prilog VII

06.9.2013

06.9.2013

Doramectin

Vidi Prilog VIII

Vidi Prilog VIII

09.9.2013

25.9.2013

Diclofenac

Vidi Prilog IX

Vidi Prilog IX

26.9.2013

27.9.2013

Ergot derivatives (dihydroergocristine)

Vidi Prilog X

Vidi Prilog X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

Vidi Prilog XI

Vidi Prilog XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

Vidi Prilog XII

Vidi Prilog XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

Vidi Prilog XIII

Vidi Prilog XIII

30.9.2013

—   Obustava nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | Vidi Prilog X | Vidi Prilog X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | Vidi Prilog XI | Vidi Prilog XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | Vidi Prilog XII | Vidi Prilog XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | Vidi Prilog XIII | Vidi Prilog XIII | 30.9.2013 |

Datum odluke

Naziv(i) lijeka

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

27.9.2013

Ergot derivatives (dihydroergocristine)

Vidi Prilog X

Vidi Prilog X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

Vidi Prilog XI

Vidi Prilog XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

Vidi Prilog XII

Vidi Prilog XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

Vidi Prilog XIII

Vidi Prilog XIII

30.9.2013

—   Prekid obustave nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 18.9.2013 | Aprotinin | Vidi Prilog IV | Vidi Prilog IV | 19.9.2013 |

Datum odluke

Naziv(i) lijeka

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

18.9.2013

Aprotinin

Vidi Prilog IV

Vidi Prilog IV

19.9.2013

---

(1)  SL L 311, 28.11.01, str. 67.

(2)  SL L 311, 28.11.01, str. 1.

---

DODATAK I

POPIS NAZIVA, FARMACEUTSKOG(IH) OBLIKA, JAČINE(A) LIJEK(OV)A, PUT(EV)A PRIMJENE, PODNOSITELJ(A) ZAHTJEVA / NOSITELJ(A) ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica
  EU/EGP | Nositelj odobrenja | Podnositelj zahtjeva | Zaštićeno ime Naziv | Jačina | Farmaceutski oblik | Put primjene | Sastav (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Njemačka | | Pharmapol Arzneimittelvertrieb-GmbH, |
| Kaddenbusch 11, 25578 Daegeling, |
| Germany |

Država članica

EU/EGP

Nositelj odobrenja

Podnositelj zahtjeva

Zaštićeno ime Naziv

Jačina

Farmaceutski oblik

Put primjene

Sastav (koncentracija)

Njemačka

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Solución oral

Vía oral

Holandija

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

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Solución oral

Vía oral

Ujedinjeno Kraljevstvo

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

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Solución oral

Vía oral

---

DODATAK II

POPIS IMENA, FARMACEUTSKOG OBLIKA, JAČINE VETERINARSKO MEDICINSKOG PROIZVODA, CILJANIH VRSTA ŽIVOTINJA, NAČINA I PUTEVA PRIMJENE, PODNOSITELJA ZAHTIJEVA U ZEMLJAMA ČLANICAMA EU.

| Država članica EU/EEA | Podnositelj zahtijeva | Naziv veterinarsko medicinskog proizvoda | Djelatna tvar | Jačina | Farmaceutski oblik | Ciljane vrste životinja | Način i putevi primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Virbac |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Država članica EU/EEA

Podnositelj zahtijeva

Naziv veterinarsko medicinskog proizvoda

Djelatna tvar

Jačina

Farmaceutski oblik

Ciljane vrste životinja

Način i putevi primjene

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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 otopina

Goveda

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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 otopina

Goveda

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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 otopina

Goveda

Topical use

Poland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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

Otopina za kožni poliv

Goveda i ovce

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 otopina

Goveda

Topical use

---

DODATAK III

POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U DRŽAVAMA ČLANICAMA

| Država članica
  (u EGP) | Nositelj odobrenja za stavljanje lijeka u promet | Međunarodni nezaštićeni naziv | Zaštićeni naziv | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Pharmacosmos A/S |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Država članica

(u EGP)

Nositelj odobrenja za stavljanje lijeka u promet

Međunarodni nezaštićeni naziv

Zaštićeni naziv

Jačina

Farmaceutski oblik

Put primjene

Austrija

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Austrija

| 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

Željezova karboksimaltoza

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

50 mg/ml

Otopina za injekciju/infuziju

U venu

Austrija

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Kompleks željezova (III) hidroksida i saharoze

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

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Austrija

| 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

Kompleks saharoze i željezova (III) hidroksida

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Austrija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid

Monofer 100 mg/ml Injektions- oder Infusionslösung

100 mg/ml

Otopina za injekciju/infuziju

U venu

Austrija

| 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

Kompleks saharoze i željezova (III) hidroksida

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Belgija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida s dekstranom

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

U venu

Belgija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid

Monover

100 mg/ml

Otopina za injekciju/infuziju

U venu

Belgija

| 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

Željezo (saharoza)

Venofer

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Belgija

| 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

Željezo (željezova karboksimaltoza)

Injectafer

50,00 mg/ml

Otopina za injekciju/infuziju

U venu

Bugarska

| 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

Željezo (u obliku željezove karoboksimaltoze)

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Bugarska

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

Pharmalog AG,

33 Cherni vrah blvd.,

1421 Sofia

Bulgaria

Kompleks željezova hidroksida sa saharozom

Idafer

20 mg/ml

Otopina za injekciju

U venu

Bugarska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova hidroksida s dekstranom

Cosmofer

50 mg/ml

Otopina za injekciju

U venu

Bugarska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) oksida s dekstranom

Monofer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Cipar

| 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

Željezo (u obliku željezove karboksimaltoze)

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML

50 mg/ml

Otopina za injekciju/infuziju

U venu

Cipar

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza (III) i oligosaharida

MONOFER SOLUTION FOR INJECTION OR INFUSION 100MG/ML

100 mg/ml

Otopina za injekciju/infuziju

U venu

Cipar

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza (III) i dekstrana

COSMOFER SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML

50 mg/ml

Otopina za injekciju/infuziju

U venu

Cipar

| 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

Željezov oksid u kombinaciji sa saharozom

VENOFER INJECTION 100MG IRON/5ML

100 mg/5 ml

Otopina za injekciju

U venu

Cipar

| 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

Željezo (u obliku kompleksa željezova hidroksida sa saharozom)

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

20 mg/ml

Otopina za injekciju/infuziju

U venu

Češka Republika

| 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

Željezo (u kombinaciji željezova oksida sa saharozom)

VENOFER

20 mg/ml

Otopina za injekciju

U venu

Češka Republika

| 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

Željezo (kao kombinacija željezova oksida sa saharozom)

FERROLOGIC 20 MG/ML

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Češka Republika

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

PHARMABIDE LTD

20, Lakonias str, 15234 Halandri

Athens - Greece

Željezo (kao kombinacija željezova oksida sa saharozom)

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Češka Republika

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Željezo (kao kombinacija željezova oksida sa saharozom)

FERION 20 MG/ML

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Češka Republika

| 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

Željezo (u obliku kompleksa željeza i natrijeva glukonata)

FERRLECIT

12,5 mg/ml

Otopina za injekciju

U venu

Češka Republika

| 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

Željezo (u obliku željezove karboksimaltoze)

FERINJECT

50 mg/ml

Otopina za injekciju/infuziju

U venu

Danska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

U venu

Danska

| 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

Željezova karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Danska

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Kompleks željezova (III) hidroksida sa saharozom

Ferion

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Danska

| 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

Željezov (III) saharat

Ferrologic

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Danska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov dekstran

Jerndextran "Pharmacosmos"

50 mg/ml

Otopina za injekciju/infuziju

U venu

Danska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov dekstran

MonoFer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Danska

| 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

Željezov (III) oksid u kombinaciji sa saharozom

Venofer

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Estonija

| 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

Kompleks saharoze i željezova (III) hidroksida

Venofer

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Estonija

| 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

Kompleks saharoze i željezova (III) hidroksida

Ferrologic 20mg/ml

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Estonija

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Kompleks saharoze i željezova (III) hidroksida

Ferion

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Estonija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Estonija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) izomaltozida 1 000

Monofer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Estonija

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

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Kompleks željezova (III) hidroksida i dekstrana

Ferrum Lek

50 mg/ml

Otopina za injekciju

U mišić

Finska

| 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

Željezova karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Finska

| 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

Kombinacija željezova (III) hidroksida i saharoze

Ferrologic

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Finska

| 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

Kompleks saharoze i željezova (III) hidroksida

Venofer

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Finska

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

Alternova A/S

Lodshusvej 11

4230 Skaelskoer

Denmark

Kompleks saharoze i željezova (III) hidroksida

Venotrix

20 mg/ml

Koncentrat za otopinu za infuziju/otopina za injekciju

U venu

Finska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

U venu

Finska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza (III) i izomaltida 1 000

Monofer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Francuska

| 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

Željezova (III) karboksimaltoza

FERINJECT 50 mg/ml, solution injectable/pour perfusion

50 mg/ml

Otopina za injekciju/infuziju

U venu

Francuska

| 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

Kompleks željeza i saharoze

VENOFER 20mg/ml, solution injectable

20 mg/ml

Otopina za injekciju

U venu

Francuska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

FERRISAT 50 mg/ml, solution injectable ou pour perfusion

50 mg/ml

Otopina za injekciju/infuziju

U venu

Francuska

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

Pharmaki Generics Ltd

5 Bourlet Close

W1W 7BL London

United Kingdom

Kompleks željeza i dekstrana

FER ACTAVIS 100 mg/5 ml, solution injectable

100 mg/5 ml

Otopina za injekciju

U venu

Francuska

| 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

Kompleks saharoze i željeza

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

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Francuska

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

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

Kompleks željeza i saharoze

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

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Francuska

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Kompleks željeza i saharoze

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

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Francuska

| 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

Kompleks željeza i saharoze

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

100 mg/5 ml

Otopina za injekciju

U venu

Njemačka

| 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

Kompleks željezova (III) hidroksida i saharoze

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

1 709 mg/5 ml

Koncentrat za otopinu za infuziju/otopina za injekciju

U venu

Njemačka

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Kompleks željezova (III) hidroksida i saharoze

FerMed

1 563 - 1 887 mg/5 ml

Koncentrat za otopinu za infuziju/otopina za injekciju

U venu

Njemačka

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Kompleks željezova (III) hidroksida i saharoze

Nefro-Fer

1 563 - 1 887 mg/5 ml

Otopina za injekciju

U venu

Njemačka

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida oksida i citrata izomaltozaoligosaharida

Monofer 100 mg/ml Lösung zur Injektion/Infusion

377-465 mg/ml

Otopina za injekciju/infuziju

U venu

Njemačka

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

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

Kompleks saharoze i željezova (III) natrijeva glukonata (= kompleks natrijeva željezova (III) glukonata)

Ferrlecit 40 mg

1 288,9 mg/3,2 ml

Otopina za injekciju

U venu

Njemačka

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

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

Kompleks saharoze i željezova (III) natrijeva glukonata (= kompleks natrijeva željezova (III) glukonata)

Ferrlecit 62,5 mg

2 013,9 mg/5 ml

Otopina za injekciju

U venu

Njemačka

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

Pharmacosmos A/S

Roervangsvei 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Njemačka

| 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

Kompleks željezove (III) karboksimaltoze

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung

180 mg/ml

Otopina za injekciju/infuziju

U venu

Njemačka

| 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

Kompleks željezova (III) hidroksida i saharoze

Venofer 20 mg FR / ml Injektionslösung

2 700 mg/5 ml

Koncentrat za otopinu za infuziju/otopina za injekciju

U venu

Grčka

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

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Kompleks željezova hidroksida sa saharozom

REOXYL

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Vianex S.A.

Tatoiou Street

Nea Erythrea 14671

Greece

Kompleks željezova hidroksida sa saharozom

INTRAFER

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Kompleks željezova hidroksida sa saharozom

FAREMIO

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Kompleks željezova hidroksida sa saharozom

DEXTRIFER-S

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

| 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

Kompleks željezova hidroksida sa saharozom

VENOFER

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Demo ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Kompleks željezova (III) hidroksida s dekstranom

COSMOFER

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Grčka

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

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Kompleks željezova hidroksida sa saharozom

FERROVIN

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Nephrotech S.A.

Parnithos 44

Metamorfosi Attikis 14452

Greece

Kompleks željezova hidroksida sa saharozom

SUCRO-FER

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

| 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

Kompleks željezova hidroksida sa saharozom

HEMAFER-S

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Grčka

| 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

Kompleks željezova hidroksida sa saharozom

NEPHROFEROL

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Kompleks željezova hidroksida sa saharozom

FERRINEMIA

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Specifar AEBE

28th October Street 1

Agia Barbara 12351

Greece

Kompleks željezova hidroksida sa saharozom

ALVOFER

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Alet Pharmaceuticals

M. Alexander 121,

Agia Varvara, 12351

Greece

Kompleks željezova hidroksida sa saharozom

SUCROVEN

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Kompleks željezova hidroksida sa saharozom

IRONCROSE

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Kompleks željetova (III) hidroksida s dekstranom

IRONATE

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Grčka

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

Demo ABEE

21st km National Highway

Athens-Lamia, 14565

Greece

Kompleks željezova (III) oligosaharida)

MONOFER

100 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Grčka

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

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Kompleks željezova hidroksida sa saharozom

VENIRON

100 mg/5 ml

Koncentrat za otopinu za infuziju

U venu

Grčka

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

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Kompleks željezova hidroksida s dekstranom

IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Mađarska

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Mađarska

| 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

Željezov (III) hidroksid

Venofer

20 mg/ml

Otopina za injekciju/infuziju

U venu

Mađarska

| 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

Kompleks željezova (III) hidroksida i saharoze

Ferrologic

20 mg/ml

Otopina za injekciju/infuziju

U venu

Mađarska

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

Sanofi-Aventis Zrt

Tó utca 1-5,

1045 Budapest

Hungary

Kompleks natrijeva željezova (III) glukonata

Ferrlecit

12,5 mg/ml

Otopina za injekciju

U venu

Island

| 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

Željezova (III) karboksimaltoza INN

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Island

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid

Monofer

100 mg/ml

Otopina za infuziju

U venu

Island

| 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

Željezov (III) oksid u kombinaciji sa saharozom

Venofer

20 mg/ml

Otopina za injekciju

U venu

Irska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

CosmoFer 50mg/ml solution for infusion and injection

50 mg/ml

Otopina za injekciju/infuziju

U venu

Irska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) izomaltozida 1 000

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

100 mg/ml

Otopina za injekciju/infuziju

U venu

Irska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) izomaltozida 1 000

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

100 mg/ml

Otopina za injekciju/infuziju

U venu

Irska

| 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

Željezo (III)

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Irska

| 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

Željezo (u obliku željezove karboksimaltoze)

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Otopina za injekciju/infuziju

U venu

Irska

| 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

Željezo (III) kao željezo saharoza (kompleks željezova (III) hidroksida)

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

20 mg/ml

Otopina za injekciju/infuziju

U venu

Irska

| 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

Željezova saharoza [kompleks željezova (III) hidroksida i saharoze] jednako Fe(III)

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

20 mg/ml

Otopina za injekciju

U venu

Italija

| 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

Željezova (III) karboksimaltoza

FERINJECT

50 mg/ml

Otopina za injekciju/infuziju

U venu

Italija

| 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

Kompleks željeza i saharoze

FERRO SACCARATO FME

20 mg/ml

Koncentrat za otopinu za infuziju/otopina za injekciju

U venu

Italija

| 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

Kompleks željeza i saharoze

VENOFER

20 mg/ml

Otopina za injekciju

U venu

Italija

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

Sanofi-Aventis SPA

Viale Luigi Bodio, 37/B

20158 Milano

Italy

Natrijev željezov (III) glukonat (= kompleks natrijeva željezova (III) glukonata)

FERLIXIT

62,5 mg/5 ml

Oralna otopina ili otopina za infuziju

Kroz usta

U venu

Latvija

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Latvija

| 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

Željezo

Venofer

20 mg/ml

Otopina za injekciju

U venu

Latvija

| 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

Kompleks željezova (III) hidroksida i saharoze

FerroLogic

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Latvija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks dekstrana i željezova (III) hidroksida

CosmoFer

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Latvija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezo

Monofer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Litva

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Litva

| 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

Kompleks željezova (III) hidroksida i saharoze

Venofer

20 mg/ml

Otopina za injekciju

U venu

Litva

| 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

Kompleks željezova (III) hidroksida i saharoze

Ferrologic

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Litva

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid

Monofer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Litva

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

CosmoFer

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Luksemburg

| 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

Željezo (željezova karboskimaltoza) 50 mg/ml

Injectafer-50mg/l

50 mg/ml

Otopina za injekciju

U venu

Luksemburg

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks dekstrana i željezova (III) hidroksida 50 mg/ml.

Cosmofer-50mg/ml

50 mg/ml

Otopina za injekciju

U venu

Luksemburg

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Kompleks željezova (III) hidroksida i saharoze 100 mg/5 ml

Fermed-100mg/5ml

100 mg/5 ml

Otopina za perfuziju

U venu

Luksemburg

| 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

Kompleks saharoze i željezova (III) hidroksida

Ferrologic-20mg/ml

20 mg/ml

Otopina za perfuziju

U venu

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

Željezo u obliku željezove (III) karboksimaltoze

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Otopina za injekciju/infuziju

U venu

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

Željezo saharoza [kompleks željezova (III) hidroksida i saharoze].

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Norveška

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

Parenteralna primjena

Norveška

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

Parenteralna primjena

Norveška

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Kompleks saharoze i željezova (III) hidroksida

Ferion

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

Parenteralna primjena

Norveška

| 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

Kompleks saharoze i željezova (III) hidroksida

Ferrologic

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

Parenteralna primjena

Norveška

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid 1 000

Monofer

100 mg/ml

Otopina za injekciju/infuziju

Parenteralna primjena

Norveška

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

Uniferon

200 mg/ml

Otopina za injekciju

Parenteralna primjena

Norveška

| 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

Kompleks saharoze i željezova (III) hidroksida

Venofer

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

Parenteralna primjena

Poljska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks dekstrana i željezova hidroksida

CosmoFer

50 mg/ml

Otopina za injekciju/infuziju

U venu

Poljska

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

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju

U venu

Poljska

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

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

Kompleks saharoze i željezova (III) hidroksida

Venofer

20 mg/ml

Otopina za injekciju/infuziju

U venu

Poljska

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Kompleks saharoze i željezova (III) hidroksida

Ferion

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Poljska

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

Fresenius Medical Care Nephrologica Deutschland GmbH

61346 Bad Homburg

Germany

Kompleks saharoze i željezova (III) hidroksida

Ferrologic 20 mg/ml

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Poljska

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Kompleks željezova (III) hidroksida i poliizomaltoze

Ferrum-Lek

50 mg/ml

Otopina za injekciju

U mišić

Poljska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid 1 000

Monover

100 mg/ml

Otopina za injekciju/infuziju

U venu

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

Željezov oksid u kombinaciji sa saharozom

Referen

100 mg/5 ml

Otopina za injekciju

U venu

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

Željezov oksid u kombinaciji sa saharozom

Venofer

100 mg/5 ml

Otopina za injekciju

U venu

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

Željezov oksid u kombinaciji sa saharozom

Óxido Férrico Sacarosado Combino

100 mg/5 ml

Otopina za injekciju

U venu

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

Željezov oksid u kombinaciji sa saharozom

Óxido Férrico Sacarosado Farmoz

100 mg/5 ml

Otopina za injekciju

U venu

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

Željezov oksid u kombinaciji sa saharozom

Óxido Férrico Sacarosado Generis

100 mg/5 ml

Otopina za injekciju

U venu

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

Željezov oksid u kombinaciji sa saharozom

Óxido Férrico Sacarosado Normon

100 mg/5 ml

Otopina za injekciju

U venu

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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Portugal

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Portugal

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

Monofar

100 mg/ml

Otopina za injekciju/infuziju

U venu

Rumunjska

| 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

Kompleks saharoze i željezova (III) hidroksida

VENOFER®

20 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Rumunjska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) izomaltozata

MONOFER 100 mg/ml

100 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Rumunjska

| 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

Željezova (III) karboksimaltoza

FERINJECT 50 mg fer/ml

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Slovačka

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

Slovačka

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Kompleks saharoze i željezova (III) hidroksida

Ferion 20 mg/ml

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Slovačka

| 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

Kompleks željezova (III) hidroksida i saharoze

Ferrologic 20 mg/ml

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Slovačka

| 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

Kompleks željezova (III) hidroksida i saharoze

Venofer

20 mg/ml

Otopina za injekciju

U venu

Slovenija

| 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

Željezov oksid u kombinaciji sa saharozom

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Slovenija

| 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

Polimaltozni kompleksi željezova oksida

Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje

50 mg/ml

Otopina za injekciju/infuziju

U venu

Slovenija

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

Lek farmacevtska družba d.d.,

Verovškova 57,

1000 Ljubljana

Slovenia

Željezov oksid u kombinaciji sa saharozom

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Španjolska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željezova (III) hidroksida i dekstrana

COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50 mg/ml

Otopina za injekciju

Otopina za infuziju

U venu

u mišić

Španjolska

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

GUERBET B.P.

57400 ROISSY CdG

CEDEX F-95943

France

Nanočestice željezova oksida

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

11,2 mg/ml

Koncentrat za suspenziju za infuziju

U venu

Španjolska

| 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

Kompleks željeza i saharoze

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Španjolska

| 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

Kompleks željeza i saharoze

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Španjolska

| 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

Kompleks željeza i saharoze

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Španjolska

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Kompleks željeza i saharoze

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

100 mg/5 ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Španjolska

| 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

Kompleks željeza i saharoze

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Španjolska

| 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

Željezova (III) karboskimaltoza

FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION

50 mg/ml

Otopina za injekciju

Otopina za infuziju

U venu

Španjolska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezova (III) izomaltozid

MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN

100 mg/ml

Otopina za injekciju

Otopina za infuziju

U venu

Švedska

| 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

Kompleks željeza i saharoze

Venofer®

20 mg/ml

Koncentrat za otopinu za injekciju

U venu

Švedska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

Cosmofer®

50 mg/ml

Otopina za injekciju

U venu

Švedska

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju

U venu

Švedska

| 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

Kompleks željeza i saharoze

Ferrologic

20 mg/ml

Koncentrat za otopinu za injekciju

U venu

Švedska

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Kompleks željeza i saharoze

Ferion

20 mg/ml

Koncentrat za otopinu za injekciju

U venu

Švedska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid 1 000

MonoFer®

100 mg/ml

Otopina za injekciju

U venu

Nizozemska

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

Pharmamatch B.V.

Egelenburg 2

Amsterdam GK - 1081

The Netherlands

Kompleks saharoze i željezova (III) hidroksida

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Nizozemska

| 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

Kompleks saharoze i željezova (III) hidroksida

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Nizozemska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid 1 000

MonoFer 100 mg/ml oplossing voor injectie/infusie

100 mg/ml

Otopina za injekciju/infuziju

U venu

Nizozemska

| 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

Kompleks saharoze i željezova (III) hidroksida

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Nizozemska

| 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

Kompleks željezova (III) hidroksida i dekarboksimaltoze

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

50 mg/ml

Otopina za injekciju/infuziju

U venu

Nizozemska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

CosmoFer 50 mg/ml oplossing voor infusie en injectie

50 mg/ml

Otopina za injekciju/infuziju

U venu

Nizozemska

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

Pharmachemie B.V.

Haarlem - 2031 GA

The Netherlands

Kompleks saharoze i željezova (III) hidroksida

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

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Ujedinjeno Kraljevstvo

| 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

Kompleks željeza i saharoze

Venofer

20 mg/ml

Otopina za injekciju/infuziju

U venu

Ujedinjeno Kraljevstvo

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezo (III) izomaltozid 1 000

Monofer

100 mg/ml

Otopina za injekciju/infuziju

U venu

Ujedinjeno Kraljevstvo

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Željezov (III) izomaltozid 1 000

Diafer

50 mg/ml

Otopina za injekciju

U venu

Ujedinjeno Kraljevstvo

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Kompleks željeza i dekstrana

Cosmofer

50 mg/ml

Otopina za injekciju/infuziju

U venu

u mišić

Ujedinjeno Kraljevstvo

| 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

Kompleks željeza, saharoze i dekstrana

Ferrologic

20 mg/ml

Otopina za injekciju

Koncentrat za otopinu za infuziju

U venu

Ujedinjeno Kraljevstvo

| 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

Željezova (III) karboksimaltoza

Ferinject

50 mg/ml

Otopina za injekciju/infuziju

U venu

---

DODATAK IV

POPIS ZAŠTIĆENIH IMENA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE I NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U ZEMLJAMA ČLANICAMA

Lijekovi koji sadrže aprotinin s odobrenjem za stavljanje lijeka u promet u Europskoj uniji

| Zemlja članica
  (EU/EGP) | Nositelj odobrenja za stavljanje lijeka u promet | Zaštićeno ime | Doza | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| AT-Austrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| A-1160 Wien |
| Austrija |

Zemlja članica

(EU/EGP)

Nositelj odobrenja za stavljanje lijeka u promet

Zaštićeno ime

Doza

Farmaceutski oblik

Put primjene

AT-Austrija

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Austrija

Trasylol 10 000 KIE/ml - Infusionsflasche

10 000 KIU/ml

Otopina za infuziju

U venu

BE-Belgija

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

Belgium Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

Belgija

Trasylol

10 000 KIU/ml

Otopina za infuziju

U venu

CZ-Republika Češka

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

Chemical Works of Gedeon Richter Plc.

Gyömrői út 19-21.

HU-1103 Budapest

Mađarska

Gordox

10 ku/ml

Otopina za injekciju

U venu

CZ- Republika Češka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| 13353 Berlin |
| Njemačka |

Bayer Schering Pharma AG

Müllerstrasse 178

13353 Berlin

Njemačka

Trasylol 500 000 KIE

10 ku/ml

Otopina za infuziju

U venu

DE-Njemačka

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

Otopina za infuziju

U venu

DE-Njemačka

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

Otopina za infuziju

U venu

DE-Njemačka

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 2,0

280,0 mg /200 ml

Otopina za infuziju

U venu

DE-Njemačka

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

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 0,5

70,0 mg /50 ml

Otopina za infuziju

U venu

DE-Njemačka

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

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 1,0

140,0 mg /100 ml

Otopina za infuziju

U venu

DE-Njemačka

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

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 2,0

280,0 mg /200 ml

Otopina za infuziju

U venu

DK-Danska

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

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin

Njemačka

Trasylol

10 000 KIE/ml

Otopina za injekciju

U venu

EL-Grčka

| 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

Otopina za infuziju

U venu

ES-Španjolska

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

QUIMICA FARMACEUTICA BAYER, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despi

Barcelona - Španjolska

TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA

10 000 K 10 000 KIU/ml IU/ml

Otopina za perfuziju

U venu

FI-Finska

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

Bayer HealthCare AG,

51368 Leverkusen,

Njemačka

TRASYLOL

10 000 KIU/ml

Otopina za injekciju / infuziju

U venu

FR-Francuska

| 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

Otopina za injekciju

U venu

FR-Francuska

| 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

Otopina za injekciju

U venu

FR-Francuska

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

BAYER SANTE - 220,

avenue de la recherche 59120 LOOS

Trasylol

500 000 UIK / 50 mL

Otopina za injekciju

U venu

HU-Mađarska

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

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest

Mađarska

Gordox

100 000 KIU/10 ml

Otopina za injekciju

U venu

HU-Mađarska

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

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest

Mađarska

Gordox

500 000 KIU/50 ml

Otopina za infuziju

U venu

HU-Mađarska

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

Bayer Healthcare AG

Kaiser-Wilhelm-Allee, Bldg. E39

51368 Leverkusen,

Njemačka

Trasylol

500 000 KIU / 50 ml

Otopina za infuziju

U venu

LU-Luksemburg

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

Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

TRASYLOL

50 000 KIU/50ml

Otopina za injekciju

U venu

LV - Latvija

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

Gedeon Richter Ltd.

Gyomroi ut 19-21

Budapest HU-1103

Mađarska

Gordox 10 000 KSV/ml šķīdums infūzijām

10 000 KIU/ml

Otopina za infuziju

U venu

MT-Malta

| Bayer Plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| Velika Britanija |

Bayer Plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

Velika Britanija

poslujući kao Bayer Plc, Pharmaceutical Division

TRASYLOL

10 000 KIU/ML

Otopina za infuziju

U venu

NL-Nizozemska

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Nizozemska |

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Nizozemska

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

10 000 KIU/ml

Otopina za infuziju

U venu

PL-Poljska

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

Bayer Pharma AG

Berlin, D-13342

Njemačka

Trasylol

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

Otopina za infuziju

U venu

PL- Poljska

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

Bayer Pharma AG

Berlin, D-13342

Njemačka

Trasylol

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

Otopina za infuziju

U venu

PL- Poljska

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

Bayer Pharma AG

Berlin, D-13342,

Njemačka

Trasylol

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

Otopina za infuziju

U venu

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

Otopina za infuziju

U venu

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

Otopina za infuziju

U venu

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

Otopina za infuziju

U venu

SE-Švedska

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

Bayer Schering Pharma AG

Müllerstrasse 178

DE-133 42 Berlin

Njemačka

Trasylol

10 000 KIE/ml

Otopina za injekciju / infuziju

U venu

SK-Slovačka

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

Richter Gedeon Nyrt

Budapest 10

Pf. 27., H-1475

Mađarska

GORDOX

100 000 IU/10 ml

Otopina za injekciju

U venu

SI-Slovenija

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

Bayer d.o.o.

Bravničarjeva 13,

Ljubljana,

Slovenija

TRASYLOL

10 000 KIU/ml

Otopina za injekciju i infuziju

U venu

UK- Velika Britanija

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

Bayer plc

Bayer House,

Strawberry Hill

Newbury,

Berkshire RG14 1JA

Velika Britanija

Trasylol Solution

10,000 KIU/ML

Otopina za injekciju

U venu

UK-Velika Britanija

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

Nordic Pharma Limited,

Abbey House,

1650 Arlington Business Park,

Theale, Reading,

Berkshire RG7 4SA,

Velika Britanija

Aprotinin 10,000 KIU/ml Injection

10,000 KIU/ml

Otopina za injekciju

U venu

---

DODATAK V

LISTA IMENA, FARMACEUTSKIH OBLIKA, JAČINA VETERINARSKO MEDICINSKOG PROIZVODA, VRSTE ŽIVOTINJA, PUTEVI PRIMJENE, PODNOSITELJI/NOSITELJI ODOBRENJA ZA STAVLJANJE U PROMET U ZEMLJAMA ČLANICAMA

| Zemlja članica
  EU/EEA | Podnositelji/nositelji odobrenja za stavljanje u promet | Ime | INN | Jačina | Farmaceutski oblik | Put primjene | Vrste životinja |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Pfizer Corp. Austria G.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Austrija |

Zemlja članica

EU/EEA

Podnositelji/nositelji odobrenja za stavljanje u promet

Ime

INN

Jačina

Farmaceutski oblik

Put primjene

Vrste životinja

Austrija

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

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austrija

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Belgija

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

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgija

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Danska

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

Pfizer Oy, Animal Health

Tietokuja 4

00330 Helsinki

Finska

Cydectin TriclaMox

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Francuska

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

Pfizer Holding France

23-25 avenue du Docteur Lannelongue

F – 75668 Paris Cedex 14

Francuska

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Njemačka

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

Pfizer GmbH

Linkstraße 10

10785 Berlin

Njemačka

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Grčka

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

Pfizer Hellas AE

Mesogion Avenue 243

154 51 N. Psychiko

Athens

Grčka

Cydectin TriclaMox

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Irska

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

Pfizer Healthcare Ireland

Ringaskiddy

Co Cork

Irska

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

04100 Latina

Italija

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Luksemburg

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

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgija

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

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

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Slovenija

| 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

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Španjolska

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

Zoetis Spain, S.L.

Avda. de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Španjolska

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

Velika Britanija

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich CT13 9NJ |
| Velika Britanija |

Pfizer Ltd

Ramsgate Road

Sandwich CT13 9NJ

Velika Britanija

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

Moxidectin

5,0 mg

Poliv, otopina

na kožu - na leđa životinje

Goveda

Triclabendazole

200,0 mg

---

DODATAK VI

POPIS ZAŠTIĆENIH IMENA, FARMACEUTSKIH OBLIKA, DOZA LIJEKOVA, PUTOVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U DRŽAVAMA ČLANICAMA

| Zemlja članica EU/EEA | Ime i adresa nositelja odobrenja | Zaštićeno ime Ime | Doza | Farmaceutski oblik | Put primjene | Sastav (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | sanofi-aventis GmbH, |
| Leonard-Bernstein-Straße 10, |
| A-1220 Beč, |
| Austrija |

Zemlja članica EU/EEA

Ime i adresa nositelja odobrenja

Zaštićeno ime Ime

Doza

Farmaceutski oblik

Put primjene

Sastav (koncentracija)

Austrija

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Beč,

Austrija

Targocid 100 mg Trockenstechampullen mit Lösungsmittel

100 mg

prašak i otapalo za otopinu za injekciju/infuziju i oralnu otopinu

primjena u mišić, primjena u venu, primjena kroz usta

100 mg/1,5 ml

Austrija

| sanofi-aventis GmbH, |
| --- |
| Leonard-Bernstein-Straße 10, |
| A-1220 Beč, |
| Austrija |

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Beč,

Austrija

Targocid 200 mg Trockenstechampullen mit Lösungsmittel

200 mg

prašak i otapalo za otopinu za injekciju/infuziju i oralnu otopinu

primjena u mišić, primjena u venu, primjena kroz usta

200 mg/3 ml

Austrija

| sanofi-aventis GmbH, |
| --- |
| Leonard-Bernstein-Straße 10, |
| A-1220 Beč, |
| Austrija |

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Beč,

Austrija

Targocid 400 mg Trockenstechampullen mit Lösungsmittel

400 mg

prašak i otapalo za otopinu za injekciju/infuziju i oralnu otopinu

primjena u mišić, primjena u venu, primjena kroz usta

400 mg/3 ml

Belgija

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgija

Targocid 200 mg, poeder en oplosmiddel voor oplossing voor injectie

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Belgija

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgija

Targocid 400 mg, poeder en oplosmiddel voor oplossing voor injectie

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Bugarska

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

sanofi-aventis Bulgaria EOOD

1303 Sofija,

103 Alexander Stamboliiski Blvd. fl.8.,

Bugarska

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

400 mg

prašak i otapalo za otopinu za injekciju/infuziju

primjena u mišić/primjena u venu, primjena kroz usta

400 mg/3 ml

Češka Republika

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a, |
| 160 00 Prag 6, |
| Češka Republika |

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Prag 6,

Češka Republika

Targocid 200 mg

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Češka Republika

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a, |
| 160 00 Prag 6, |
| Češka Republika |

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Prag 6,

Češka Republika

Targocid 400 mg

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Danska

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

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Danska

Targocid

100 mg

prašak za otopinu za injekciju

primjena u mišić/primjena u venu

100 mg/1,5 ml

Danska

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

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Danska

Targocid

200 mg

prašak za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Danska

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

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Danska

Targocid

400 mg

prašak za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Finska

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

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Finska

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

200 mg

prašak za otopinu za injekciju /infuziju

primjena u mišić/primjena u venu

200 mg/3 ml

Finska

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

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Finska

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

400 mg

prašak za otopinu za injekciju /infuziju

primjena u mišić/primjena u venu

400 mg/3 ml

Francuska

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Pariz,

Francuska

TARGOCID 100 mg, lyophilisat et solution pour usage parentéral

100 mg

prašak i otapalo za injekciju

primjena u mišić/primjena u venu

100 mg/1,5 ml

Francuska

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Pariz,

Francuska

TARGOCID 200 mg, lyophilisat et solution pour usage parentéral

200 mg

prašak i otapalo za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Francuska

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Pariz,

Francuska

TARGOCID 400 mg, lyophilisat et solution pour usage parentéral

400 mg

prašak i otapalo za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Njemačka

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt na Majni, |
| Njemačka |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt na Majni,

Njemačka

Targocid® 100 mg

100 mg

prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu

primjena u mišić/primjena u venu, primjena kroz usta

100 mg/1,5 ml

Njemačka

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt na Majni, |
| Njemačka |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt na Majni,

Njemačka

Targocid® 200 mg

200 mg

prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu

primjena u mišić/primjena u venu, primjena kroz usta

200 mg/3 ml

Njemačka

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt na Majni, |
| Njemačka |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt na Majni,

Njemačka

Targocid® 400 mg

400 mg

prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu

primjena u mišić/primjena u venu, primjena kroz usta

400 mg/3 ml

Njemačka

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt na Majni, |
| Njemačka |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt na Majni,

Njemačka

Teicoplanin Sanofi-Aventis 100 mg

100 mg

prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu

primjena u mišić/primjena u venu, primjena kroz usta

100 mg/1,5 ml

Njemačka

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt na Majni, |
| Njemačka |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt na Majni,

Njemačka

Teicoplanin Sanofi-Aventis 200 mg

200 mg

prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu

primjena u mišić/primjena u venu, primjena kroz usta

200 mg/3 ml

Njemačka

| sanofi-aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Geb. K 703, |
| 65926 Frankfurt na Majni, |
| Njemačka |

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt na Majni,

Njemačka

Teicoplanin Sanofi-Aventis 400 mg

400 mg

prašak i otapalo za otopinu za infuziju/injekciju ili oralnu otopinu

primjena u mišić/primjena u venu, primjena kroz usta

400 mg/3 ml

Grčka

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

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Grčka

TARGOCID®

200 mg

prašak i otapalo za injekciju ili infuziju

primjena u mišić/primjena u venu

200 mg/3 ml

Grčka

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

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Grčka

TARGOCID®

400mg

prašak i otapalo za injekciju ili infuziju

primjena u mišić/primjena u venu

400 mg/3 ml

Mađarska

| sanofi-aventis Zrt. |
| --- |
| 1-5. Tó u., |
| 1045 Budimpešta, |
| Mađarska |

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budimpešta,

Mađarska

Targocid 200 mg por és oldószer oldatos injekcióhoz

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Mađarska

| sanofi-aventis Zrt. |
| --- |
| 1-5. Tó u., |
| 1045 Budimpešta, |
| Mađarska |

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budimpešta,

Mađarska

Targocid 400 mg por és oldószer oldatos injekcióhoz

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Irska

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

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

Irska

Targocid 200mg Powder and Solvent for Solution for Injection

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Irska

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

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

Irska

Targocid 400mg Powder and Solvent for Solution for Injection

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Italija

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italija

TARGOSID

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Italija

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italija

TARGOSID

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Italija

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italija

TEICOMID

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Italija

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italija

TEICOMID

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Luksemburg

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgija

TARGOCID

200 mg

prašak za pripravke za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Luksemburg

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgija

TARGOCID

400 mg

prašak za pripravke za injekciju

primjena u mišić/primjena u venu

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

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Nizozemska

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

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

Nizozemska

TARGOCID® 200

200 mg

prašak za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Nizozemska

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

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

Nizozemska

TARGOCID® 400

400 mg

prašak za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Norveška

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

sanofi-aventis Norge AS,

Strandveien 15,

PO Box 133, 1325 Lysaker,

Norveška

TARGOCID®

400 mg

prašak za otopinu za injekciju/infuziju

primjena u mišić/primjena u venu

400 mg/3 ml

Poljska

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| Ujedinjeno Kraljevstvo |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

Ujedinjeno Kraljevstvo

TARGOCID

200 mg

prašak i otapalo za otopinu za injekciju i infuziju

primjena u mišić/primjena u venu

200 mg/3 ml

Poljska

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| Ujedinjeno Kraljevstvo |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

Ujedinjeno Kraljevstvo

TARGOCID

400 mg

prašak i otapalo za otopinu za injekciju i infuziju

primjena u mišić/primjena u venu

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

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu

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

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu

400 mg/3 ml

Rumunjska

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

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

Ujedinjeno Kraljevstvo

TARGOCID® 200 mg

200 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Rumunjska

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

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

Ujedinjeno Kraljevstvo

TARGOCID® 400 mg

400 mg

prašak i otapalo za otopinu za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

Slovačka Republika

| sanofi-aventis Pharma |
| --- |
| Slovakia s.r.o Einsteinova 24, |
| 85101 Bratislava, |
| Slovačka Republika |

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovačka Republika

Targocid 200

200 mg

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu, primjena kroz usta

200 mg/3 ml

Slovačka Republika

| sanofi-aventis Pharma |
| --- |
| Slovakia s.r.o Einsteinova 24, |
| 85101 Bratislava, |
| Slovačka Republika |

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovačka Republika

Targocid 400

400 mg

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu, primjena kroz usta

400 mg/3 ml

Slovenija

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

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenija

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

200 mg

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu

200 mg/3 ml

Slovenija

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

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenija

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

400 mg

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu

400 mg/3 ml

Španjolska

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

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Španjolska

TARGOCID

200 mg

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu

200 mg/3 ml

Španjolska

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

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Španjolska

TARGOCID

400 mg

prašak i otapalo za otopinu za injekciju ili infuziju

primjena u mišić/primjena u venu

400 mg/3 ml

Švedska

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

sanofi-aventis AB

Box 14142

167 14 Bromma,

Švedska

Targocid

200 mg

prašak za injekciju/infuziju, otopina

primjena u mišić/primjena u venu

200 mg/3 ml

Švedska

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

sanofi-aventis AB

Box 14142

167 14 Bromma,

Švedska

Targocid

400 mg

prašak za injekciju/infuziju, otopina

primjena u mišić/primjena u venu

400 mg/3 ml

Ujedinjeno Kraljevstvo

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

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

One Onslow Street

Guildford

Surrey

GU1 4YS

Ujedinjeno Kraljevstvo

posluje pod imenom

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| Ujedinjeno Kraljevstvo |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

Ujedinjeno Kraljevstvo

TARGOCID®

200 mg

prašak za injekciju

primjena u mišić/primjena u venu

200 mg/3 ml

Ujedinjeno Kraljevstvo

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

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

One Onslow Street

Guildford

Surrey

GU1 4YS

Ujedinjeno Kraljevstvo

posluje pod imenom

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| Ujedinjeno Kraljevstvo |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

Ujedinjeno Kraljevstvo

TARGOCID®

400 mg

prašak za injekciju

primjena u mišić/primjena u venu

400 mg/3 ml

---

DODATAK VII.

POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTA PRIMJENE, NOSITELJA ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica
  (u EGP-u) | Nositelj odobrenja | Naziv | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Bugarska | Zentiva k.s. |
| 130 U kabelovn |
| Prague 10237 |
| Češka Republika |

Država članica

(u EGP-u)

Nositelj odobrenja

Naziv

Jačina

Farmaceutski oblik

Put primjene

Bugarska

Zentiva k.s.

130 U kabelovn

Prague 10237

Češka Republika

Flupizen

100 mg

kapsula, tvrda

kroz usta

Estonija

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Nizozemska

KATADOLON

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Njemačka

Flupirtinmaleat AbZ 100 mg Kapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Njemačka

Flupirtinmaleat AL 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Awegal inject

164,5 mg / 3 ml

otopina za injekciju

u mišić

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Katadolon inject

164,5 mg / 3 ml

otopina za injekciju

u mišić

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Katadolon Kinderzäpfchen

75 mg

supozitorij

rektalno

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Katadolon Zäpfchen

150 mg

supozitorij

rektalno

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Trancopal Dolo

100 mg

kapsula

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Trancopal Dolo Suppositorien

150 mg

supozitorij

rektalno

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Katadolon S long

400 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Katadolon

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Trancolong

400 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Katadolon retard

400 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Njemačka

Flupirtinmaleat Winthrop 400 mg Retardtabletten

400 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Njemačka

Flupirtinmaleat-CT 100 mg Hartkapsel

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Njemačka

Flupin 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Njemačka

Dolokadin einmal täglich

400 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Njemačka

Flupigamma 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Njemačka

Flupirtinmaleat-Hormosan 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Njemačka

Flupigil 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Njemačka

Flupigil 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Midas Pharma GmbH

Rheinstr. 49

55218 Ingelheim

Njemačka

Flupirtinmaleat Midas 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Njemačka

Flupirtinmaleat-ratiopharm 100 mg Hartkapsel

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Njemačka

Miflumal 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Njemačka

Flupirtinmaleat Vitapharma 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Njemačka

Flupivil 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Njemačka

Flupirtinmaleat Viatris 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Njemačka

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Njemačka

Flupimal 100 mg Hertkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Njemačka

Flupsadim 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Njemačka

Miphaflumix 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Njemačka

Fluporol 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Njemačka

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Njemačka

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

kapsula, tvrda

kroz usta

Mađarska

| ZENTIVA k.s. |
| --- |
| Ul. kabelovny 130, Dolní Mecholupy |
| 10237 Prague 10 |
| Češka Republika |

ZENTIVA k.s.

Ul. kabelovny 130, Dolní Mecholupy

10237 Prague 10

Češka Republika

Flupizen 100 mg kemény kapszula

100 mg

kapsula, tvrda

kroz usta

Italija

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

MEDA PHARMA S.p.A.,

Viale Brenta 18, 20139 Milano

Italija

EFIRET

100 mg

kapsula, tvrda

kroz usta

Latvija

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

Teva Pharma B.V.,

Computerweg 10,

3542 DR Utrecht

Nizozemska

Katadolon 100 mg hard capsules

100 mg

kapsula, tvrda

kroz usta

Litva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Nizozemska

Katadolon

100 mg

kapsula, tvrda

kroz usta

Poljska

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

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poljska

Katadolon

100 mg

kapsula, tvrda

kroz usta

Portugal

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

Midas Pharma GmbH

Rheinstrasse, 49

55218 Ingelheim

Njemačka

Flupirtina Midas

100 mg

kapsula, tvrda

kroz usta

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

kapsula, tvrda

kroz usta

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

kapsula, tvrda

kroz usta

Rumunjska

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

Zentiva k.s.

U Kabelovny 130, Dolní Měcholupy

102 37, Praga 10,

Češka Republika

FLUPIZEN 100 mg

100 mg

kapsula

kroz usta

Slovačka

| Zentiva k.s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Češka Republika |

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Češka Republika

Flupizen 100 mg tvrdé kapsuly

100 mg

kapsula, tvrda

kroz usta

Slovačka

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

TEVA Pharmaceuticals Slovakia, s.r.o.

Teslova 26

821 02 Bratislava

Slovačka

Katadolon

100 mg

kapsula, tvrda

kroz usta

---

ANNEX VIII

LISTA IMENA, FARMACEUTSKIH OBLIKA, JAČINA VETERINARSKO MEDICINSKOG PROIZVODA, VRSTE ŽIVOTINJA, PUTEVI PRIMJENE, PODNOSITELJI/NOSITELJI ODOBRENJA ZA STAVLJANJE U PROMET U ZEMLJAMA ČLANICAMA

| Zemlja članica EU/EEA | Podnositelji/nositelji odobrenja za stavljanje u promet | Ime | INN | Jačina | Farmaceutski oblik | Put primjene | Vrste životinja |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Pfizer Corporation Austrija Gesellschaft m.b.H. |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AUSTRIJA |

Zemlja članica EU/EEA

Podnositelji/nositelji odobrenja za stavljanje u promet

Ime

INN

Jačina

Farmaceutski oblik

Put primjene

Vrste životinja

Austrija

Pfizer Corporation Austrija Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIJA

Dectomax 1 % - Injektionslösung für Rinder und Schafe

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Austrija

| Pfizer Corporation Austrija Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AUSTRIJA |

Pfizer Corporation Austrija Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIJA

Dectomax S 10 mg/ml Injektionslösung für Schweine

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Austrija

| Pfizer Corporation Austrija Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AUSTRIJA |

Pfizer Corporation Austrija Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIJA

Dectomax Pour-On 5 mg/ml Lösung für Rinder

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Belgija

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

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIJA

DECTOMAX

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Belgija

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

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIJA

DECTOMAX POUR-ON

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Belgija

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

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIJA

DECTOMAX SOLUTION INJECTABLE POUR PORCS

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Bugarska

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

Pfizer S.A.,

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

37401 Amboise Cedex,

FRANCUSKA

Дектомакс 1 % инжективен разтвор

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Bugarska

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

BIOVET AD

39 Petar Rakov str.

Peshtera 4550

BUGARSKA

Ендектовет 1 % инжекционен разтвор за говеда, овце и свине

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Cipar

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

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GRČKA

DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Češka Republika

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| ČEŠKA REPUBLIKA |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha

ČEŠKA REPUBLIKA

DECTOMAX 10 mg/ml injekční roztok

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Češka Republika

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

Prontax 10 mg/ml Otopina za injekciju for Goveda, ovce and Svinje

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Danska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax Pour-On Vet.

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Danska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax Vet.

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, svinje

Danska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Danska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano

Goveda

Estonija

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

Pfizer Animal Health S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

BELGIJA

Dectomax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Estonija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

Prontax 10 mg/ml Otopina za injekciju for Goveda, ovce and Svinje

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Finska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

DECTOMAX vet 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, reindeer, svinje

Finska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax 5 mg/ml kertavaleluliuos

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Finska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Francuska

| Lilly Francuska |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCUSKA |

Lilly Francuska

13 Rue Pages

92158 Suresnes Cedex

FRANCUSKA

ZEARL

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Francuska

| Lilly Francuska |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCUSKA |

Lilly Francuska

13 Rue Pages

92158 Suresnes Cedex

FRANCUSKA

ZEARL POUR ON

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Francuska

| Lilly Francuska |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCUSKA |

Lilly Francuska

13 Rue Pages

92158 Suresnes Cedex

FRANCUSKA

ZEARL PORCS

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Francuska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Francuska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

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

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Njemačka

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NJEMAČKA

Dectomax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Njemačka

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NJEMAČKA

Dectomax Pour-On

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Njemačka

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NJEMAČKA

Dectomax-S Injektionslösung

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Grčka

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

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GRČKA

DECTOMAX ing sol

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

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

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Island

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax, vet.

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Island

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Island

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Irska

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

VELIKA BRITANIJA

Zearl Poliv, otopina for Goveda 5 mg/ml

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Irska

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

VELIKA BRITANIJA

Zearl 10 mg/ml Otopina za injekciju for Goveda and Ovce

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Irska

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

VELIKA BRITANIJA

Zearl 10 mg/ml Otopina za injekciju for Svinje

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Irska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

Dectomax 5 mg/ml Poliv, otopina for Goveda

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Irska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

DECTOMAX 10 mg/ml Otopina za injekciju for Goveda, ovce and Svinje

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Italija

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

ITALIJA

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

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Italija

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

ITALIJA

DECTOMAX POUR ON 5 mg/ml

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Latvija

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

Pfizer Animal Health S.A.,

Rue Laid Burniat, 1,

1348 Louvain-la-Neuve,

BELGIJA

Dectomax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Latvija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

Dectomax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Litva

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

Pfizer S.A.,

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

37401 Amboise Cedex,

FRANCUSKA

DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Litva

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

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

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Nizozemska

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

NIZOZEMSKA

Dectomax Pour-On Oplossing voor Rundvee 5 mg/ml

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Nizozemska

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

NIZOZEMSKA

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

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Norveška

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax Pour-On vet

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Norveška

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax vet

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Norveška

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Norveška

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Poljska

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

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

ul. Postępu 17 B

02-676 Warszawa

POLJSKA

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

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

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

Poliv, otopina

na kožu - na leđa životinje

Goveda

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

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Rumunjska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

DECTOMAX

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Rumunjska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

PRONTAX 10 mg/ml Injectable Solution for Goveda, ovce and Svinje

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Rumunjska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| VELIKA BRITANIJA |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

VELIKA BRITANIJA

PRONTAX 5 mg/ml Pour On Solution for Goveda

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Slovačka Republika

| 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

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Slovenija

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

Pfizer Luksemburg SARL

51, Avenue J.F. Kennedy

L-1855 Luksemburg

LUKSEMBURG

DECTOMAX 10 mg/ml raztopina za injiciranje

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Španjolska

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

ŠPANJOLSKA

DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Španjolska

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

ŠPANJOLSKA

DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Španjolska

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

ŠPANJOLSKA

DECTOMAX SOLUCION INYECTABLE

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax vet.

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, reindeer

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax Suis vet.

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce, svinje

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax pour-on vet.

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

Velika Britanija

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

VELIKA BRITANIJA

Dectomax 10 mg/ml Otopina za injekciju for Goveda and Ovce

Doramectin

10 mg/ml

Otopina za injekciju

supkutano, intramuskularno

Goveda, ovce

Velika Britanija

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

VELIKA BRITANIJA

Dectomax 10 mg/ml Otopina za injekciju for Svinje

Doramectin

10 mg/ml

Otopina za injekciju

intramuskularno

Svinje

Velika Britanija

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

VELIKA BRITANIJA

Dectomax Poliv, otopina for Goveda 5 mg/ml

Doramectin

5 mg/ml

Poliv, otopina

na kožu - na leđa životinje

Goveda

---

DODATAK IX

POPIS IMENA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica
  (EGP) | Nositelj odobrenja | Međunarodni nezaštićeni naziv (INN) | Zaštićeno ime | Jačine | Farmaceutski oblici | Putevi primjene |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Pfizer Corporation Austria Ges.m.b.H |
| Floridsdorfer Hauptstraße 1, |
| 1210 Vienna |
| Austria |

Država članica

(EGP)

Nositelj odobrenja

Međunarodni nezaštićeni naziv (INN)

Zaštićeno ime

Jačine

Farmaceutski oblici

Putevi primjene

Austrija

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

diklofenaknatrij

mizoprostol

Arthrotec forte - Manteltabletten

75 mg

0,2 mg

obložena tableta

kroz usta

Austrija

| 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

diklofenaknatrij

mizoprostol

Arthrotec - Manteltabletten

50 mg

0,2 mg

obložena tableta

kroz usta

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Dedolor akut 75 mg – Kapseln

75 mg

želučanootporna kapsula, tvrda

kroz usta

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Dedolor DRS 100 mg – Kapseln

100 mg

kapsula, tvrda

kroz usta

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Deflamat DRS 75 mg – Kapseln

75 mg

kapsula, tvrda

kroz usta

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Deflamat 75 mg - Ampullen

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Deflamat 50 mg – Kapseln

50 mg

kapsula, tvrda

kroz usta

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Deflamat 100 mg – Suppositorien

100 mg

čepić

rektalno

Austrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

diklofenaknatrij

Deflamat retard 100 mg – Kapseln

100 mg

kapsula, tvrda

kroz usta

Austrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

DiclacHexal 50 mg - Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

DiclacHexal rapid 50 mg - lösbare Tabletten

50 mg

tableta za oralnu otopinu

kroz usta

Austrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

DiclacHexal retard 150 mg - Tabletten

150 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

DiclacHexal retard 75 mg - Tabletten

75 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene 75 mg – Ampullen

75 mg/2 ml

otopina za injekciju/infuziju

u mišić, u venu

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene 25 mg – Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene 50 mg – Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene 100 mg – Zäpfchen

100 mg

čepić

rektalno

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene 50 mg – Zäpfchen

50 mg

čepić

rektalno

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene retard 100 mg - Kapseln

100 mg

kapsula, tvrda

kroz usta

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenaknatrij

Diclobene uno 150 mg - Retardtabletten

150 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten

50 mg

tableta za oralnu otopinu

kroz usta

Austrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

diklofenaknatrij

Diclofenac Genericon 75 mg - Ampullen

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Austrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

diklofenaknatrij

Diclofenac "Genericon" 50 mg - Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

diklofenaknatrij

Diclofenac Genericon retard 100 mg Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

diklofenaknatrij

DICLOFENAC "S.Med" 25 mg-Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Austrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

diklofenaknatrij

DICLOFENAC "S.Med" 50 mg - Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

diklofenaknatrij

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

75 mg/3 ml

otopina za injekciju

u mišić

Austrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

diklofenaknatrij

DICLOFENAC "S.Med" retard 100 mg - Tabletten

100 mg

tableta

kroz usta

Austrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

diklofenaknatrij

DICLOFENAC "S.Med" retard 75 mg - Tabletten

75 mg

tableta

kroz usta

Austrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

Diclofenac G.L. 50 mg - Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Diclofenac 1A Pharma retard 150 mg - Tabletten

150 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Diclofenac 1A Pharma retard 75 mg - Tabletten

75 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

Diclofenac G.L. retard 100 mg - Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclofenac Sandoz 75 mg – Ampullen

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Austrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclofenac Sandoz 50 mg – Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclofenac Sandoz 150 mg - Retardtabletten

150 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclofenac Sandoz 75 mg - Retardtabletten

75 mg

tableta s produljenim oslobađanjem

kroz usta

Austrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclofenac "Sandoz" retard 100 mg – Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

diklofenaknatrij

Diclo-B „Lannacher“-Kapseln

50 mg

kapsula, tvrda

kroz usta

Austrija

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

diklofenaknatrij

Diclo-B G.L.

50 mg

kapsula, tvrda

kroz usta

Austrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

diklofenaknatrij

Diclostad Ampullen

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Austrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

diklofenaknatrij

Diclostad 50 mg Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

diklofenaknatrij

Diclostad retard 100 mg Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

Diclovit-Kapseln

50 mg

kapsula, tvrda

kroz usta

Austrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

Dolpasse 75 mg – Infusionslösung

75 mg/250 ml

otopina za infuziju

u venu

Austrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

Dolpasse retard 100 mg - Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

orfenadrincitrat

Neodolpasse – Infusionslösung

75 mg/250 ml

30 mg/250 ml

otopina za infuziju

u venu

Austrija

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

MERCK GesmbH

Zimbagasse 5

1147 Vienna

Austria

diklofenaknatrij

Neurofenac - Kapseln

50 mg

kapsula, tvrda

kroz usta

Austrija

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenaknatrij

Tratul retard 100 mg - Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren 25 mg - Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren 50 mg - Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren 75 mg/3 ml - Injektionslösung

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren 25 mg - Zäpfchen

25 mg

čepić

rektalno

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren 100 mg - Zäpfchen für Erwachsene

100 mg

čepić

rektalno

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren 50 mg - Zäpfchen für Erwachsene

50 mg

čepić

rektalno

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenaknatrij

Voltaren retard 100 mg - Filmtabletten

100 mg

filmom obložena tableta

kroz usta

Austrija

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenatna kiselina

Tratul 50 mg - Kapseln

50 mg

želučanootporna kapsula, meka

kroz usta

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenatna kiselina

Voltaren dispers - lösliche Tabletten

46,5 mg

tableta za oralnu otopinu

kroz usta

Austrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

diklofenakkalij

Diclobene rapid 50 mg Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenakkalij

Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen

50 mg

prašak za oralnu otopinu

kroz usta

Austrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

diklofenakkalij

Voltaren rapid 50 mg - Dragees

50 mg

obložena tableta

kroz usta

Belgija

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

diklofenaknatrij

mizoprostol

ARTHROTEC 50

50 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Belgija

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

diklofenaknatrij

mizoprostol

ARTHROTEC 75

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenakkalij

CATAFLAM 50 MG

50 mg

obložena tableta

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenakkalij

CATAFLAM 50 MG

50 mg

prašak za oralnu otopinu

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenak

CATAFLAM DISPERSIBLE

46,5 mg

tableta za oralnu suspenziju

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC APOTEX 100 MG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC APOTEX 75 MG

75 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC EG 100 MG

100 mg

čepić

rektalno

Belgija

| 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

diklofenaknatrij

DICLOFENAC EG 25 MG

25 mg

obložena tableta

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC EG 50 MG

50 mg

obložena tableta

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC EG 75 MG

75 mg/3 ml

otopina za injekciju

u mišić

Belgija

| 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

diklofenaknatrij

DICLOFENAC EG RETARD 100 MG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC EG RETARD 75 MG

75 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

diklofenaknatrij

DICLOFENAC RETARD MYLAN 100 MG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

diklofenaknatrij

DICLOFENAC RETARD MYLAN 75 MG

75 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

diklofenaknatrij

DICLOFENAC SANDOZ 50 MG

50 mg

želučanootporna tableta

kroz usta

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

diklofenaknatrij

DICLOFENAC SANDOZ 75 MG

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

diklofenaknatrij

DICLOFENAC SANDOZ RETARD 100 MG

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

diklofenaknatrij

DICLOFENAC SANDOZ RETARD 75 MG

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

diklofenaknatrij

DICLOFENAC TEVA 100

100 mg

čepić

rektalno

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

diklofenaknatrij

DICLOFENAC TEVA 100 MG RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

diklofenaknatrij

DICLOFENAC TEVA 50 MG

50 mg

želučanootporna tableta

kroz usta

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

diklofenaknatrij

DICLOFENAC TEVA 75 MG / 3 ML

75 mg/3 ml

otopina za injekciju

u mišić

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

diklofenaknatrij

DICLOFENAC TEVA 75 MG RETARD

75 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

diklofenakkalij

DICLOFENAC-K-TEVA 50 MG COMPR

50 mg

filmom obložena tableta

kroz usta

Belgija

| 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

diklofenaknatrij

DICLOFENAC-RATIOPHARM 50 MG GASTRO-

50 mg

želučanootporna tableta

kroz usta

Belgija

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

LABORATORIA QUALIPHAR N.V/S.A

Rijksweg 9

2880 Bornem

Belgium

diklofenaknatrij

DICLOFENACUM NATRI QUALIPHAR 50 MG

50 mg

želučanootporna tableta

kroz usta

Belgija

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

diklofenaknatrij

FLAMPHAR 50 MG

50 mg

tableta

kroz usta

Belgija

| 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

diklofenaknatrij

MOTIFENE 75 MG

75 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Belgija

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

diklofenaknatrij

POLYFLAM 75 MG

75 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

diklofenaknatrij

POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG

50 mg

obložena tableta

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenaknatrij

VOLTAREN 100

100 mg

čepić

rektalno

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenaknatrij

VOLTAREN 25

25 mg

želučanootporna tableta

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenaknatrij

VOLTAREN 50

50 mg

želučanootporna tableta

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenaknatrij

VOLTAREN 75 MG/3 ML

75 mg/3 ml

otopina za injekciju

u mišić

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenaknatrij

VOLTAREN RETARD 100

100 mg

tableta

kroz usta

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diklofenaknatrij

VOLTAREN RETARD 75 MG

75 mg

tableta

kroz usta

Belgija

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

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

diklofenakkalij

VOLTATABS 12,5 MG(EX:ZYMAMED)

12,5 mg

obložena tableta

kroz usta

Bugarska

| 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

diklofenaknatrij

Almiral

50 mg

želučanootporna tableta

kroz usta

Bugarska

| 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

diklofenaknatrij

Almiral

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Bugarska

| 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

diklofenaknatrij

Diclofenac Duo

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Bugarska

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

Tchaikapharma Highquality Medicines

1 G. M. Dimitrov Blvd.

Sofia 1172

Bulgaria

diklofenaknatrij

Diclofenac-Tchaikapharma

50 mg

želučanootporna tableta

kroz usta

Bugarska

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Bugarska

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Bugarska

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Bugarska

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

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

diklofenaknatrij

Feloran

100 mg

čepić

rektalno

Bugarska

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

Actavis EAD

29 Atanas Dukov Str.

Sofia 1407

Bulgaria

diklofenaknatrij

Feloran Actavis

100 mg

tableta s produljenim oslobađanjem

kroz usta

Bugarska

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen SR

100 mg

tableta s produljenim oslobađanjem

kroz usta

Bugarska

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen DUO

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Bugarska

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen

75 mg/3 ml

otopina za injekciju

u mišić

Bugarska

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen

50 mg

želučanootporna tableta

kroz usta

Bugarska

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

orfenadrincitrat

Neodolpasse

75 mg/250 ml

30 mg/250 ml

otopina za infuziju

u venu

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

25 mg

želučanootporna tableta

kroz usta

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

100 mg

čepić

rektalno

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

50 mg

čepić

rektalno

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenakkalij

Voltfast

50 mg

prašak za oralnu otopinu

kroz usta

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

50 mg

želučanootporna tableta

kroz usta

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Bugarska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Bugarska

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenakkalij

Voltaren Dolo

12,5 mg

kapsula, meka

kroz usta

Bugarska

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenakkalij

Voltaren Dolo

12,5 mg

filmom obložena tableta

kroz usta

Bugarska

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

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

diklofenaknatrij

Feloran

25 mg/ml

otopina za injekciju

u mišić, u venu

Cipar

| 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

diklofenaknatrij

ALMIRAL INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

u mišić

Cipar

| 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

diklofenaknatrij

ALMIRAL SUPPOSITORY 100 MG

100 mg

čepić

rektalno

Cipar

| 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

diklofenaknatrij

ALMIRAL SUPPOSITORY 50 MG

50 mg

čepić

rektalno

Cipar

| 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

diklofenaknatrij

ALMIRAL GASTRO-RESISTANT TABLET 25 MG

25 mg

tableta

kroz usta

Cipar

| 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

diklofenaknatrij

ALMIRAL GASTRO-RESISTANT TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

| 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

diklofenaknatrij

ARESTON TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenakkalij

CATAFLAM ORAL DROPS 1.5 %

15 mg/ml

oralne kapi, otopina

kroz usta

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenakkalij

CATAFLAM COATED TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

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

P.T.Hadjigeorgiou CO ltd,

P.O.Box 53158

3301 Lemesos

Cyprus

diklofenaknatrij

DICLAC INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

u mišić

Cipar

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75 MG

75 mg

tableta

kroz usta

Cipar

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

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

diklofenaknatrij

DIFENE DUAL CAPSULE 100 MG

100 mg

kapsula

kroz usta

Cipar

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

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

diklofenaknatrij

DIFENE DUAL CAPSULE 75 MG

75 mg

kapsula

kroz usta

Cipar

| 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

diklofenaknatrij

NERITAN GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

| 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

diklofenaknatrij

NERITAN GASTRO RESISTANT TABLET 25 MG

25 mg

tableta

kroz usta

Cipar

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

diklofenaknatrij

REMETHAN SUPPOSITORY 100 MG

100 mg

čepić

rektalno

Cipar

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

diklofenaknatrij

REMETHAN SUSTAINED RELEASE TABLET 100 MG

100 mg

tableta

kroz usta

Cipar

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

diklofenaknatrij

REMETHAN GASTRO RESISTANT TABLET 25 MG

25 mg

tableta

kroz usta

Cipar

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

diklofenaknatrij

REMETHAN GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

| 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

diklofenaknatrij

TAKS INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

u mišić

Cipar

| 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

diklofenaknatrij

TAKS GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

u mišić

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN SUPPOSITORY 100 MG

100 mg

čepić

rektalno

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN SUPPOSITORY 50 MG

50 mg

čepić

rektalno

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN D DISPERSIBLE TABLET 50 MG

50 mg

tableta

kroz usta

Cipar

| 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

diklofenaknatrij

VOLTAREN DOLO FILM COATED TABLET 12,5 MG

12,5 mg

tableta

kroz usta

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN FOR CHILDREN SUPPOSITORY 12,5 MG

12,5 mg

čepić

rektalno

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN RETARD SUSTAINED RELEASE TABLET 100 MG

100 mg

tableta

kroz usta

Cipar

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

VOLTAREN SR SUSTAINED RELEASE TABLET 75 MG

75 mg

tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

ALMIRAL

25 mg/ml

otopina za injekciju

u mišić, u venu

Češka Republika

| 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

diklofenaknatrij

ALMIRAL 50

50 mg

želučanootporna tableta

kroz usta

Češka Republika

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

APO-DICLO SR 100

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Češka Republika

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

APO-DICLO 25 MG

25 mg

želučanootporna tableta

kroz usta

Češka Republika

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

APO-DICLO 50 MG

50 mg

želučanootporna tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

DICLOFENAC AL RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Češka Republika

| 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

diklofenaknatrij

DICLOFENAC AL 25

25 mg

filmom obložena tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

DICLOFENAC AL 50

50 mg

filmom obložena tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

DICLOFENAC DUO PHARMASWISS 75 MG

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Češka Republika

| 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

diklofenaknatrij

DICLOREUM

25 mg/ml

otopina za injekciju

u mišić

Češka Republika

| 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

diklofenaknatrij

DICLOREUM RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Češka Republika

| 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

diklofenaknatrij

DICLOREUM 100

100 mg

čepić

rektalno

Češka Republika

| 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

diklofenaknatrij

DICLOREUM 50

50 mg

čepić

rektalno

Češka Republika

| 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

diklofenaknatrij

DICLOREUM 50

50 mg

želučanootporna tableta

kroz usta

Češka Republika

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

DICUNO 25 MG POTAHOVANÉ TABLETY

25 mg

filmom obložena tableta

kroz usta

Češka Republika

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

DICUNO 50 MG POTAHOVANÉ TABLETY

50 mg

filmom obložena tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

DOLMINA INJ

25 mg/ml

otopina za injekciju

u mišić, u venu

Češka Republika

| 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

diklofenaknatrij

DOLMINA 100 SR

100 mg

tableta s produljenim oslobađanjem

kroz usta

Češka Republika

| 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

diklofenaknatrij

DOLMINA 50

50 mg

filmom obložena tableta

kroz usta

Češka Republika

| IBSA Slovakia s.r.o. |
| --- |
| Mytna 42 |
| 811 05 Bratislava |
| Slovak Republic |

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

diklofenakepolamin

FLECTOR EP RAPID 50 MG

50 mg

granule za oralnu otopinu

kroz usta

Češka Republika

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestrasse 26 |
| Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

diklofenaknatrij

MONOFLAM 100 MG

100 mg

čepić

rektalno

Češka Republika

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestrasse 26 |
| Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

diklofenaknatrij

MONOFLAM 50 MG

50 mg

želučanootporna tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

MYOGIT 25

25 mg

želučanootporna tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

MYOGIT 50

50 mg

želučanootporna tableta

kroz usta

Češka Republika

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

NAKLOFEN DUO TOBOLKY

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Češka Republika

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

orfenadrincitrat

Neodolpasse

75 mg/250 ml

30 mg/250 ml

otopina za infuziju

u venu

Češka Republika

| 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

diklofenaknatrij

OLFEN-100 SR

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Češka Republika

| 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

diklofenaknatrij

OLFEN-50

50 mg

filmom obložena tableta

kroz usta

Češka Republika

| 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

diklofenaknatrij

OLFEN-75

37,5 mg/ml

otopina za injekciju

u mišić

Češka Republika

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

UNO

150 mg

tableta s produljenim oslobađanjem

kroz usta

Češka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenaknatrij

VERAL 100 MG

100 mg

čepić

rektalno

Češka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenaknatrij

VERAL 100 RETARD

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Češka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenaknatrij

VERAL 25 MG

25 mg

želučanootporna tableta

kroz usta

Češka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenaknatrij

VERAL 50 MG

50 mg

želučanootporna tableta

kroz usta

Češka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenaknatrij

VERAL 75

25 mg/ml

otopina za injekciju

u mišić, u venu

Češka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenaknatrij

VERAL 75 RETARD

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Češka Republika

| 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

diklofenaknatrij

VOLTAREN

25 mg/ml

otopina za injekciju

u mišić, u venu

Češka Republika

| 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

diklofenaknatrij

VOLTAREN RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Češka Republika

| 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

diklofenaknatrij

VOLTAREN 50

50 mg

želučanootporna tableta

kroz usta

Češka Republika

| 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

diklofenakkalij

VOLTAREN RAPID 50 MG TABLETY

50 mg

obložena tableta

kroz usta

Češka Republika

| 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

diklofenakkalij

VOLTAREN ACTIGO

12,5 mg

filmom obložena tableta

kroz usta

Češka Republika

| 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

diklofenakkalij

VOLTAREN ACTIGO EXTRA

25 mg

obložena tableta

kroz usta

Češka Republika

| 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

diklofenakkalij

VOLTAREN RAPID 12,5 MG

12,5 mg

kapsula, meka

kroz usta

Češka Republika

| 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

diklofenakkalij

VOLTAREN RAPID 25 MG

25 mg

kapsula, meka

kroz usta

Danska

| PharmaCoDane ApS |
| --- |
| Marielundvej 46 A |
| DK-2730 Herlev |
| Denmark |

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

diklofenak

Diclodan

50 mg

čepić

rektalno

Danska

| PharmaCoDane ApS |
| --- |
| Marielundvej 46 A |
| DK-2730 Herlev |
| Denmark |

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

diklofenak

Diclodan

100 mg

čepić

rektalno

Danska

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Købenahvn S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

diklofenak

Diclon

100 mg

čepić

rektalno

Danska

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Købenahvn S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

diklofenak

Diclon Rapid

50 mg

filmom obložena tableta

kroz usta

Danska

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Købenahvn S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

diklofenak

Diclon Rapid

25 mg

filmom obložena tableta

kroz usta

Danska

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

diklofenak

Diklofenak "Mylan"

50 mg

želučanootporna tableta

kroz usta

Danska

| 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

diklofenak

Diklofenak "Orifarm"

25 mg

želučanootporna tableta

kroz usta

Danska

| 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

diklofenak

Diklofenak "Orifarm"

50 mg

želučanootporna tableta

kroz usta

Danska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenak

Modifenac

75 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren

25 mg

želučanootporna tableta

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren

50 mg

želučanootporna tableta

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren

100 mg

čepić

rektalno

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren

25 mg/ml

otopina za injekciju

u mišić

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren

50 mg

čepić

rektalno

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren Dolo

12,5 mg

filmom obložena tableta

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren Dolo

12,5 mg

kapsula, meka

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren Dolo

12,5 mg

tableta

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren Rapid

50 mg

tableta

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

diklofenak

Voltaren Retard

75 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

diklofenak

Diclofenac "BMM Pharma"

50 mg

želučanootporna tableta

kroz usta

Danska

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

diklofenak

Diclofenac "BMM Pharma"

25 mg

želučanootporna tableta

kroz usta

Danska

| Actavis Nordic A/S |
| --- |
| Ørnegårdsvej 16 |
| DK-2820 Gentofte |
| Denmark |

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

diklofenak

Diclofenac Rapid "Actavis"

50 mg

filmom obložena tableta

kroz usta

Danska

| Actavis Nordic A/S |
| --- |
| Ørnegårdsvej 16 |
| DK-2820 Gentofte |
| Denmark |

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

diklofenak

Diclofenac Rapid "Actavis"

25 mg

filmom obložena tableta

kroz usta

Danska

| 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

diklofenak

Diclofenac Rapid "Orifarm"

50 mg

filmom obložena tableta

kroz usta

Danska

| 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

diklofenak

Diclofenac Rapid "Orifarm"

25 mg

filmom obložena tableta

kroz usta

Danska

| Teva Denmark A/S |
| --- |
| Parallelvej 10-12 |
| DK-2800 Kongens Lyngby |
| Denmark |

Teva Denmark A/S

Parallelvej 10-12

DK-2800 Kongens Lyngby

Denmark

diklofenak

Diclofenac Rapid "Teva"

50 mg

filmom obložena tableta

kroz usta

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

50 mg

želučanootporna tableta

kroz usta

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

100 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

75 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

25 mg

želučanootporna tableta

kroz usta

Danska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenak

Diclopax

25 mg

filmom obložena tableta

kroz usta

Danska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenak

Diclopax

50 mg

filmom obložena tableta

kroz usta

Danska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenak

Diklotab

25 mg

filmom obložena tableta

kroz usta

Danska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenak

Diklotab

50 mg

filmom obložena tableta

kroz usta

Danska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenak

Eeze

25 mg

filmom obložena tableta

kroz usta

Danska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenak

Fenacta

12,5 mg

filmom obložena tableta

kroz usta

Danska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

50 mg

filmom obložena tableta

kroz usta

Danska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

25 mg

filmom obložena tableta

kroz usta

Danska

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

diklofenak

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta

kroz usta

Danska

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

diklofenak

mizoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta

kroz usta

Estonija

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenak

DICLOBERL 75 MG/3 ML

25 mg/ml

otopina za injekciju

u mišić

Estonija

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenak

DICLOBERL RETARD

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Estonija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

DICLOMELAN 50 MG

50 mg

želučanootporna tableta

kroz usta

Estonija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

DICLOMELAN

100 mg

čepić

rektalno

Estonija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

DICLOMELAN RETARD 100 MG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Estonija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

NAKLOFEN

50 mg

želučanootporna tableta

kroz usta

Estonija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

NAKLOFEN

50 mg

čepić

rektalno

Estonija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

NAKLOFEN

25 mg/ml

otopina za injekciju

u mišić

Estonija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

NAKLOFEN SR

100 mg

tableta s produljenim oslobađanjem

kroz usta

Estonija

| 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

diklofenak

ALMIRAL

25 mg/ml

otopina za injekciju

u mišić, u venu

Estonija

| 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

diklofenak

OLFEN DEPOCAPS

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Estonija

| 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

diklofenak

OLFEN DEPOCAPS

75 mg

tableta s produljenim oslobađanjem

kroz usta

Estonija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

CATAFLAM

50 mg

obložena tableta

kroz usta

Estonija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

VOLTAREN

25 mg/ml

otopina za injekciju

u mišić

Estonija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

VOLTAREN RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Estonija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

VOLTAREN AKTI

12,5 mg

filmom obložena tableta

kroz usta

Estonija

| 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

diklofenak

mizoprostol

ARTHROTEC

50 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Estonija

| Pharmaswiss Eesti OÜ |
| --- |
| Tammsaare tee 47 |
| 11316 Tallinn |
| Estonia |

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

Estonia

diklofenak

DICLORAPID

75 mg

želučanootporna kapsula, tvrda

kroz usta

Estonija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

DICLOFENAC- RATIOPHARM 50 MG

50 mg

želučanootporna tableta

kroz usta

Estonija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

DICLOFENAC-RATIOPHARM 50 MG

50 mg

čepić

rektalno

Estonija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

DICLOFENAC-RATIOPHARM 100 MG

100 mg

čepić

rektalno

Estonija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

DICLOFENAC-RATIOPHARM 75 MG/2 ML

75 mg/2 ml

otopina za injekciju

u mišić

Estonija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

DICLOFENAC-RATIOPHARM UNO

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Estonija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

DICLAC 100

100 mg

čepić

rektalno

Estonija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

DICLAC

25 mg/ml

otopina za injekciju

u mišić

Estonija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

DICLAC ID 75 MG

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Estonija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

DICLAC ID 150 MG

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Estonija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

DICLAC 100 MG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Estonija

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

DICUNO

25 mg

filmom obložena tableta

kroz usta

Estonija

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

DICUNO

50 mg

filmom obložena tableta

kroz usta

Finska

| 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

diklofenakkalij

Diclofenac Rapid Orifarm

50 mg

filmom obložena tableta

kroz usta

Finska

| ratiopharm Oy |
| --- |
| P.O.Box 67 |
| 02631 Espoo |
| Finland |

ratiopharm Oy

P.O.Box 67

02631 Espoo

Finland

diklofenakkalij

Diclomex Rapid

50 mg

filmom obložena tableta

kroz usta

Finska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

25 mg

filmom obložena tableta

kroz usta

Finska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

50 mg

filmom obložena tableta

kroz usta

Finska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenakkalij

Eeze

25 mg

filmom obložena tableta

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenakkalij

Voltaren Rapid

25 mg

obložena tableta

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenakkalij

Voltaren Rapid

50 mg

obložena tableta

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenakkalij

Voltfast

50 mg

prašak za oralnu otopinu

kroz usta

Finska

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

diklofenaknatrij

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta

kroz usta

Finska

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

diklofenaknatrij

mizoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta s produljenim oslobađanjem

kroz usta

Finska

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

diklofenaknatrij

Diclofenac BMM Pharma

25 mg

želučanootporna tableta

kroz usta

Finska

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

diklofenaknatrij

Diclofenac BMM Pharma

50 mg

želučanootporna tableta

kroz usta

Finska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclomex

25 mg

želučanootporna tableta

kroz usta

Finska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclomex

50 mg

želučanootporna tableta

kroz usta

Finska

| Oy Stada Pharma Ab |
| --- |
| P.O.Box 1310 |
| 00101 Helsinki |
| Finland |

Oy Stada Pharma Ab

P.O.Box 1310

00101 Helsinki

Finland

diklofenaknatrij

Motifene Dual

75 mg

kapsula s produljenim oslobađanjem

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren

100 mg

čepić

rektalno

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren

25 mg

želučanootporna tableta

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren

25 mg/ml

otopina za injekciju/koncentrat za otopinu za infuziju

u mišić, u venu

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren

50 mg

želučanootporna tableta

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Finska

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren Retard

75 mg

tableta s produljenim oslobađanjem

kroz usta

Francuska

| 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

diklofenakepolamin

FLECTOR 25 mg, granulés pour solution buvable en sachet-dose

25 mg

granule za oralnu otopinu

kroz usta

Francuska

| 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

diklofenakepolamin

FLECTOR 50 mg, granulés pour solution buvable en sachet-dose

50 mg

granule za oralnu otopinu

kroz usta

Francuska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé

12,5 mg

filmom obložena tableta

kroz usta

Francuska

| NOVARTIS SANTE FAMILIALE |
| --- |
| 14, boulevard Richelieu |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS SANTE FAMILIALE

14, boulevard Richelieu

92500 Rueil-Malmaison

France

diklofenakkalij

VOLTARENDOLO 12,5 mg, comprimé enrobé

12,5 mg

obložena tableta

kroz usta

Francuska

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

diklofenaknatrij

DICLOFENAC ARROW 50 mg, comprimé gastro-résistant

50 mg

želučanootporna tableta

kroz usta

Francuska

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

diklofenaknatrij

DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant

50 mg

filmom obložena želučanootporna tableta

kroz usta

Francuska

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

diklofenaknatrij

DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant

50 mg

želučanootporna tableta

kroz usta

Francuska

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

CRISTERS

22 quai Gallieni

92150 Suresnes

France

diklofenaknatrij

DICLOFENAC CRISTERS 50 mg, comprimé gastro-résistant

50 mg

želučanootporna tableta

kroz usta

Francuska

| 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

diklofenaknatrij

DICLOFENAC EG 50 mg, comprimé gastro-résistant

50 mg

želučanootporna tableta

kroz usta

Francuska

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

diklofenaknatrij

DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant

25 mg

želučanootporna tableta

kroz usta

Francuska

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

diklofenaknatrij

DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant

50 mg

želučanootporna tableta

kroz usta

Francuska

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

diklofenaknatrij

DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant

50 mg

želučanootporna obložena tableta

kroz usta

Francuska

| 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

diklofenaknatrij

DICLOFENAC TEVA 25 mg, comprimé enrobé gastro-résistant

25 mg

želučanootporna obložena tableta

kroz usta

Francuska

| 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

diklofenaknatrij

DICLOFENAC TEVA 50 mg, comprimé enrobé gastro-résistant

50 mg

želučanootporna obložena tableta

kroz usta

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE 100 mg, suppositoire

100 mg

čepić

rektalno

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE 25 mg, comprimé gastro-résistant

25 mg

želučanootporna tableta

kroz usta

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE 50 mg, comprimé enrobé gastro-résistant

50 mg

želučanootporna obložena tableta

kroz usta

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE 75 mg/3 ml, solution injectable

75 mg/3 ml

otopina za injekciju

u mišić

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE ENFANT, suppositoire

25 mg

čepić

rektalno

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée

100 mg

obložena tableta s produljenim oslobađanjem

kroz usta

Francuska

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

diklofenaknatrij

VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée

75 mg

obložena tableta s produljenim oslobađanjem

kroz usta

Francuska

| Pfizer Holding France |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

diklofenaknatrij

mizoprostol

ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant

50 mg

0,2 mg

želučanootporna tableta

kroz usta

Francuska

| Pfizer Holding France |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

diklofenaknatrij

mizoprostol

ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant

75 mg

0,2 mg

želučanootporna tableta

kroz usta

Francuska

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

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

diklofenaknatrij

Xelaran Brausetablette 25 mg

25 mg

šumeća tableta

kroz usta

Njemačka

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

diklofenaknatrij

Diclo 100 retard - 1 A Pharma

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

diklofenaknatrij

Diclo 25 - 1 A Pharma

25 mg

želučanootporna tableta

kroz usta

Njemačka

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

diklofenaknatrij

Diclo 50 - 1 A Pharma

50 mg

želučanootporna tableta

kroz usta

Njemačka

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

diklofenaknatrij

Diclo 75 SL - 1 A Pharma

75 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

diklofenaknatrij

Diclofenac- 1 A Pharma 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| 1 A Pharma |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

diklofenaknatrij

Diclofenac- 1 A Pharma 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclofenac AbZ 25 mg Tabletten

25 mg

želučanootporna tableta

kroz usta

Njemačka

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclofenac AbZ 50 mg Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclofenac AbZ 50 mg Trinktabletten

50 mg

tableta za oralnu suspenziju

kroz usta

Njemačka

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

diklofenaknatrij

Diclo Divido

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

diklofenaknatrij

Diclo-Divido long

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

diklofenaknatrij

Diclofenac-Actavis 100 mg

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| Actavis Deutschland GmbH & Co. KG |
| --- |
| Willy-Brandt-Allee 2 |
| 81829 München |
| Germany |

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

diklofenaknatrij

Diclofenac-Actavis 50 mg

50 mg

želučanootporna kapsula

kroz usta

Njemačka

| 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

diklofenakkalij

Diclo AL akut 12,5 mg

12,5 mg

filmom obložena tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Diclofenac AL 100

100 mg

čepić

rektalno

Njemačka

| 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

diklofenaknatrij

Diclofenac AL 25

25 mg

želučanootporna tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Diclofenac AL 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Diclofenac AL 50 Supp.

50 mg

čepić

rektalno

Njemačka

| 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

diklofenaknatrij

Diclofenac AL i.m.

75 mg

otopina za injekciju

u mišić

Njemačka

| 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

diklofenaknatrij

Diclofenac AL retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 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

diklofenakkalij

Diclofenac-Kalium AL 25 mg Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

diklofenaknatrij

Rewodina 25 mg

25 mg

želučanootporna tableta

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

diklofenaknatrij

Rewodina 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

diklofenaknatrij

Rewodina dual 75 Kaps

75 mg

kapsula

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

diklofenaknatrij

Rewodina uno 100

100 mg

kapsula

kroz usta

Njemačka

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

diklofenaknatrij

Xelaran Brausetablette 50 mg

50 mg

šumeća tableta

kroz usta

Njemačka

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl 50 mg

Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl N 75

75 mg

otopina za injekciju

u mišić

Njemačka

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

diklofenaknatrij

Diclo dispers

50 mg

tableta za oralnu suspenziju

kroz usta

Njemačka

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

diklofenaknatrij

Diclofenbeta 100

100 mg

čepić

rektalno

Njemačka

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

diklofenaknatrij

Diclofenbeta 100 retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

diklofenaknatrij

Diclofenbeta 25

25 mg

želučanootporna tableta

kroz usta

Njemačka

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| 86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

diklofenaknatrij

Diclofenbeta 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Muehlstr. 50 |
| 66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

diklofenaknatrij

Diclo-saar 100 mg Retardtablette

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Muehlstr. 50 |
| 66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

diklofenaknatrij

Diclo-saar 50 mg magensaftresistente Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Chephasaar Chemisch-Pharmazeutische Fabrik GmbH |
| --- |
| Muehlstr. 50 |
| 66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

diklofenaknatrij

Diclo-saar 75 mg SF Injektionslösung

75 mg

otopina za injekciju

u mišić

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo-CT 100 mg Supp.

100 mg

čepić

rektalno

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo-CT 25 mg Tabletten

25 mg

želučanootporna tableta

kroz usta

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo-CT 50 mg Trinktabletten

50 mg

tableta za oralnu suspenziju

kroz usta

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo-CT 50 mg Supp.

50 mg

čepić

rektalno

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo-CT 50 mg Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo-CT 75 mg/2 ml Ampullen

75 mg

otopina za injekciju

u mišić

Njemačka

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenakkalij

Diclo-CT akut 12,5 mg Filmtabletten

12,5 mg

filmom obložena tableta

kroz usta

Njemačka

| Denk Pharma GmbH & Co. KG |
| --- |
| Prinzregentenstr. 79 |
| 81675 München |
| Germany |

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

diklofenaknatrij

Diclo-Denk 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| Denk Pharma GmbH & Co. KG |
| --- |
| Prinzregentenstr. 79 |
| 81675 München |
| Germany |

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

diklofenaknatrij

DICLO-DENK 100 mg RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Dexcel Pharma GmbH |
| --- |
| Carl-Zeiss-Str. 2 |
| 63755 Alzenau |
| Germany |

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

diklofenaknatrij

Diclofenac Atid 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Dexcel Pharma GmbH |
| --- |
| Carl-Zeiss-Str. 2 |
| 63755 Alzenau |
| Germany |

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

diklofenaknatrij

Diclofenac Atid retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| DOCPHARM Arzneimittelvertrieb GmbH & Co. |
| --- |
| Kommanditgesellschaft auf Aktien |
| Greschbachstr. 7 |
| 76229 Karlsruhe |
| Germany |

DOCPHARM Arzneimittelvertrieb GmbH & Co.

Kommanditgesellschaft auf Aktien

Greschbachstr. 7

76229 Karlsruhe

Germany

diklofenaknatrij

Diclafenac PB retard 100 mg

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 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

diklofenaknatrij

Dolgit-Diclo 100

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 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

diklofenaknatrij

Dolgit-Diclo 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Myogit 100

100 mg

čepić

rektalno

Njemačka

| 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

diklofenaknatrij

Myogit 25

25 mg

želučanootporna tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Myogit 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

diklofenaknatrij

Diclo KD 100

100 mg

čepić

rektalno

Njemačka

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

diklofenaknatrij

Diclo KD 50

50 mg

čepić

rektalno

Njemačka

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

diklofenaknatrij

Diclo KD 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

diklofenaknatrij

Diclo KD 75 akut

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Njemačka

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

diklofenaknatrij

Diclo KD retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| hameln pharma plus gmbh |
| --- |
| Langes Feld 13 |
| 31789 Hameln |
| Germany |

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

diklofenaknatrij

Diclo-Weimer

75 mg

otopina za injekciju

u mišić

Njemačka

| Hermes Arzneimittel GmbH |
| --- |
| Georg-Kalb-Str. 5-8 |
| 82049 Großhesselohe |
| Germany |

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

diklofenaknatrij

Diclofenac Natrium HERMES 25 mg Brausetabletten

25 mg

šumeća tableta

kroz usta

Njemačka

| Hermes Arzneimittel GmbH |
| --- |
| Georg-Kalb-Str. 5-8 |
| 82049 Großhesselohe |
| Germany |

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

diklofenaknatrij

Diclofenac Natrium HERMES 50 mg Brausetabletten

50 mg

šumeća tableta

kroz usta

Njemačka

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

diklofenaknatrij

Diclofenac 100 Heumann Supp.

100 mg

čepić

rektalno

Njemačka

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

diklofenaknatrij

Diclofenac 100 retard Heumenn

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

diklofenaknatrij

Diclofenac 25 Heumenn

25 mg

želučanootporna tableta

kroz usta

Njemačka

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

diklofenaknatrij

Diclofenac 50 Heumann

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Heumann Pharma GmbH & Generica Co. KG |
| --- |
| Südwestpark 50 |
| 90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

diklofenaknatrij

Diclofenac 50 Heumenn Supp.

50 mg

čepić

rektalno

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac

75 mg

otopina za injekciju

u mišić

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 150 mg ID

150 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 25

25 mg

želučanootporna tableta

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 75 mg ID

75 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac Dispers

50 mg

tableta za oralnu suspenziju

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenakkalij

Diclac Dolo 12,5 mg

12,5 mg

filmom obložena tableta

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenakkalij

Diclac Dolo 25 mg

25 mg

obložena tableta

kroz usta

Njemačka

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 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

diklofenaknatrij

Diclofenac Hikma 75 mg

75 mg

otopina za injekciju

u mišić

Njemačka

| Juta Pharma GmbH |
| --- |
| Gutenbergstr. 13 |
| 24941 Flensburg |
| Germany |

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

diklofenaknatrij

Jutafenac 100 mg Retardtabletten

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Kappler Pharma Consult GmbH |
| --- |
| Fonyoder Str. 18 |
| 89340 Leipheim |
| Germany |

Kappler Pharma Consult GmbH

Fonyoder Str. 18

89340 Leipheim

Germany

diklofenakkalij

Diclofen Kalium KPC 25 mg Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Njemačka

| KSK-Pharma Vertriebs AG |
| --- |
| Finkenstr. 1 |
| 76327 Pfinztal-Berghausen |
| Germany |

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

diklofenaknatrij

Diclo KSK 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

diklofenaknatrij

Diclofenac MEDA 25 mg Brausetabletten

25 mg

šumeća tableta

kroz usta

Njemačka

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

diklofenaknatrij

Diclofenac MEDA 50 mg Brausetabletten

50 mg

šumeća tableta

kroz usta

Njemačka

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

diklofenaknatrij

Diclofenac dura 100 mg Retardtabletten

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

diklofenaknatrij

Diclofenac dura 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

diklofenaknatrij

Diclofenac dura 25 mg

25 mg

želučanootporna tableta

kroz usta

Njemačka

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

diklofenaknatrij

Diclofenac dura 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

diklofenaknatrij

Diclofenac Mylan 100 mg Retardtabletten

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

diklofenakkalij

Diclofenac NCH 25 mg

25 mg

obložena tableta

kroz usta

Njemačka

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

diklofenakkalij

Optalidon Zahnschmerz mit Diclofenac 25 mg

25 mg

obložena tableta

kroz usta

Njemačka

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

diklofenakkalij

Voltaren Dolo 12,5 mg

12,5 mg

filmom obložena tableta

kroz usta

Njemačka

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

diklofenakkalij

Voltaren Dolo 25 mg

25 mg

obložena tableta

kroz usta

Njemačka

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

diklofenakkalij

Voltaren Dolo 25 mg

25 mg

obložena tableta

kroz usta

Njemačka

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

diklofenakkalij

Voltaren Dolo Liquid 12,5 mg

12,5 mg

kapsula, meka

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

kodeinfosfat hemihidrat

Combaren 50 mg/50 mg Filmtabletten

50 mg

50 mg

filmom obložena tableta

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren 100 mg retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren 25 mg

25 mg

želučanootporna tableta

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren 25 mg Zäpfchen

25 mg

čepić

rektalno

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

Voltaren Dispers

50 mg

tableta za oralnu suspenziju

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenakkalij

Voltaren K Migräne 50 mg

50 mg

obložena tableta

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenaknatrij

kodeinfosfat hemihidrat

Voltaren Plus 50 mg/50 mg Filmtabletten

50 mg

50 mg

filmom obložena tableta

kroz usta

Njemačka

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90426 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

diklofenak kolestiramin

Voltaren Resinat

140 mg

kapsula, tvrda

kroz usta

Njemačka

| Pharmacia GmbH |
| --- |
| Linkstrasse 10 |
| 10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

diklofenaknatrij

mizoprostol

Arthotec

50 mg

0,2 mg

obložena tableta

kroz usta

Njemačka

| Pharmacia GmbH |
| --- |
| Linkstrasse 10 |
| 10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

diklofenaknatrij

mizoprostol

Arthotec forte

75 mg

0,2 mg

obložena tableta

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 100 mg Retardkapseln

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 25 mg magensaftresistente Tabletten

25 mg

želučanootporna tableta

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 50 mg Disperstabletten

50 mg

tableta za oralnu suspenziju

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 50 mg magensaftresistente Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 75 mg SL Retardkapseln

75 mg

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 75 mg/2 ml Injektionslösung

75 mg/2 ml

otopina za injekciju

u mišić

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenakkalij

Diclofenac-ratiopharm Lösung bei Migräne

50 mg/1 ml

oralne kapi, otopina

kroz usta

Njemačka

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenakkalij

Diclofenac-ratiopharm Schmerztabletten 12,5 mg

12,5 mg

filmom obložena tableta

kroz usta

Njemačka

| Rotexmedica GmbH Arzneimittelwerk |
| --- |
| Bunsenstr. 4 |
| 22946 Trittau |
| Germany |

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

22946 Trittau

Germany

diklofenaknatrij

Diclofenac SF-Rotexmedica

75 mg/3 ml

otopina za injekciju

u mišić

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz 100 mg Retardtabletten

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz 25 mg magensaftresistente Tabletten

25 mg

želučanootporna tableta

kroz usta

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz 50 mg magensaftresistente Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz parenteral 75 mg Injektionslösung

75 mg

otopina za injekciju

u mišić

Njemačka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

diklofenaknatrij

Diclofenac Sandoz Uno 150 mg Retardtabletten

150 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| sigapharm GmbH |
| --- |
| Temmlerstr. 2 |
| 35039 Marburg/Lahn |
| Germany |

sigapharm GmbH

Temmlerstr. 2

35039 Marburg/Lahn

Germany

diklofenaknatrij

Sigafenac 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenaknatrij

Diclofenac STADA 100 mg Retardtabletten

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenaknatrij

Diclofenac STADA 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenaknatrij

Diclofenac STADA 25 mg magensaftresistente Tabletten

25 mg

želučanootporna tableta

kroz usta

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenaknatrij

Diclofenac STADA 50 mg magensaftresistente Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenaknatrij

Diclofenac Stada 50 mg Zäpfchen

50 mg

čepić

rektalno

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenaknatrij

Diclofenac STADA N 75 mg/3 ml Injektionslösung

75 mg/3 ml

otopina za injekciju

u mišić

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenakkalij

Diclofenac-Kalium STADA 12,5 mg Filmtabletten

12,5 mg

filmom obložena tableta

kroz usta

Njemačka

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

diklofenakkalij

Diclofenac-Kalium STADA 25 mg Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Njemačka

| T & D Pharma GmbH |
| --- |
| Kleine Knopheide 4 |
| 32657 Lemgo |
| Germany |

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

diklofenaknatrij

Allvoran 100 mg Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| T & D Pharma GmbH |
| --- |
| Kleine Knopheide 4 |
| 32657 Lemgo |
| Germany |

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

diklofenaknatrij

Allvoran SF

75 mg/3 ml

otopina za injekciju

u mišić

Njemačka

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

diklofenaknatrij

Allvoran 25 mg

25 mg

želučanootporna tableta

kroz usta

Njemačka

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

diklofenaknatrij

Allvoran 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

diklofenaknatrij

Allvoran S 100 mg

100 mg

čepić

rektalno

Njemačka

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

diklofenaknatrij

Allvoran S 50 mg

50 mg

čepić

rektalno

Njemačka

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

diklofenaknatrij

Allvoran uno

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclo-Klinge 75 mg magensaftresistente Hartkapsel

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclo-Klinge 75 mg spezial

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclofenac spezial 100 mg Klinge

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclofenac spezial 75 mg Klinge

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclofenac Temmler 25 mg Hartkapseln

25 mg

želučanootporna kapsula, tvrda

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclofenac Temmler SL 100 mg Retardkapseln

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

diklofenaknatrij

Diclofenac Temmler SL 75 mg Retardkapseln

75 mg

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| 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

diklofenaknatrij

Effekton 100 mg Retardtabletten

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| 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

diklofenaknatrij

Effekton 100 mg Zäpfchen

100 mg

čepić

rektalno

Njemačka

| 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

diklofenaknatrij

Effekton 25 mg magensaftresistente Tabletten

25 mg

želučanootporna tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Effekton 50 mg magensaftresistente Tabletten

50 mg

želučanootporna tableta

kroz usta

Njemačka

| 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

diklofenaknatrij

Effekton 75 mg/3 ml Injektionslösung

75 mg/3 ml

otopina za injekciju

u mišić

Njemačka

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

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

diklofenaknatrij

Xelaran Brausetablette 25 mg

25 mg

šumeća tableta

kroz usta

Njemačka

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Diclotin 25 mg Filmtabletten

25 mg

filmom obložena tableta

kroz usta

Njemačka

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Diclotin 50 mg Filmtabletten

50 mg

filmom obložena tableta

kroz usta

Njemačka

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

diklofenaknatrij

Diclowal 100 mg retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

diklofenaknatrij

DICLOWAL 50

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

diklofenaknatrij

DICLOWAL 75 mg

75 mg

otopina za injekciju

u mišić

Njemačka

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

diklofenaknatrij

DICLOWAL Supp.

100 mg

čepić

rektalno

Njemačka

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

diklofenaknatrij

Monoflam 100 mg

100 mg

čepić

rektalno

Njemačka

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

diklofenaknatrij

Monoflam 50 mg

50 mg

želučanootporna tableta

kroz usta

Njemačka

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

diklofenaknatrij

Monoflam 50 mg

50 mg

čepić

rektalno

Njemačka

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

diklofenaknatrij

Monoflam retard N

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

diklofenaknatrij

Dignofenac 100 mg

100 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

diklofenaknatrij

Dignofenac 25 mg

25 mg

želučanootporna tableta

kroz usta

Njemačka

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

diklofenaknatrij

Dignofenac 50 mg

50 mg

želučanootporna tableta

kroz usta

Grčka

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| Dilou 9, Peristeri |
| Attikis, 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9, Peristeri

Attikis, 12134

Greece

diklofenaknatrij

BATAFIL

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

| 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

diklofenaknatrij

VOLTAREN

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

diklofenaknatrij

DELIMON

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

diklofenaknatrij

VURDON

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

diklofenaknatrij

EVINOPON

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

diklofenaknatrij

URIGON

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

diklofenaknatrij

RUVOMINOX

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

| 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

diklofenaknatrij

RHEUMAVEK

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

| MEDICUS S.A |
| --- |
| Valaoritou 10 |
| Metamorfosi 14452 |
| Greece |

MEDICUS S.A

Valaoritou 10

Metamorfosi 14452

Greece

diklofenaknatrij

DIFEND

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Grčka

| 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

diklofenaknatrij

VOLTAREN

25 mg

želučanootporna obložena tableta

kroz usta

Grčka

| 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

diklofenaknatrij

VOLTAREN

50 mg

želučanootporna tableta

kroz usta

Grčka

| 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

diklofenaknatrij

VOLTAREN

100 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Grčka

| 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

diklofenaknatrij

VOLTAREN

75 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Grčka

| 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

diklofenaknatrij

VOLTAREN

50 mg

tableta za oralnu suspenziju

kroz usta

Grčka

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

diklofenaknatrij

DELIMON

25 mg

želučanootporna tableta

kroz usta

Grčka

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

diklofenaknatrij

DELIMON

50 mg

želučanootporna tableta

kroz usta

Grčka

| D.A.S.T. BIOTECH Pharmaceutical Ltd |
| --- |
| Larissis 10 |
| Pallini 15351 |
| Greece |

D.A.S.T. BIOTECH Pharmaceutical Ltd

Larissis 10

Pallini 15351

Greece

diklofenaknatrij

FLEFARMIN

50 mg

želučanootporna tableta

kroz usta

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

diklofenaknatrij

VURDON

25 mg

želučanootporna tableta

kroz usta

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

diklofenaknatrij

VURDON

100 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Grčka

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

diklofenaknatrij

EVINOPON

25 mg

želučanootporna tableta

kroz usta

Grčka

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

diklofenaknatrij

EVINOPON

50 mg

želučanootporna tableta

kroz usta

Grčka

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

diklofenaknatrij

URIGON

25 mg

želučanootporna tableta

kroz usta

Grčka

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

diklofenaknatrij

URIGON

50 mg

želučanootporna tableta

kroz usta

Grčka

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

diklofenaknatrij

RUVOMINOX

50 mg

obložena tableta

kroz usta

Grčka

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

diklofenaknatrij

RUVOMINOX

25 mg

obložena tableta

kroz usta

Grčka

| 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

diklofenaknatrij

RHEUMAVEK

25 mg

želučanootporna tableta

kroz usta

Grčka

| 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

diklofenaknatrij

RHEUMAVEK

50 mg

želučanootporna tableta

kroz usta

Grčka

| Pfizer Hellas A.E. |
| --- |
| Messoghion Ave. 243 |
| Neo Psychiko 15451 |
| Greece |

Pfizer Hellas A.E.

Messoghion Ave. 243

Neo Psychiko 15451

Greece

diklofenaknatrij

mizoprostol

ARTHROTEC

50 mg

0,2 mg

tableta s kontroliranim oslobađanjem

kroz usta

Grčka

| PHARMANEL COMMERCE PHARMACEUTICAL S.A. |
| --- |
| Marathonos Avenue 106, Gerakas 15344 |
| Greece |

PHARMANEL COMMERCE PHARMACEUTICAL S.A.

Marathonos Avenue 106, Gerakas 15344

Greece

diklofenaknatrij

FENOCLOF

75 mg

kapsula s kontroliranim oslobađanjem

kroz usta

Grčka

| 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

diklofenakkalij

VOLTAREN ACTI-GO

25 mg

obložena tableta

kroz usta

Grčka

| 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

diklofenakkalij

VOLTAREN ACTI-GO

50 mg

obložena tableta

kroz usta

Grčka

| 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

diklofenakkalij

VOLTAREN ACTI-GO

12,5 mg

obložena tableta

kroz usta

Grčka

| 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

diklofenakkalij

VOLTAREN FAST

50 mg

prašak za oralnu otopinu

kroz usta

Grčka

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

diklofenaknatrij

DICLO DUO

75 mg

kapsula s kontroliranim oslobađanjem

kroz usta

Grčka

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

diklofenaknatrij

COUNTERFLAME

75 mg

želučanootporna kapsula

kroz usta

Grčka

| 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

diklofenaknatrij

VOLTAREN

50 mg

čepić

rektalno

Grčka

| 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

diklofenaknatrij

VOLTAREN

100 mg

čepić

rektalno

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

diklofenaknatrij

VURDON

50 mg

čepić

rektalno

Grčka

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

diklofenaknatrij

VURDON

100 mg

čepić

rektalno

Grčka

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

diklofenaknatrij

EVINOPON

50 mg

čepić

rektalno

Grčka

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

diklofenaknatrij

RUVOMINOX

50 mg

čepić

rektalno

Mađarska

| 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

diklofenak

CATAFLAM belsőleges szuszpenziós cseppek

15 mg/ml

oralne kapi, suspenzija

kroz usta

Mađarska

| 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

diklofenak

CATAFLAM 50 mg bevont tabletta

50 mg

obložena tableta

kroz usta

Mađarska

| 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

diklofenak

CATAFLAM-V 50 mg tabletta

50 mg

tableta

kroz usta

Mađarska

| Sandoz Hungária Kft.,., |
| --- |
| Bartók Béla út 43.-47. |
| Budapest, 1114 |
| Hungary |

Sandoz Hungária Kft.,.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

diklofenak

DICLAC 75 mg retard tabletta

75 mg

tableta s produljenim oslobađanjem

kroz usta

Mađarska

| Sandoz Hungária Kft.,., |
| --- |
| Bartók Béla út 43.-47. |
| Budapest, 1114 |
| Hungary |

Sandoz Hungária Kft.,.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

diklofenak

DICLAC 150 mg retard tabletta

150 mg

tableta s produljenim oslobađanjem

kroz usta

Mađarska

| 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

diklofenak

DICLOFENAC AL 50 mg végbélkúp

50 mg

čepić

rektalno

Mađarska

| 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

diklofenak

DICLOFENAC AL 50 mg gyomornedv-ellenálló filmtabletta

50 mg

želučanootporna filmom obložena tableta

kroz usta

Mađarska

| 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

diklofenak

DICLOFENAC AL 100 mg végbélkúp

100 mg

čepić

rektalno

Mađarska

| 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

diklofenak

DICLOFENAC AL 75 mg/3 ml oldatos injekció

75 mg/3 ml

otopina za injekciju

parenteralno,

u mišić

Mađarska

| 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

diklofenak

DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula

75 mg

kapsula, tvrda

kroz usta

Mađarska

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| Bad Vilbel 61118 |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

diklofenak

DICLOFENAC STADA 100 mg retard filmtabletta

100 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Mađarska

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

diklofenak

DICLOFENAC-RATIOPHARM 25 mg filmtabletta

25 mg

filmom obložena tableta

kroz usta

Mađarska

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

diklofenak

DICLOFENAC-RATIOPHARM 100 mg retard kemény kapszula

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Mađarska

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

diklofenak

DICLOFENAC-RATIOPHARM 50 mg filmtabletta

50 mg

filmom obložena tableta

kroz usta

Mađarska

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

diklofenak

DICLOFENAC-RATIOPHARM retard tabletta

150 mg

tableta s produljenim oslobađanjem

kroz usta

Mađarska

| TEVA Gyógyszergyár zRt. |
| --- |
| Pallagi út 13 |
| Debrecen 4042 |
| Hungary |

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

diklofenak

DICLOFENAC-TEVA 100 mg végbélkúp

100 mg

čepić

rektalno

Mađarska

| PANNONPHARMA Gyógyszergyártó Kft. |
| --- |
| PannonPharma út 1. |
| Pécsvárad 7720 |
| Hungary |

PANNONPHARMA Gyógyszergyártó Kft.

PannonPharma út 1.

Pécsvárad 7720

Hungary

diklofenak

DICLOMEL SR 100 mg retard tabletta

100 mg

tableta s produljenim oslobađanjem

kroz usta

Mađarska

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

orfenadrincitrat

NEODOLPASSE oldatos infúzió

75 mg/250 ml

30 mg/250 ml

otopina za infuziju

parenteralno,

u venu

Mađarska

| 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

diklofenak

VOLTAREN 100 mg retard filmtabletta

100 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Mađarska

| 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

diklofenak

VOLTAREN 25 mg gyomornedv-ellenálló filmtabletta

25 mg

želučanootporna filmom obložena tableta

kroz usta

Mađarska

| 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

diklofenak

VOLTAREN 50 mg gyomornedv-ellenálló filmtabletta

50 mg

želučanootporna filmom obložena tableta

kroz usta

Mađarska

| 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

diklofenak

VOLTAREN 50 mg végbélkúp

50 mg

čepić

rektalno

Mađarska

| 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

diklofenak

VOLTAREN 75 mg retard filmtabletta

75 mg

tableta s produljenim oslobađanjem

kroz usta

Mađarska

| 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

diklofenak

VOLTAREN 75 mg/3 ml oldatos injekció

75 mg/3 ml

otopina za injekciju

parenteralno; injekcija u mišić ili infuzija u venu. Nije primjenjivo za bolusnu injekciju u venu

Mađarska

| 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

diklofenak

VOLTAREN DOLO 12,5 mg filmtabletta

12,5 mg

filmom obložena tableta

kroz usta

Mađarska

| 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

diklofenak

VOLTAREN DOLO 12,5 mg lágy kapszula

12,5 mg

kapsula, meka

kroz usta

Mađarska

| 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

diklofenak

VOLTAREN DOLO 25 mg bevont tabletta

25 mg

obložena tableta

kroz usta

Mađarska

| 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

diklofenakkalij

VOLTAREN DOLO 25 mg lágy kapszula

25 mg

kapsula, meka

kroz usta

Mađarska

| 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

diklofenak

FLECTOR RAPID 50 mg granulátum

50 mg

granule

kroz usta

Mađarska

| TEVA Gyógyszergyár zRt. |
| --- |
| Pallagi út 13 |
| Debrecen 4042 |
| Hungary |

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

diklofenak

FORTEDOL 50 mg filmtabletta

50 mg

filmom obložena tableta

kroz usta

Island

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

diklofenaknatrij

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta

kroz usta

Island

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

diklofenaknatrij

mizoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta

kroz usta

Island

| ratiopharm GmbH |
| --- |
| Graf-Arco Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclomex

50 mg

filmom obložena tableta

kroz usta

Island

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

diklofenaknatrij

Diklofenak Mylan

50 mg

želučanootporna tableta

kroz usta

Island

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenaknatrij

Klofen L

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Island

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenaknatrij

Modifenac

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenaknatrij

Voltaren

100 mg

čepić

rektalno

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenaknatrij

Voltaren

25 mg

želučanootporna tableta

kroz usta

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenaknatrij

Voltaren

25 mg/ml

otopina za injekciju

u mišić

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenaknatrij

Voltaren

50 mg

čepić

rektalno

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenaknatrij

Voltaren

50 mg

želučanootporna tableta

kroz usta

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenakkalij

Voltaren Dolo

12,5 mg

filmom obložena tableta

kroz usta

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenakkalij

Voltaren Dolo

12,5 mg

kapsula, meka

kroz usta

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenakkalij

Voltaren Dolo

25 mg

obložena tableta

kroz usta

Island

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

diklofenakkalij

Voltaren Rapid

50 mg

obložena tableta

kroz usta

Island

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Vóstar-S

25 mg

filmom obložena tableta

kroz usta

Island

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Vóstar-S

50 mg

filmom obložena tableta

kroz usta

Irska

| 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

diklofenaknatrij

Voltarol 25 mg Gastro-Resistant Tablets

25 mg

želučanootporna tableta

kroz usta

Irska

| 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

diklofenaknatrij

Voltarol 50 mg Gastro-Resistant Tablets

50 mg

želučanootporna tableta

kroz usta

Irska

| 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

diklofenaknatrij

Voltarol 12,5 mg Suppositories

12,5 mg

čepić

rektalno

Irska

| 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

diklofenaknatrij

Voltarol 100 mg Suppositories

100 mg

čepić

rektalno

Irska

| 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

diklofenaknatrij

Voltarol Ampoules 75 mg/3 ml, solution for injection

75 mg/3 ml

otopina za injekciju

u mišić

Irska

| 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

diklofenaknatrij

Voltarol Retard 100 mg Film-coated Prolonged Release Tablets

100 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Irska

| 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

diklofenaknatrij

Voltarol Retard 75 mg Film-coated Prolonged-release Tablets

75 mg

filmom obložena tableta s produljenim oslobađanjem

kroz usta

Irska

| 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

diklofenakkalij

Cataflam 25 mg Coated Tablets

25 mg

obložena tableta

kroz usta

Irska

| 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

diklofenakkalij

Cataflam 50 mg Coated Tablets

50 mg

obložena tableta

kroz usta

Irska

| 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

diklofenakkalij

Voltfast Sachets 50 mg Powder for Oral Solution

50 mg

prašak za oralnu otopinu

kroz usta

Irska

| 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

diklofenakkalij

Diclofenac potassium NCH 12,5 mg Film-coated tablets

12,5 mg

filmom obložena tableta

kroz usta

Irska

| 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

diklofenakkalij

Otriflu 12,5 mg Film-coated Tablets

12,5 mg

filmom obložena tableta

kroz usta

Irska

| Pinewood Laboratories Ltd |
| --- |
| (T/A Pinewood Heathcare) Ballymacarbry |
| Clonmel, Co. Tipperary |
| Ireland |

Pinewood Laboratories Ltd

(T/A Pinewood Heathcare) Ballymacarbry

Clonmel, Co. Tipperary

Ireland

diklofenaknatrij

Diclo 75 mg prolonged release tablets.

75 mg

tableta s produljenim oslobađanjem

kroz usta

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

diklofenaknatrij

Diclac 75 mg Prolonged -Release Tablets

75 mg

tableta s produljenim oslobađanjem

kroz usta

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

diklofenaknatrij

Diclac Retard 100 mg Prolonged-release Tablets

100 mg

tableta s produljenim oslobađanjem

kroz usta

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

diklofenaknatrij

Diclac 25 mg Gastro-resistant Tablets

25 mg

želučanootporna tableta

kroz usta

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

diklofenaknatrij

Diclac 50 mg Gastro-resistant Tablets

50 mg

želučanootporna tableta

kroz usta

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

diklofenaknatrij

Diclac 100 mg Suppositories

100 mg

čepić

rektalno

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

diklofenaknatrij

Diclac 25 mg/ml Solution for Injection 3 ml Ampoule

25 mg

otopina za injekciju

u mišić

Irska

| 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

diklofenaknatrij

Arthrotec 50 modified release tablets

50 mg

tableta s prilagođenim oslobađanjem

kroz usta

Irska

| 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

diklofenaknatrij

Arthrotec 75 modified-release tablets

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Irska

| 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

diklofenaknatrij

Difene 25 mg Capsules

25 mg

kapsula

kroz usta

Irska

| 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

diklofenaknatrij

Difene 50 mg Capsules

50 mg

kapsula

kroz usta

Irska

| 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

diklofenaknatrij

Difene 75 mg Dual Release Capsules

75 mg

kapsula s dvostrukim oslobađanjem

kroz usta

Irska

| 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

diklofenaknatrij

Difene 100 mg Dual Release Capsules

100 mg

kapsula s dvostrukim oslobađanjem

kroz usta

Irska

| 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

diklofenaknatrij

Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion

75 mg/3 ml

otopina za injekciju ili koncentrat za otopinu za infuziju

u mišić, u venu

Irska

| 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

diklofenaknatrij

Difene 100 mg Suppositories

100 mg

čepić

rektalno

Irska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Kyflam 50 mg Film Coated Tablet

50 mg

filmom obložena tableta

kroz usta

Irska

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

diklofenaknatrij

mizoprostol

Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets

50 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Irska

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

diklofenaknatrij

mizoprostol

Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Italija

| 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

diklofenak

VOLTAREN

50 mg

tableta za oralnu otopinu

kroz usta

Italija

| 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

diklofenak

VOLTAREN

50 mg

želučanootporna tableta

kroz usta

Italija

| 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

diklofenak

VOLTAREN

75 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| 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

diklofenak

VOLTAREN

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| 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

diklofenak

VOLTAREN

100 mg

čepić

rektalno

Italija

| 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

diklofenak

VOLTAREN

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

ALGOSENAC

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Bayer S.p.a. |
| --- |
| Viale Certosa, 130 |
| Milano - 20156 |
| Italy |

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

diklofenak hidroksietilpirolidin

BAIFENAC

50 mg

granule

kroz usta

Italija

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

diklofenaknatrij

DEALGIC

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Italija

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

diklofenaknatrij

DEALGIC

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Italija

| 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

diklofenaknatrij

DEFLAMAT

25 mg/ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

DEFLAMAT

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Italija

| 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

diklofenaknatrij

DEFLAMAT

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Italija

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

diklofenaknatrij

DICLOFAN

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

diklofenaknatrij

DICLOFAN

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

diklofenaknatrij

DICLOFENAC

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

diklofenaknatrij

DICLOFENAC

100 mg

čepić

rektalno

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

50 mg

čepić

rektalno

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

100 mg

čepić

rektalno

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

25 mg

tableta

kroz usta

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

50 mg

tableta

kroz usta

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

150 mg

kapsula s produljenim oslobađanjem

kroz usta

Italija

| 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

diklofenaknatrij

DICLOFENAC ALPHA BIOTECH

25 mg/ml

oralne kapi, otopina

kroz usta

Italija

| Almus S.r.l. |
| --- |
| Via Cesarea, 11/10 |
| Genova - 16121 |
| Italy |

Almus S.r.l.

Via Cesarea, 11/10

Genova - 16121

Italy

diklofenaknatrij

DICLOFENAC ALMUS

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

diklofenaknatrij

DICLOFENAC ANGENERICO

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

diklofenaknatrij

DICLOFENAC ANGENERICO

100 mg

čepić

rektalno

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

diklofenaknatrij

DICLOFENAC ANGENERICO

50 mg

želučanootporna tableta

kroz usta

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

diklofenaknatrij

DICLOFENAC ANGENERICO

25 mg

želučanootporna tableta

kroz usta

Italija

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC DOC

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC DOC GENERICI

75 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC DOC GENERICI

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC EG

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC EG

50 mg

želučanootporna tableta

kroz usta

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC EG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC EG

100 mg

čepić

rektalno

Italija

| Germed Pharma S.p.a. |
| --- |
| Via Cantu, 11, Balsamo |
| Milano, 20092 |
| Italy |

Germed Pharma S.p.a.

Via Cantu, 11, Balsamo

Milano, 20092

Italy

diklofenaknatrij

DICLOFENAC GERMED

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

DICLOFENAC HEXAL

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

DICLOFENAC HEXAL

100 mg

čepić

rektalno

Italija

| 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

diklofenaknatrij

DICLOFENAC HEXAL

50 mg

želučanootporna tableta

kroz usta

Italija

| 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

diklofenaknatrij

DICLOFENAC HEXAL

25 mg

želučanootporna tableta

kroz usta

Italija

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC MYLAN GENERICS

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

diklofenaknatrij

DICLOFENAC MYLAN GENERICS

100 mg

čepić

rektalno

Italija

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

diklofenaknatrij

DICLOFENAC SODICO

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| 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

diklofenaknatrij

DICLOFENAC SODICO BIL

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

DICLOREUM

50 mg

čepić

rektalno

Italija

| 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

diklofenaknatrij

DICLOREUM

100 mg

čepić

rektalno

Italija

| 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

diklofenaknatrij

DICLOREUM

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

DICLOREUM

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| 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

diklofenaknatrij

DICLOREUM

150 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Italija

| 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

diklofenaknatrij

DICLOREUM

50 mg

granule

kroz usta

Italija

| 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

diklofenaknatrij

DICLOREUM

50 mg

želučanootporna tableta

kroz usta

Italija

| 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

diklofenaknatrij

DICLOREUM

25 mg/ml

oralne kapi, otopina

kroz usta

Italija

| 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

diklofenaknatrij

DICLOREUM

46,5 mg/ml

oralne kapi, otopina

kroz usta

Italija

| 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

diklofenak hidroksietilpirolidin

DIEP

25 mg

želučanootporna tableta

kroz usta

Italija

| 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

diklofenak hidroksietilpirolidin

DIEP

25 mg

granule za oralnu suspenziju

kroz usta

Italija

| 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

diklofenakkalij

EMINOCS

50 mg

oralne kapi, otopina

kroz usta

Italija

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

diklofenaknatrij

FENADOL

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| Wellington Street Development Pharma Limited |
| --- |
| 47 Oaklands Drive Rathgar |
| Dublin 6 |
| Ireland |

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

diklofenaknatrij

FENDER

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| Wellington Street Development Pharma Limited |
| --- |
| 47 Oaklands Drive Rathgar |
| Dublin 6 |
| Ireland |

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

diklofenaknatrij

FENDER

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| Bayer S.p.a. |
| --- |
| Viale Certosa, 130 |
| Milano - 20156 |
| Italy |

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

diklofenak hidroksietilpirolidin

FLECTOR DOLORE

25 mg

granule za oralnu otopinu

kroz usta

Italija

| 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

diklofenaknatrij

FLOGOFENAC

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Italija

| 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

diklofenakkalij

ITAMIFAST

25 mg

filmom obložena tableta

kroz usta

Italija

| 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

diklofenakkalij

ITAMIFAST

50 mg

filmom obložena tableta

kroz usta

Italija

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

diklofenakkalij

KAPPADI

25 mg

filmom obložena tableta

kroz usta

Italija

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

diklofenakkalij

KAPPADI

50 mg

filmom obložena tableta

kroz usta

Italija

| 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

diklofenaknatrij

NOVAPIRINA

25 mg

obložena tableta

kroz usta

Italija

| O. P. PHARMA S.r.l. |
| --- |
| Via Torino 51 |
| Milano - 20123 |
| Italy |

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

diklofenaknatrij

TRAULEN

100 mg

filmom obložena tableta

kroz usta

Italija

| O. P. PHARMA S.r.l. |
| --- |
| Via Torino 51 |
| Milano - 20123 |
| Italy |

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

diklofenaknatrij

TRAULEN

75 mg/3 ml

otopina za injekciju

u mišić

Italija

| 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

diklofenaknatrij

VOLTADVANCE

25 mg

prašak za oralnu otopinu

kroz usta

Italija

| 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

diklofenaknatrij

VOLTADVANCE

25 mg

filmom obložena tableta

kroz usta

Italija

| 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

diklofenakkalij

VOLTFAST

50 mg

obložena tableta

kroz usta

Italija

| 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

diklofenakkalij

VOLTFAST

25 mg

obložena tableta

kroz usta

Italija

| 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

diklofenakkalij

VOLTFAST

50 mg

granule za oralnu otopinu

kroz usta

Italija

| Altergon Italia S.r.l. |
| --- |
| Via Dell'Industria |
| Pietradefusi - 83030 Avellino |
| Italy |

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

diklofenak

INFORCE

75 mg/ml

otopina za injekciju

u mišić, potkožno

Italija

| Altergon Italia S.r.l. |
| --- |
| Via Dell'Industria |
| Pietradefusi - 83030 Avellino |
| Italy |

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

diklofenaknatrij

INDICAM

75 mg/ml

otopina za injekciju

u mišić, potkožno

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

diklofenaknatrij

mizoprostol

MISOFENAC

50 mg

0,2 mg

tableta

kroz usta

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

diklofenaknatrij

mizoprostol

MISOFENAC

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

diklofenaknatrij

mizoprostol

ARTROTEC

50 mg

0,2 mg

tableta

kroz usta

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

diklofenaknatrij

mizoprostol

ARTROTEC

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Italija

| HEXAL AG S.p.a. |
| --- |
| Industriestrasse, 25, D-83607 |
| HOLZKIRCHEN |
| Germany |

HEXAL AG S.p.a.

Industriestrasse, 25, D-83607

HOLZKIRCHEN

Germany

diklofenaknatrij

DICLOFENAC HEXAL AG

100 mg

tableta s produljenim oslobađanjem

kroz usta

Italija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

DICLOFENAC RATIOPHARM

50 mg

želučanootporna tableta

kroz usta

Italija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

DICLOFENAC RATIOPHARM

75 mg/3 ml

otopina za injekciju

u mišić

Latvija

| 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

diklofenaknatrij

Profenac 75 mg/3 ml solution for injection

75 mg/3 ml

otopina za injekciju

u mišić

Latvija

| 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

diklofenaknatrij

Profenac SR 100 mg prolonged-release tablets

100 mg

tableta s produljenim oslobađanjem

kroz usta

Latvija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 50 mg gastro-resistant tablets

50 mg

želučanootporna tableta

kroz usta

Latvija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 25 mg gastro-resistant tablets

25 mg

želučanootporna tableta

kroz usta

Latvija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm uno 150 mg prolonged-release tablets

150 mg

tableta s produljenim oslobađanjem

kroz usta

Latvija

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac-ratiopharm 75 mg/2 ml solution for injection

75 mg/2 ml

otopina za injekciju

u mišić

Latvija

| 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

diklofenaknatrij

Diclogen 50 mg suppositories

50 mg

čepić

rektalno

Latvija

| 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

diklofenaknatrij

Diclogen 100 mg suppositories

100 mg

čepić

rektalno

Latvija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenaknatrij

Diclac 75 mg/3 ml solution for injection/infusion

75 mg/3 ml

otopina za injekciju i infuziju

u mišić, u venu

Latvija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenaknatrij

Diclac 100 mg modified release tablets

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Latvija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenaknatrij

Diclac ID 75 mg modified release tablets

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Latvija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenaknatrij

Diclac ID 150 mg modified release tablets

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

Diclomelan retard 100 mg sustained-release tablets

100 mg

tableta s produljenim oslobađanjem

kroz usta

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

Diclomelan 50 mg gastro-resistant tablets

50 mg

želučanootporna tableta

kroz usta

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

Diclomelan 100 mg suppositories

100 mg

čepić

rektalno

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenaknatrij

tiaminklorid

piridoksinklorid

cijanokobalamin

Diclovit hard capsules

50 mg

50 mg

50 mg

0,25 mg

kapsula, tvrda

kroz usta

Latvija

| SIA Briz |
| --- |
| Rasas iela 5 |
| Riga, LV-1057 |
| Latvia |

SIA Briz

Rasas iela 5

Riga, LV-1057

Latvia

diklofenaknatrij

Feloran 75 mg/3 ml solution for injection

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Latvija

| 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

diklofenaknatrij

lidokainklorid

Olfen 75 mg/20 mg/2 ml solution for injection

75 mg/2 ml

20 mg/2 ml

otopina za injekciju

u mišić

Latvija

| 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

diklofenaknatrij

Olfen Lactab 50 mg gastro-resistant tablets

50 mg

želučanootporna tableta

kroz usta

Latvija

| 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

diklofenaknatrij

Olfen Depocaps 100 mg prolonged-release capsules, hard

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Latvija

| 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

diklofenaknatrij

Olfen Rectocaps 100 mg rectal capsules

100 mg

kapsula za rektum

rektalno

Latvija

| 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

diklofenaknatrij

Olfen Depotabs 75 mg prolonged release tablets

75 mg

tableta s produljenim oslobađanjem

kroz usta

Latvija

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno 25 mg film-coated tablets

25 mg

filmom obložena tableta

kroz usta

Latvija

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno 50 mg film-coated tablets

50 mg

filmom obložena tableta

kroz usta

Latvija

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl 75 mg/3 ml solution for injection

75 mg/3 ml

otopina za injekciju

u mišić

Latvija

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl 100 mg suppositories

100 mg

čepić

rektalno

Latvija

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl 50 mg gastro-resistant tablets

50 mg

želučanootporna tableta

kroz usta

Latvija

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl retard 100 mg prolonged release capsules

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Latvija

| Pharmaceutical Works POLPHARMA SA |
| --- |
| ul. Pelplińska 19 |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

diklofenaknatrij

Majamil retard 100 mg prolonged-release tablets

100 mg

tableta s produljenim oslobađanjem

kroz usta

Latvija

| A/S “Olainfarm” |
| --- |
| Rupnicu iela 5 |
| Olaine, LV – 2114 |
| Latvia |

A/S “Olainfarm”

Rupnicu iela 5

Olaine, LV – 2114

Latvia

diklofenakkalij

Dikloferol 50 mg coated tablets

50 mg

obložena tableta

kroz usta

Latvija

| SIA PharmaSwiss Latvia |
| --- |
| Gertrudes iela 54 – 5 |
| Riga, LV 1011 |
| Latvia |

SIA PharmaSwiss Latvia

Gertrudes iela 54 – 5

Riga, LV 1011

Latvia

diklofenaknatrij

Diclorapid 75 mg gastro-resistant capsules, hard

75 mg

želučanootporna kapsula, tvrda

kroz usta

Latvija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren 75 mg/3 ml solution for injection

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Latvija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenakkalij

Voltaren Akti 12,5 mg film-coated tablets

12,5 mg

filmom obložena tableta

kroz usta

Latvija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenakkalij

Voltaren Akti 25 mg soft capsules

25 mg

kapsula, meka

kroz usta

Latvija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenaknatrij

Voltaren Retard 100 mg modified-release film-coated tablets

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Latvija

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenakkalij

Cataflam 50 mg film-coated tablets

50 mg

filmom obložena tableta

kroz usta

Latvija

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

diklofenaknatrij

Diclofenac 50 mg suppositories

50 mg

čepić

rektalno

Latvija

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

diklofenaknatrij

Diclofenac 100 mg suppositories

100 mg

čepić

rektalno

Latvija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen SR 100 mg prolonged-release tablets

100 mg

tableta s produljenim oslobađanjem

kroz usta

Latvija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen 75 mg/3 ml solution for injection

75 mg/3 ml

otopina za injekciju

u mišić

Latvija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen 50 mg gastro-resistant tablets

50 mg

želučanootporna tableta

kroz usta

Latvija

| 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

diklofenaknatrij

Almiral 25 mg/ml solution for injection and infusion

25 mg/ml

otopina za injekciju i infuziju

u mišić, u venu

Latvija

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

diklofenaknatrij

Diclo CT 75 mg/2 ml solution for injection

75 mg/2 ml

otopina za injekciju

u mišić

Litva

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

Diclac

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Litva

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

Diclac

100 mg

tableta s produljenim oslobađanjem

kroz usta

Litva

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

Diclac ID

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Litva

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

diklofenak

Diclac ID

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Litva

| UAB „PharmaSwiss“ |
| --- |
| Šeimyniškių g. 21B |
| LT-09200, Vilnius |
| Lithuania |

UAB „PharmaSwiss“

Šeimyniškių g. 21B

LT-09200, Vilnius

Lithuania

diklofenak

DicloRapid

75 mg

želučanootporna kapsula, tvrda

kroz usta

Litva

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenak

Dicloberl

75 mg/3 ml

otopina za injekciju

u mišić

Litva

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenak

Dicloberl

50 mg

želučanootporna tableta

kroz usta

Litva

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenak

Dicloberl

100 mg

čepić

rektalno

Litva

| UAB „BERLIN CHEMIE MENARINI BALTIC“ |
| --- |
| Jasinskio g. 16 a, |
| 01112 Vilnius |
| Lithuania |

UAB „BERLIN CHEMIE MENARINI BALTIC“

Jasinskio g. 16 a,

01112 Vilnius

Lithuania

diklofenak

Dicloberl retard

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Litva

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclofenac-ratiopharm

50 mg

želučanootporna tableta

kroz usta

Litva

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclofenac-ratiopharm

100 mg

čepić

rektalno

Litva

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclofenac-ratiopharm

50 mg

čepić

rektalno

Litva

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclofenac-ratiopharm

75 mg/2 ml

otopina za injekciju

u mišić

Litva

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclofenac-ratiopharm

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Litva

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclofenac-ratiopharm uno

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Litva

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

Diclomelan

100 mg

čepić

rektalno

Litva

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

Diclomelan

50 mg

želučanootporna tableta

kroz usta

Litva

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

Diclomelan retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Litva

| UAB Corpus Medica |
| --- |
| Sukilėlių pr. 61 |
| LT-49333 Kaunas |
| Lithuania |

UAB Corpus Medica

Sukilėlių pr. 61

LT-49333 Kaunas

Lithuania

diklofenak

FELORAN

75 mg/3 ml

otopina za injekciju

u mišić

Litva

| Actavis Nordic A/S |
| --- |
| Ørnegårdsvej 16 |
| DK-2820 Gentofte |
| Denmark |

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

diklofenak

Feloran

100 mg

tableta s produljenim oslobađanjem

kroz usta

Litva

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen

75 mg/3 ml

otopina za injekciju

u mišić

Litva

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen

50 mg

želučanootporna tableta

kroz usta

Litva

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen

50 mg

čepić

rektalno

Litva

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen SR

100 mg

tableta s produljenim oslobađanjem

kroz usta

Litva

| 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

diklofenak

Olfen Depocaps

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Litva

| 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

diklofenak

Olfen Depotabs

75 mg

tableta s produljenim oslobađanjem

kroz usta

Litva

| 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

diklofenak

Olfen Lactab

50 mg

želučanootporna obložena tableta

kroz usta

Litva

| 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

diklofenak

Olfen Rectocaps

100 mg

kapsula za rektum

rektalno

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren

75 mg/3 ml

otopina za injekciju/infuziju

u mišić, u venu

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren

100 mg

čepić

rektalno

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren Akti

25 mg

obložena tableta

kroz usta

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren Akti

12,5 mg

filmom obložena tableta

kroz usta

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren Akti

25 mg

kapsula, meka

kroz usta

Litva

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Cataflam

50 mg

obložena tableta

kroz usta

Litva

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

25 mg

filmom obložena tableta

kroz usta

Litva

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

50 mg

filmom obložena tableta

kroz usta

Litva

| 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

diklofenak

lidokain

Olfen

75 mg/2 ml

20 mg/2 ml

otopina za injekciju

u mišić

Litva

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

tiamin

piridoksin

cijanokobalamin

Diclovit

50 mg

50 mg

50 mg

0,25 mg

kapsula, tvrda

kroz usta

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenakkalij

Cataflam

50 mg

obložena tableta

kroz usta

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac retard 100

100 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac 75 mg/3 ml Injektionslösung

75 mg

otopina za injekciju

u mišić

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac-100 Zäpfchen

100 mg

čepić

rektalno

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac-25

25 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac-50

50 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenaknatrij

Diclac-50 Zäpfchen

50 mg

čepić

rektalno

Luksemburg

| 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

diklofenaknatrij

Diclofenac EG-25

25 mg

obložena tableta

kroz usta

Luksemburg

| 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

diklofenaknatrij

Diclofenac EG-50

50 mg

obložena tableta

kroz usta

Luksemburg

| 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

diklofenaknatrij

Diclofenac EG retard 75

75 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

| 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

diklofenaknatrij

Diclofenac EG retard 100

100 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

| 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

diklofenaknatrij

Diclofenac EG 75 mg/3 ml solution injectable

75 mg

otopina za injekciju

u mišić, u venu

Luksemburg

| 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

diklofenaknatrij

Diclofenac EG 100 suppositoire

100 mg

čepić

rektalno

Luksemburg

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

diklofenaknatrij

Diclofenac Mylan-75 Retard

75 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

diklofenaknatrij

Diclofenac Mylan-100 Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac Ratiopharm-100 Zäpfchen

100 mg

čepić

rektalno

Luksemburg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac Ratiopharm-25

25 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac Ratiopharm-50

50 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung

75 mg

otopina za injekciju

u mišić

Luksemburg

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac Retard Ratiopharm-100

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Luksemburg

| 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

diklofenaknatrij

Motifene-75

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Luksemburg

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

diklofenaknatrij

Polyflam-50

50 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

diklofenaknatrij

Polyflam-75

75 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

diklofenaknatrij

mizoprostol

Arthrotec-50

50 mg

0,2 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Luksemburg

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

diklofenaknatrij

mizoprostol

Arthrotec-75

75 mg

0,2 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren-100 Zäpfchen

100 mg

čepić

rektalno

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren-25

25 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren-50

50 mg

želučanootporna obložena tableta

kroz usta

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren injekt

75 mg

otopina za injekciju

u mišić

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak kolestiramin

Voltaren resinat

145,6 mg

kapsula, tvrda

kroz usta

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren Retard-100

100 mg

tableta s produljenim oslobađanjem

kroz usta

Luksemburg

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

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

diklofenakkalij

Voltatabs

12,5 mg

obložena tableta

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenakkalij

Cataflam

25 mg

obložena tableta

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenakkalij

Cataflam

50 mg

obložena tableta

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenakkalij

Catafast

50 mg

prašak za oralnu otopinu

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

12,5 mg

čepić

rektalno

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

50 mg

čepić

rektalno

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

100 mg

čepić

rektalno

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

25 mg

želučanootporna tableta

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

50 mg

želučanootporna tableta

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

50 mg

tableta za oralnu suspenziju

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltaren

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

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

diklofenaknatrij

Fenadol

100 mg

čepić

rektalno

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

diklofenaknatrij

Fenadol

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

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

diklofenakkalij

Areston

50 mg

filmom obložena tableta

kroz usta

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

diklofenaknatrij

Almiral 25 mg tablets

25 mg

želučanootporna tableta

kroz usta

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

diklofenaknatrij

Almiral 50 mg tablets

50 mg

želučanootporna tableta

kroz usta

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

diklofenaknatrij

Almiral injection

75 mg/3 ml

otopina za injekciju ili infuziju

u mišić, u venu

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

diklofenaknatrij

Olfen-75 Ampoules

75 mg/2 ml

otopina za injekciju

u mišić

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

diklofenaknatrij

Olfen-25 Lactab

25 mg

želučanootporna filmom obložena tableta

kroz usta

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

diklofenaknatrij

Olfen-50 Lactab

50 mg

želučanootporna filmom obložena tableta

kroz usta

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

diklofenaknatrij

Olfen-100 Rectocaps

100 mg

čepić

rektalno

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

diklofenaknatrij

Olfen-75 SR Depotabs

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

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

diklofenaknatrij

Olfen-100 SR Depocaps

100 mg

kapsula s prilagođenim oslobađanjem

kroz usta

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

diklofenaknatrij

Remethan 25 mg Tablets

25 mg

želučanootporna tableta

kroz usta

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

diklofenaknatrij

Urigon 75 mg/3 ml solution for injection

75 mg/3 ml

otopina za injekciju

u mišić

Norveška

| 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

diklofenakkalij

Diclofenackalium Orifarm

25 mg

filmom obložena tableta

kroz usta

Norveška

| 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

diklofenakkalij

Diclofenackalium Orifarm

50 mg

filmom obložena tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Voltarol

12,5 mg

kapsula, meka

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Voltarol

25 mg

kapsula, meka

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Voltarol

12,5 mg

filmom obložena tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Voltarol

25 mg

obložena tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Cataflam

12,5 mg

obložena tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Cataflam

50 mg

obložena tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenakkalij

Cataflam

50 mg

prašak za oralnu otopinu

kroz usta

Norveška

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

25 mg

filmom obložena tableta

kroz usta

Norveška

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

50 mg

filmom obložena tableta

kroz usta

Norveška

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Difenassium

25 mg

filmom obložena tableta

kroz usta

Norveška

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Difenassium

50 mg

filmom obložena tableta

kroz usta

Norveška

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Diclofenac Actavis

12,5 mg

filmom obložena tableta

kroz usta

Norveška

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenaknatrij

Modifenac

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Norveška

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenakkalij

DiclofenacKalium ratiopharm

50 mg

filmom obložena tableta

kroz usta

Norveška

| Pfizer AS |
| --- |
| Lilleakerveien 2B |
| 1324 Lysaker |
| Norway |

Pfizer AS

Lilleakerveien 2B

1324 Lysaker

Norway

diklofenaknatrij

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Norveška

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac ratiopharm

25 mg

želučanootporna tableta

kroz usta

Norveška

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenaknatrij

Diclofenac ratiopharm

50 mg

želučanootporna tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenaknatrij

Voltaren

25 mg

želučanootporna tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenaknatrij

Voltaren

50 mg

želučanootporna tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenaknatrij

Voltaren

25 mg/ml

otopina za infuziju /koncentrat za otopinu za infuziju

parenteralno

Norveška

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

diklofenaknatrij

Diclofenac BMM Pharma

25 mg

želučanootporna tableta

kroz usta

Norveška

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

diklofenaknatrij

Diclofenac BMM Pharma

50 mg

želučanootporna tableta

kroz usta

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenaknatrij

Voltaren

25 mg

čepić

rektalno

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenaknatrij

Voltaren

50 mg

čepić

rektalno

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

diklofenaknatrij

Voltaren

100 mg

čepić

rektalno

Poljska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Vostar

12,5 mg

filmom obložena tableta

kroz usta

Poljska

| 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

diklofenaknatrij

Dicloreum

50 mg

želučanootporna filmom obložena tableta

kroz usta

Poljska

| 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

diklofenaknatrij

Dicloreum

25 mg/ml

otopina za injekciju

u mišić

Poljska

| 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

diklofenaknatrij

Dicloreum retard

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl retard

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

diklofenaknatrij

Dicloberl 50

50 mg

čepić

rektalno

Poljska

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

diklofenaknatrij

Diclofenac GSK

50 mg

čepić

rektalno

Poljska

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

diklofenaknatrij

Diclofenac GSK

100 mg

čepić

rektalno

Poljska

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen

25 mg/ml

otopina za injekciju

u mišić

Poljska

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenaknatrij

Naklofen Duo

75 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| 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

diklofenaknatrij

Olfen 100

100 mg

kapsula za rektum

rektalno

Poljska

| 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

diklofenaknatrij

Olfen 50

50 mg

kapsula za rektum

rektalno

Poljska

| 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

diklofenaknatrij

lidokainklorid

Olfen 75

37,5 mg/ml

10 mg/ml

otopina za injekciju

u mišić

Poljska

| 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

diklofenaknatrij

Olfen 100 SR

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| 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

diklofenaknatrij

Olfen 25

25 mg

filmom obložena tableta

kroz usta

Poljska

| 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

diklofenaknatrij

Olfen 50

50 mg

filmom obložena tableta

kroz usta

Poljska

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenakkalij

Voltaren Acti

12,5 mg

filmom obložena tableta

kroz usta

Poljska

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenakkalij

Voltaren Express

12,5 mg

kapsula, meka

kroz usta

Poljska

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenakkalij

Voltaren Acti Forte

25 mg

filmom obložena tableta

kroz usta

Poljska

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenakkalij

Voltaren Express Forte

25 mg

kapsula, meka

kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenakkalij

Cataflam 50

50 mg

filmom obložena tableta

kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

25 mg/ml

otopina za injekciju

u mišić, u venu

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

50 mg

želučanootporna tableta

kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren SR 100

100 mg

tableta s produljenim oslobađanjem

kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren SR 75

75 mg

tableta s produljenim oslobađanjem

kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

50 mg

čepić

rektalno

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

25 mg

čepić

rektalno

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenaknatrij

Voltaren

100 mg

čepić

rektalno

Poljska

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

diklofenak

mizoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta

kroz usta

Poljska

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

diklofenaknatrij

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta

kroz usta

Poljska

| 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

diklofenaknatrij

DicloDuo

75 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Dicloratio Retard 100

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Dicloratio 25

25 mg

želučanootporna tableta

kroz usta

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

lidokain

Dicloratio

75 mg/2 ml

20 mg/2 ml

otopina za injekciju

u mišić

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Dicloratio 50

50 mg

želučanootporna tableta

kroz usta

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Olfen UNO

150 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Dicloratio 100

100 mg

čepić

rektalno

Poljska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Dicloratio 50

50 mg

čepić

rektalno

Poljska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclac

75 mg/3 ml

otopina za injekciju

u mišić

Poljska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclac 75 Duo

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Poljska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclac 150 Duo

150 mg

tableta s prilagođenim oslobađanjem

kroz usta

Poljska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclac 100

100 mg

čepić

rektalno

Poljska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diclac 50

50 mg

čepić

rektalno

Poljska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

25 mg

filmom obložena tableta

kroz usta

Poljska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

50 mg

filmom obložena tableta

kroz usta

Poljska

| 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

diklofenaknatrij

Difadol

25 mg/ml

otopina za injekciju

u mišić, u venu

Poljska

| 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

diklofenaknatrij

Majamil prolongatum

100 mg

kapsula s produljenim oslobađanjem

kroz usta

Poljska

| 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

diklofenaknatrij

Majamil PPH

25 mg

želučanootporna tableta

kroz usta

Poljska

| 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

diklofenaknatrij

Majamil PPH

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta

kroz usta

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

diklofenak

mizoprostol

Arthrotec 75

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Portugal

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina

Portugal

diklofenak

Diclofenac Alter 50 mg Comprimidos

50 mg

obložena tableta

kroz usta

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

diklofenak

Diclofenac Generis 50 mg Comprimidos Revestidos

50 mg

obložena tableta

kroz usta

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

diklofenak

Diclofenac Labesfal

100 mg

čepić

rektalno

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

diklofenak

Diclofenac Labesfal

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

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

diklofenak

Diclofenac Labesfal

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Diclofenac Labesfal 75 mg/3 ml Solução injectável

75 mg/3 ml

otopina za injekciju

u mišić, u venu

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

diklofenak

Diclofenac Mylan

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

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

diklofenak

Diclofenac Ratiopharm

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Diclofenac Ratiopharm 100 mg Supositórios

100 mg

čepić

rektalno

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

diklofenak

Diclofenac Retard Ratiopharm

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

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

diklofenak

Diclofenac Sandoz 50 mg Comprimidos revestidos

50 mg

obložena tableta

kroz usta

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

diklofenak

Dolacen

75 mg/2 ml

otopina za injekciju

u mišić

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

diklofenak

Dorcalor

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Fenil-V

75 mg/2 ml

otopina za injekciju

u mišić

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

diklofenak

Fenil-V

100 mg

čepić

rektalno

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

diklofenak

Fenil-V

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Fenil-V Retard

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

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

diklofenak

Flameril

75 mg/3 ml

otopina za injekciju

u mišić, u venu

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

diklofenak

Flameril

100 mg

čepić

rektalno

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

diklofenak

Flameril

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Flameril Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

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

diklofenak

Olfen

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Painex 25

25 mg

obložena tableta

kroz usta

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

diklofenak

Painex 50

50 mg

obložena tableta

kroz usta

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

diklofenak

Painex R

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

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

diklofenak

Voltaren

100 mg

čepić

rektalno

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

diklofenak

Voltaren

75 mg/3 ml

otopina za injekciju

u mišić, u venu

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

diklofenak

Voltaren

50 mg

želučanootporna tableta

kroz usta

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

diklofenak

Voltaren 75

75 mg

tableta s produljenim oslobađanjem

kroz usta

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

diklofenak

Voltaren Retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

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

diklofenak

Cataflam

50 mg

obložena tableta

kroz usta

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

diklofenak

Otriflu

12,5 mg

obložena tableta

kroz usta

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

diklofenak

Voltaren 12,5

12,5 mg

filmom obložena tableta

kroz usta

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

diklofenak

Voltaren 12,5

12,5 mg

kapsula, meka

kroz usta

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

diklofenak

Voltaren 25

25 mg

kapsula, meka

kroz usta

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

diklofenak

Voltaren Rapid

50 mg

obložena tableta

kroz usta

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

diklofenak

Fenil-V Dispersivel

46,5 mg

tableta za oralnu suspenziju

kroz usta

Rumunjska

| 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

diklofenak

DICLOFENAC DUO PHARMASWISS 75 mg

75 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Rumunjska

| 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

diklofenak

DICLOREUM 150 mg

150 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Rumunjska

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL 50 mg

50 mg

želučanootporna kapsula, meka

kroz usta

Rumunjska

| 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

diklofenak

DICLOTARD® 100 mg

100 mg

tableta s produljenim oslobađanjem

kroz usta

Rumunjska

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenak

DICLAC® 75 ID

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN® RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Rumunjska

| 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

diklofenak

REFEN® RETARD

100 mg

tableta s produljenim oslobađanjem

kroz usta

Rumunjska

| 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

diklofenak

DICLOFENAC 50 mg

50 mg

želučanootporna tableta

kroz usta

Rumunjska

| SC ANTIBIOTICE SA |
| --- |
| Str. Valea Lupului nr. 1 |
| 6600-Iași |
| România |

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

diklofenak

CLAFEN 50 mg

50 mg

želučanootporna tableta

kroz usta

Rumunjska

| 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

diklofenak

RHEUMAVEK

25 mg

želučanootporna tableta

kroz usta

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN® 50

50 mg

želučanootporna tableta

kroz usta

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN® 25

25 mg

želučanootporna tableta

kroz usta

Rumunjska

| 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

diklofenak

DICLOFENAC 50 mg

50 mg

želučanootporna tableta

kroz usta

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN RAPID®

50 mg

obložena tableta

kroz usta

Rumunjska

| 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

diklofenak

DICLOFENAC ARENA 50 mg

25 mg

obložena tableta

kroz usta

Rumunjska

| 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

diklofenak

DICLOFENAC ARENA 50 mg

50 mg

obložena tableta

kroz usta

Rumunjska

| 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

diklofenak

N - DICLOFENAC

50 mg

obložena tableta

kroz usta

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN®

25 mg/ml

otopina za injekciju

u mišić, u venu

Rumunjska

| 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

diklofenak

DICLOFENAC AL I.M.

75 mg/3 ml

otopina za injekciju

u mišić

Rumunjska

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL®

30 mg/ml

otopina za injekciju

u mišić

Rumunjska

| 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

diklofenak

ALMIRAL

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Rumunjska

| 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

diklofenak

DICLOFENAC 75 mg

75 mg/3 ml

otopina za injekciju

u mišić

Rumunjska

| 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

diklofenak

REFEN 75 mg

25 mg/ml

otopina za injekciju

u mišić, u venu

Rumunjska

| 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

diklofenak

RHEUMAVEK

25 mg/ml

otopina za injekciju

u mišić

Rumunjska

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL 120 mg

120 mg

čepić

rektalno

Rumunjska

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL 60 mg

60 mg

čepić

rektalno

Rumunjska

| SC ANTIBIOTICE SA |
| --- |
| Str. Valea Lupului nr. 1 |
| 6600-Iași |
| România |

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

diklofenak

CLAFEN 100 mg

100 mg

čepić

rektalno

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN®

100 mg

čepić

rektalno

Rumunjska

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN®

50 mg

čepić

rektalno

Rumunjska

| 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

diklofenak

DICLOFENAC SODIC 100 mg

100 mg

čepić

rektalno

Rumunjska

| 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

diklofenak

DICLOFENAC 100 mg

100 mg

čepić

rektalno

Rumunjska

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenaknatrij

orfenadrincitrat

Neodolpasse

75 mg/250 ml

30 mg/250 ml

otopina za infuziju

u venu

Rumunjska

| PFIZER EUROPE MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PFIZER EUROPE MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

diklofenaknatrij

mizoprostol

ARTHROTEC 75

75 mg

0,2 mg

želučanootporna tableta

kroz usta

Rumunjska

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

diklofenaknatrij

tiaminklorid

piridoksinklorid

cijanokobalamin

TRATUL PLUS

50 mg

50 mg

50 mg

0,25 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

ALMIRAL

75 mg/3 ml

otopina za injekciju

u mišić, u venu

Slovačka Republika

| 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

diklofenak

ALMIRAL 50 mg

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenak

Diclac retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclobene 150 mg retard

150 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclobene 25 mg

25 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenak

Diclobene 50 mg

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Diclofenac AL 25

25 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Diclofenac AL 50

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Diclofenac AL retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| 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

diklofenak

Diclofenac Duo PharmaSwiss 75 mg

75 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Slovačka Republika

| 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

diklofenak

DICLOREUM 25 mg

25 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

DICLOREUM 50 mg

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

DICLOREUM 50 mg

50 mg

čepić

rektalno

Slovačka Republika

| 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

diklofenak

DICLOREUM 100 mg

100 mg

čepić

rektalno

Slovačka Republika

| 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

diklofenak

DICLOREUM 75 mg

75 mg/3 ml

otopina za injekciju

u mišić

Slovačka Republika

| 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

diklofenak

DICLOREUM retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno 25 mg filmom obalené tablety

25 mg

filmom obložena tableta

kroz usta

Slovačka Republika

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno 50 mg filmom obalené tablety

50 mg

filmom obložena tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Dolmina 50

50 mg

filmom obložena tableta

kroz usta

Slovačka Republika

| 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

diklofenak

DOLMINA INJ

75 mg/3 ml

otopina za injekciju

u mišić

Slovačka Republika

| IBSA Slovakia s.r.o. |
| --- |
| Mytna 42 |
| 811 05 Bratislava |
| Slovak Republic |

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

diklofenak

Flector EP Rapid 50 mg

50 mg

granule

kroz usta

Slovačka Republika

| 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

diklofenak

Myogit 50

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenak

VERAL 100 mg

100 mg

čepić

rektalno

Slovačka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenak

VERAL 100 retard

100 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenak

VERAL 25 mg

25 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenak

VERAL 50 mg

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenak

VERAL 75

75 mg/3 ml

otopina za injekciju

u mišić

Slovačka Republika

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

diklofenak

VERAL 75 retard

75 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren 100

100 mg

čepić

rektalno

Slovačka Republika

| 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

diklofenak

Voltaren 50

50 mg

želučanootporna tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren 75 mg/3 ml

75 mg/3 ml

otopina za injekciju

u mišić

Slovačka Republika

| 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

diklofenak

Voltaren Actigo Extra 25 mg

25 mg

obložena tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren Rapid 12,5 mg

12,5 mg

kapsula, meka

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren Rapid 25 mg

25 mg

kapsula, meka

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren Rapid 50 mg

50 mg

obložena tableta

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren Rapid Sachets

50 mg

prašak za oralnu otopinu

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren Retard 100

100 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| 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

diklofenak

Voltaren SR 75

75 mg

tableta s produljenim oslobađanjem

kroz usta

Slovačka Republika

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

diklofenak

mizoprostol

ARTHROTEC FORTE

75 mg

0,2 mg

filmom obložena tableta

kroz usta

Slovačka Republika

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

diklofenak

orfenadrin

Neodolpasse

75 mg/250 ml

30 mg/250 ml

otopina za infuziju

u venu

Slovenija

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| 1000 Ljubljana |
| Slovenia |

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

diklofenak

Diclo Duo 75 mg trde gastrorezistentne kapsule

75 mg

želučanootporna kapsula, tvrda

kroz usta

Slovenija

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| 1000 Ljubljana |
| Slovenia |

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

diklofenak

DicloJet 75 mg trde gastrorezistentne kapsule

75 mg

želučanootporna kapsula, tvrda

kroz usta

Slovenija

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno 25 mg filmsko obložene tablete

25 mg

filmom obložena tableta

kroz usta

Slovenija

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno 50 mg filmsko obložene tablete

50 mg

filmom obložena tableta

kroz usta

Slovenija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen 25 mg/ml raztopina za injiciranje

25 mg/ml

otopina za injekciju

u mišić

Slovenija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen 50 mg gastrorezistentne tablete

50 mg

želučanootporna tableta

kroz usta

Slovenija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen 50 mg svečke

50 mg

čepić

rektalno

Slovenija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen duo 75 mg trde kapsule

75 mg

kapsula, tvrda

kroz usta

Slovenija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diklofenak

Naklofen SR 100 mg tablete s podaljšanim sproščanjem

100 mg

tableta s produljenim oslobađanjem

kroz usta

Slovenija

| Medias International d.o.o. |
| --- |
| Leskoškova cesta 9D |
| 1000 Ljubljana |
| Slovenia |

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

diklofenak

Neodolpasse 75 mg/30 mg raztopina za infundiranje

2,5 mg/ml

otopina za infuziju

u venu

Slovenija

| 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

diklofenak

Olfen 100 mg trde kapsule s podaljšanim sproščanjem

100 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Slovenija

| 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

diklofenak

Voltaren 12,5 mg svečke

12,5 mg

čepić

rektalno

Slovenija

| 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

diklofenak

Voltaren 25 mg svečke

25 mg

čepić

rektalno

Slovenija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

diklofenak

Voltaren Dolo 12,5 mg filmsko obložene tablete

12,5 mg

filmom obložena tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

VOLTAREN 100 mg supositorios

100 mg

čepić

rektalno

Španjolska

| 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

diklofenaknatrij

VOLTAREN 50 mg comprimidos gastrorresistentes

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DOLO-VOLTAREN 50 mg comprimidos dispersables

50 mg

tableta za oralnu suspenziju

kroz usta

Španjolska

| 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

diklofenaknatrij

VOLTAREN RETARD 75 mg comprimidos de liberación modificada

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Španjolska

| 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

diklofenaknatrij

VOLTAREN RETARD 100 mg comprimidos de liberación modificada

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Španjolska

| 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

diklofenaknatrij

VOLTAREN 75 mg/3 ml solución inyectable

75 mg/3 ml

otopina za injekciju

u mišić

Španjolska

| 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

diklofenaknatrij

DICLOFENACO ALDO-UNION comprimidos EFG

50 mg

tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO RETARD STADA 100 mg comprimidos EFG

100 mg

filmom obložena tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO STADA 50 mg comprimidos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO NORMON 50 mg comprimidos dispersables EFG

50 mg

tableta za oralnu suspenziju

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO NORMON 50 mg comprimidos entéricos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

diklofenaknatrij

DOLOTREN 50 mg comprimidos gastrorresistentes

50 mg

želučanootporna tableta

kroz usta

Španjolska

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

diklofenaknatrij

DOLOTREN RETARD 100 mg cápsulas duras de liberación prolongada

100 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Španjolska

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

diklofenaknatrij

DOLOTREN DISPERSABLE comprimidos

50 mg

tableta za oralnu suspenziju

kroz usta

Španjolska

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

diklofenaknatrij

DOLOTREN supositorios

100 mg

čepić

rektalno

Španjolska

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

diklofenaknatrij

DOLOTREN ampollas

75 mg/3 ml

otopina za injekciju

u mišić

Španjolska

| 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

diklofenaknatrij

LUASE 50 mg comprimidos

50 mg

želučanootporna tableta

kroz usta

Španjolska

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

diklofenaknatrij

DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

diklofenaknatrij

DICLOFENACO LLORENS 75 mg solución inyectable EFG

75 mg/3 ml

otopina za injekciju

u mišić

Španjolska

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

diklofenaknatrij

DI-RETARD 100 mg comprimidos de liberación modificada

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Španjolska

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

diklofenaknatrij

DICLOFENACO LLORENS 100 mg supositorios EFG

100 mg

čepić

rektalno

Španjolska

| 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

diklofenaknatrij

DICLOFENACO RATIOPHARM 50 mg comprimidos

50 mg

obložena tableta

kroz usta

Španjolska

| LABORATORIOS ALTER, S.A. |
| --- |
| Mateo Inurria, 30 |
| 28036 Madrid |
| Spain |

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

diklofenaknatrij

DICLOFENACO ALTER 50 mg comprimidos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO PENSA 50 mg comprimidos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

diklofenaknatrij

DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

diklofenaknatrij

DICLOFENACO SANDOZ 100 mg supositorios EFG

100 mg

čepić

rektalno

Španjolska

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

diklofenaknatrij

DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Španjolska

| LABORATORIOS RANBAXY, S.L. |
| --- |
| Passeig de Gracia, 9 |
| 08007 Barcelona |
| Spain |

LABORATORIOS RANBAXY, S.L.

Passeig de Gracia, 9

08007 Barcelona

Spain

diklofenaknatrij

DICLOFENACO MUNDOGEN 50 mg comprimidos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

DICLOFENACO EDIGEN 50 mg comprimidos EFG

50 mg

želučanootporna tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

mizoprostol

ARTROTEC

50 mg

0,2 mg

filmom obložena tableta

kroz usta

Španjolska

| 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

diklofenaknatrij

mizoprostol

NORMULEN

50 mg

0,2 mg

filmom obložena tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenaknatrij

Voltaren®

25 mg

želučanootporna tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenaknatrij

Voltaren®

50 mg

želučanootporna tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenakkalij

Voltaren® T

12,5 mg

filmom obložena tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenaknatrij

Voltaren®

25 mg/ml

otopina za injekciju

parenteralno

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenakkalij

Voltaren® T

25 mg

obložena tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenakkalij

Voltaren® T

50 mg

obložena tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenakkalij

Voltaren® T

12,5 mg

kapsula, meka

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenakkalij

Voltaren® T

25 mg

kapsula, meka

kroz usta

Švedska

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

diklofenaknatrij

Diklofenak Mylan

25 mg

želučanootporna tableta

kroz usta

Švedska

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

diklofenaknatrij

Diklofenak Mylan

50 mg

želučanootporna tableta

kroz usta

Švedska

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

diklofenak

mizoprostol

Arthrotec

50 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Švedska

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

diklofenaknatrij

mizoprostol

Arthrotec forte

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Švedska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diklofenak Sandoz

25 mg

želučanootporna tableta

kroz usta

Švedska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenaknatrij

Diklofenak Sandoz

50 mg

želučanootporna tableta

kroz usta

Švedska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenakkalij

Diclofenac T ratiopharm

25 mg

filmom obložena tableta

kroz usta

Švedska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

diklofenakkalij

Diclofenac T ratiopharm

50 mg

filmom obložena tableta

kroz usta

Švedska

| 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

diklofenaknatrij

Diklofenak Orifarm

25 mg

želučanootporna tableta

kroz usta

Švedska

| 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

diklofenaknatrij

Diklofenak Orifarm

50 mg

želučanootporna tableta

kroz usta

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenakkalij

Eeze

25 mg

filmom obložena tableta

kroz usta

Švedska

| Evolan Pharma AB |
| --- |
| Box: 120 |
| 182 12 Danderyd |
| Sweden |

Evolan Pharma AB

Box: 120

182 12 Danderyd

Sweden

diklofenakkalij

Diklofenak T Evolan

50 mg

filmom obložena tableta

kroz usta

Švedska

| 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

diklofenaknatrij

Diklofenak T Orifarm

25 mg

filmom obložena tableta

kroz usta

Švedska

| 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

diklofenaknatrij

Diklofenak T Orifarm

50 mg

filmom obložena tableta

kroz usta

Švedska

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

diklofenakkalij

Diklofenak T Actavis

25 mg

filmom obložena tableta

kroz usta

Švedska

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

diklofenakkalij

Diklofenak T Actavis

50 mg

filmom obložena tableta

kroz usta

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenaknatrij

Diclofenac BMM Pharma

25 mg

želučanootporna tableta

kroz usta

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenaknatrij

Diclofenac BMM Pharma

50 mg

želučanootporna tableta

kroz usta

Švedska

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

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

diklofenakkalij

Instantin

50 mg

prašak za oralnu otopinu

kroz usta

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenakkalij

Eezeneo

25 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Eezeneo

50 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Eeze

12,5 mg

filmom obložena tableta

kroz usta

Švedska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

25 mg

filmom obložena tableta

kroz usta

Švedska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenakkalij

Dicuno

50 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Diklotab

25 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Diklotab

50 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Diklok

25 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Diklok

50 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Kappadi

25 mg

filmom obložena tableta

kroz usta

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenakkalij

Kappadi

50 mg

filmom obložena tableta

kroz usta

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenaknatrij

Voltaren®

100 mg

čepić

rektalno

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenaknatrij

Voltaren®

50 mg

čepić

rektalno

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

diklofenaknatrij

Voltaren®

25 mg

čepić

rektalno

Švedska

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

diklofenaknatrij

Diklofenak Mylan

100 mg

čepić

rektalno

Švedska

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

diklofenaknatrij

Diklofenak Mylan

50 mg

čepić

rektalno

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis Retard 75 mg, tabletten met gereguleerde afgifte

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis 25 mg, zetpillen

25 mg

čepić

rektalno

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis 50 mg, zetpillen

50 mg

čepić

rektalno

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

diklofenaknatrij

Diclofenacnatrium Actavis 100 mg, zetpillen

100 mg

čepić

rektalno

Nizozemska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Diclofenac Kalium Actavis 12,5 mg, filmomhulde tabletten

12,5 mg

filmom obložena tableta

kroz usta

Nizozemska

| 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

diklofenakkalij

Eminocs 50 mg/ml, drank

50 mg

oralne kapi, otopina

kroz usta

Nizozemska

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Nizozemska

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

Diclofenacnatrium Apotex retard 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

Diclofenacnatrium Apotex 25 mg, zetpillen

25 mg

čepić

rektalno

Nizozemska

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

Diclofenacnatrium Apotex 50 mg, zetpillen

50 mg

čepić

rektalno

Nizozemska

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

diklofenaknatrij

Diclofenacnatrium Apotex 100 mg, zetpillen

100 mg

čepić

rektalno

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na CF 25 mg/ml, oplossing voor injectie

25 mg/ml

otopina za injekciju

u mišić, u venu

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na CF 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na CF 50 mg, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na zetpil CF 50 mg, zetpillen

50 mg

čepić

rektalno

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na zetpil CF 100 mg, zetpillen

100 mg

čepić

rektalno

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na retard CF 75 mg, tabletten met gereguleerde afgifte

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

diklofenaknatrij

Diclofenac Na retard CF 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar EC 25, maagsapresistente tabletten 25 mg

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar EC 50, maagsapresistente tabletten 50 mg

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar Retard 75, tabletten met gereguleerde afgifte 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar Retard 100, tabletten met gereguleerde afgifte 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar 25, zetpillen 25 mg

25 mg

čepić

rektalno

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar 50, zetpillen 50 mg

50 mg

čepić

rektalno

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

diklofenaknatrij

Diclofenacnatrium Disphar 100, zetpillen 100 mg

100 mg

čepić

rektalno

Nizozemska

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

diklofenaknatrij

Diclofenacnatrium Manston 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

diklofenaknatrij

Diclofenacnatrium Manston 50 mg, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

diklofenaknatrij

Diclofenacnatrium retard Manston 100 mg, maagsapresistente tabletten

100 mg

želučanootporna tableta

kroz usta

Nizozemska

| Marel B.V. |
| --- |
| Archimedesweg 2 |
| 2333 CN Leiden |
| The Netherlands |

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

diklofenakkalij

Kruidvat Diclofenac kalium 12,5 mg, filmomhulde tabletten

12,5 mg

filmom obložena tableta

kroz usta

Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

diklofenaknatrij

Diclofenacnatrium 50 mg, zetpillen

50 mg

čepić

rektalno

Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

diklofenaknatrij

Diclofenacnatrium 100 mg, zetpillen

100 mg

čepić

rektalno

Nizozemska

| 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

diklofenakkalij

Voltaren K 12,5 mg, filmomhulde tabletten

12,5 mg

filmom obložena tableta

kroz usta

Nizozemska

| 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

diklofenakkalij

Voltaren K 25 mg, omhulde tabletten

25 mg

obložena tableta

kroz usta

Nizozemska

| 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

diklofenakkalij

Otriflu, omhulde tabletten 12,5 mg

12,5 mg

obložena tableta

kroz usta

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

diklofenaknatrij

Voltaren 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

diklofenaknatrij

Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

otopina za injekciju

u mišić, u venu

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

diklofenakkalij

Cataflam 50, omhulde tabletten 50 mg

50 mg

obložena tableta

kroz usta

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

diklofenaknatrij

Voltaren Retard 75 mg, tabletten met verlengde afgifte

75 mg

tableta s produljenim oslobađanjem

kroz usta

Nizozemska

| 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

diklofenaknatrij

mizoprostol

Arthrotec 50, tabletten

50 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| 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

diklofenaknatrij

mizoprostol

Arthrotec 75, tabletten 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 25 PCH, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 50 PCH, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 25 PCH, zetpillen 25 mg

25 mg

čepić

rektalno

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 50 PCH, zetpillen 50 mg

50 mg

čepić

rektalno

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 100 PCH, zetpillen 100 mg

100 mg

čepić

rektalno

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenac Na retard 75 PCH, tabletten met gereguleerde afgifte 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenac Na Retard 100 PCH tabletten met gereguleerde afgifte 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

diklofenaknatrij

Diclofenacnatrium Pharmacin 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

diklofenaknatrij

Diclofenacnatrium Pharmacin 50 mg, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

diklofenaknatrij

Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

diklofenaknatrij

Diclofenac Na ratiopharm retard 75 mg, tabletten met gereguleerde afgifte

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

diklofenaknatrij

Diclofenacnatrium Sandoz retard 75, tabletten met gereguleerde afgite 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

diklofenaknatrij

Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

diklofenaknatrij

Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

diklofenaknatrij

Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg

50 mg

želučanootporna tableta

kroz usta

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

diklofenaknatrij

Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

otopina za injekciju

u mišić, u venu

Nizozemska

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

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 25 mg Teva, zetpilen

25 mg

čepić

rektalno

Nizozemska

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

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 50 mg Teva, zetpilen

50 mg

čepić

rektalno

Nizozemska

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

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

diklofenaknatrij

Diclofenacnatrium 100 mg Teva, zetpilen

100 mg

čepić

rektalno

Nizozemska

| 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

diklofenaknatrij

Diclofenacnatrium 25 mg, maagsapresistente tabletten

25 mg

želučanootporna tableta

kroz usta

Nizozemska

| 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

diklofenaknatrij

Diclofenacnatrium 50 mg, maagsapresistente tabletten

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenakkalij

Voltarol Pain-Eze Extra Strength Tablets

25 mg

obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenakkalij

Voltarol Pain-Eze Tablets

12,5 mg

obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

diklofenaknatrij

Arthrotec 50 Modified-Release tablets

50 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

diklofenaknatrij

Arthrotec 75 Modified-Release tablets

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Injection 75 mg/3 ml

75 mg

otopina za injekciju

u mišić, u venu

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenak slobodna kiselina

Voltarol Dispersible Tablets 50 mg

46,5 mg

tableta za oralnu otopinu

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Retard Tablets 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol SR Tablets

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Suppositories 12,5 mg

12,5 mg

čepić

rektalno

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Suppositories 25 mg

25 mg

čepić

rektalno

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Suppositories 50 mg

50 mg

čepić

rektalno

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Suppositories 100 mg

100 mg

čepić

rektalno

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Tablets 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Tablets 50 mg

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Rapid Tablets 25 mg

25 mg

obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

diklofenaknatrij

Voltarol Rapid Tablets 50 mg

50 mg

obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon EX32 8NS |
| United Kingdom |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon EX32 8NS

United Kingdom

diklofenaknatrij

Flamatak MR Tablets 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Teva UK Diclofenac Sodium Tablets 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Teva UK Diclofenac Sodium Tablets 50 mg

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| Chatfield Pharmaceuticals Limited |
| --- |
| Kramer Mews |
| London SW5 9JL |
| United Kingdom |

Chatfield Pharmaceuticals Limited

Kramer Mews

London SW5 9JL

United Kingdom

diklofenaknatrij

Chatfield Pharms Diclofenac Sodium Tablets 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Antigen Diclofenac Sodium Injection 2.5 % w/v

75 mg

otopina za injekciju

u mišić

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Lagap Pharms Diclofenac Tablets 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Lagap Pharms Diclofenac Tablets 50 mg

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Sandoz Ltd Rhumalgan SR Modified Release Capsules 75 mg

75 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Ujedinjeno Kraljevstvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

diklofenaknatrij

Sandoz Ltd Rhumalgan XL Modified Release Capsules 100 mg

100 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Ujedinjeno Kraljevstvo

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

diklofenaknatrij

Generics UK Diclofenac Sodium Tablets 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

diklofenaknatrij

Generics UK Diclofenac Sodium Tablets 50 mg

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Rheumatac Retard Tablets 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Motifene Capsules 75 mg

75 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Volsaid Retard Tablets 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Volsaid Retard Tablets 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Econac Suppositories 100 mg

100 mg

čepić

rektalno

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Econac Injection 75 mg/3 ml

75 mg

otopina za injekciju

u mišić

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Mercury Pharms Diclofenac Solution for Injection 75 mg/3 ml

75 mg

otopina za injekciju

u mišić, u venu

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Mercury Pharms Econac SR Prolonged Release Tablet 75 mg

75 mg

tableta s produljenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Mercury Pharms Econac XL Prolonged Release Tablet 100 mg

100 mg

tableta s produljenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Mercury Pharms Diclofenac Sodium Tablets 25 mg

25 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Mercury Pharms Diclofenac Sodium Tablets 75 mg

50 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Diclo-XL 100

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Diclo-SR 75

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100 mg

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75 mg

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Dexcel-Pharma Diclofenac Sodium Tablets 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Dexcel-Pharma Diclofenac Sodium Tablets 75 mg

75 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Volraman 25 mg Gastro-resistant tablets

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Volraman 50 mg Gastro-resistant tablets

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenakkalij

Adacium Rapid 50 mg Tablets

50 mg

filmom obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

diklofenaknatrij

mizoprostol

Misofen 50 mg/200 mcg modified released tablets

50 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

diklofenaknatrij

mizoprostol

Misofen 75 mg/200 mcg modified released tablets

75 mg

0,2 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenak

Crescent Pharma Diclofenac Tablets BP 25 mg

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenak

Crescent Pharma Diclofenac Tablets BP 50 mg

50 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Dyloject 75 mg/2 ml solution for injection

75 mg/2 ml

otopina za injekciju

u mišić, u venu

Ujedinjeno Kraljevstvo

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

diklofenaknatrij

Diclomax SR

75 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

diklofenaknatrij

Diclomax Retard

100 mg

kapsula s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Doble action pain relief

12,5 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Diclofenac potassium 12,5 mg Tablets

12,5 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Diclofenac potassium 25 mg Tablets

25 mg

filmom obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

diklofenakkalij

Diclofenac potassium 50 mg Tablets

50 mg

filmom obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| Chelonia Healthcare Limited |
| --- |
| Boumpoulinas 11 |
| 3rd, Nicosia |
| CY-1060 |
| Cyprus |

Chelonia Healthcare Limited

Boumpoulinas 11

3rd, Nicosia

CY-1060

Cyprus

diklofenaknatrij

Diclofenac sodium 25 mg Tablets

25 mg

želučanootporna tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Slofenac 75 mg SR

75 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenaknatrij

Slofenac 100 mg SR

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

diklofenaknatrij

Enstar SR 75 mg Tablets

75 mg

tableta s produljenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

diklofenaknatrij

Enstar XL 100 mg Tablets

100 mg

tableta s prilagođenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenakkalij

Diclofenac potassium 12,5 mg Tablets

12,5 mg

filmom obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenakkalij

Diclofenac potassium 25 mg Tablets

25 mg

filmom obložena tableta

kroz usta

Ujedinjeno Kraljevstvo

| 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

diklofenakkalij

Diclofenac potassium 50 mg Tablets

50 mg

filmom obložena tableta

kroz usta

---

PRILOG X

LISTA NAZIVA, FARMACEUTSKIH OBLIKA, JAČINE MEDICINSKOG (MEDICINSKIH) PROIZVODA, NAČIN(I) PRIMJENE, NOSITELJ (I) MARKETING AUTORIZACIJE U DRŽAVAMA ČLANICAMA

| Država članica (u EEZ) | Nositelj marketing autorizacije | (Zaštićeno) ime | Jačina | Farmaceutski oblik | Način primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | WABOSAN |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Austria |

Država članica (u EEZ)

Nositelj marketing autorizacije

(Zaštićeno) ime

Jačina

Farmaceutski oblik

Način primjene

Austrija

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Austria

Ergomed retard - Kapseln

2.5 mg (1:1:1)

kapsule s produljenim oslobađanjem, meke

peroralno

Austrija

| 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)

kapi za peroralnu uporabu, otopina

peroralno

Češka Republika

| 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

Kapi za peroralnu uporabu, otopina

peroralno

Francuska

| 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

tablete

peroralno

Francuska

| 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

tablete

peroralno

Francuska

| 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

oralna otopina

peroralno

Francuska

| 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

Otopina za injekcije

i.v./i.m.

Grčka

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greece |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

3mg/kaps

Kapsule, meke

peroralno

Grčka

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greece |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

6mg/PO JEDNOJ DOZI

prašak za oralnu otopinu za jednu dozu

peroralno

Grčka

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greece |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

6mg/TABL

Tablete

peroralno

Grčka

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, |
| GLYFADA, 16674 |
| Greece |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150,

GLYFADA, 16674

Greece

ERGOFIL

6mg/TABL

tablete

peroralno

Grčka

| 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/TABL

tablete

peroralno

Grčka

| ANTOR LTD |
| --- |
| P. MAVROMIHALI 1 |
| VRILISSIA 15235 |
| Greece |

ANTOR LTD

P. MAVROMIHALI 1

VRILISSIA 15235

Greece

THRIOLAN

6mg/TABL

tablete

peroralno

Grčka

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, |
| ARGYROUPOLI, 16452 |
| Greece |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22,

ARGYROUPOLI, 16452

Greece

FENITINA

6mg/TABL

tablete

peroralno

Grčka

| 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/TABL

tablete

peroralno

Grčka

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, |
| GERAKAS, 15344 |
| Greece |

FINIXFARM EPE

DERVENAKION 38 & SAHINI,

GERAKAS, 15344

Greece

CRISTIL

6mg/TABL

tablete

peroralno

Grčka

| 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/TABL

tablete

peroralno

Luksemburg

| Pierre Fabre Médicaments |
| --- |
| 45, PLACE ABEL GANCE |
| F 92654 BOULOGNE |
| CEDEX |
| Francuska |

Pierre Fabre Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE

CEDEX

Francuska

Iskedyl Fort

2.40 mg/19.20 mg

tablete

peroralno

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

Kapsula, tvrda

peroralno

Španjolska

| 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 (vrećica sa jednom dozom)

kapi za peroralnu uporabu, otopina

peroralno

Španjolska

| 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

kapi za peroralnu uporabu, otopina

peroralno

---

PRILOG XI

POPIS NAZIVA, FARMACEUTSKOG(IH) OBLIKA, JAČINE(A) LIJEK(OV)A, PUT(EV)A PRIMJENE, NOSITELJ(A) ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica
  (u EGP-u) | Nositelj odobrenja | (Zaštićeno) ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Francuska | CHIESI |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| France |

Država članica

(u EGP-u)

Nositelj odobrenja

(Zaštićeno) ime

Jačina

Farmaceutski oblik

Put primjene

Francuska

CHIESI

11, avenue Dubonnet

92400 Courbevoie

France

VASOBRAL, comprimé sécable

4 mg/40 mg

tableta

kroz usta

Francuska

| 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

oralna otopina

kroz usta

---

DODATAK XII

POPIS NAZIVA, FARMACEUTSKOG(IH) OBLIKA, JAČINE(A) LIJEK(OV)A, PUT(EV)A PRIMJENE, NOSITELJ(A) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U DRŽAVAMA ČLANICAMA

| Država članica (u EGP-u) | Nositelj odobrenja za stavljanje lijeka u promet | (Zaštićeni) naziv | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | Kwizda Pharma GmbH |
| Effingergasse 21 |
| 1160 Vienna |
| Austrija |

Država članica (u EGP-u)

Nositelj odobrenja za stavljanje lijeka u promet

(Zaštićeni) naziv

Jačina

Farmaceutski oblik

Put primjene

Austrija

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austrija

Ergotop 10 mg - Tabletten

10 mg

tableta

kroz usta

Austrija

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Austrija |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austrija

Ergotop 20 mg - Filmtabletten

20 mg

filmom obložena tableta

kroz usta

Austrija

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Austrija |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austrija

Ergotop 30 mg - Filmtabletten

30 mg

filmom obložena tableta

kroz usta

Austrija

| Rösch & Handel |
| --- |
| Scheringgasse 2/Objekt 2 |
| 1140 Vienna |
| Austrija |

Rösch & Handel

Scheringgasse 2/Objekt 2

1140 Vienna

Austrija

Nicergin - Filmtabletten

30 mg

filmom obložena tableta

kroz usta

Austrija

| Pfizer Corporation Austrija GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Vienna |
| Austrija |

Pfizer Corporation Austrija GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austrija

Sermion 30 mg - Filmtabletten

30 mg

filmom obložena tableta

kroz usta

Bugarska

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

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luksemburg

Sermion

4 mg/4 ml

prašak i otapalo za otopinu za injekciju

u mišić i u venu

Bugarska

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

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luksemburg

Sermion

30 mg

filmom obložene tablete

kroz usta

Češka Republika

| Pfizer, spol. s r.o., Praha |
| --- |
| Stroupežnického 17 |
| 150 00 Prague 5 |
| Češka Republika |

Pfizer, spol. s r.o., Praha

Stroupežnického 17

150 00 Prague 5

Češka Republika

SERMION

30mg

filmom obložena tableta

kroz usta

Francuska

| SANOFI AVENTIS Francuska |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francuska |

SANOFI AVENTIS Francuska

1-13, boulevard Romain Rolland

75014 Paris

Francuska

SERMION 10 mg, gélule

10 mg

kapsula, tvrda

kroz usta

Francuska

| SANOFI AVENTIS Francuska |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francuska |

SANOFI AVENTIS Francuska

1-13, boulevard Romain Rolland

75014 Paris

Francuska

SERMION 5 mg, gélule

5 mg

kapsula, tvrda

kroz usta

Francuska

| SANOFI AVENTIS Francuska |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francuska |

SANOFI AVENTIS Francuska

1-13, boulevard Romain Rolland

75014 Paris

Francuska

SERMION 5 mg, poudre pour solution pour perfusion

5 mg

prašak za otopinu za infuziju

u venu

Francuska

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francuska |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francuska

NICERGOLINE BIOGARAN 10 mg, gélule

10 mg

kapsula, tvrda

kroz usta

Francuska

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francuska |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francuska

NICERGOLINE BIOGARAN 5 mg, gélule

5 mg

kapsula, tvrda

kroz usta

Francuska

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francuska |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francuska

NICERGOLINE EG 10 mg, gélule

10 mg

kapsula, tvrda

kroz usta

Francuska

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francuska |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francuska

NICERGOLINE EG 5 mg, gélule

5 mg

kapsula, tvrda

kroz usta

Francuska

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francuska |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francuska

NICERGOLINE MYLAN 10 mg, gélule

10 mg

kapsula, tvrda

kroz usta

Francuska

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francuska |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francuska

NICERGOLINE MYLAN 5 mg, gélule

5 mg

kapsula, tvrda

kroz usta

Francuska

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francuska |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

Francuska

NICERGOLINE QUALIMED 10 mg, gélule

10 mg

kapsula, tvrda

kroz usta

Francuska

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francuska |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

Francuska

NICERGOLINE QUALIMED 5 mg, gélule

5 mg

kapsula, tvrda

kroz usta

Francuska

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

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

Francuska

NICERGOLINE TEVA 10 mg, gélule

10 mg

kapsula, tvrda

kroz usta

Francuska

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

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

Francuska

NICERGOLINE TEVA 5 mg, gélule

5 mg

kapsula, tvrda

kroz usta

Mađarska

| Pfizer Kft. |
| --- |
| Alkotás u. 53., MOM Park F épület |
| 1123 Budapest |
| Mađarska |

Pfizer Kft.

Alkotás u. 53., MOM Park F épület

1123 Budapest

Mađarska

SERMION 30 mg filmtabletta

30 mg

filmom obložena tableta

kroz usta

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

10 mg/ml

prašak i otapalo za oralnu otopinu

kroz usta

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

5 mg

obložena tableta

kroz usta

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

10 mg

obložena tableta

kroz usta

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

30 mg

filmom obložena tableta

kroz usta

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

30 mg

tableta za oralnu otopinu

kroz usta

Italija

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italija |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italija

NICERGOLINA ANGENERICO

10 mg/ml

prašak i otapalo za oralnu otopinu

kroz usta

Italija

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italija |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italija

NICERGOLINA ANGENERICO

30 mg

tableta

kroz usta

Italija

| Sandoz spa |
| --- |
| Largo Umberto Boccioni, |
| 1 21040 Origgio - Varese |
| Italija |

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italija

NICERGOLINA SANDOZ

30 mg

šumeća tableta

kroz usta

Italija

| Sandoz spa |
| --- |
| Largo Umberto Boccioni, |
| 1 21040 Origgio - Varese |
| Italija |

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italija

NICERGOLINA SANDOZ

30 mg

tableta

kroz usta

Italija

| EG spa |
| --- |
| Via Scarlatti Domenico, |
| 31 20124 Milano |
| Italija |

EG spa

Via Scarlatti Domenico,

31 20124 Milano

Italija

NICERGOLINA EG

30 mg

tableta

kroz usta

Latvija

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

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

10 mg

filmom obložene tablete

kroz usta

Latvija

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

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

30 mg

kapsule, tvrde

kroz usta

Latvija

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

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italija

Sermion

5 mg

filmom obložene tablete

kroz usta

Latvija

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

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italija

Sermion

10 mg

filmom obložene tablete

kroz usta

Litva

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italija |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italija

Sermion

4mg

prašak i otapalo za otopinu za injekciju

u mišić u venu

Litva

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT) |
| Italija |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT)

Italija

Sermion

5 mg

obložena tableta

kroz usta

Litva

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italija |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italija

Sermion

10 mg

obložena tableta

kroz usta

Litva

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italija |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italija

Sermion

30 mg

filmom obložena tableta

kroz usta

Litva

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

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

30 mg

kapsula, tvrda

kroz usta

Litva

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

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

10 mg

filmom obložena tableta

kroz usta

Poljska

| Farmaceutyczna Spółdzielnia Pracy FILOFARM |
| --- |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poljska |

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poljska

Nicergolin

10 mg

tableta

kroz usta

Poljska

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| CT13 9 NJ Kent, Sandwich |
| Ujedinjeno Kraljevstvo |

Pfizer Europe MA EEIG

Ramsgate Road

CT13 9 NJ Kent, Sandwich

Ujedinjeno Kraljevstvo

Nicergolin

10 mg

obložena tableta

kroz usta

Poljska

| Pfizer Italia S.r.l. |
| --- |
| Borgo San Michele SS 156 Km 50 |
| Latina |
| Italija |

Pfizer Italia S.r.l.

Borgo San Michele SS 156 Km 50

Latina

Italija

Nicergolin

4 mg

prašak i otapalo za otopinu za injekciju

u mišić u venu

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

filmom obložena tableta

kroz usta

Rumunjska

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Rumunjska |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Rumunjska

NICERGOLINA LPH 5 mg

5 mg

filmom obložena tableta

kroz usta

Rumunjska

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Rumunjska |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Rumunjska

NICERGOLINA LPH 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Rumunjska |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Rumunjska

NICERGOLINA LPH 30 mg

30 mg

filmom obložena tableta

kroz usta

Rumunjska

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Rumunjska |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Rumunjska

GRALIN 5 mg

5 mg

filmom obložena tableta

kroz usta

Rumunjska

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Rumunjska |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Rumunjska

GRALIN 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Rumunjska |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Rumunjska

GRALIN 30 mg

30 mg

filmom obložena tableta

kroz usta

Rumunjska

| HEXAL AG |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Njemačka |

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Njemačka

NICERIUM® 10

10 mg

obložena tableta

kroz usta

Rumunjska

| Hexal AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Njemačka |

Hexal AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Njemačka

NICERIUM® 15

15 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Rumunjska

| HEXAL AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Njemačka |

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Njemačka

NICERIUM® 30 UNO

30 mg

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Španjolska

| PFIZER, S.L. |
| --- |
| Avenida de Europa, |
| 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) |
| Španjolska |

PFIZER, S.L.

Avenida de Europa,

20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)

Španjolska

SERMION 5 mg

5 mg

obložena tableta

kroz usta

---

DODATAK XIII

POPIS NAZIVA, FARMACEUTSKOG(IH) OBLIKA, JAČINE(A) LIJEK(OV)A, PUT(EV)A PRIMJENE, NOSITELJ(A) ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica
  (u EGP-u) | Nositelj odobrenja | (Zaštićeno) ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | Boehringer Ingelheim |
| RCV GmbH & Co KG, |
| Dr. Boehringer-Gasse 5-11, |
| A-1121 Vienna |
| Austria |

Država članica

(u EGP-u)

Nositelj odobrenja

(Zaštićeno) ime

Jačina

Farmaceutski oblik

Put primjene

Austrija

Boehringer Ingelheim

RCV GmbH & Co KG,

Dr. Boehringer-Gasse 5-11,

A-1121 Vienna

Austria

Effortil comp. - Tropfen

2 mg/ml, 10 mg/ml

oralne kapi, otopina

kroz usta

Austrija

| 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

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Austrija

| 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

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Austrija

Amdipharm Ltd.

3, Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot 2,5 mg - Tabletten

2,5 mg

tableta

kroz usta

Austrija

| 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

oralne kapi, otopina

kroz usta

Austrija

| 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

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Austrija

| 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

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Belgija

| Amdipharm Limited |
| --- |
| Burlington Road, 3 |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Burlington Road, 3

Dublin 4

Ireland

Dihydergot Forte

2,5 mg

tableta

kroz usta

Belgija

| 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

tableta

kroz usta

Finska

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

ORSTANORM

2,5 mg

tableta

kroz usta

Francuska

| 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

tableta s produljenim oslobađanjem

kroz usta

Francuska

| 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

oralne kapi, otopina

kroz usta

Francuska

| 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

oralna otopina

kroz usta

Francuska

| 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

tvrda kapsula

kroz usta

Francuska

| 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

oralni liofilizat

kroz usta

Francuska

| 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

meka kapsula

kroz usta

Francuska

| 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

oralna otopina

kroz usta

Francuska

| 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

tableta

kroz usta

Njemačka

| 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

otopina

kroz usta

Njemačka

| 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

otopina

kroz usta

Njemačka

| 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

otopina

kroz usta

Njemačka

| 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

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| 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

kapsula s produljenim oslobađanjem

kroz usta

Njemačka

| 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

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Njemačka

| 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

otopina

kroz usta

Grčka

| Amdipharm Ltd. |
| --- |
| 3 Burlington Road, |
| Temple Chambers, |
| Dublin 4 |
| Ireland |

Amdipharm Ltd.

3 Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot

2,5 mg

tableta

kroz usta

Italija

| 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

oralna otopina

kroz usta

Italija

| 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

tableta

kroz usta

Italija

| 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

kapsula s prilagođenim oslobađanjem, tvrda

kroz usta

Luksemburg

| 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

oralna otopina

kroz usta

Luksemburg

| 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

tablete

kroz usta

Poljska

| 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

oralna otopina

kroz usta

Poljska

| 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

tableta

kroz usta

Portugal

| Laboratórios Azevedos – |
| --- |
| Indústria Farmacêutica, |
| S.A. PRT |
| Edifícios Azevedos – |
| Estrada Nacional 117-2, Alfragide |
| 2614-504Amadora |
| Portugal |

Laboratórios Azevedos –

Indústria Farmacêutica,

S.A. PRT

Edifícios Azevedos –

Estrada Nacional 117-2, Alfragide

2614-504Amadora

Portugal

Seglor Retard

5 mg

kapsula s produljenim oslobađanjem, tvrda

kroz usta

Slovenija

| 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

tableta

kroz usta

Španjolska

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DIHYDERGOT COMPRIMIDOS

1 mg

tableta

kroz usta

Švedska

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

2,5 mg

tablete

kroz usta

Švedska

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

5 mg

tablete

kroz usta

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