# Uradni list C 311/2013

| | ISSN 1977-1045
  doi:10.3000/19771045.C_2013.311.slv |
| --- | --- |
| Uradni list
  Evropske unije | C 311 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5625. oktober 2013 |

ISSN 1977-1045

doi:10.3000/19771045.C_2013.311.slv

Uradni list

Evropske unije

C 311

Slovenska izdaja

Informacije in objave

Zvezek 5625. oktober 2013

---

| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2013/C 311/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. septembra 2013 do 30. septembra 2013(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2013/C 311/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. septembra 2013 do 30. septembra 2013(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES) | 8 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2013/C 311/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. septembra 2013 do 30. septembra 2013(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

1

2013/C 311/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. septembra 2013 do 30. septembra 2013(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

8

| SL | |
| --- | --- |

SL

---

IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 25.10.2013 | SL | Uradni list Evropske unije | C 311/1 |
| --- | --- | --- | --- |

25.10.2013

SL

Uradni list Evropske unije

C 311/1

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. septembra 2013 do 30. septembra 2013

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (1)
  )

2013/C 311/01

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.9.2013 | Procysbi | merkaptamin (cisteaminijev bitartrat) | Raptor Pharmaceuticals Europe BV |
| Naritaweg 165, NL-1043 BW Amsterdam, Nederland |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

6.9.2013

Procysbi

merkaptamin (cisteaminijev bitartrat)

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/13/861

Gastrorezistentna kapsula, trda

A16AA04

10.9.2013

6.9.2013

Provenge

Avtologne mononuklearne celice iz periferne krvi, aktivirane s prostatičnim kislim, granulocitne in makrofagne kolonije stimulirajočim faktorjem (PAP-GM-CSF, prostatic acid phosphatase-granculocyte macrophage-colony stimulating factor) (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 infundiranje

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

Prašek za koncentrat za raztopino za infundiranje

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

Prašek za koncentrat za raztopino za infundiranje

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 raztopino za infundiranje

Pending

16.9.2013

12.9.2013

Orphacol

Holinska kislina

| 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, trda

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

Filmsko obložene tablete

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

Filmsko obložene tablete

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

Prašek za inhaliranje, trde kapsule

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

Filmsko obložene tablete

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

Filmsko obložene tablete

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

Prašek za inhaliranje, trde kapsule

R03AL04

23.9.2013

25.9.2013

EVARREST

Humani fibrinogen / Humani 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 z lepilom za tkiva

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

Filmsko obložene tablete

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, trda

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

Rztopina za injiciranje

G03GA05

1.10.2013

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Zavrnjena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 6.9.2013 | Labazenit | LABORATOIRES SMB SA |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

6.9.2013

Labazenit

LABORATOIRES SMB SA

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

—

10.9.2013

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Neulasta | Amgen Europe B.V. |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Rasitrio | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.9.2013

Rasitrio

Novartis Europharm Limited

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

EU/1/11/730

5.9.2013

Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (2)
  ): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.9.2013 | Apoquel | oklacitinibijevega maleata | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

12.9.2013

Apoquel

oklacitinibijevega maleata

Zoetis Belgium S.A.

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

EU/2/13/154

Filmsko obložene tablete

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

Žvečljive tablete

QP54AB51

23.9.2013

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 12.9.2013 | Equip WNV | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Ukinitev dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 19.9.2013 | Netvax | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

19.9.2013

Netvax

Intervet International B.V.

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

EU/2/09/093

23.9.2013

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

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

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

---

| 25.10.2013 | SL | Uradni list Evropske unije | C 311/8 |
| --- | --- | --- | --- |

25.10.2013

SL

Uradni list Evropske unije

C 311/8

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. septembra 2013 do 30. septembra 2013

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
   (1)
  ali člena 38 Direktive 2001/82/ES
   (2)
  )

2013/C 311/02

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 5.9.2013 | Okrido | Glej Prilogo I | Glej Prilogo I | 6.9.2013 |
| 24.9.2013 | Deltanil | Glej Prilogo II | Glej Prilogo II | 26.9.2013 |
| 13.9.2013 | Iron | Glej Prilogo III | Glej Prilogo III | 16.9.2013 |
| 18.9.2013 | Aprotinin | Glej Prilogo IV | Glej Prilogo IV | 19.9.2013 |
| 25.9.2013 | Cydectin | Glej Prilogo V | Glej Prilogo V | 26.9.2013 |
| 12.9.2013 | Targocid | Glej Prilogo VI | Glej Prilogo VI | 13.9.2013 |
| 05/09/2013 | Flupirtine | Glej Prilogo VII | Glej Prilogo VII | 06/09/2013 |
| 6.9.2013 | Doramectin | Glej Prilogo VIII | Glej Prilogo VIII | 9.9.2013 |
| 25.9.2013 | Diclofenac | Glej Prilogo IX | Glej Prilogo IX | 26.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | Glej Prilogo X | Glej Prilogo X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | Glej Prilogo XI | Glej Prilogo XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | Glej Prilogo XII | Glej Prilogo XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | Glej Prilogo XIII | Glej Prilogo XIII | 30.9.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

5.9.2013

Okrido

Glej Prilogo I

Glej Prilogo I

6.9.2013

24.9.2013

Deltanil

Glej Prilogo II

Glej Prilogo II

26.9.2013

13.9.2013

Iron

Glej Prilogo III

Glej Prilogo III

16.9.2013

18.9.2013

Aprotinin

Glej Prilogo IV

Glej Prilogo IV

19.9.2013

25.9.2013

Cydectin

Glej Prilogo V

Glej Prilogo V

26.9.2013

12.9.2013

Targocid

Glej Prilogo VI

Glej Prilogo VI

13.9.2013

05/09/2013

Flupirtine

Glej Prilogo VII

Glej Prilogo VII

06/09/2013

6.9.2013

Doramectin

Glej Prilogo VIII

Glej Prilogo VIII

9.9.2013

25.9.2013

Diclofenac

Glej Prilogo IX

Glej Prilogo IX

26.9.2013

27.9.2013

Ergot derivatives (dihydroergocristine)

Glej Prilogo X

Glej Prilogo X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

Glej Prilogo XI

Glej Prilogo XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

Glej Prilogo XII

Glej Prilogo XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

Glej Prilogo XIII

Glej Prilogo XIII

30.9.2013

—   Umik nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | Glej Prilogo X | Glej Prilogo X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | Glej Prilogo XI | Glej Prilogo XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | Glej Prilogo XII | Glej Prilogo XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | Glej Prilogo XIII | Glej Prilogo XIII | 30.9.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

27.9.2013

Ergot derivatives (dihydroergocristine)

Glej Prilogo X

Glej Prilogo X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

Glej Prilogo XI

Glej Prilogo XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

Glej Prilogo XII

Glej Prilogo XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

Glej Prilogo XIII

Glej Prilogo XIII

30.9.2013

—   Preklic umika nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 18.9.2013 | Aprotinin | Glej Prilogo IV | Glej Prilogo IV | 19.9.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

18.9.2013

Aprotinin

Glej Prilogo IV

Glej Prilogo IV

19.9.2013

---

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

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

---

DODATEK I

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | Izmišljeno ime Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebina (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Nemčija | | Pharmapol Arzneimittelvertrieb-GmbH, |
| Kaddenbusch 11, 25578 Daegeling, |
| Germany |

Država članica

EU/EGP

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebina (koncentracija)

Nemčija

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Peroralna raztopina

Peroralna uporaba

Nizozemska

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

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Peroralna raztopina

Peroralna uporaba

Združeno kraljestvo

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

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Peroralna raztopina

Peroralna uporaba

---

PRILOGA II

SEZNAM IMEN, FARMACEVTSKE OBLIKE, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKE VRSTE, NAČIN DAJANJA ZDRAVILA, VLAGATELJ V DRŽAVAH ČLANICAH

| Država članica EU/EGP | vlagatelj | Name | INN | Jakost | Farmacevtska oblika | živalske vrste | Način dajanja zdravila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Virbac |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCIJA |

Država članica EU/EGP

vlagatelj

Name

INN

Jakost

Farmacevtska oblika

živalske vrste

Način dajanja zdravila

Austria

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Belgium

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Belgium

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Raztopina za kožni nanos

Govedo

Topikalna uporaba

Bulgaria

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Cyprus

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Czech Republic

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Denmark

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Estonia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

Deltanil, 10 mg/ml, kriipsususpensioon veistele ja lammastele

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

France

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

France

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Germany

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Germany

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

Deltanil 100 mg Spot- on Lösung zum Auftropfen für Rinder

Deltamethrin

10 mg/ml

Raztopina za kožni nanos

Govedo

Topikalna uporaba

Greece

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Hungary

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Iceland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Ireland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Italy

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Latvia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Lithuania

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Luxembourg

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

The Netherlands

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

The Netherlands

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

Deltanil 100 mg Spot- on Oplossing voor runderen

Deltamethrin

10 mg/ml

Raztopina za kožni nanos

Govedo

Topikalna uporaba

Poland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Portugal

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Romania

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Slovakia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Slovenia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

Spain

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

United Kingdom

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

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

Deltamethrin

10 mg/ml

Raztopina za kožni poliv

Govedo in ovce

Topikalna uporaba

United Kingdom

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCIJA

Deltanil 100 mg Spot- on Solution for cattle

Deltamethrin

10 mg/ml

Raztopina za kožni nanos

Govedo

Topikalna uporaba

---

PRILOGA III

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, POTI UPORABE ZDRAVIL IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILI V DRŽAVAH ČLANICAH

| Država članica
  (v EGP) | Imetnik dovoljenja za promet | INN | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Pharmacosmos A/S |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Država članica

(v EGP)

Imetnik dovoljenja za promet

INN

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe

Avstrija

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Avstrija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

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

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Avstrija

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron(III)-hydroxide sucrose complex

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

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Avstrija

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

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron(III)-hydroxide sucrose complex

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Avstrija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside

Monofer 100 mg/ml Injektions- oder Infusionslösung

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Avstrija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron(III)-hydroxide sucrose complex

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Belgija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Belgija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) Isomaltoside

Monover

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Iron (sucrose)

Venofer

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Fer (Ferric Carboxymaltose)

Injectafer

50,00 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Bolgarija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron (kot Ferric carboxymaltose)

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Bolgarija

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

Pharmalog AG,

33 Cherni vrah blvd.,

1421 Sofia

Bulgaria

Saccharated iron oxide

Idafer

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Bolgarija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric oxide dextran complex

Cosmofer

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Bolgarija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric oxide dextran complex

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Ciper

| 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

Ferrum (kot carboxymaltosum ferricum)

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Ciper

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) oligosaccharide complex

MONOFER SOLUTION FOR INJECTION OR INFUSION 100MG/ML

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Ciper

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) dextran complex

COSMOFER SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Ciper

| 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

Saccharated iron oxide

VENOFER INJECTION 100MG IRON/5ML

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Ciper

| 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

Ferrum (kot ferri oxidum saccharatum)

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

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferrum (kot ferri oxidum saccharatum)

VENOFER

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferrum (kot ferri oxidum saccharatum)

FERROLOGIC 20 MG/ML

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Češka republika

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

PHARMABIDE LTD

20, Lakonias str, 15234 Halandri

Athens - Greece

Ferrum (kot ferri oxidum saccharatum)

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Češka republika

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Ferrum (kot ferri oxidum saccharatum)

FERION 20 MG/ML

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Ferrum (kot ferri natrii gluconas complex)

FERRLECIT

12,5 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferrum (kot carboxymaltosum ferricum)

FERINJECT

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Danska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferricarboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Danska

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Ferrioxidsaccharat

Ferion

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Ferrioxidsaccharat

Ferrologic

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Danska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Jerndextran "Pharmacosmos"

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Danska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

MonoFer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferrioxidsaccharat

Venofer

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Iron (III) hydroxide sucrose complex

Venofer

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Iron (III) hydroxide sucrose complex

Ferrologic 20mg/ml

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Estonija

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron (III) hydroxide sucrose complex

Ferion

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Estonija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Estonija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) isomaltoside 1 000 complex

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Estonija

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

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Iron (III)-hydroxide dextran complex

Ferrum Lek

50 mg/ml

Raztopina za injiciranje

Intramuskularna uporaba

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

Iron carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferri oxidum saccharatum

Ferrologic

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Iron(III)hydroxide sucrose complex

Venofer

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Finska

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

Alternova A/S

Lodshusvej 11

4230 Skaelskoer

Denmark

Iron(III)hydroxide sucrose complex

Venotrix

20 mg/ml

Koncentrat za raztopino za infundiranje/raztopina za injiciranje

Intravenska uporaba

Finska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran complex

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Finska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)isomaltoside 1 000 complex

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Francija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

FERINJECT 50 mg/ml, solution injectable/pour perfusion

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Francija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose

VENOFER 20mg/ml, solution injectable

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Francija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

FERRISAT 50 mg/ml, solution injectable ou pour perfusion

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Francija

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

Pharmaki Generics Ltd

5 Bourlet Close

W1W 7BL London

United Kingdom

Iron sucrose

FER ACTAVIS 100 mg/5 ml, solution injectable

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Francija

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

IBD3 Pharma Consulting

Immeuble l'Orient

10, place Charles Béraudier

69003 Lyon

France

Iron sucrose

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

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Francija

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

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

Iron sucrose

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

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Francija

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Iron sucrose

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

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Francija

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

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

FRANCE

Iron sucrose

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

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Nemčija

| 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

Ferric(III) hydroxide sucrose complex

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

1 709 mg/5 ml

Koncentrat za raztopino za infundiranje/raztopina za injiciranje

Intravenska uporaba

Nemčija

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Ferric(III) hydroxide sucrose complex

FerMed

1 563–1 887 mg/5 ml

Koncentrat za raztopino za infundiranje/raztopina za injiciranje

Intravenska uporaba

Nemčija

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Ferric(III) hydroxide sucrose complex

Nefro-Fer

1 563–1 887 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Nemčija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric(III) hydroxide oxide citrate isomaltoseoligosaccharide complex

Monofer 100 mg/ml Lösung zur Injektion/Infusion

377–465 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Nemčija

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

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

Fer(III) sodium gluconate sucrose complex (= Sodium ferric gluconate complex)

Ferrlecit 40 mg

1 288,9 mg/3,2 ml

Raztopina za injiciranje

Intravenska uporaba

Nemčija

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

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

Fer(III) sodium gluconate sucrose complex (= Sodium ferric gluconate complex)

Ferrlecit 62,5 mg

2 013,9 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Nemčija

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

Pharmacosmos A/S

Roervangsvei 30

Holbaek DK-4300

Denmark

Ferric(III) hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Nemčija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxa maltose complex

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung

180 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Nemčija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric(III) hydroxide sucrose complex

Venofer 20 mg FR / ml Injektionslösung

2 700 mg/5 ml

Koncentrat za raztopino za infundiranje/raztopina za injiciranje

Intravenska uporaba

Grčija

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

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron hydroxide sucrose

REOXYL

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Vianex S.A.

Tatoiou Street

Nea Erythrea 14671

Greece

Iron hydroxide sucrose

INTRAFER

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Iron hydroxide sucrose

FAREMIO

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Iron hydroxide sucrose

DEXTRIFER-S

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron hydroxide sucrose

VENOFER

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Demo ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Iron III - hydroxide dextr

COSMOFER

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Grčija

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

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Iron hydroxide sucrose

FERROVIN

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Nephrotech S.A.

Parnithos 44

Metamorfosi Attikis 14452

Greece

Iron hydroxide sucrose

SUCRO-FER

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Uni-Pharma Kleon Tseitis

Pharmaceutical Laboratories

14KM National Highway

Athens-Lamia

Kifissia 14564

Greece

Iron hydroxide sucrose

HEMAFER-S

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Verisfield (UK) Ltd, U.K.

41 Chalton street

London, NW1 1JD

United Kingdom

Iron hydroxide sucrose

NEPHROFEROL

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron hydroxide sucrose

FERRINEMIA

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Specifar AEBE

28th October Street 1

Agia Barbara 12351

Greece

Iron hydroxide sucrose

ALVOFER

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Alet Pharmaceuticals

M. Alexander 121,

Agia Varvara, 12351

Greece

Iron hydroxide sucrose

SUCROVEN

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Iron hydroxide sucrose

IRONCROSE

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron III - hydroxide dextran

IRONATE

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Grčija

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

Demo ABEE

21st km National Highway

Athens-Lamia, 14565

Greece

Iron III oligosaccharide complex

MONOFER

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Grčija

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

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Iron hydroxide sucrose

VENIRON

100 mg/5 ml

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Grčija

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

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron III - hydroxide dextran

IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Madžarska

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Madžarska

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric hydroxide

Venofer

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Madžarska

| 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

Ferric hydroxide sucrose complex

Ferrologic

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Madžarska

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

Sanofi-Aventis Zrt

Tó utca 1-5,

1045 Budapest

Hungary

Sodium ferric gluconate complex

Ferrlecit

12,5 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Islandija

| 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

Ferricum carboxymaltosum INN

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Islandija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) isomaltoside

Monofer

100 mg/ml

Raztopina za infundiranje

Intravenska uporaba

Islandija

| 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

Ferri oxidum saccharated

Venofer

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Irska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) – hydroxide dextran complex

CosmoFer 50mg/ml solution for infusion and injection

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Irska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) isomaltoside 1 000 complex

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

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Irska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) isomaltoside 1 000 complex

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

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Iron (III)

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Iron (kot Iron Carboxymaltose)

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Iron (III) kot iron sucrose (iron (III)- hydroxide complex)

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

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Iron Sucrose [iron(III)-hydroxide sucrose complex] enakovredno Fe(III)

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

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferric carboxymaltose

FERINJECT

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Iron sucrose

FERRO SACCARATO FME

20 mg/ml

Koncentrat za raztopino za infundiranje/raztopina za injiciranje

Intravenska uporaba

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

Iron sucrose

VENOFER

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Italija

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

Sanofi-Aventis SPA

Viale Luigi Bodio, 37/B

20158 Milano

Italy

Sodium ferric gluconate (= Sodium ferric gluconate complex)

FERLIXIT

62,5 mg/5 ml

Oralna raztopina ali raztopina za infundiranje

Oralna uporaba

Intravenska uporaba

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

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferrum

Venofer

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferric (III) hydroxide sucrose complex

FerroLogic

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Latvija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric(III)-hydroxyde dextran complex

CosmoFer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Latvija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferrum

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferric (III) carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferric (III) hydroxide sucrose complex

Venofer

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferric (III) hydroxide sucrose complex

Ferrologic

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Litva

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric (III) isomaltoside

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Litva

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

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

Fer (carboxymaltose ferrique) 50 mg/ml

Injectafer-50mg/l

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Luksemburg

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Fer (III) Hydroxyde dextrane 50 mg/ml

Cosmofer-50mg/ml

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Fer (III) Hydroxyde saccharose 100 mg/5 ml

Fermed-100mg/5ml

100 mg/5 ml

Raztopina za perfundiranje

Intravenska uporaba

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

Fer (III) hydroxyde sucrose complexe

Ferrologic-20mg/ml

20 mg/ml

Raztopina za perfundiranje

Intravenska uporaba

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

Iron kot ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Malta

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

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose [iron(III)-hydroxide sucrose complex].

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Norveška

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Parenteralna uporaba

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

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Parenteralna uporaba

Norveška

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron(III)-hydroxide sucrose complex

Ferion

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Parenteralna uporaba

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

Iron(III)-hydroxide sucrose complex

Ferrologic

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Parenteralna uporaba

Norveška

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-isomaltoside 1 000

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Parenteralna uporaba

Norveška

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Uniferon

200 mg/ml

Raztopina za injiciranje

Parenteralna uporaba

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

Iron(III)-hydroxide sucrose complex

Venofer

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Parenteralna uporaba

Poljska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferri hydroxidum dextranum

CosmoFer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Carboxymaltosum ferricum

Ferinject

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferri hydroxidum saccharum

Venofer

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Poljska

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Ferri hydroxidum saccharum

Ferion

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Poljska

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

Fresenius Medical Care Nephrologica Deutschland GmbH

61346 Bad Homburg

Germany

Ferri hydroxidum saccharum

Ferrologic 20 mg/ml

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Poljska

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Ferri hydroxidum polyisomaltosum

Ferrum-Lek

50 mg/ml

Raztopina za injiciranje

Intramuskularna uporaba

Poljska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferrii (III) isomaltosidum 1 000

Monover

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Portugalska

| 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

Saccharated iron oxide

Referen

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Portugalska

| 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

Saccharated iron oxide

Venofer

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Portugalska

| 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

Saccharated iron oxide

Óxido Férrico Sacarosado Combino

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Portugalska

| 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

Saccharated iron oxide

Óxido Férrico Sacarosado Farmoz

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Portugalska

| 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

Saccharated iron oxide

Óxido Férrico Sacarosado Generis

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Portugalska

| 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

Saccharated iron oxide

Óxido Férrico Sacarosado Normon

100 mg/5 ml

Raztopina za injiciranje

Intravenska uporaba

Portugalska

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

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Portugalska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron-dextran complex

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Portugalska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron-dextran complex

Monofar

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Romunija

| 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

Complex de hidroxid de fer (III) sucroza

VENOFER®

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Romunija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Complex de fer (III) izomaltozat

MONOFER 100 mg/ml

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Romunija

| 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

Ferri carboxymaltosum

FERINJECT 50 mg fer/ml

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Slovaška 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

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Slovaška republika

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron (III)-hydroxide sucrose complex

Ferion 20 mg/ml

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Slovaška 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

Iron(III)-Hydroxide Sucrose Complex

Ferrologic 20 mg/ml

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Slovaška 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

Iron(III)-Hydroxide Sucrose Complex

Venofer

20 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Saccharated iron oxide

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Ferric oxide polymaltose complexes

Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Slovenija

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

Lek farmacevtska družba d.d.,

Verovškova 57,

1000 Ljubljana

Slovenia

Saccharated iron oxide

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Španija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50 mg/ml

Raztopina za injiciranje

Raztopina za infundiranje

Intravenska uporaba

intramuskularna uporaba

Španija

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

GUERBET B.P.

57400 ROISSY CdG

CEDEX F-95943

France

Iron oxide nanoparticles

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

11,2 mg/ml

Koncentrat za suspenzijo za infundiranje

Intravenska uporaba

Španija

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

G.E.S. Genericos Espanoles Laboratorio

S.A.Cólquide, 6 - Portal 2, 1

Oficina F.Las Rozas

28230 MADRID

Spain

Iron sucrose

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Španija

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

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Španija

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

Laboratorios Normon S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos

Madrid

Spain

Iron sucrose

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Španija

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

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose

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

100 mg/5 ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Španija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Španija

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION

50 mg/ml

Raztopina za injiciranje

Raztopina za infundiranje

Intravenska uporaba

Španija

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-Isomaltoside

MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN

100 mg/ml

Raztopina za injiciranje

Raztopina za infundiranje

Intravenska uporaba

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

Iron sucrose

Venofer®

20 mg/ml

Koncentrat za raztopino za injiciranje

Intravenska uporaba

Švedska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Cosmofer®

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

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

Iron sucrose

Ferrologic

20 mg/ml

Koncentrat za raztopino za injiciranje

Intravenska uporaba

Švedska

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose

Ferion

20 mg/ml

Koncentrat za raztopino za injiciranje

Intravenska uporaba

Švedska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)isomaltoside 1 000

MonoFer®

100 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Nizozemska

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

Pharmamatch B.V.

Egelenburg 2

Amsterdam GK - 1081

The Netherlands

Ferrihydroxide sucrose complex

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Ferrihydroxide sucrose complex

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Nizozemska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-isomaltoside 1 000

MonoFer 100 mg/ml oplossing voor injectie/infusie

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

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

Ferrihydroxide sucrose complex

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

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

Iron(III)hydroxidecarboxymaltose complex

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

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Nizozemska

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran complex

CosmoFer 50 mg/ml oplossing voor infusie en injectie

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Nizozemska

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

Pharmachemie B.V.

Haarlem - 2031 GA

The Netherlands

Ferrihydroxide sucrose complex

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

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Združeno kraljestvo

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose

Venofer

20 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Združeno kraljestvo

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(lll) Isomaltoside 1 000

Monofer

100 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

Združeno kraljestvo

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(lll) Isomaltoside 1 000

Diafer

50 mg/ml

Raztopina za injiciranje

Intravenska uporaba

Združeno kraljestvo

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran complex

Cosmofer

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

intramuskularna uporaba

Združeno kraljestvo

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

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron dextran sucrose

Ferrologic

20 mg/ml

Raztopina za injiciranje

Koncentrat za raztopino za infundiranje

Intravenska uporaba

Združeno kraljestvo

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

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Raztopina za injiciranje/infundiranje

Intravenska uporaba

---

PRILOGA IV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

Zdravila, ki vsebujejo aprotinin, z dovoljenjem za promet v Evropski uniji

| Država članica
  EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| AT-Avstrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| A-1160 Wien |
| Avstrija |

Država članica

EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

AT-Avstrija

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Avstrija

Trasylol 10 000 KIE/ml - Infusionsflasche

10 000 KIU/ml

raztopina za infundiranje

intravenska uporaba

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

raztopina za infundiranje

intravenska uporaba

CZ-Češka

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

Chemical Works of Gedeon Richter Plc.

Gyömrői út 19-21.

HU-1103 Budapest

Madžarska

Gordox

10 ku/ml

raztopina za injiciranje

intravenska uporaba

CZ- Češka

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

Bayer Schering Pharma AG

Müllerstrasse 178

13353 Berlin

Nemčija

Trasylol 500 000 KIE

10 ku/ml

raztopina za infundiranje

intravenska uporaba

DE-Nemčija

Bayer Pharma Aktiengesellschaft

sedež podjetja:

| Müllerstr. 178 |
| --- |
| 13353 Berlin |
| poštni naslov: |
| 13342 Berlin |
| Nemčija |

Müllerstr. 178

13353 Berlin

poštni naslov:

13342 Berlin

Nemčija

Trasynin 0,5

70.0 mg /50 ml

raztopina za infundiranje

intravenska uporaba

DE-Nemčija

Bayer Pharma Aktiengesellschaft

sedež podjetja:

| Müllerstr. 178 |
| --- |
| 13353 Berlin |
| poštni naslov: |
| 13342 Berlin |
| Nemčija |

Müllerstr. 178

13353 Berlin

poštni naslov:

13342 Berlin

Nemčija

Trasynin 1,0

140.0 mg /100 ml

raztopina za infundiranje

intravenska uporaba

DE-Nemčija

Bayer Pharma Aktiengesellschaft

sedež podjetja:

| Müllerstr. 178 |
| --- |
| 13353 Berlin |
| poštni naslov: |
| 13342 Berlin |
| Nemčija |

Müllerstr. 178

13353 Berlin

poštni naslov:

13342 Berlin

Nemčija

Trasynin 1,0

140.0 mg /100 ml

raztopina za infundiranje

intravenska uporaba

DE-Nemčija

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer Vital GmbH

51368 Leverkusen

Nemčija

Trasylol 0,5

70.0 mg /50 ml

raztopina za infundiranje

intravenska uporaba

DE-Nemčija

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer Vital GmbH

51368 Leverkusen

Nemčija

Trasylol 1,0

140.0 mg /100 ml

raztopina za infundiranje

intravenska uporaba

DE-Nemčija

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer Vital GmbH

51368 Leverkusen

Nemčija

Trasylol 2,0

280.0 mg /200 ml

raztopina za infundiranje

intravenska uporaba

DK-Danska

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| 13353 Berlin |
| Nemčija |

Bayer Schering Pharma AG

Müllerstrasse 170-178

13353 Berlin

Nemčija

Trasylol

10 000 KIE/ml

raztopina za injiciranje

intravenska uporaba

EL-Grčija

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

Bayer Hellas AG

18 - 20, Sorou Str.

151 25, Marousi Athens Grčija

TRASYLOL

500 000 KIU / 50ML

raztopina za infundiranje

intravenska uporaba

ES-Španija

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

QUIMICA FARMACEUTICA BAYER, S.L.

Av. Baix Llobregat, 3-5

Sant Joan Despi 08970

BARCELONA Španija

TRASYLOL RAZTOPINA ZA INTRAVENSKO PERFUZIJO

10 000 K 10 000 KIU/ml IU/ml

raztopina za perfuzijo

intravenska uporaba

FI-Finska

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

51368 Leverkusen

Nemčija

TRASYLOL

10 000 KIU/ml

raztopina za injiciranje / infundiranje

intravenska uporaba

FR-Francija

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

BAYER SANTE 220,

avenue de la recherche 59120 LOOS

Francija

Trasylol

1 000 000 KUI / 100 mL

raztopina za injiciranje

intravenska uporaba

FR-Francija

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

BAYER SANTE 220,

avenue de la recherche 59120 LOOS

Francija

Trasylol

2 000 000 KUI / 200 mL

raztopina za injiciranje

intravenska uporaba

FR-Francija

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

BAYER SANTE 220,

avenue de la recherche 59120 LOOS

Francija

Trasylol

500 000 UIK / 50 mL

raztopina za injiciranje

intravenska uporaba

HU - Madžarska

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

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest

Madžarska

Gordox

100 000 KIU/10 ml

raztopina za injiciranje

intravenska uporaba

HU - Madžarska

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

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest

Madžarska

Gordox

500 000 KIU/50 ml

raztopina za infundiranje

intravenska uporaba

HU-Madžarska

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

Bayer Healthcare AG

Kaiser-Wilhelm-Allee, Bldg. E39

51368 Leverkusen

Nemčija

Trasylol

500 000 KIU / 50 ml

raztopina za infundiranje

intravenska uporaba

LU-Luksemburg

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

Bayer S.A.

14, J.E. Mommaertslaan

B-1831 Diegem

Belgija

TRASYLOL

50 000 KIU/50ml

raztopina za injiciranje

intravenska uporaba

LV - Latvija

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

Gedeon Richter Ltd.

Gyomroi ut 19-21

Budapest HU-1103

Madžarska

Gordox 10 000 KSV/ml šķīdums infūzijām

10 000 KIU/ml

raztopina za infundiranje

intravenska uporaba

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

posluje kot Bayer Plc, Pharmaceutical Division

TRASYLOL

10 000 KIU/ML

raztopina za infundiranje

intravenska uporaba

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

raztopina za infundiranje

intravenska uporaba

PL-Poljska

| Bayer Pharma AG |
| --- |
| 13342 Berlin |
| Nemčija |

Bayer Pharma AG

13342 Berlin

Nemčija

Trasylol

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

raztopina za infundiranje

intravenska uporaba

PL-Poljska

| Bayer Pharma AG |
| --- |
| 13342 Berlin |
| Nemčija |

Bayer Pharma AG

13342 Berlin

Nemčija

Trasylol

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

raztopina za infundiranje

intravenska uporaba

PL-Poljska

| Bayer Pharma AG |
| --- |
| 13342 Berlin |
| Nemčija |

Bayer Pharma AG

13342 Berlin

Nemčija

Trasylol

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

raztopina za infundiranje

intravenska uporaba

PT-Portugalska

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

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugalska

Trasylol

500 000 U.I.C / 50 ml

raztopina za infundiranje

intravenska uporaba

PT-Portugalska

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

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugalska

Trasylol 1 000 000 UIC

1 000 000 U.I.C / 100 ml

raztopina za infundiranje

intravenska uporaba

PT-Portugalska

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

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugalska

Trasylol 2 000 000 UIC

2 000 000 U.I.C / 200 ml

raztopina za infundiranje

intravenska uporaba

SE-Švedska

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

Bayer Schering Pharma AG

Müllerstrasse 178

13353 Berlin

Nemčija

Trasylol

10 000 KIE/ml

raztopina za injiciranje / infundiranje

intravenska uporaba

SI-Slovenija

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

Bayer d.o.o.

Bravničarjeva 13

Ljubljana

Slovenija

TRASYLOL

10 000 KIU/ml

raztopina za injiciranje in infundiranje

intravenska uporaba

SK-Slovaška

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

Richter Gedeon Nyrt

Budapest 10

Pf. 27., H-1475

Madžarska

GORDOX

100 000 IU/10 ml

raztopina za injiciranje

intravenska uporaba

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

raztopina za injiciranje

intravenska uporaba

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

raztopina za injiciranje

intravenska (injiciranje in infundiranje)

---

PRILOGA V

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE, PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH

| Država
  članica/EEA | Predlagatelj/ Imetnik dovoljenja za promet | Ime | INN | Jakost | Farmacevtska oblika | Pot uporabe | Živalska vrsta |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Pfizer Corp. Austria G.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Avstrija |

Država

članica/EEA

Predlagatelj/ Imetnik dovoljenja za promet

Ime

INN

Jakost

Farmacevtska oblika

Pot uporabe

Živalska vrsta

Avstrija

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

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Avstrija

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

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

Francija

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

Pfizer Holding France

23-25 avenue du Docteur Lannelongue

F – 75668 Paris Cedex 14

Francija

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

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

Nemčija

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

Pfizer GmbH

Linkstraße 10

10785 Berlin

Nemčija

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

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

Grčija

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

Pfizer Hellas AE

Mesogion Avenue 243

154 51 N. Psychiko

Athens

Grčija

Cydectin TriclaMox

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

Portugalska

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

Laboratórios Pfizer, Lda

Lagoas Park – Edíficio 10

2740-271 Porto Salvo

Portugalska

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

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

Španija

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

Zoetis Spain, S.L.

Avda. de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Španija

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

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

Združeno Kraljestvo

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich CT13 9NJ |
| Združeno Kraljestvo |

Pfizer Ltd

Ramsgate Road

Sandwich CT13 9NJ

Združeno Kraljestvo

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

Moxidectin

5,0 mg

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Triclabendazole

200,0 mg

---

PRILOGA VI

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebina (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | sanofi-aventis GmbH, |
| Leonard-Bernstein-Straße 10, |
| A-1220 Vienna, |
| Avstrija |

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebina (koncentracija)

Avstrija

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Avstrija

Targocid 100 mg Trockenstechampullen mit Lösungsmittel

100 mg

prašek in vehikel za raztopino za injiciranje / infundiranje in za peroralno raztopino

intramuskularna uporaba, intravenska uporaba, peroralna uporaba

100 mg/1,5 ml

Avstrija

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

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Avstrija

Targocid 200 mg Trockenstechampullen mit Lösungsmittel

200 mg

prašek in vehikel za raztopino za injiciranje / infundiranje in za peroralno raztopino

intramuskularna uporaba, intravenska uporaba, peroralna uporaba

200 mg/3 ml

Avstrija

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

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Avstrija

Targocid 400 mg Trockenstechampullen mit Lösungsmittel

400 mg

prašek in vehikel za raztopino za injiciranje / infundiranje in za peroralno raztopino

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Bolgarija

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

sanofi-aventis Bulgaria EOOD

1303 Sofia,

103 Alexander Stamboliiski Blvd. fl.8.,

Bolgarija

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

400 mg

prašek in vehikel za raztopino za injiciranje / infundiranje

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

400 mg/3 ml

Češka

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

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Češka

Targocid 200 mg

200 mg

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Češka

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

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Češka

Targocid 400 mg

400 mg

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek za raztopino za injiciranje / infundiranje

intramuskularna uporaba/ intravenska uporaba

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

prašek za raztopino za injiciranje / infundiranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Francija

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

Francija

TARGOCID 100 mg, lyophilisat et solution pour usage parentéral

100 mg

prašek in vehikel za injiciranje

intramuskularna uporaba/ intravenska uporaba

100 mg/1.5 ml

Francija

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

Francija

TARGOCID 200 mg, lyophilisat et solution pour usage parentéral

200 mg

prašek in vehikel za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Francija

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

Francija

TARGOCID 400 mg, lyophilisat et solution pour usage parentéral

400 mg

prašek in vehikel za injiciranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Nemčija

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Nemčija

Targocid® 100 mg

100 mg

prašek in vehikel za raztopino za infundiranje / injiciranje ali za peroralno raztopino

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

100 mg/1.5 ml

Nemčija

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Nemčija

Targocid® 200 mg

200 mg

prašek in vehikel za raztopino za infundiranje / injiciranje ali za peroralno raztopino

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

200 mg/3 ml

Nemčija

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Nemčija

Targocid® 400 mg

400 mg

prašek in vehikel za raztopino za infundiranje / injiciranje ali peroralna raztopina

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

400 mg/3 ml

Nemčija

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Nemčija

Teicoplanin Sanofi-Aventis 100 mg

100 mg

prašek in vehikel za raztopino za infundiranje / injiciranje ali peroralna raztopina

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

100 mg/1.5 ml

Nemčija

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Nemčija

Teicoplanin Sanofi-Aventis 200 mg

200 mg

prašek in vehikel za raztopino za infundiranje / injiciranje ali peroralna raztopina

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

200 mg/3 ml

Nemčija

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Nemčija

Teicoplanin Sanofi-Aventis 400 mg

400 mg

prašek in vehikel za raztopino za infundiranje / injiciranje ali peroralna raztopina

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

400 mg/3 ml

Grčija

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

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Grčija

TARGOCID®

200 mg

Prašek in vehikel za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Grčija

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

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Grčija

TARGOCID®

400mg

Prašek in vehikel za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Madžarska

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

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

Madžarska

Targocid 200 mg por és oldószer oldatos injekcióhoz

200 mg

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Madžarska

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

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

Madžarska

Targocid 400 mg por és oldószer oldatos injekcióhoz

400 mg

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Luksemburg

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgija

TARGOCID

200 mg

prašek za injekcijske pripravke

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Luksemburg

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgija

TARGOCID

400 mg

prašek za injekcijske pripravke

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Nizozemska

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

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The Nizozemska

TARGOCID® 200

200 mg

prašek za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Nizozemska

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

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The Nizozemska

TARGOCID® 400

400 mg

prašek za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

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

prašek za raztopino za injiciranje / infundiranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Poljska

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| Velika Britanija |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

Velika Britanija

TARGOCID

200 mg

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Poljska

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| Velika Britanija |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

Velika Britanija

TARGOCID

400 mg

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Portugalska

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

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Portugalska

Targosid

200 mg/3 ml

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Portugalska

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

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Portugalska

Targosid

400 mg/3 ml

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Romunija

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

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

Velika Britanija

TARGOCID® 200 mg

200 mg

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Romunija

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

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

Velika Britanija

TARGOCID® 400 mg

400 mg

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Slovaška

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

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovaška

Targocid 200

200 mg

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

200 mg/3 ml

Slovaška

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

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovaška

Targocid 400

400 mg

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba, peroralna uporaba

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

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

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

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Španija

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

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Španija

TARGOCID

200 mg

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Španija

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

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Španija

TARGOCID

400 mg

prašek in vehikel za raztopino za injiciranje ali infundiranje

intramuskularna uporaba/ intravenska uporaba

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

Prašek injiciranje / infundiranje, raztopina

intramuskularna uporaba/ intravenska uporaba

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

Prašek injiciranje /infundiranje, raztopina

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

Velika Britanija

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

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

One Onslow Street

Guildford

Surrey

GU1 4YS

Velika Britanija

trženje

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| Velika Britanija |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

Velika Britanija

TARGOCID®

200 mg

prašek za injiciranje

intramuskularna uporaba/ intravenska uporaba

200 mg/3 ml

Velika Britanija

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

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

One Onslow Street

Guildford

Surrey

GU1 4YS

Velika Britanija

trženje

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| Velika Britanija |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

Velika Britanija

TARGOCID®

400 mg

prašek za injiciranje

intramuskularna uporaba/ intravenska uporaba

400 mg/3 ml

---

DODATEK VII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Bolgarija | Zentiva k.s. |
| 130 U kabelovn |
| Prague 10237 |
| Czech Republic |

Država članica

EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Bolgarija

Zentiva k.s.

130 U kabelovn

Prague 10237

Czech Republic

Flupizen

100 mg

kapsula, trda

peroralna uporaba

Estonija

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

KATADOLON

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat AbZ 100 mg Kapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Flupirtinmaleat AL 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Awegal inject

164,5 mg / 3 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon inject

164,5 mg / 3 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon Kinderzäpfchen

75 mg

svečka

rektalna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon Zäpfchen

150 mg

svečka

rektalna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancopal Dolo

100 mg

kapsula

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancopal Dolo Suppositorien

150 mg

svečka

rektalna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon S long

400 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancolong

400 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon retard

400 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Flupirtinmaleat Winthrop 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat-CT 100 mg Hartkapsel

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupin 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Dolokadin einmal täglich

400 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Germany

Flupigamma 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Germany

Flupirtinmaleat-Hormosan 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Flupigil 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Flupigil 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Midas Pharma GmbH

Rheinstr. 49

55218 Ingelheim

Germany

Flupirtinmaleat Midas 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat-ratiopharm 100 mg Hartkapsel

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Miflumal 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupirtinmaleat Vitapharma 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupivil 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupirtinmaleat Viatris 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupimal 100 mg Hertkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupsadim 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Miphaflumix 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Fluporol 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

kapsula, trda

peroralna uporaba

Madžarska

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

ZENTIVA k.s.

Ul. kabelovny 130, Dolní Mecholupy

10237 Prague 10

Czeh Republic

Flupizen 100 mg kemény kapszula

100 mg

kapsula, trda

peroralna uporaba

Italija

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

MEDA PHARMA S.p.A.,

Viale Brenta 18, 20139 Milano

Italy

EFIRET

100 mg

kapsula, trda

peroralna uporaba

Latvija

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

Teva Pharma B.V.,

Computerweg 10,

3542 DR Utrecht

The Netherlands

Katadolon 100 mg hard capsules

100 mg

kapsula, trda

peroralna uporaba

Litva

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Katadolon

100 mg

kapsula, trda

peroralna uporaba

Poljska

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

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poland

Katadolon

100 mg

kapsula, trda

peroralna uporaba

Portugalska

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

Midas Pharma GmbH

Rheinstrasse, 49

55218 Ingelheim

Germany

Flupirtina Midas

100 mg

kapsula, trda

peroralna uporaba

Portugalska

| 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, trda

peroralna uporaba

Portugalska

| 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, trda

peroralna uporaba

Romunija

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

Zentiva k.s.

U Kabelovny 130, Dolní Měcholupy

102 37, Praga 10,

Czech Republic

FLUPIZEN 100 mg

100 mg

kapsula

peroralna uporaba

Slovaška

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

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

Flupizen 100 mg tvrdé kapsuly

100 mg

kapsula, trda

peroralna uporaba

Slovaška

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

TEVA Pharmaceuticals Slovakia, s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Katadolon

100 mg

kapsula, trda

peroralna uporaba

---

DODATEK VIII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE, PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH.

| Država članica/EEA | Predlagatelj/ Imetnik dovoljenja za promet | Ime | INN | Jakost | Farmacevtska oblika | Pot uporabe | Živalska vrsta |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Pfizer Corporation Austria Gesellschaft m.b.H. |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| AVSTRIJA |

Država članica/EEA

Predlagatelj/ Imetnik dovoljenja za promet

Ime

INN

Jakost

Farmacevtska oblika

Pot uporabe

Živalska vrsta

Avstrija

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AVSTRIJA

Dectomax 1 % - Injektionslösung für Rinder und Schafe

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce

Avstrija

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

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax S 10 mg/ml Injektionslösung für Schweine

Doramectin

10 mg/ml

Raztopina za injiciranje

intramuskularno

Prašiči

Avstrija

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

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AVSTRIJA

Dectomax Pour-On 5 mg/ml Lösung für Rinder

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, 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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

intramuskularno

Prašiči

Bulgaria

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

Pfizer S.A.,

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

37401 Amboise Cedex,

FRANCIJA

Дектомакс 1 % инжективен разтвор

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Bolgarija

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

BIOVET AD

39 Petar Rakov str.

Peshtera 4550

BOLGARIJA

Ендектовет 1 % инжекционен разтвор за говеда, овце и свине

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Ciper

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

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GRČIJA

DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Češka Republika

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, prašiči

Danska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Danska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Estonija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, jelen, prašiči

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Francija

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

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCIJA

ZEARL

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce

Francija

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

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCIJA

ZEARL POUR ON

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Francija

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

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCIJA

ZEARL PORCS

Doramectin

10 mg/ml

Raztopina za injiciranje

intramuskularno

Prašiči

Francija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Francija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Nemčija

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NEMČIJA

Dectomax

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce

Nemčija

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NEMČIJA

Dectomax Pour-On

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Nemčija

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NEMČIJA

Dectomax-S Injektionslösung

Doramectin

10 mg/ml

Raztopina za injiciranje

intramuskularno

Prašiči

Grčija

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

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GRČIJA

DECTOMAX ing sol

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Madžarska

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

Pfizer Kft.

Alkotás u. 53.

1123 Budapest

MADŽARSKA

Dectomax injekció A.U.V.

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Islandija

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Dectomax, vet.

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Islandija

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Islandija

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Irska

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

ZDRUŽENO KRALJESTVO

Zearl Pour-On Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Irska

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce

Irska

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

ZDRUŽENO KRALJESTVO

Zearl 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Raztopina za injiciranje

intramuskularno

Prašiči

Irska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

Dectomax 5 mg/ml Pour-On Solution for Cattle

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Irska

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Latvija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

Dectomax

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Litva

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

Pfizer S.A.,

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

37401 Amboise Cedex,

FRANCIJA

DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Litva

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Norveška

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Norveška

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Portugalska

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

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

PORTUGALSKA

Dectomax Pour-on

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Portugalska

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

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

PORTUGALSKA

Dectomax solução injectável

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Romunija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

DECTOMAX

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Romunija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Romunija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| ZDRUŽENO KRALJESTVO |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

ZDRUŽENO KRALJESTVO

PRONTAX 5 mg/ml Pour On Solution for Cattle

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Slovaška Republika

| Pfizer Luxemburg SARL, o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 811 09 Bratislava |
| SLOVAŠKA REPUBLIKA |

Pfizer Luxemburg SARL, o.z.

Pfizer AH

Pribinova 25

811 09 Bratislava

SLOVAŠKA REPUBLIKA

Dectomax 10 mg/ml injekčný roztok

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

DECTOMAX 10 mg/ml raztopina za injiciranje

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

Španija

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

ŠPANIJA

DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO

Doramectin

10 mg/ml

Raztopina za injiciranje

intramuskularno

Prašiči

Španija

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

ŠPANIJA

DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Španija

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

ŠPANIJA

DECTOMAX SOLUCION INYECTABLE

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, 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

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, jelen

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

Raztopina za injiciranje

intramuskularno

Prašiči

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce, prašiči

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

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Švedska

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINSKA

Prontax

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

Združeno Kraljestvo

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

ZDRUŽENO KRALJESTVO

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

Doramectin

10 mg/ml

Raztopina za injiciranje

subkutano, intramuskularno

Govedo, ovce

Združeno Kraljestvo

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

ZDRUŽENO KRALJESTVO

Dectomax 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Raztopina za injiciranje

intramuskularno

Prašiči

Združeno Kraljestvo

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

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

ZDRUŽENO KRALJESTVO

Dectomax Pour-on Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Kožni poliv, raztopina

topikalno - na hrbet živali

Govedo

---

PRILOGA IX

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  (v EGP) | Imetnik dovoljenja za promet z zdravilom | Mednarodno nelastniško ime | Izmišljeno ime | Jakosti | Farmacevtske oblike | Poti uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Pfizer Corporation Austria Ges.m.b.H |
| Floridsdorfer Hauptstraße 1, |
| 1210 Vienna |
| Austria |

Država članica

(v EGP)

Imetnik dovoljenja za promet z zdravilom

Mednarodno nelastniško ime

Izmišljeno ime

Jakosti

Farmacevtske oblike

Poti uporabe zdravila

Avstrija

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

natrijev diklofenakat

misoprostol

Arthrotec forte - Manteltabletten

75 mg

0,2 mg

obložena tableta

peroralna uporaba

Avstrija

| 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

natrijev diklofenakat

misoprostol

Arthrotec - Manteltabletten

50 mg

0,2 mg

obložena tableta

peroralna uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Dedolor akut 75 mg – Kapseln

75 mg

gastrorezistentna kapsula, trda

peroralna uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Dedolor DRS 100 mg – Kapseln

100 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Deflamat DRS 75 mg – Kapseln

75 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Deflamat 75 mg - Ampullen

75 mg/3 ml

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Deflamat 50 mg – Kapseln

50 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Deflamat 100 mg – Suppositorien

100 mg

svečka

rektalna uporaba

Avstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

natrijev diklofenakat

Deflamat retard 100 mg – Kapseln

100 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

DiclacHexal 50 mg - Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

DiclacHexal rapid 50 mg - lösbare Tabletten

50 mg

tableta za peroralno raztopino

peroralna uporaba

Avstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

DiclacHexal retard 150 mg - Tabletten

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

DiclacHexal retard 75 mg - Tabletten

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene 75 mg – Ampullen

75 mg/2 ml

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene 25 mg – Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene 50 mg – Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene 100 mg – Zäpfchen

100 mg

svečka

rektalna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene 50 mg – Zäpfchen

50 mg

svečka

rektalna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene retard 100 mg - Kapseln

100 mg

kapsula, trda

peroralna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

natrijev diklofenakat

Diclobene uno 150 mg - Retardtabletten

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten

50 mg

tableta za peroralno raztopino

peroralna uporaba

Avstrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

natrijev diklofenakat

Diclofenac Genericon 75 mg - Ampullen

75 mg/3 ml

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Avstrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

natrijev diklofenakat

Diclofenac "Genericon" 50 mg - Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

natrijev diklofenakat

Diclofenac Genericon retard 100 mg Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

natrijev diklofenakat

DICLOFENAC "S.Med" 25 mg-Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

natrijev diklofenakat

DICLOFENAC "S.Med" 50 mg - Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

natrijev diklofenakat

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

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Avstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

natrijev diklofenakat

DICLOFENAC "S.Med" retard 100 mg - Tabletten

100 mg

tableta

peroralna uporaba

Avstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

natrijev diklofenakat

DICLOFENAC "S.Med" retard 75 mg - Tabletten

75 mg

tableta

peroralna uporaba

Avstrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

Diclofenac G.L. 50 mg - Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Diclofenac 1A Pharma retard 150 mg - Tabletten

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Diclofenac 1A Pharma retard 75 mg - Tabletten

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

Diclofenac G.L. retard 100 mg - Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclofenac Sandoz 75 mg – Ampullen

75 mg/3 ml

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Avstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclofenac Sandoz 50 mg – Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclofenac Sandoz 150 mg - Retardtabletten

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclofenac Sandoz 75 mg - Retardtabletten

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Avstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclofenac "Sandoz" retard 100 mg – Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

natrijev diklofenakat

Diclo-B „Lannacher“-Kapseln

50 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

natrijev diklofenakat

Diclo-B G.L.

50 mg

kapsula, trda

peroralna uporaba

Avstrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

natrijev diklofenakat

Diclostad Ampullen

75 mg/3 ml

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Avstrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

natrijev diklofenakat

Diclostad 50 mg Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

natrijev diklofenakat

Diclostad retard 100 mg Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

Diclovit-Kapseln

50 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

Dolpasse 75 mg – Infusionslösung

75 mg/250 ml

raztopina za infundiranje

intravenska uporaba

Avstrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

Dolpasse retard 100 mg - Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

orfenadrinijev citrat

Neodolpasse – Infusionslösung

75 mg/250 ml

30 mg/250 ml

raztopina za infundiranje

intravenska uporaba

Avstrija

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

MERCK GesmbH

Zimbagasse 5

1147 Vienna

Austria

natrijev diklofenakat

Neurofenac - Kapseln

50 mg

kapsula, trda

peroralna uporaba

Avstrija

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

natrijev diklofenakat

Tratul retard 100 mg - Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren 25 mg - Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren 50 mg - Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren 75 mg/3 ml - Injektionslösung

75 mg/3 ml

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren 25 mg - Zäpfchen

25 mg

svečka

rektalna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren 100 mg - Zäpfchen für Erwachsene

100 mg

svečka

rektalna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren 50 mg - Zäpfchen für Erwachsene

50 mg

svečka

rektalna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

natrijev diklofenakat

Voltaren retard 100 mg - Filmtabletten

100 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

kislina diklofenaka

Tratul 50 mg - Kapseln

50 mg

gastrorezistentna kapsula, mehka

peroralna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

kislina diklofenaka

Voltaren dispers - lösliche Tabletten

46,5 mg

tableta za peroralno raztopino

peroralna uporaba

Avstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

kalijev diklofenakat

Diclobene rapid 50 mg Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

kalijev diklofenakat

Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen

50 mg

prašek za peroralno raztopino

peroralna uporaba

Avstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

kalijev diklofenakat

Voltaren rapid 50 mg - Dragees

50 mg

obložena tableta

peroralna uporaba

Belgija

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

natrijev diklofenakat

misoprostol

ARTHROTEC 50

50 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Belgija

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

natrijev diklofenakat

misoprostol

ARTHROTEC 75

75 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

kalijev diklofenakat

CATAFLAM 50 MG

50 mg

obložena tableta

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

kalijev diklofenakat

CATAFLAM 50 MG

50 mg

prašek za peroralno raztopino

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

diclofenac

CATAFLAM DISPERSIBLE

46,5 mg

disperzibilna tableta

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC APOTEX 100 MG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC APOTEX 75 MG

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC EG 100 MG

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOFENAC EG 25 MG

25 mg

obložena tableta

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC EG 50 MG

50 mg

obložena tableta

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC EG 75 MG

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOFENAC EG RETARD 100 MG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC EG RETARD 75 MG

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Belgija

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

natrijev diklofenakat

DICLOFENAC RETARD MYLAN 100 MG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Belgija

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

natrijev diklofenakat

DICLOFENAC RETARD MYLAN 75 MG

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

natrijev diklofenakat

DICLOFENAC SANDOZ 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

natrijev diklofenakat

DICLOFENAC SANDOZ 75 MG

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

natrijev diklofenakat

DICLOFENAC SANDOZ RETARD 100 MG

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Belgija

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

natrijev diklofenakat

DICLOFENAC SANDOZ RETARD 75 MG

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

natrijev diklofenakat

DICLOFENAC TEVA 100

100 mg

svečka

rektalna uporaba

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

natrijev diklofenakat

DICLOFENAC TEVA 100 MG RETARD

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

natrijev diklofenakat

DICLOFENAC TEVA 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

natrijev diklofenakat

DICLOFENAC TEVA 75 MG / 3 ML

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

natrijev diklofenakat

DICLOFENAC TEVA 75 MG RETARD

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

kalijev diklofenakat

DICLOFENAC-K-TEVA 50 MG COMPR

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC-RATIOPHARM 50 MG GASTRO-

50 mg

gastrorezistentna tableta

peroralna uporaba

Belgija

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

LABORATORIA QUALIPHAR N.V/S.A

Rijksweg 9

2880 Bornem

Belgium

natrijev diklofenakat

DICLOFENACUM NATRI QUALIPHAR 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Belgija

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

natrijev diklofenakat

FLAMPHAR 50 MG

50 mg

tablet

peroralna uporaba

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

natrijev diklofenakat

MOTIFENE 75 MG

75 mg

kapsula s prirejenim sproščanjem

peroralna uporaba

Belgija

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

natrijev diklofenakat

POLYFLAM 75 MG

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Belgija

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

natrijev diklofenakat

POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG

50 mg

obložena tableta

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

natrijev diklofenakat

VOLTAREN 100

100 mg

svečka

rektalna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

natrijev diklofenakat

VOLTAREN 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

natrijev diklofenakat

VOLTAREN 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

natrijev diklofenakat

VOLTAREN 75 MG/3 ML

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

natrijev diklofenakat

VOLTAREN RETARD 100

100 mg

tableta

peroralna uporaba

Belgija

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

natrijev diklofenakat

VOLTAREN RETARD 75 MG

75 mg

tableta

peroralna uporaba

Belgija

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

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

kalijev diklofenakat

VOLTATABS 12,5 MG(EX:ZYMAMED)

12,5 mg

obložena tableta

peroralna uporaba

Bolgarija

| 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

natrijev diklofenakat

Almiral

50 mg

gastrorezistentna tableta

peroralna uporaba

Bolgarija

| 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

natrijev diklofenakat

Almiral

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Bolgarija

| 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

natrijev diklofenakat

Diclofenac Duo

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Bolgarija

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

Tchaikapharma Highquality Medicines

1 G. M. Dimitrov Blvd.

Sofia 1172

Bulgaria

natrijev diklofenakat

Diclofenac-Tchaikapharma

50 mg

gastrorezistentna tableta

peroralna uporaba

Bolgarija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Bolgarija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Bolgarija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac

150 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Bolgarija

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

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

natrijev diklofenakat

Feloran

100 mg

svečka

rektalna uporaba

Bolgarija

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

Actavis EAD

29 Atanas Dukov Str.

Sofia 1407

Bulgaria

natrijev diklofenakat

Feloran Actavis

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Bolgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

natrijev diklofenakat

Naklofen SR

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Bolgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

natrijev diklofenakat

Naklofen DUO

75 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Bolgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

natrijev diklofenakat

Naklofen

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Bolgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

natrijev diklofenakat

Naklofen

50 mg

gastrorezistentna tableta

peroralna uporaba

Bolgarija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

orfenadrinijev citrat

Neodolpasse

75 mg/250 ml

30 mg/250 ml

raztopina za infundiranje

intravenska uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

25 mg

gastrorezistentna tableta

peroralna uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

100 mg

svečka

rektalna uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

50 mg

svečka

rektalna uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

kalijev diklofenakat

Voltfast

50 mg

prašek za peroralno raztopino

peroralna uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

50 mg

gastrorezistentna tableta

peroralna uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren Retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Bolgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Bolgarija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

kalijev diklofenakat

Voltaren Dolo

12,5 mg

kapsula, mehka

peroralna uporaba

Bolgarija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

kalijev diklofenakat

Voltaren Dolo

12,5 mg

filmsko obložena tableta

peroralna uporaba

Bolgarija

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

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

natrijev diklofenakat

Feloran

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Ciper

| 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

natrijev diklofenakat

ALMIRAL INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

intramuskularna uporaba

Ciper

| 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

natrijev diklofenakat

ALMIRAL SUPPOSITORY 100 MG

100 mg

svečka

rektalna uporaba

Ciper

| 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

natrijev diklofenakat

ALMIRAL SUPPOSITORY 50 MG

50 mg

svečka

rektalna uporaba

Ciper

| 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

natrijev diklofenakat

ALMIRAL GASTRO-RESISTANT TABLET 25 MG

25 mg

tablet

peroralna uporaba

Ciper

| 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

natrijev diklofenakat

ALMIRAL GASTRO-RESISTANT TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

| 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

natrijev diklofenakat

ARESTON TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

kalijev diklofenakat

CATAFLAM ORAL DROPS 1.5 %

15 mg/ml

peroralne kapljice, raztopina

peroralna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

kalijev diklofenakat

CATAFLAM COATED TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

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

P.T.Hadjigeorgiou CO ltd,

P.O.Box 53158

3301 Lemesos

Cyprus

natrijev diklofenakat

DICLAC INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

intramuskularna uporaba

Ciper

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75 MG

75 mg

tableta

peroralna uporaba

Ciper

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

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

natrijev diklofenakat

DIFENE DUAL CAPSULE 100 MG

100 mg

kapsula

peroralna uporaba

Ciper

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

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

natrijev diklofenakat

DIFENE DUAL CAPSULE 75 MG

75 mg

kapsula

peroralna uporaba

Ciper

| 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

natrijev diklofenakat

NERITAN GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

| 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

natrijev diklofenakat

NERITAN GASTRO RESISTANT TABLET 25 MG

25 mg

tableta

peroralna uporaba

Ciper

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

natrijev diklofenakat

REMETHAN SUPPOSITORY 100 MG

100 mg

svečka

rektalna uporaba

Ciper

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

natrijev diklofenakat

REMETHAN SUSTAINED RELEASE TABLET 100 MG

100 mg

tableta

peroralna uporaba

Ciper

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

natrijev diklofenakat

REMETHAN GASTRO RESISTANT TABLET 25 MG

25 mg

tableta

peroralna uporaba

Ciper

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

natrijev diklofenakat

REMETHAN GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

| 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

natrijev diklofenakat

TAKS INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

intramuskularna uporaba

Ciper

| 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

natrijev diklofenakat

TAKS GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN INJECTION 75 MG/3 ML

75 mg/3 ml

injekcija

intramuskularna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN SUPPOSITORY 100 MG

100 mg

svečka

rektalna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN SUPPOSITORY 50 MG

50 mg

svečka

rektalna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN GASTRO RESISTANT TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN D DISPERSIBLE TABLET 50 MG

50 mg

tableta

peroralna uporaba

Ciper

| 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

natrijev diklofenakat

VOLTAREN DOLO FILM COATED TABLET 12,5 MG

12,5 mg

tableta

peroralna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN FOR CHILDREN SUPPOSITORY 12,5 MG

12,5 mg

svečka

rektalna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN RETARD SUSTAINED RELEASE TABLET 100 MG

100 mg

tableta

peroralna uporaba

Ciper

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

VOLTAREN SR SUSTAINED RELEASE TABLET 75 MG

75 mg

tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

ALMIRAL

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Češka

| 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

natrijev diklofenakat

ALMIRAL 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

APO-DICLO SR 100

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Češka

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

APO-DICLO 25 MG

25 mg

gastrorezistentna tableta

peroralna uporaba

Češka

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

APO-DICLO 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DICLOFENAC AL RETARD

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DICLOFENAC AL 25

25 mg

filmsko obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DICLOFENAC AL 50

50 mg

filmsko obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DICLOFENAC DUO PHARMASWISS 75 MG

75 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DICLOREUM

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

Češka

| 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

natrijev diklofenakat

DICLOREUM RETARD

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DICLOREUM 100

100 mg

svečka

rektalna uporaba

Češka

| 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

natrijev diklofenakat

DICLOREUM 50

50 mg

svečka

rektalna uporaba

Češka

| 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

natrijev diklofenakat

DICLOREUM 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

natrijev diklofenakat

DICUNO 25 MG POTAHOVANÉ TABLETY

25 mg

filmsko obložena tableta

peroralna uporaba

Češka

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

natrijev diklofenakat

DICUNO 50 MG POTAHOVANÉ TABLETY

50 mg

filmsko obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DOLMINA INJ

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Češka

| 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

natrijev diklofenakat

DOLMINA 100 SR

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Češka

| 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

natrijev diklofenakat

DOLMINA 50

50 mg

filmsko obložena tableta

peroralna uporaba

Češka

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

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

epolaminijev dikofenakat

FLECTOR EP RAPID 50 MG

50 mg

zrnca za peroralno raztopino

peroralna uporaba

Češka

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

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

natrijev diklofenakat

MONOFLAM 100 MG

100 mg

svečka

rektalna uporaba

Češka

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

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

natrijev diklofenakat

MONOFLAM 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

MYOGIT 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

MYOGIT 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

natrijev diklofenakat

NAKLOFEN DUO TOBOLKY

75 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Češka

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

orfenadrinijev citrat

Neodolpasse

75 mg/250 ml

30 mg/250 ml

raztopina za infundiranje

intravenska uporaba

Češka

| 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

natrijev diklofenakat

OLFEN-100 SR

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Češka

| 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

natrijev diklofenakat

OLFEN-50

50 mg

filmsko obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

OLFEN-75

37,5 mg/ml

raztopina za injiciranje

intramuskularna uporaba

Češka

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

UNO

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Češka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

natrijev diklofenakat

VERAL 100 MG

100 mg

svečka

rektalna uporaba

Češka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

natrijev diklofenakat

VERAL 100 RETARD

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Češka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

natrijev diklofenakat

VERAL 25 MG

25 mg

gastrorezistentna tableta

peroralna uporaba

Češka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

natrijev diklofenakat

VERAL 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

natrijev diklofenakat

VERAL 75

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Češka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

natrijev diklofenakat

VERAL 75 RETARD

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN RETARD

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN RAPID 50 MG TABLETY

50 mg

obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN ACTIGO

12,5 mg

filmsko obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN ACTIGO EXTRA

25 mg

obložena tableta

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN RAPID 12,5 MG

12,5 mg

kapsula, mehka

peroralna uporaba

Češka

| 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

natrijev diklofenakat

VOLTAREN RAPID 25 MG

25 mg

kapsula, mehka

peroralna uporaba

Danska

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

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

diklofenak

Diclodan

50 mg

svečka

rektalna uporaba

Danska

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

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

diklofenak

Diclodan

100 mg

svečka

rektalna uporaba

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

svečka

rektalna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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 prirejenim sproščanjem

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

svečka

rektalna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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

svečka

rektalna uporaba

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

filmsko obložena tableta

peroralna uporaba

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, mehka

peroralna uporaba

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

peroralna uporaba

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

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

50 mg

gastrorezistentna tableta

peroralna uporaba

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Danska

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

diklofenak

Diclon

25 mg

gastrorezistentna tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

Danska

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

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenak

Diklotab

25 mg

filmsko obložena tableta

peroralna uporaba

Danska

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

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

diklofenak

Diklotab

50 mg

filmsko obložena tableta

peroralna uporaba

Danska

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

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

diklofenak

Eeze

25 mg

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

Danska

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

50 mg

filmsko obložena tableta

peroralna uporaba

Danska

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

25 mg

filmsko obložena tableta

peroralna uporaba

Danska

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

diklofenak

misoprostol

Arthrotec

50 mg

0,2 mg

tableta

peroralna uporaba

Danska

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

diklofenak

misoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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 podaljšanim sproščanjem, trda

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

Estonija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

dikofenak

DICLOMELAN

100 mg

svečka

rektalna uporaba

Estonija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

dikofenak

DICLOMELAN RETARD 100 MG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

dikofenak

NAKLOFEN

50 mg

gastrorezistentna tableta

peroralna uporaba

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

dikofenak

NAKLOFEN

50 mg

svečka

rektalna uporaba

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

dikofenak

NAKLOFEN

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

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

dikofenak

NAKLOFEN SR

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

dikofenak

ALMIRAL

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

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

dikofenak

OLFEN DEPOCAPS

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

dikofenak

OLFEN DEPOCAPS

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

dikofenak

CATAFLAM

50 mg

obložena tableta

peroralna uporaba

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

dikofenak

VOLTAREN

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

dikofenak

VOLTAREN RETARD

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

dikofenak

VOLTAREN AKTI

12,5 mg

filmsko obložena tableta

peroralna uporaba

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

dikofenak

misoprostol

ARTHROTEC

50 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Estonija

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

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

Estonia

dikofenak

DICLORAPID

75 mg

gastrorezistentna kapsula, trda

peroralna uporaba

Estonija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

dikofenak

DICLOFENAC- RATIOPHARM 50 MG

50 mg

gastrorezistentna tableta

peroralna uporaba

Estonija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

dikofenak

DICLOFENAC-RATIOPHARM 50 MG

50 mg

svečka

rektalna uporaba

Estonija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

dikofenak

DICLOFENAC-RATIOPHARM 100 MG

100 mg

svečka

rektalna uporaba

Estonija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

dikofenak

DICLOFENAC-RATIOPHARM 75 MG/2 ML

75 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba

Estonija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

dikofenak

DICLOFENAC-RATIOPHARM UNO

150 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Estonija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

dikofenak

DICLAC 100

100 mg

svečka

rektalna uporaba

Estonija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

dikofenak

DICLAC

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

Estonija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

dikofenak

DICLAC ID 75 MG

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Estonija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

dikofenak

DICLAC ID 150 MG

150 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Estonija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

dikofenak

DICLAC 100 MG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Estonija

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

dikofenak

DICUNO

25 mg

filmsko obložena tableta

peroralna uporaba

Estonija

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

dikofenak

DICUNO

50 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Diclofenac Rapid Orifarm

50 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

ratiopharm Oy

P.O.Box 67

02631 Espoo

Finland

kalijev diklofenakat

Diclomex Rapid

50 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Dicuno

25 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Dicuno

50 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

kalijev diklofenakat

Eeze

25 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

kalijev diklofenakat

Voltaren Rapid

25 mg

obložena tableta

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

kalijev diklofenakat

Voltaren Rapid

50 mg

obložena tableta

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

kalijev diklofenakat

Voltfast

50 mg

prašek za peroralno raztopino

peroralna uporaba

Finska

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

natrijev diklofenakat

misoprostol

Arthrotec

50 mg

0,2 mg

tableta

peroralna uporaba

Finska

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

natrijev diklofenakat

misoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Finska

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

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

natrijev diklofenakat

Diclofenac BMM Pharma

25 mg

gastrorezistentna tableta

peroralna uporaba

Finska

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

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

natrijev diklofenakat

Diclofenac BMM Pharma

50 mg

gastrorezistentna tableta

peroralna uporaba

Finska

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclomex

25 mg

gastrorezistentna tableta

peroralna uporaba

Finska

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclomex

50 mg

gastrorezistentna tableta

peroralna uporaba

Finska

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

Oy Stada Pharma Ab

P.O.Box 1310

00101 Helsinki

Finland

natrijev diklofenakat

Motifene Dual

75 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren

100 mg

svečka

rektalna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren

25 mg

gastrorezistentna tableta

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren

25 mg/ml

raztopina za injiciranje /koncentrat zaraztopino za infundiranje

intramuskularna uporaba, intravenska uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren

50 mg

gastrorezistentna tableta

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren Retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren Retard

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Francija

| 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

epolaminijev diklofenakat

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

25 mg

zrnca za peroralno raztopino

peroralna uporaba

Francija

| 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

epolaminijev diklofenakat

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

50 mg

zrnca za peroralno raztopino

peroralna uporaba

Francija

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé

12,5 mg

filmsko obložena tableta

peroralna uporaba

Francija

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

NOVARTIS SANTE FAMILIALE

14, boulevard Richelieu

92500 Rueil-Malmaison

France

kalijev diklofenakat

VOLTARENDOLO 12,5 mg, comprimé enrobé

12,5 mg

obložena tableta

peroralna uporaba

Francija

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

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

natrijev diklofenakat

DICLOFENAC ARROW 50 mg, comprimé gastro-résistant

50 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

natrijev diklofenakat

DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant

50 mg

filmsko obložena gastrorezistentna tableta

peroralna uporaba

Francija

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

natrijev diklofenakat

DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant

50 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

CRISTERS

22 quai Gallieni

92150 Suresnes

France

natrijev diklofenakat

DICLOFENAC CRISTERS 50 mg, comprimé gastro-résistant

50 mg

gastrorezistentna tableta

peroralna uporaba

Francija

| 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

natrijev diklofenakat

DICLOFENAC EG 50 mg, comprimé gastro-résistant

50 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

natrijev diklofenakat

DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant

25 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

natrijev diklofenakat

DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant

50 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

natrijev diklofenakat

DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Francija

| 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

natrijev diklofenakat

DICLOFENAC TEVA 25 mg, comprimé enrobé gastro-résistant

25 mg

gastrorezistentna obložena tableta

peroralna uporaba

Francija

| 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

natrijev diklofenakat

DICLOFENAC TEVA 50 mg, comprimé enrobé gastro-résistant

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE 100 mg, suppositoire

100 mg

svečka

rektalna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE 25 mg, comprimé gastro-résistant

25 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE 50 mg, comprimé enrobé gastro-résistant

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE 75 mg/3 ml, solution injectable

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE ENFANT, suppositoire

25 mg

svečka

rektalna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée

100 mg

obložena tableta s podaljšanim sproščanjem

peroralna uporaba

Francija

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

natrijev diklofenakat

VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée

75 mg

obložena tableta s podaljšanim sproščanjem

peroralna uporaba

Francija

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

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

natrijev diklofenakat

misoprostol

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

50 mg

0,2 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

natrijev diklofenakat

misoprostol

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

75 mg

0,2 mg

gastrorezistentna tableta

peroralna uporaba

Francija

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

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

natrijev diklofenakat

Xelaran Brausetablette 25 mg

25 mg

šumeča tableta

peroralna uporaba

Nemčija

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

natrijev diklofenakat

Diclo 100 retard - 1 A Pharma

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

natrijev diklofenakat

Diclo 25 - 1 A Pharma

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

natrijev diklofenakat

Diclo 50 - 1 A Pharma

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

natrijev diklofenakat

Diclo 75 SL - 1 A Pharma

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

natrijev diklofenakat

Diclofenac- 1 A Pharma 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

natrijev diklofenakat

Diclofenac- 1 A Pharma 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclofenac AbZ 25 mg Tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclofenac AbZ 50 mg Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclofenac AbZ 50 mg Trinktabletten

50 mg

disperzibilna tableta

peroralna uporaba

Nemčija

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

natrijev diklofenakat

Diclo Divido

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

natrijev diklofenakat

Diclo-Divido long

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

natrijev diklofenakat

Diclofenac-Actavis 100 mg

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

natrijev diklofenakat

Diclofenac-Actavis 50 mg

50 mg

gastrorezistentna kapsula

peroralna uporaba

Nemčija

| 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

kalijev diklofenakat

Diclo AL akut 12,5 mg

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac AL 100

100 mg

svečka

rektalna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac AL 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac AL 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac AL 50 Supp.

50 mg

svečka

rektalna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac AL i.m.

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac AL retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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

kalijev diklofenakat

Diclofenac-Kalium AL 25 mg Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

natrijev diklofenakat

Rewodina 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

natrijev diklofenakat

Rewodina 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

natrijev diklofenakat

Rewodina dual 75 Kaps

75 mg

capsule

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

natrijev diklofenakat

Rewodina uno 100

100 mg

capsule

peroralna uporaba

Nemčija

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

natrijev diklofenakat

Xelaran Brausetablette 50 mg

50 mg

šumeča tableta

peroralna uporaba

Nemčija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl 50 mg

Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl N 75

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

natrijev diklofenakat

Diclo dispers

50 mg

disperzibilna tableta

peroralna uporaba

Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

natrijev diklofenakat

Diclofenbeta 100

100 mg

svečka

rektalna uporaba

Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

natrijev diklofenakat

Diclofenbeta 100 retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

natrijev diklofenakat

Diclofenbeta 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

natrijev diklofenakat

Diclofenbeta 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

natrijev diklofenakat

Diclo-saar 100 mg Retardtablette

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

natrijev diklofenakat

Diclo-saar 50 mg magensaftresistente Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

natrijev diklofenakat

Diclo-saar 75 mg SF Injektionslösung

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo-CT 100 mg Supp.

100 mg

svečka

rektalna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo-CT 25 mg Tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo-CT 50 mg Trinktabletten

50 mg

disperzibilna tableta

peroralna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo-CT 50 mg Supp.

50 mg

svečka

rektalna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo-CT 50 mg Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo-CT 75 mg/2 ml Ampullen

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

kalijev diklofenakat

Diclo-CT akut 12,5 mg Filmtabletten

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

natrijev diklofenakat

Diclo-Denk 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

natrijev diklofenakat

DICLO-DENK 100 mg RETARD

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| Dexcel Pharma GmbH |
| --- |
| Carl-Zeiss-Str. 2 |
| 637,5 Alzenau |
| Germany |

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

637,5 Alzenau

Germany

natrijev diklofenakat

Diclofenac Atid 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| Dexcel Pharma GmbH |
| --- |
| Carl-Zeiss-Str. 2 |
| 637,5 Alzenau |
| Germany |

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

637,5 Alzenau

Germany

natrijev diklofenakat

Diclofenac Atid retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

DOCPHARM Arzneimittelvertrieb GmbH & Co.

Kommanditgesellschaft auf Aktien

Greschbachstr. 7

76229 Karlsruhe

Germany

natrijev diklofenakat

Diclafenac PB retard 100 mg

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Dolgit-Diclo 100

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Dolgit-Diclo 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Myogit 100

100 mg

svečka

rektalna uporaba

Nemčija

| 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

natrijev diklofenakat

Myogit 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Myogit 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

natrijev diklofenakat

Diclo KD 100

100 mg

svečka

rektalna uporaba

Nemčija

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

natrijev diklofenakat

Diclo KD 50

50 mg

svečka

rektalna uporaba

Nemčija

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

natrijev diklofenakat

Diclo KD 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

natrijev diklofenakat

Diclo KD 75 akut

75 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Nemčija

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

natrijev diklofenakat

Diclo KD retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

natrijev diklofenakat

Diclo-Weimer

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

natrijev diklofenakat

Diclofenac Natrium HERMES 25 mg Brausetabletten

25 mg

šumeča tableta

peroralna uporaba

Nemčija

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

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

natrijev diklofenakat

Diclofenac Natrium HERMES 50 mg Brausetabletten

50 mg

šumeča tableta

peroralna uporaba

Nemčija

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

natrijev diklofenakat

Diclofenac 100 Heumann Supp.

100 mg

svečka

rektalna uporaba

Nemčija

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

natrijev diklofenakat

Diclofenac 100 retard Heumenn

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

natrijev diklofenakat

Diclofenac 25 Heumenn

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

natrijev diklofenakat

Diclofenac 50 Heumann

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

natrijev diklofenakat

Diclofenac 50 Heumenn Supp.

50 mg

svečka

rektalna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 150 mg ID

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 75 mg ID

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac Dispers

50 mg

disperzibilna tableta

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

kalijev diklofenakat

Diclac Dolo 12,5 mg

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

kalijev diklofenakat

Diclac Dolo 25 mg

25 mg

obložena tableta

peroralna uporaba

Nemčija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Diclofenac Hikma 75 mg

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

natrijev diklofenakat

Jutafenac 100 mg Retardtabletten

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Kappler Pharma Consult GmbH

Fonyoder Str. 18

89340 Leipheim

Germany

kalijev diklofenakat

Diclofen Kalium KPC 25 mg Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

natrijev diklofenakat

Diclo KSK 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

natrijev diklofenakat

Diclofenac MEDA 25 mg Brausetabletten

25 mg

šumeča tableta

peroralna uporaba

Nemčija

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

natrijev diklofenakat

Diclofenac MEDA 50 mg Brausetabletten

50 mg

šumeča tableta

peroralna uporaba

Nemčija

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

natrijev diklofenakat

Diclofenac dura 100 mg Retardtabletten

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

natrijev diklofenakat

Diclofenac dura 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

natrijev diklofenakat

Diclofenac dura 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

natrijev diklofenakat

Diclofenac dura 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

natrijev diklofenakat

Diclofenac Mylan 100 mg Retardtabletten

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

kalijev diklofenakat

Diclofenac NCH 25 mg

25 mg

obložena tableta

peroralna uporaba

Nemčija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

kalijev diklofenakat

Optalidon Zahnschmerz mit Diclofenac 25 mg

25 mg

obložena tableta

peroralna uporaba

Nemčija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

kalijev diklofenakat

Voltaren Dolo 12,5 mg

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

kalijev diklofenakat

Voltaren Dolo 25 mg

25 mg

obložena tableta

peroralna uporaba

Nemčija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

kalijev diklofenakat

Voltaren Dolo 25 mg

25 mg

obložena tableta

peroralna uporaba

Nemčija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

kalijev diklofenakat

Voltaren Dolo Liquid 12,5 mg

12,5 mg

kapsula, mehka

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

kodeinijevfosfat hemihidrat

Combaren 50 mg/50 mg Filmtabletten

50 mg

50 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren 100 mg retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren 25 mg Zäpfchen

25 mg

svečka

rektalna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

Voltaren Dispers

50 mg

disperzibilna tableta

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

kalijev diklofenakat

Voltaren K Migräne 50 mg

50 mg

obložena tableta

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

natrijev diklofenakat

kodeinijev fosfat hemihidrat

Voltaren Plus 50 mg/50 mg Filmtabletten

50 mg

50 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

holestiraminijev diklofenakat

Voltaren Resinat

140 mg

kapsula, trda

peroralna uporaba

Nemčija

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

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

natrijev diklofenakat

misoprostol

Arthotec

50 mg

0,2 mg

obložena tableta

peroralna uporaba

Nemčija

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

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

natrijev diklofenakat

misoprostol

Arthotec forte

75 mg

0,2 mg

obložena tableta

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 100 mg Retardkapseln

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 25 mg magensaftresistente Tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 50 mg Disperstabletten

50 mg

disperzibilna tableta

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 50 mg magensaftresistente Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 75 mg SL Retardkapseln

75 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 75 mg/2 ml Injektionslösung

75 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

kalijev diklofenakat

Diclofenac-ratiopharm Lösung bei Migräne

50 mg/1 ml

peroralne kapljice, raztopina

peroralna uporaba

Nemčija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

kalijev diklofenakat

Diclofenac-ratiopharm Schmerztabletten 12,5 mg

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

22946 Trittau

Germany

natrijev diklofenakat

Diclofenac SF-Rotexmedica

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz 100 mg Retardtabletten

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz 25 mg magensaftresistente Tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz 50 mg magensaftresistente Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz parenteral 75 mg Injektionslösung

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

natrijev diklofenakat

Diclofenac Sandoz Uno 150 mg Retardtabletten

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

sigapharm GmbH

Temmlerstr. 2

35039 Marburg/Lahn

Germany

natrijev diklofenakat

Sigafenac 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

natrijev diklofenakat

Diclofenac STADA 100 mg Retardtabletten

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

natrijev diklofenakat

Diclofenac STADA 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

natrijev diklofenakat

Diclofenac STADA 25 mg magensaftresistente Tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

natrijev diklofenakat

Diclofenac STADA 50 mg magensaftresistente Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

natrijev diklofenakat

Diclofenac Stada 50 mg Zäpfchen

50 mg

svečka

rektalna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

natrijev diklofenakat

Diclofenac STADA N 75 mg/3 ml Injektionslösung

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

kalijev diklofenakat

Diclofenac-Kalium STADA 12,5 mg Filmtabletten

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

kalijev diklofenakat

Diclofenac-Kalium STADA 25 mg Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

natrijev diklofenakat

Allvoran 100 mg Retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

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

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

natrijev diklofenakat

Allvoran SF

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

natrijev diklofenakat

Allvoran 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

natrijev diklofenakat

Allvoran 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

natrijev diklofenakat

Allvoran S 100 mg

100 mg

svečka

rektalna uporaba

Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

natrijev diklofenakat

Allvoran S 50 mg

50 mg

svečka

rektalna uporaba

Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

natrijev diklofenakat

Allvoran uno

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclo-Klinge 75 mg magensaftresistente Hartkapsel

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclo-Klinge 75 mg spezial

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclofenac spezial 100 mg Klinge

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclofenac spezial 75 mg Klinge

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclofenac Temmler 25 mg Hartkapseln

25 mg

gastrorezistentna kapsula, trda

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclofenac Temmler SL 100 mg Retardkapseln

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| Temmler Werke GmbH |
| --- |
| Weihenstephaner Str. 28 |
| 81673 München |
| Germany |

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

natrijev diklofenakat

Diclofenac Temmler SL 75 mg Retardkapseln

75 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Effekton 100 mg Retardtabletten

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Effekton 100 mg Zäpfchen

100 mg

svečka

rektalna uporaba

Nemčija

| 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

natrijev diklofenakat

Effekton 25 mg magensaftresistente Tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Effekton 50 mg magensaftresistente Tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| 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

natrijev diklofenakat

Effekton 75 mg/3 ml Injektionslösung

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Nemčija

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

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

natrijev diklofenakat

Xelaran Brausetablette 25 mg

25 mg

šumeča tableta

peroralna uporaba

Nemčija

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Diclotin 25 mg Filmtabletten

25 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Diclotin 50 mg Filmtabletten

50 mg

filmsko obložena tableta

peroralna uporaba

Nemčija

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

natrijev diklofenakat

Diclowal 100 mg retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

natrijev diklofenakat

DICLOWAL 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

natrijev diklofenakat

DICLOWAL 75 mg

75 mg

raztopina za injiciranje

intramuskularna uporaba

Nemčija

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

natrijev diklofenakat

DICLOWAL Supp.

100 mg

svečka

rektalna uporaba

Nemčija

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

natrijev diklofenakat

Monoflam 100 mg

100 mg

svečka

rektalna uporaba

Nemčija

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

natrijev diklofenakat

Monoflam 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

natrijev diklofenakat

Monoflam 50 mg

50 mg

svečka

rektalna uporaba

Nemčija

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

natrijev diklofenakat

Monoflam retard N

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

natrijev diklofenakat

Dignofenac 100 mg

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Nemčija

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

natrijev diklofenakat

Dignofenac 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nemčija

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

natrijev diklofenakat

Dignofenac 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Grčija

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| Dilou 9, Peristeri |
| Attikis, 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9, Peristeri

Attikis, 12134

Greece

natrijev diklofenakat

BATAFIL

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

natrijev diklofenakat

DELIMON

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

natrijev diklofenakat

VURDON

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

natrijev diklofenakat

EVINOPON

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

natrijev diklofenakat

URIGON

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

natrijev diklofenakat

RUVOMINOX

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

| 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

natrijev diklofenakat

RHEUMAVEK

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

| MEDICUS S.A |
| --- |
| Valaoritou 10 |
| Metamorfosi 14452 |
| Greece |

MEDICUS S.A

Valaoritou 10

Metamorfosi 14452

Greece

natrijev diklofenakat

DIFEND

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

25 mg

gastrorezistentnafilmsko obložena tableta

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

50 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

100 mg

filmsko obložena tableta s podaljšanim sproščanjem

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

75 mg

filmsko obložena tableta s podaljšanim sproščanjem

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

50 mg

disperzibilna tableta

peroralna uporaba

Grčija

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

natrijev diklofenakat

DELIMON

25 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

natrijev diklofenakat

DELIMON

50 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

| D.A.S.T. BIOTECH Pharmaceutical Ltd |
| --- |
| Larissis 10 |
| Pallini 15351 |
| Greece |

D.A.S.T. BIOTECH Pharmaceutical Ltd

Larissis 10

Pallini 15351

Greece

natrijev diklofenakat

FLEFARMIN

50 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

natrijev diklofenakat

VURDON

25 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

natrijev diklofenakat

VURDON

100 mg

filmsko obložena tableta s podaljšanim sproščanjem

peroralna uporaba

Grčija

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

natrijev diklofenakat

EVINOPON

25 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

natrijev diklofenakat

EVINOPON

50 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

natrijev diklofenakat

URIGON

25 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

natrijev diklofenakat

URIGON

50 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

natrijev diklofenakat

RUVOMINOX

50 mg

obložena tableta

peroralna uporaba

Grčija

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

natrijev diklofenakat

RUVOMINOX

25 mg

obložena tableta

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

RHEUMAVEK

25 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

RHEUMAVEK

50 mg

tableta z gastrorezistentno oblogo

peroralna uporaba

Grčija

| Pfizer Hellas A.E. |
| --- |
| Messoghion Ave. 243 |
| Neo Psychiko 15451 |
| Greece |

Pfizer Hellas A.E.

Messoghion Ave. 243

Neo Psychiko 15451

Greece

natrijev diklofenakat

misoprostol

ARTHROTEC

50 mg

0,2 mg

controlled release tablet

peroralna uporaba

Grčija

| PHARMANEL COMMERCE PHARMACEUTICAL S.A. |
| --- |
| Marathonos Avenue 106, Gerakas 15344 |
| Greece |

PHARMANEL COMMERCE PHARMACEUTICAL S.A.

Marathonos Avenue 106, Gerakas 15344

Greece

natrijev diklofenakat

FENOCLOF

75 mg

kapsula z nadzorovanim sproščanjem

peroralna uporaba

Grčija

| 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

kalijev diklofenakat

VOLTAREN ACTI-GO

25 mg

obložena tableta

peroralna uporaba

Grčija

| 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

kalijev diklofenakat

VOLTAREN ACTI-GO

50 mg

obložena tableta

peroralna uporaba

Grčija

| 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

kalijev diklofenakat

VOLTAREN ACTI-GO

12,5 mg

obložena tableta

peroralna uporaba

Grčija

| 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

kalijev diklofenakat

VOLTAREN FAST

50 mg

prašek za peroralno raztopino

peroralna uporaba

Grčija

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

natrijev diklofenakat

DICLO DUO

75 mg

kapsula z nadzorovanim sproščanjem

peroralna uporaba

Grčija

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

natrijev diklofenakat

COUNTERFLAME

75 mg

gastrorezistentna kapsula

peroralna uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

50 mg

svečka

rektalna uporaba

Grčija

| 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

natrijev diklofenakat

VOLTAREN

100 mg

svečka

rektalna uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

natrijev diklofenakat

VURDON

50 mg

svečka

rektalna uporaba

Grčija

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

natrijev diklofenakat

VURDON

100 mg

svečka

rektalna uporaba

Grčija

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

natrijev diklofenakat

EVINOPON

50 mg

svečka

rektalna uporaba

Grčija

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

natrijev diklofenakat

RUVOMINOX

50 mg

svečka

rektalna uporaba

Madžarska

| 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

peroralne kapljice, suspenzija

peroralna uporaba

Madžarska

| 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

peroralna uporaba

Madžarska

| 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

peroralna uporaba

Madžarska

| 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 podaljšanim sproščanjem

peroralna uporaba

Madžarska

| 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 podaljšanim sproščanjem

peroralna uporaba

Madžarska

| 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

svečka

rektalna uporaba

Madžarska

| 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

gastrorezistentna filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

svečka

rektalna uporaba

Madžarska

| 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

raztopina za injiciranje

parenteralna uporaba,

intramuskularna uporaba

Madžarska

| 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, trda

peroralna uporaba

Madžarska

| 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

prolonged-release filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

Madžarska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

Madžarska

| 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 podaljšanim sproščanjem

peroralna uporaba

Madžarska

| 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

svečka

rektalna uporaba

Madžarska

| 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 podaljšanim sproščanjem

peroralna uporaba

Madžarska

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

orfenadrinijev citrat

NEODOLPASSE oldatos infúzió

75 mg/250 ml

30 mg/250 ml

raztopina za infundiranje

parenteralna uporaba,

intravenska uporaba

Madžarska

| 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

prolonged-release filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

gastrorezistentna filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

gastrorezistentna filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

svečka

rektalna uporaba

Madžarska

| 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

prolonged-release filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

raztopina za injiciranje

parenteralna uporaba; intramuskularno injiciranje ali intravensko infundiranje; ni primerno za bolusno intravensko injiciranje

Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

Madžarska

| 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, mehka

peroralna uporaba

Madžarska

| 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

peroralna uporaba

Madžarska

| 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

kalijev diklofenakat

VOLTAREN DOLO 25 mg lágy kapszula

25 mg

kapsula, mehka

peroralna uporaba

Madžarska

| 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

zrnca

peroralna uporaba

Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

Islandija

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

natrijev diklofenakat

misoprostol

Arthrotec

50 mg

0,2 mg

tableta

peroralna uporaba

Islandija

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

natrijev diklofenakat

misoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta

peroralna uporaba

Islandija

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

ratiopharm GmbH

Graf-Arco Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclomex

50 mg

filmsko obložena tableta

peroralna uporaba

Islandija

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

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

natrijev diklofenakat

Diklofenak Mylan

50 mg

gastrorezistentna tableta

peroralna uporaba

Islandija

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

natrijev diklofenakat

Klofen L

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Islandija

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

natrijev diklofenakat

Modifenac

75 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

natrijev diklofenakat

Voltaren

100 mg

svečka

rektalna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

natrijev diklofenakat

Voltaren

25 mg

gastrorezistentna tableta

peroralna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

natrijev diklofenakat

Voltaren

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

natrijev diklofenakat

Voltaren

50 mg

svečka

rektalna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

natrijev diklofenakat

Voltaren

50 mg

gastrorezistentna tableta

peroralna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

kalijev diklofenakat

Voltaren Dolo

12,5 mg

filmsko obložena tableta

peroralna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

kalijev diklofenakat

Voltaren Dolo

12,5 mg

kapsula, mehka

peroralna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

kalijev diklofenakat

Voltaren Dolo

25 mg

obložena tableta

peroralna uporaba

Islandija

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

kalijev diklofenakat

Voltaren Rapid

50 mg

obložena tableta

peroralna uporaba

Islandija

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Vóstar-S

25 mg

filmsko obložena tableta

peroralna uporaba

Islandija

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Vóstar-S

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Voltarol 25 mg Gastro-Resistant Tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Voltarol 50 mg Gastro-Resistant Tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Voltarol 12,5 mg Suppositories

12,5 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Voltarol 100 mg Suppositories

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Voltarol Ampoules 75 mg/3 ml, solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Voltarol Retard 100 mg Film-coated Prolonged Release Tablets

100 mg

filmsko obložena tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Voltarol Retard 75 mg Film-coated Prolonged-release Tablets

75 mg

filmsko obložena tableta s podaljšanim sproščanjem

peroralna uporaba

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

kalijev diklofenakat

Cataflam 25 mg Coated Tablets

25 mg

obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Cataflam 50 mg Coated Tablets

50 mg

obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Voltfast Sachets 50 mg Powder for Oral Solution

50 mg

prašek za peroralno raztopino

peroralna uporaba

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

kalijev diklofenakat

Diclofenac potassium NCH 12,5 mg Film-coated tablets

12,5 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Otriflu 12,5 mg Film-coated Tablets

12,5 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Diclo 75 mg prolonged release tablets.

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

natrijev diklofenakat

Diclac 75 mg Prolonged -Release Tablets

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

natrijev diklofenakat

Diclac Retard 100 mg Prolonged-release Tablets

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

natrijev diklofenakat

Diclac 25 mg Gastro-resistant Tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

natrijev diklofenakat

Diclac 50 mg Gastro-resistant Tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

natrijev diklofenakat

Diclac 100 mg Suppositories

100 mg

svečka

rektalna uporaba

Irska

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

natrijev diklofenakat

Diclac 25 mg/ml Solution for Injection 3 ml Ampoule

25 mg

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Arthrotec 50 modified release tablets

50 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Arthrotec 75 modified-release tablets

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Difene 25 mg Capsules

25 mg

kapsula

peroralna uporaba

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

natrijev diklofenakat

Difene 50 mg Capsules

50 mg

kapsula

peroralna uporaba

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

natrijev diklofenakat

Difene 75 mg Dual Release Capsules

75 mg

kapsula z dvojnim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Difene 100 mg Dual Release Capsules

100 mg

kapsula z dvojnim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion

75 mg/3 ml

raztopina za injiciranje ali koncentrat za raztopino za infundiranje

intramuskularna uporaba, intravenska uporaba

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

natrijev diklofenakat

Difene 100 mg Suppositories

100 mg

svečka

rektalna uporaba

Irska

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Kyflam 50 mg Film Coated Tablet

50 mg

filmsko obložena tableta

peroralna uporaba

Irska

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

natrijev diklofenakat

misoprostol

Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets

50 mg

0,2 mg

modified release tablet

peroralna uporaba

Irska

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

natrijev diklofenakat

misoprostol

Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets

75 mg

0,2 mg

modified release tablet

peroralna uporaba

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 peroralno raztopino

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

svečka

rektalna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

ALGOSENAC

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

zrnca

peroralna uporaba

Italija

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

natrijev diklofenakat

DEALGIC

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Italija

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

natrijev diklofenakat

DEALGIC

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

natrijev diklofenakat

DEFLAMAT

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DEFLAMAT

75 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

natrijev diklofenakat

DEFLAMAT

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

Italija

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

natrijev diklofenakat

DICLOFAN

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Italija

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

natrijev diklofenakat

DICLOFAN

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOFENAC

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOFENAC

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

50 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

25 mg

tablet

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

50 mg

tablet

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

150 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC ALPHA BIOTECH

25 mg/ml

peroralne kapljice, raztopina

peroralna uporaba

Italija

| Almus S.r.l. |
| --- |
| Via Cesarea, 11/10 |
| Genova - 16121 |
| Italy |

Almus S.r.l.

Via Cesarea, 11/10

Genova - 16121

Italy

natrijev diklofenakat

DICLOFENAC ALMUS

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

natrijev diklofenakat

DICLOFENAC ANGENERICO

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

natrijev diklofenakat

DICLOFENAC ANGENERICO

100 mg

svečka

rektalna uporaba

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

natrijev diklofenakat

DICLOFENAC ANGENERICO

50 mg

gastrorezistentna tableta

peroralna uporaba

Italija

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

natrijev diklofenakat

DICLOFENAC ANGENERICO

25 mg

gastrorezistentna tableta

peroralna uporaba

Italija

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC DOC

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Italija

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC DOC GENERICI

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Italija

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC DOC GENERICI

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC EG

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC EG

50 mg

gastrorezistentna tableta

peroralna uporaba

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC EG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Italija

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC EG

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOFENAC GERMED

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOFENAC HEXAL

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOFENAC HEXAL

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOFENAC HEXAL

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

DICLOFENAC HEXAL

25 mg

gastrorezistentna tableta

peroralna uporaba

Italija

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC MYLAN GENERICS

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Italija

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

natrijev diklofenakat

DICLOFENAC MYLAN GENERICS

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

NATRIJEV DIKLOFENAKAT

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

NATRIJEV DIKLOFENAKAT BIL

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOREUM

50 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOREUM

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

DICLOREUM

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

DICLOREUM

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

DICLOREUM

150 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

natrijev diklofenakat

DICLOREUM

50 mg

zrnca

peroralna uporaba

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

natrijev diklofenakat

DICLOREUM

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

DICLOREUM

25 mg/ml

peroralne kapljice, raztopina

peroralna uporaba

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

natrijev diklofenakat

DICLOREUM

46,5 mg/ml

peroralne kapljice, raztopina

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

zrnca za peroralno suspenzijo

peroralna uporaba

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

kalijev diklofenakat

EMINOCS

50 mg

peroralne kapljice, raztopina

peroralna uporaba

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

natrijev diklofenakat

FENADOL

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

FENDER

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

FENDER

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

zrnca za peroralno raztopino

peroralna uporaba

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

natrijev diklofenakat

FLOGOFENAC

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

kalijev diklofenakat

ITAMIFAST

25 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

ITAMIFAST

50 mg

filmsko obložena tableta

peroralna uporaba

Italija

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

kalijev diklofenakat

KAPPADI

25 mg

filmsko obložena tableta

peroralna uporaba

Italija

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

kalijev diklofenakat

KAPPADI

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

NOVAPIRINA

25 mg

obložena tableta

peroralna uporaba

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

natrijev diklofenakat

TRAULEN

100 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

TRAULEN

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

VOLTADVANCE

25 mg

prašek za peroralno raztopino

peroralna uporaba

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

natrijev diklofenakat

VOLTADVANCE

25 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

VOLTFAST

50 mg

obložena tableta

peroralna uporaba

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

kalijev diklofenakat

VOLTFAST

25 mg

obložena tableta

peroralna uporaba

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

kalijev diklofenakat

VOLTFAST

50 mg

zrnca za peroralno raztopino

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba, subkutana uporaba

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

natrijev diklofenakat

INDICAM

75 mg/ml

raztopina za injiciranje

intramuskularna uporaba, subkutana uporaba

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

natrijev diklofenakat

misoprostol

MISOFENAC

50 mg

0,2 mg

tableta

peroralna uporaba

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

natrijev diklofenakat

misoprostol

MISOFENAC

75 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

natrijev diklofenakat

misoprostol

ARTROTEC

50 mg

0,2 mg

tablet

peroralna uporaba

Italija

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

natrijev diklofenakat

misoprostol

ARTROTEC

75 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Italija

| HEXAL AG S.p.a. |
| --- |
| Industriestrasse, 25, D-83607 |
| HOLZKIRCHEN |
| Germany |

HEXAL AG S.p.a.

Industriestrasse, 25, D-83607

HOLZKIRCHEN

Germany

natrijev diklofenakat

DICLOFENAC HEXAL AG

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Italija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

DICLOFENAC RATIOPHARM

50 mg

gastrorezistentna tableta

peroralna uporaba

Italija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

DICLOFENAC RATIOPHARM

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Profenac 75 mg/3 ml solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Profenac SR 100 mg prolonged-release tablets

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Latvija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 50 mg gastro-resistant tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

Latvija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 25 mg gastro-resistant tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

Latvija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm uno 150 mg prolonged-release tablets

150 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Latvija

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac-ratiopharm 75 mg/2 ml solution for injection

75 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Diclogen 50 mg suppositories

50 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclogen 100 mg suppositories

100 mg

svečka

rektalna uporaba

Latvija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

natrijev diklofenakat

Diclac 75 mg/3 ml solution for injection/infusion

75 mg/3 ml

raztopina za injiciranje in infundiranje

intramuskularna uporaba, intravenska uporaba

Latvija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

natrijev diklofenakat

Diclac 100 mg modified release tablets

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Latvija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

natrijev diklofenakat

Diclac ID 75 mg modified release tablets

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Latvija

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

natrijev diklofenakat

Diclac ID 150 mg modified release tablets

150 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

Diclomelan retard 100 mg sustained-release tablets

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

Diclomelan 50 mg gastro-resistant tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

Diclomelan 100 mg suppositories

100 mg

svečka

rektalna uporaba

Latvija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

natrijev diklofenakat

tiaminijev klorid

piridoksinijev klorid

cianokobalamin

Diclovit hard capsules

50 mg

50 mg

50 mg

0,25 mg

kapsula, trda

peroralna uporaba

Latvija

| SIA Briz |
| --- |
| Rasas iela 5 |
| Riga, LV-1057 |
| Latvia |

SIA Briz

Rasas iela 5

Riga, LV-1057

Latvia

natrijev diklofenakat

Feloran 75 mg/3 ml solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

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

natrijev diklofenakat

lidokainijev klorid

Olfen 75 mg/20 mg/2 ml solution for injection

75 mg/2 ml

20 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Olfen Lactab 50 mg gastro-resistant tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Olfen Depocaps 100 mg prolonged-release capsules, hard

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

natrijev diklofenakat

Olfen Rectocaps 100 mg rectal capsules

100 mg

rektalna kapsula

rektalna uporaba

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

natrijev diklofenakat

Olfen Depotabs 75 mg prolonged release tablets

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Latvija

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

natrijev diklofenakat

Dicuno 25 mg film-coated tablets

25 mg

filmsko obložena tableta

peroralna uporaba

Latvija

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

natrijev diklofenakat

Dicuno 50 mg film-coated tablets

50 mg

filmsko obložena tableta

peroralna uporaba

Latvija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl 75 mg/3 ml solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Latvija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl 100 mg suppositories

100 mg

svečka

rektalna uporaba

Latvija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl 50 mg gastro-resistant tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

Latvija

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl retard 100 mg prolonged release capsules

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Majamil retard 100 mg prolonged-release tablets

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Latvija

| A/S “Olainfarm” |
| --- |
| Rupnicu iela 5 |
| Olaine, LV – 2114 |
| Latvia |

A/S “Olainfarm”

Rupnicu iela 5

Olaine, LV – 2114

Latvia

natrijev diklofenakat

Dikloferol 50 mg coated tablets

50 mg

obložena tableta

peroralna uporaba

Latvija

| SIA PharmaSwiss Latvia |
| --- |
| Gertrudes iela 54 – 5 |
| Riga, LV 1011 |
| Latvia |

SIA PharmaSwiss Latvia

Gertrudes iela 54 – 5

Riga, LV 1011

Latvia

natrijev diklofenakat

Diclorapid 75 mg gastro-resistant capsules, hard

75 mg

gastrorezistentna kapsula, trda

peroralna uporaba

Latvija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren 75 mg/3 ml solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Latvija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren Akti 12,5 mg film-coated tablets

12,5 mg

filmsko obložena tableta

peroralna uporaba

Latvija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren Akti 25 mg soft capsules

25 mg

kapsula, mehka

peroralna uporaba

Latvija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Voltaren Retard 100 mg modified-release film-coated tablets

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Latvija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

natrijev diklofenakat

Cataflam 50 mg film-coated tablets

50 mg

filmsko obložena tableta

peroralna uporaba

Latvija

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

natrijev diklofenakat

Diclofenac 50 mg suppositories

50 mg

svečka

rektalna uporaba

Latvija

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

natrijev diklofenakat

Diclofenac 100 mg suppositories

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Naklofen SR 100 mg prolonged-release tablets

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Naklofen 75 mg/3 ml solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Naklofen 50 mg gastro-resistant tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Almiral 25 mg/ml solution for injection and infusion

25 mg/ml

raztopina za injiciranje in infundiranje

intramuskularna uporaba, intravenska uporaba

Latvija

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

natrijev diklofenakat

Diclo CT 75 mg/2 ml solution for injection

75 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba

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

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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 prirejenim sproščanjem

peroralna uporaba

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 prirejenim sproščanjem

peroralna uporaba

Litva

| UAB „PharmaSwiss“ |
| --- |
| Šeimyniškių g. 21B |
| LT-09200, Vilnius |
| Lithuania |

UAB „PharmaSwiss“

Šeimyniškių g. 21B

LT-09200, Vilnius

Lithuania

diklofenak

DicloRapid

75 mg

gastrorezistentna kapsula, trda

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

svečka

rektalna uporaba

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 podaljšanim sproščanjem, trda

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

svečka

rektalna uporaba

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

svečka

rektalna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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 podaljšanim sproščanjem, trda

peroralna uporaba

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 prirejenim sproščanjem

peroralna uporaba

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

svečka

rektalna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

svečka

rektalna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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 podaljšanim sproščanjem, trda

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

gastrorezistentna obložena tableta

peroralna uporaba

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

rektalna kapsula

rektalna uporaba

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

raztopina za injiciranje/infundiranje

intramuskularna uporaba, intravenska uporaba

Litva

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

diklofenak

Voltaren

100 mg

svečka

rektalna uporaba

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

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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, mehka

peroralna uporaba

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

peroralna uporaba

Litva

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

25 mg

filmsko obložena tableta

peroralna uporaba

Litva

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

diklofenak

Dicuno

50 mg

filmsko obložena tableta

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

Litva

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

diklofenak

tiamin

piridoksin

cianokobalamin

Diclovit

50 mg

50 mg

50 mg

0,25 mg

kapsula, trda

peroralna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

kalijev diklofenakat

Cataflam

50 mg

obložena tableta

peroralna uporaba

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac retard 100

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac 75 mg/3 ml Injektionslösung

75 mg

raztopina za injiciranje

intramuskularna uporaba

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac-100 Zäpfchen

100 mg

svečka

rektalna uporaba

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac-25

25 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac-50

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

natrijev diklofenakat

Diclac-50 Zäpfchen

50 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclofenac EG-25

25 mg

obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenac EG-50

50 mg

obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenac EG retard 75

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Diclofenac EG retard 100

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Diclofenac EG 75 mg/3 ml solution injectable

75 mg

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

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

natrijev diklofenakat

Diclofenac EG 100 suppositoire

100 mg

svečka

rektalna uporaba

Luksemburg

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

natrijev diklofenakat

Diclofenac Mylan-75 Retard

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Luksemburg

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

natrijev diklofenakat

Diclofenac Mylan-100 Retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Luksemburg

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac Ratiopharm-100 Zäpfchen

100 mg

svečka

rektalna uporaba

Luksemburg

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac Ratiopharm-25

25 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac Ratiopharm-50

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung

75 mg

raztopina za injiciranje

intramuskularna uporaba

Luksemburg

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac Retard Ratiopharm-100

100 mg

kapsula s podaljšanim sproščanjem, trda

peroralna uporaba

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

natrijev diklofenakat

Motifene-75

75 mg

modified- release kapsula, trda

peroralna uporaba

Luksemburg

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

natrijev diklofenakat

Polyflam-50

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

natrijev diklofenakat

Polyflam-75

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Luksemburg

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

natrijev diklofenakat

misoprostol

Arthrotec-50

50 mg

0,2 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Luksemburg

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

natrijev diklofenakat

misoprostol

Arthrotec-75

75 mg

0,2 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren-100 Zäpfchen

100 mg

svečka

rektalna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren-25

25 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren-50

50 mg

gastrorezistentna obložena tableta

peroralna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren injekt

75 mg

raztopina za injiciranje

intramuskularna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

holestiraminijev diklofenakat

Voltaren resinat

145,6 mg

kapsula, trda

peroralna uporaba

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren Retard-100

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Luksemburg

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

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

kalijev diklofenakat

Voltatabs

12,5 mg

obložena tableta

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

kalijev diklofenakat

Cataflam

25 mg

obložena tableta

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

kalijev diklofenakat

Cataflam

50 mg

obložena tableta

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

kalijev diklofenakat

Catafast

50 mg

prašek za peroralno raztopino

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

12,5 mg

svečka

rektalna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

50 mg

svečka

rektalna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

100 mg

svečka

rektalna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

25 mg

gastrorezistentna tableta

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

50 mg

gastrorezistentna tableta

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

50 mg

disperzibilna tableta

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Malta

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltaren

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Fenadol

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Fenadol

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

kalijev diklofenakat

Areston

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Almiral 25 mg tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Almiral 50 mg tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Almiral injection

75 mg/3 ml

raztopina za injiciranje ali infundiranje

intramuskularna uporaba, intravenska uporaba

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

natrijev diklofenakat

Olfen-75 Ampoules

75 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Olfen-25 Lactab

25 mg

filmsko obložena, gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Olfen-50 Lactab

50 mg

filmsko obložena, gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Olfen-100 Rectocaps

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Olfen-75 SR Depotabs

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Olfen-100 SR Depocaps

100 mg

kapsula s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Remethan 25 mg Tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Urigon 75 mg/3 ml solution for injection

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

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

kalijev diklofenakat

Diclofenackalium Orifarm

25 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Diclofenackalium Orifarm

50 mg

filmsko obložena tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Voltarol

12,5 mg

kapsula, mehka

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Voltarol

25 mg

kapsula, mehka

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Voltarol

12,5 mg

filmsko obložena tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Voltarol

25 mg

obložena tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Cataflam

12,5 mg

obložena tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Cataflam

50 mg

obložena tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

kalijev diklofenakat

Cataflam

50 mg

prašek za peroralno raztopino

peroralna uporaba

Norveška

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Dicuno

25 mg

filmsko obložena tableta

peroralna uporaba

Norveška

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Dicuno

50 mg

filmsko obložena tableta

peroralna uporaba

Norveška

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

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Difenassium

25 mg

filmsko obložena tableta

peroralna uporaba

Norveška

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

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Difenassium

50 mg

filmsko obložena tableta

peroralna uporaba

Norveška

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Diclofenac Actavis

12,5 mg

filmsko obložena tableta

peroralna uporaba

Norveška

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

natrijev diklofenakat

Modifenac

75 mg

modified- release kapsula, trda

peroralna uporaba

Norveška

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

kalijev diklofenakat

DiclofenacKalium ratiopharm

50 mg

filmsko obložena tableta

peroralna uporaba

Norveška

| Pfizer AS |
| --- |
| Lilleakerveien 2B |
| 1324 Lysaker |
| Norway |

Pfizer AS

Lilleakerveien 2B

1324 Lysaker

Norway

natrijev diklofenakat

misoprostol

Arthrotec

50 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Norveška

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac ratiopharm

25 mg

gastrorezistentna tableta

peroralna uporaba

Norveška

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

natrijev diklofenakat

Diclofenac ratiopharm

50 mg

gastrorezistentna tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

natrijev diklofenakat

Voltaren

25 mg

gastrorezistentna tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

natrijev diklofenakat

Voltaren

50 mg

gastrorezistentna tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

natrijev diklofenakat

Voltaren

25 mg/ml

raztopina za infundiranje /koncentrat za raztopino za infundiranje

parenteralna uporaba

Norveška

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

natrijev diklofenakat

Diclofenac BMM Pharma

25 mg

gastrorezistentna tableta

peroralna uporaba

Norveška

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

natrijev diklofenakat

Diclofenac BMM Pharma

50 mg

gastrorezistentna tableta

peroralna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

natrijev diklofenakat

Voltaren

25 mg

svečka

rektalna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

natrijev diklofenakat

Voltaren

50 mg

svečka

rektalna uporaba

Norveška

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

natrijev diklofenakat

Voltaren

100 mg

svečka

rektalna uporaba

Poljska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

natrijev diklofenakat

Vostar

12,5 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Dicloreum

50 mg

gastrorezistentna filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Dicloreum

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Dicloreum retard

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Poljska

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl retard

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

Poljska

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

natrijev diklofenakat

Dicloberl 50

50 mg

svečka

rektalna uporaba

Poljska

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

natrijev diklofenakat

Diclofenac GSK

50 mg

svečka

rektalna uporaba

Poljska

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

natrijev diklofenakat

Diclofenac GSK

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Naklofen

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Naklofen Duo

75 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Olfen 100

100 mg

rektalna kapsula

rektalna uporaba

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

natrijev diklofenakat

Olfen 50

50 mg

rektalna kapsula

rektalna uporaba

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

natrijev diklofenakat

lidokainijev klorid

Olfen 75

37,5 mg/ml

10 mg/ml

raztopina za injiciranje

intramuskularna uporaba

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

natrijev diklofenakat

Olfen 100 SR

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Olfen 25

25 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Olfen 50

50 mg

filmsko obložena tableta

peroralna uporaba

Poljska

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

natrijev diklofenakat

Voltaren Acti

12,5 mg

filmsko obložena tableta

peroralna uporaba

Poljska

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

natrijev diklofenakat

Voltaren Express

12,5 mg

kapsula, mehka

peroralna uporaba

Poljska

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

natrijev diklofenakat

Voltaren Acti Forte

25 mg

filmsko obložena tableta

peroralna uporaba

Poljska

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

natrijev diklofenakat

Voltaren Express Forte

25 mg

kapsula, mehka

peroralna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Cataflam 50

50 mg

filmsko obložena tableta

peroralna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

50 mg

gastrorezistentna tableta

peroralna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren SR 100

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren SR 75

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

50 mg

svečka

rektalna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

25 mg

svečka

rektalna uporaba

Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

natrijev diklofenakat

Voltaren

100 mg

svečka

rektalna uporaba

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

misoprostol

Arthrotec Forte

75 mg

0,2 mg

tableta

peroralna uporaba

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

natrijev diklofenakat

misoprostol

Arthrotec

50 mg

0,2 mg

tableta

peroralna uporaba

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

natrijev diklofenakat

DicloDuo

75 mg

kapsula s prirejenim sproščanjem

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

svečka

rektalna uporaba

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

svečka

rektalna uporaba

Poljska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclac

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Poljska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclac 75 Duo

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Poljska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclac 150 Duo

150 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Poljska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclac 100

100 mg

svečka

rektalna uporaba

Poljska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diclac 50

50 mg

svečka

rektalna uporaba

Poljska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

natrijev diklofenakat

Dicuno

25 mg

filmsko obložena tableta

peroralna uporaba

Poljska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

natrijev diklofenakat

Dicuno

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Difadol

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

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

natrijev diklofenakat

Majamil prolongatum

100 mg

kapsula s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Majamil PPH

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Majamil PPH

50 mg

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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

misoprostol

Arthrotec

50 mg

0,2 mg

tablet

peroralna uporaba

Portugalska

| 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

misoprostol

Arthrotec 75

75 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

svečka

rektalna uporaba

Portugalska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Portugalska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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

svečka

rektalna uporaba

Portugalska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

raztopina za injiciranje

intramuskularna uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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

raztopina za injiciranje

intramuskularna uporaba

Portugalska

| 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

svečka

rektalna uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Portugalska

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Portugalska

| 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

svečka

rektalna uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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 podaljšanim sproščanjem

peroralna uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Portugalska

| 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

svečka

rektalna uporaba

Portugalska

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Portugalska

| 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

gastrorezistentna tableta

peroralna uporaba

Portugalska

| 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 podaljšanim sproščanjem

peroralna uporaba

Portugalska

| 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 podaljšanim sproščanjem

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

filmsko obložena tableta

peroralna uporaba

Portugalska

| 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, mehka

peroralna uporaba

Portugalska

| 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, mehka

peroralna uporaba

Portugalska

| 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

peroralna uporaba

Portugalska

| 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

disperzibilna tableta

peroralna uporaba

Romunija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Romunija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Romunija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL 50 mg

50 mg

gastrorezistentna kapsula, mehka

peroralna uporaba

Romunija

| 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 podaljšanim sproščanjem

peroralna uporaba

Romunija

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenak

DICLAC® 75 ID

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Romunija

| 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 podaljšanim sproščanjem

peroralna uporaba

Romunija

| 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 podaljšanim sproščanjem

peroralna uporaba

Romunija

| 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

gastrorezistentna tableta

peroralna uporaba

Romunija

| 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

gastrorezistentna tableta

peroralna uporaba

Romunija

| 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

gastrorezistentna tableta

peroralna uporaba

Romunija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN® 50

50 mg

gastrorezistentna tableta

peroralna uporaba

Romunija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN® 25

25 mg

gastrorezistentna tableta

peroralna uporaba

Romunija

| 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

gastrorezistentna tableta

peroralna uporaba

Romunija

| 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

peroralna uporaba

Romunija

| 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

peroralna uporaba

Romunija

| 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

peroralna uporaba

Romunija

| 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

peroralna uporaba

Romunija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN®

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Romunija

| 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

raztopina za injiciranje

intramuskularna uporaba

Romunija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL®

30 mg/ml

raztopina za injiciranje

intramuskularna uporaba

Romunija

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Romunija

| 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

raztopina za injiciranje

intramuskularna uporaba

Romunija

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Romunija

| 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

raztopina za injiciranje

intramuskularna uporaba

Romunija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL 120 mg

120 mg

svečka

rektalna uporaba

Romunija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

diklofenak

TRATUL 60 mg

60 mg

svečka

rektalna uporaba

Romunija

| 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

svečka

rektalna uporaba

Romunija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN®

100 mg

svečka

rektalna uporaba

Romunija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

diklofenak

VOLTAREN®

50 mg

svečka

rektalna uporaba

Romunija

| 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

svečka

rektalna uporaba

Romunija

| 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

svečka

rektalna uporaba

Romunija

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

natrijev diklofenakat

orfenadrinijev citrat

Neodolpasse

75 mg/250 ml

30 mg/250 ml

raztopina za infundiranje

intravenska uporaba

Romunija

| PFIZER EUROPE MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PFIZER EUROPE MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

diklofenak

misoprostol

ARTHROTEC 75

75 mg

0,2 mg

gastrorezistentna tableta

peroralna uporaba

Romunija

| Lannacher Heilmittel Ges.m.b.H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

natrijev diklofenakat

tiaminijev klorid

piridoksinijev klorid

cianokobalamin

TRATUL PLUS

50 mg

50 mg

50 mg

0,25 mg

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

diklofenak

Diclac retard

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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 prirejenim sproščanjem

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

svečka

rektalna uporaba

Slovaška

| 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

svečka

rektalna uporaba

Slovaška

| 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

raztopina za injiciranje

intramuskularna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

Slovaška

| 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

raztopina za injiciranje

intramuskularna uporaba

Slovaška

| 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

zrnca

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

svečka

rektalna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

raztopina za injiciranje

intramuskularna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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

svečka

rektalna uporaba

Slovaška

| 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

gastrorezistentna tableta

peroralna uporaba

Slovaška

| 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

raztopina za injiciranje

intramuskularna uporaba

Slovaška

| 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

peroralna uporaba

Slovaška

| 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, mehka

peroralna uporaba

Slovaška

| 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, mehka

peroralna uporaba

Slovaška

| 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

peroralna uporaba

Slovaška

| 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

prašek za peroralno raztopino

peroralna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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 podaljšanim sproščanjem

peroralna uporaba

Slovaška

| 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

misoprostol

ARTHROTEC FORTE

75 mg

0,2 mg

filmsko obložena tableta

peroralna uporaba

Slovaška

| 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

raztopina za infundiranje

intravenska uporaba

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

gastrorezistentna kapsula, trda

peroralna uporaba

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

gastrorezistentna kapsula, trda

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

raztopina za injiciranje

intramuskularna uporaba

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

gastrorezistentna tableta

peroralna uporaba

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

svečka

rektalna uporaba

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, trda

peroralna uporaba

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 podaljšanim sproščanjem

peroralna uporaba

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

raztopina za infundiranje

intravenska uporaba

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 podaljšanim sproščanjem, trda

peroralna uporaba

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

svečka

rektalna uporaba

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

svečka

rektalna uporaba

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

filmsko obložena tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

VOLTAREN 100 mg supositorios

100 mg

svečka

rektalna uporaba

Španija

| 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

natrijev diklofenakat

VOLTAREN 50 mg comprimidos gastrorresistentes

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DOLO-VOLTAREN 50 mg comprimidos dispersables

50 mg

orodisperzibilna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

VOLTAREN RETARD 75 mg comprimidos de liberación modificada

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Španija

| 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

natrijev diklofenakat

VOLTAREN RETARD 100 mg comprimidos de liberación modificada

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Španija

| 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

natrijev diklofenakat

VOLTAREN 75 mg/3 ml solución inyectable

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO ALDO-UNION comprimidos EFG

50 mg

tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO RETARD STADA 100 mg comprimidos EFG

100 mg

filmsko obložena tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO STADA 50 mg comprimidos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO NORMON 50 mg comprimidos dispersables EFG

50 mg

orodisperzibilna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO NORMON 50 mg comprimidos entéricos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

natrijev diklofenakat

DOLOTREN 50 mg comprimidos gastrorresistentes

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

natrijev diklofenakat

DOLOTREN RETARD 100 mg cápsulas duras de liberación prolongada

100 mg

trda kapsula s prirejenim sproščanjem

peroralna uporaba

Španija

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

natrijev diklofenakat

DOLOTREN DISPERSABLE comprimidos

50 mg

orodisperzibilna tableta

peroralna uporaba

Španija

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

natrijev diklofenakat

DOLOTREN supositorios

100 mg

svečka

rektalna uporaba

Španija

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

natrijev diklofenakat

DOLOTREN ampollas

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Španija

| 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

natrijev diklofenakat

LUASE 50 mg comprimidos

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

natrijev diklofenakat

DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

natrijev diklofenakat

DICLOFENACO LLORENS 75 mg solución inyectable EFG

75 mg/3 ml

raztopina za injiciranje

intramuskularna uporaba

Španija

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

natrijev diklofenakat

DI-RETARD 100 mg comprimidos de liberación modificada

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Španija

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

natrijev diklofenakat

DICLOFENACO LLORENS 100 mg supositorios EFG

100 mg

svečka

rektalna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO RATIOPHARM 50 mg comprimidos

50 mg

obložena tableta

peroralna uporaba

Španija

| LABORATORIOS ALTER, S.A. |
| --- |
| Mateo Inurria, 30 |
| 28036 Madrid |
| Spain |

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

natrijev diklofenakat

DICLOFENACO ALTER 50 mg comprimidos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO PENSA 50 mg comprimidos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

natrijev diklofenakat

DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

natrijev diklofenakat

DICLOFENACO SANDOZ 100 mg supositorios EFG

100 mg

svečka

rektalna uporaba

Španija

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

natrijev diklofenakat

DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Španija

| LABORATORIOS RANBAXY, S.L. |
| --- |
| Passeig de Gracia, 9 |
| 08007 Barcelona |
| Spain |

LABORATORIOS RANBAXY, S.L.

Passeig de Gracia, 9

08007 Barcelona

Spain

natrijev diklofenakat

DICLOFENACO MUNDOGEN 50 mg comprimidos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

DICLOFENACO EDIGEN 50 mg comprimidos EFG

50 mg

gastrorezistentna tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

misoprostol

ARTROTEC

50 mg

0,2 mg

filmsko obložena tableta

peroralna uporaba

Španija

| 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

natrijev diklofenakat

misoprostol

NORMULEN

50 mg

0,2 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

natrijev diklofenakat

Voltaren®

25 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

natrijev diklofenakat

Voltaren®

50 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

kalijev diklofenakat

Voltaren® T

12,5 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

natrijev diklofenakat

Voltaren®

25 mg/ml

raztopina za injiciranje

parenteralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

kalijev diklofenakat

Voltaren® T

25 mg

obložena tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

kalijev diklofenakat

Voltaren® T

50 mg

obložena tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

kalijev diklofenakat

Voltaren® T

12,5 mg

kapsula, mehka

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

kalijev diklofenakat

Voltaren® T

25 mg

kapsula, mehka

peroralna uporaba

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

natrijev diklofenakat

Diklofenak Mylan

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diklofenak Mylan

50 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

diklofenak

misoprostol

Arthrotec

50 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Švedska

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

natrijev diklofenakat

misoprostol

Arthrotec forte

75 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Švedska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diklofenak Sandoz

25 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

natrijev diklofenakat

Diklofenak Sandoz

50 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

kalijev diklofenakat

Diclofenac T ratiopharm

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

kalijev diklofenakat

Diclofenac T ratiopharm

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Diklofenak Orifarm

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diklofenak Orifarm

50 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

kalijev diklofenakat

Eeze

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Evolan Pharma AB |
| --- |
| Box: 120 |
| 182 12 Danderyd |
| Sweden |

Evolan Pharma AB

Box: 120

182 12 Danderyd

Sweden

kalijev diklofenakat

Diklofenak T Evolan

50 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Diklofenak T Orifarm

25 mg

filmsko obložena tableta

peroralna uporaba

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

natrijev diklofenakat

Diklofenak T Orifarm

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

kalijev diklofenakat

Diklofenak T Actavis

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

kalijev diklofenakat

Diklofenak T Actavis

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

natrijev diklofenakat

Diclofenac BMM Pharma

25 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

natrijev diklofenakat

Diclofenac BMM Pharma

50 mg

gastrorezistentna tableta

peroralna uporaba

Švedska

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

kalijev diklofenakat

Instantin

50 mg

prašek za peroralno raztopino

peroralna uporaba

Švedska

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

kalijev diklofenakat

Eezeneo

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Eezeneo

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Eeze

12,5 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Dicuno

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

kalijev diklofenakat

Dicuno

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Diklotab

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Diklotab

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Diklok

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Diklok

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Kappadi

25 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

kalijev diklofenakat

Kappadi

50 mg

filmsko obložena tableta

peroralna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

natrijev diklofenakat

Voltaren®

100 mg

svečka

rektalna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

natrijev diklofenakat

Voltaren®

50 mg

svečka

rektalna uporaba

Švedska

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

natrijev diklofenakat

Voltaren®

25 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diklofenak Mylan

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diklofenak Mylan

50 mg

svečka

rektalna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis Retard 75 mg, tabletten met gereguleerde afgifte

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis 25 mg, zetpillen

25 mg

svečka

rektalna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis 50 mg, zetpillen

50 mg

svečka

rektalna uporaba

Nizozemska

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Actavis 100 mg, zetpillen

100 mg

svečka

rektalna uporaba

Nizozemska

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Diclofenac Kalium Actavis 12,5 mg, filmomhulde tabletten

12,5 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Eminocs 50 mg/ml, drank

50 mg

peroralne kapljice, raztopina

peroralna uporaba

Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Apotex retard 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Apotex 25 mg, zetpillen

25 mg

svečka

rektalna uporaba

Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Apotex 50 mg, zetpillen

50 mg

svečka

rektalna uporaba

Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Apotex 100 mg, zetpillen

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclofenac Na CF 25 mg/ml, oplossing voor injectie

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

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

natrijev diklofenakat

Diclofenac Na CF 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenac Na CF 50 mg, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenac Na zetpil CF 50 mg, zetpillen

50 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclofenac Na zetpil CF 100 mg, zetpillen

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclofenac Na retard CF 75 mg, tabletten met gereguleerde afgifte

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

Diclofenac Na retard CF 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar EC 25, maagsapresistente tabletten 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar EC 50, maagsapresistente tabletten 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar Retard 75, tabletten met gereguleerde afgifte 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar Retard 100, tabletten met gereguleerde afgifte 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar 25, zetpillen 25 mg

25 mg

svečka

rektalna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar 50, zetpillen 50 mg

50 mg

svečka

rektalna uporaba

Nizozemska

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Disphar 100, zetpillen 100 mg

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclofenacnatrium Manston 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenacnatrium Manston 50 mg, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenacnatrium retard Manston 100 mg, maagsapresistente tabletten

100 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Marel B.V. |
| --- |
| Archimedesweg 2 |
| 2333 CN Leiden |
| The Netherlands |

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

kalijev diklofenakat

Kruidvat Diclofenac kalium 12,5 mg, filmomhulde tabletten

12,5 mg

filmsko obložena tableta

peroralna uporaba

Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 50 mg, zetpillen

50 mg

svečka

rektalna uporaba

Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 100 mg, zetpillen

100 mg

svečka

rektalna uporaba

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

kalijev diklofenakat

Voltaren K 12,5 mg, filmomhulde tabletten

12,5 mg

filmsko obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Voltaren K 25 mg, omhulde tabletten

25 mg

obložena tableta

peroralna uporaba

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

kalijev diklofenakat

Otriflu, omhulde tabletten 12,5 mg

12,5 mg

obložena tableta

peroralna uporaba

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

natrijev diklofenakat

Voltaren 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

natrijev diklofenakat

Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

kalijev diklofenakat

Cataflam 50, omhulde tabletten 50 mg

50 mg

obložena tableta

peroralna uporaba

Nizozemska

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

natrijev diklofenakat

Voltaren Retard 75 mg, tabletten met verlengde afgifte

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

misoprostol

Arthrotec 50, tabletten

50 mg

tableta s prirejenim sproščanjem

peroralna uporaba

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

natrijev diklofenakat

misoprostol

Arthrotec 75, tabletten 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 25 PCH, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 50 PCH, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 25 PCH, zetpillen 25 mg

25 mg

svečka

rektalna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 50 PCH, zetpillen 50 mg

50 mg

svečka

rektalna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 100 PCH, zetpillen 100 mg

100 mg

svečka

rektalna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenac Na retard 75 PCH, tabletten met gereguleerde afgifte 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenac Na Retard 100 PCH tabletten met gereguleerde afgifte 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Pharmacin 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Pharmacin 50 mg, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

natrijev diklofenakat

Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

natrijev diklofenakat

Diclofenac Na ratiopharm retard 75 mg, tabletten met gereguleerde afgifte

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Sandoz retard 75, tabletten met gereguleerde afgite 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

natrijev diklofenakat

Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Nizozemska

| Teva Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 25 mg Teva, zetpilen

25 mg

svečka

rektalna uporaba

Nizozemska

| Teva Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 50 mg Teva, zetpilen

50 mg

svečka

rektalna uporaba

Nizozemska

| Teva Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

natrijev diklofenakat

Diclofenacnatrium 100 mg Teva, zetpilen

100 mg

svečka

rektalna uporaba

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

natrijev diklofenakat

Diclofenacnatrium 25 mg, maagsapresistente tabletten

25 mg

gastrorezistentna tableta

peroralna uporaba

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

natrijev diklofenakat

Diclofenacnatrium 50 mg, maagsapresistente tabletten

50 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

kalijev diklofenakat

Voltarol Pain-Eze Extra Strength Tablets

25 mg

obložena tableta

peroralna uporaba

Združeno kraljestvo

| 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

kalijev diklofenakat

Voltarol Pain-Eze Tablets

12,5 mg

obložena tableta

peroralna uporaba

Združeno kraljestvo

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

natrijev diklofenakat

Arthrotec 50 Modified-Release tablets

50 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

natrijev diklofenakat

Arthrotec 75 Modified-Release tablets

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Injection 75 mg/3 ml

75 mg

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

prosta kislina diklofenaka

Voltarol Dispersible Tablets 50 mg

46,5 mg

tableta za peroralno raztopino

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Retard Tablets 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol SR Tablets

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Suppositories 12,5 mg

12,5 mg

svečka

rektalna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Suppositories 25 mg

25 mg

svečka

rektalna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Suppositories 50 mg

50 mg

svečka

rektalna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Suppositories 100 mg

100 mg

svečka

rektalna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Tablets 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Tablets 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Rapid Tablets 25 mg

25 mg

obložena tableta

peroralna uporaba

Združeno kraljestvo

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

natrijev diklofenakat

Voltarol Rapid Tablets 50 mg

50 mg

obložena tableta

peroralna uporaba

Združeno kraljestvo

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon EX32 8NS |
| United Kingdom |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon EX32 8NS

United Kingdom

natrijev diklofenakat

Flamatak MR Tablets 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Teva UK Diclofenac Sodium Tablets 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Teva UK Diclofenac Sodium Tablets 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| Chatfield Pharmaceuticals Limited |
| --- |
| Kramer Mews |
| London SW5 9JL |
| United Kingdom |

Chatfield Pharmaceuticals Limited

Kramer Mews

London SW5 9JL

United Kingdom

natrijev diklofenakat

Chatfield Pharms Diclofenac Sodium Tablets 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Antigen Diclofenac Sodium Injection 2.5 % w/v

75 mg

raztopina za injiciranje

intramuskularna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Lagap Pharms Diclofenac Tablets 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Lagap Pharms Diclofenac Tablets 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Sandoz Ltd Rhumalgan SR Modified Release Capsules 75 mg

75 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Združeno kraljestvo

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

natrijev diklofenakat

Sandoz Ltd Rhumalgan XL Modified Release Capsules 100 mg

100 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Združeno kraljestvo

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

natrijev diklofenakat

Generics UK Diclofenac Sodium Tablets 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

natrijev diklofenakat

Generics UK Diclofenac Sodium Tablets 50 mg

50 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Rheumatac Retard Tablets 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Motifene Capsules 75 mg

75 mg

kapsula s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Volsaid Retard Tablets 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Volsaid Retard Tablets 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Econac Suppositories 100 mg

100 mg

svečka

rektalna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Econac Injection 75 mg/3 ml

75 mg

raztopina za injiciranje

intramuskularna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Mercury Pharms Diclofenac Solution for Injection 75 mg/3 ml

75 mg

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Mercury Pharms Econac SR Prolonged Release Tablet 75 mg

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Mercury Pharms Econac XL Prolonged Release Tablet 100 mg

100 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Mercury Pharms Diclofenac Sodium Tablets 25 mg

25 mg

tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Mercury Pharms Diclofenac Sodium Tablets 75 mg

50 mg

tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Diclo-XL 100

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Diclo-SR 75

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100 mg

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75 mg

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Dexcel-Pharma Diclofenac Sodium Tablets 25 mg

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Dexcel-Pharma Diclofenac Sodium Tablets 75 mg

75 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Volraman 25 mg Gastro-resistant tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Volraman 50 mg Gastro-resistant tablets

50 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

kalijev diklofenakat

Adacium Rapid 50 mg Tablets

50 mg

filmsko obložena tableta

peroralna uporaba

Združeno kraljestvo

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

natrijev diklofenakat

misoprostol

Misofen 50 mg/200 mcg modified released tablets

50 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

natrijev diklofenakat

misoprostol

Misofen 75 mg/200 mcg modified released tablets

75 mg

0,2 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Dyloject 75 mg/2 ml solution for injection

75 mg/2 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

Združeno kraljestvo

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

natrijev diklofenakat

Diclomax SR

75 mg

kapsula s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

natrijev diklofenakat

Diclomax Retard

100 mg

kapsula s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Doble action pain relief

12,5 mg

tableta

peroralna uporaba

Združeno kraljestvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Diclofenac potassium 12,5 mg Tablets

12,5 mg

tableta

peroralna uporaba

Združeno kraljestvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Diclofenac potassium 25 mg Tablets

25 mg

filmsko obložena tableta

peroralna uporaba

Združeno kraljestvo

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

kalijev diklofenakat

Diclofenac potassium 50 mg Tablets

50 mg

filmsko obložena tableta

peroralna uporaba

Združeno kraljestvo

| Chelonia Healthcare Limited |
| --- |
| Boumpoulinas 11 |
| 3rd, Nicosia |
| CY-1060 |
| Cyprus |

Chelonia Healthcare Limited

Boumpoulinas 11

3rd, Nicosia

CY-1060

Cyprus

natrijev diklofenakat

Diclofenac sodium 25 mg Tablets

25 mg

gastrorezistentna tableta

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Slofenac 75 mg SR

75 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

natrijev diklofenakat

Slofenac 100 mg SR

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

natrijev diklofenakat

Enstar SR 75 mg Tablets

75 mg

tableta s podaljšanim sproščanjem

peroralna uporaba

Združeno kraljestvo

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

natrijev diklofenakat

Enstar XL 100 mg Tablets

100 mg

tableta s prirejenim sproščanjem

peroralna uporaba

Združeno kraljestvo

| 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

kalijev diklofenakat

Diclofenac potassium 12,5 mg Tablets

12,5 mg

filmsko obložena tableta

peroralna uporaba

Združeno kraljestvo

| 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

kalijev diklofenakat

Diclofenac potassium 25 mg Tablets

25 mg

filmsko obložena tableta

peroralna uporaba

Združeno kraljestvo

| 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

kalijev diklofenakat

Diclofenac potassium 50 mg Tablets

50 mg

filmsko obložena tableta

peroralna uporaba

---

PRILOGA X

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica (v EGP) | Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | WABOSAN |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Avstrija |

Država članica (v EGP)

Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Avstrija

Ergomed retard - Kapseln

2,5 mg (1:1:1)

kapsula s podaljšanim sproščanjem, mehka

peroralna uporaba

Avstrija

| WABOSAN |
| --- |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Avstrija |

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Avstrija

Ergomed - Tropfen

1 mg/ml (1:1:1)

peroralne kapljice, raztopina

peroralna uporaba

Češka republika

| TEVA Czech Industries s.r.o. |
| --- |
| Ostravská 29 |
| 747 70 Opava-Komárov |
| Češka republika |

TEVA Czech Industries s.r.o.

Ostravská 29

747 70 Opava-Komárov

Češka republika

ERSILAN

1mg/ml

peroralne kapljice, raztopina

peroralna uporaba

Francija

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Francija |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Francija

ISKEDYL FORT, comprimé

2,40 mg/19,20 mg

tableta

peroralna uporaba

Francija

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Francija |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Francija

ISKEDYL, comprimé

0,60 mg / 4,80 mg

tableta

peroralna uporaba

Francija

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Francija |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Francija

ISKEDYL, solution buvable en flacon

0,10 g / 0,80 g

peroralna raztopina

peroralna uporaba

Francija

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Francija |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Francija

ISKEDYL, solution injectable en ampoule

0,3125 mg /6,25 mg

raztopina za injekcije

IV/IM

Grčija

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Grčija |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Grčija

DIERTINA

3 mg/kap

kapsule, mehke

peroralna uporaba

Grčija

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Grčija |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Grčija

DIERTINA

6 MG/ENKRATNI ODMEREK

prašek za peroralno raztopino za enkratni odmerek

peroralna uporaba

Grčija

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Grčija |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Grčija

DIERTINA

6 MG/TAB

tableta

peroralna uporaba

Grčija

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, |
| GLYFADA, 16674 |
| Grčija |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150,

GLYFADA, 16674

Grčija

ERGOFIL

6 MG/TAB

tableta

peroralna uporaba

Grčija

| GENEPHARM A.E. |
| --- |
| 18TH Km MARATHONOS |
| AVENUE, PALLINI, |
| ATTIKIS, 15351 |
| Grčija |

GENEPHARM A.E.

18TH Km MARATHONOS

AVENUE, PALLINI,

ATTIKIS, 15351

Grčija

MEMOTIL / GENEPHARM

6 MG/TAB

tableta

peroralna uporaba

Grčija

| ANTOR LTD |
| --- |
| P. MAVROMIHALI 1 |
| VRILISSIA 15235 |
| Grčija |

ANTOR LTD

P. MAVROMIHALI 1

VRILISSIA 15235

Grčija

THRIOLAN

6 MG/TAB

tableta

peroralna uporaba

Grčija

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, |
| ARGYROUPOLI, 16452 |
| Grčija |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22,

ARGYROUPOLI, 16452

Grčija

FENITINA

6 MG/TAB

tableta

peroralna uporaba

Grčija

| PHARMACEUTICAL INDUSTRY PROEL EPAM. |
| --- |
| G. KORONIS |
| DILOU 9, PERISTERI, |
| ATTIKIS, 12134 |
| Grčija |

PHARMACEUTICAL INDUSTRY PROEL EPAM.

G. KORONIS

DILOU 9, PERISTERI,

ATTIKIS, 12134

Grčija

BEYTINA

6 MG/TAB

tableta

peroralna uporaba

Grčija

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, |
| GERAKAS, 15344 |
| Grčija |

FINIXFARM EPE

DERVENAKION 38 & SAHINI,

GERAKAS, 15344

Grčija

CRISTIL

6 MG/TAB

tableta

peroralna uporaba

Grčija

| S.J.A. PHARM O.E. |
| --- |
| ARKOLEON 11, KATO. |
| PATISSIA, 10445 |
| Grčija |

S.J.A. PHARM O.E.

ARKOLEON 11, KATO.

PATISSIA, 10445

Grčija

AGIOBITA

6 MG/TAB

tableta

peroralna uporaba

Luksemburg

| Pierre Fabre Médicaments |
| --- |
| 45, PLACE ABEL GANCE |
| F 92654 BOULOGNE |
| CEDEX |
| Francija |

Pierre Fabre Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE

CEDEX

Francija

Iskedyl Fort

2,40 mg/19,20 mg

tablete

peroralna uporaba

Portugalska

| Daiichi Sankyo |
| --- |
| Portugal,Lda. PRT |
| Lagoas Park, Edifício 11 |
| 2740-270 Porto Salvo |
| Portugalska |

Daiichi Sankyo

Portugal,Lda. PRT

Lagoas Park, Edifício 11

2740-270 Porto Salvo

Portugalska

Diertina

3 mg

Trda kapsula

peroralna uporaba

Španija

| LABORATORIOS DAVUR, S.L. |
| --- |
| Teide, 4 - planta baja Polígono Empresarial La Marina |
| 28703 San Sebastian de los Reyes (Madrid) |
| Španija |

LABORATORIOS DAVUR, S.L.

Teide, 4 - planta baja Polígono Empresarial La Marina

28703 San Sebastian de los Reyes (Madrid)

Španija

ERGODAVUR GOTAS

1 mg (vrečka z enkratnim odmerkom)

Peroralne kapljice, raztopina

peroralna uporaba

Španija

| TORA LABORATORIES |
| --- |
| S.L. Ferraz 80, 5o |
| 28008 Madrid |
| Španija |

TORA LABORATORIES

S.L. Ferraz 80, 5o

28008 Madrid

Španija

DIERTINE FORTE

2 mg/ ml

Peroralne kapljice, raztopina

peroralna uporaba

---

PRILOGA XI

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  (v EGP) | Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Francija | CHIESI |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| Francija |

Država članica

(v EGP)

Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Francija

CHIESI

11, avenue Dubonnet

92400 Courbevoie

Francija

VASOBRAL, zarezo tableta

4 mg/40 mg

tableta

peroralna uporaba

Francija

| CHIESI |
| --- |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| Francija |

CHIESI

11, avenue Dubonnet

92400 Courbevoie

Francija

VASOBRAL, peroralna raztopina v viali

0.10 g/1 g na 100 ml

peroralna raztopina

peroralna uporaba

---

PRILOGA XII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Kwizda Pharma GmbH |
| Effingergasse 21 |
| 1160 Vienna |
| Avstrija |

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Avstrija

Ergotop 10 mg - Tabletten

10 mg

tableta

peroralna uporaba

Avstrija

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Avstrija |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Avstrija

Ergotop 20 mg - Filmtabletten

20 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Avstrija |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Avstrija

Ergotop 30 mg - Filmtabletten

30 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

| Rösch & Handel |
| --- |
| Scheringgasse 2/Objekt 2 |
| 1140 Vienna |
| Avstrija |

Rösch & Handel

Scheringgasse 2/Objekt 2

1140 Vienna

Avstrija

Nicergin - Filmtabletten

30 mg

filmsko obložena tableta

peroralna uporaba

Avstrija

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Vienna |
| Avstrija |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Avstrija

Sermion 30 mg - Filmtabletten

30 mg

filmsko obložena tableta

peroralna uporaba

Bolgarija

| 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

prašek in vehikel za raztopino za injiciranje

intramuskularna in intravenska uporaba

Bolgarija

| 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

filmsko obložena tableta

peroralna uporaba

Češka

| Pfizer, spol. s r.o., Praha |
| --- |
| Stroupežnického 17 |
| 150 00 Prague 5 |
| Češka |

Pfizer, spol. s r.o., Praha

Stroupežnického 17

150 00 Prague 5

Češka

SERMION

30mg

filmsko obložena tableta

peroralna uporaba

Francija

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

Francija

SERMION 10 mg, gélule

10 mg

kapsula, trda

peroralna uporaba

Francija

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

Francija

SERMION 5 mg, gélule

5 mg

kapsula, trda

peroralna uporaba

Francija

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

Francija

SERMION 5 mg, poudre pour solution pour perfusion

5 mg

prašek za raztopino za infundiranje

intravenska uporaba

Francija

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francija |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francija

NICERGOLINE BIOGARAN 10 mg, gélule

10 mg

kapsula, trda

peroralna uporaba

Francija

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francija |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francija

NICERGOLINE BIOGARAN 5 mg, gélule

5 mg

kapsula, trda

peroralna uporaba

Francija

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francija

NICERGOLINE EG 10 mg, gélule

10 mg

kapsula, trda

peroralna uporaba

Francija

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francija

NICERGOLINE EG 5 mg, gélule

5 mg

kapsula, trda

peroralna uporaba

Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

NICERGOLINE MYLAN 10 mg, gélule

10 mg

kapsula, trda

peroralna uporaba

Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

NICERGOLINE MYLAN 5 mg, gélule

5 mg

kapsula, trda

peroralna uporaba

Francija

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

Francija

NICERGOLINE QUALIMED 10 mg, gélule

10 mg

kapsula, trda

peroralna uporaba

Francija

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

Francija

NICERGOLINE QUALIMED 5 mg, gélule

5 mg

kapsula, trda

peroralna uporaba

Francija

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| Francija |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

Francija

NICERGOLINE TEVA 10 mg, gélule

10 mg

kapsula, trda

peroralna uporaba

Francija

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| Francija |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

Francija

NICERGOLINE TEVA 5 mg, gélule

5 mg

kapsula, trda

peroralna uporaba

Madžarska

| Pfizer Kft. |
| --- |
| Alkotás u. 53., MOM Park F épület |
| 1123 Budapest |
| Madžarska |

Pfizer Kft.

Alkotás u. 53., MOM Park F épület

1123 Budapest

Madžarska

SERMION 30 mg filmtabletta

30 mg

filmsko obložena tableta

peroralna uporaba

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

10 mg/ml

prašek in vehikel za peroralno raztopino

peroralna uporaba

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

5 mg

obložena tableta

peroralna uporaba

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

10 mg

obložena tableta

peroralna uporaba

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

30 mg

filmsko obložena tableta

peroralna uporaba

Italija

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italija |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italija

SERMION

30 mg

tableta za peroralno raztopino

peroralna uporaba

Italija

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italija |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italija

NICERGOLINA ANGENERICO

10 mg/ml

prašek in vehikel za peroralno raztopino

peroralna uporaba

Italija

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italija |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italija

NICERGOLINA ANGENERICO

30 mg

tableta

peroralna uporaba

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

šumeča tableta

peroralna uporaba

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

peroralna uporaba

Italija

| EG spa |
| --- |
| Via Scarlatti Domenico, |
| 31 20124 Milano |
| Italija |

EG spa

Via Scarlatti Domenico,

31 20124 Milano

Italija

NICERGOLINA EG

30 mg

tableta

peroralna uporaba

Latvija

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenija |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

10 mg

filmsko obložena tableta

peroralna uporaba

Latvija

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenija |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

30 mg

kapsula, trda

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba intravenska uporaba

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

peroralna uporaba

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

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

Litva

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenija |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

30 mg

kapsula, trda

peroralna uporaba

Litva

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenija |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenija

Nicerium

10 mg

filmsko obložena tableta

peroralna uporaba

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

peroralna uporaba

Poljska

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| CT13 9 NJ Kent, Sandwich |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road

CT13 9 NJ Kent, Sandwich

Velika Britanija

Nicergolin

10 mg

obložena tableta

peroralna uporaba

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

prašek in vehikel za raztopino za injiciranje

intramuskularna uporaba intravenska uporaba

Portugalska

| Laboratórios Pfizer, |
| --- |
| Lda. PRT Lagoas Park, |
| Edifício 10 Porto Salvo |
| Portugalska |

Laboratórios Pfizer,

Lda. PRT Lagoas Park,

Edifício 10 Porto Salvo

Portugalska

Sermion 30

30 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romunija |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romunija

NICERGOLINA LPH 5 mg

5 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romunija |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romunija

NICERGOLINA LPH 10 mg

10 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romunija |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romunija

NICERGOLINA LPH 30 mg

30 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romunija |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romunija

GRALIN 5 mg

5 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romunija |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romunija

GRALIN 10 mg

10 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romunija |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romunija

GRALIN 30 mg

30 mg

filmsko obložena tableta

peroralna uporaba

Romunija

| HEXAL AG |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Nemčija |

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Nemčija

NICERIUM® 10

10 mg

obložena tableta

peroralna uporaba

Romunija

| Hexal AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Nemčija |

Hexal AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Nemčija

NICERIUM® 15

15 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Romunija

| HEXAL AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Nemčija |

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Nemčija

NICERIUM® 30 UNO

30 mg

kapsula s prirejenim sproščanjem, trda

peroralna uporaba

Španija

| PFIZER, S.L. |
| --- |
| Avenida de Europa, |
| 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) |
| Španija |

PFIZER, S.L.

Avenida de Europa,

20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)

Španija

SERMION 5 mg

5 mg

obložena tableta

peroralna uporaba

---

PRILOGA XIII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica
  (v EGP) | Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Boehringer Ingelheim |
| RCV GmbH & Co KG, |
| Dr. Boehringer-Gasse 5-11, |
| A-1121 Vienna |
| Austria |

Država članica

(v EGP)

Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Boehringer Ingelheim

RCV GmbH & Co KG,

Dr. Boehringer-Gasse 5-11,

A-1121 Vienna

Austria

Effortil comp. - Tropfen

2 mg/ml, 10 mg/ml

peroralne kapljice, raztopina

peroralna uporaba

Avstrija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Avstrija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Avstrija

Amdipharm Ltd.

3, Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot 2,5 mg - Tabletten

2,5 mg

tableta

peroralna uporaba

Avstrija

| 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

peroralne kapljice, raztopina

peroralna uporaba

Avstrija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Avstrija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Belgija

| Amdipharm Limited |
| --- |
| Burlington Road, 3 |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Burlington Road, 3

Dublin 4

Ireland

Dihydergot Forte

2,5 mg

tableta

peroralna uporaba

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

peroralna uporaba

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

peroralna uporaba

Francija

| 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 podaljšanim sproščanjem

peroralna uporaba

Francija

| 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

peroralne kapljice, raztopina

peroralna uporaba

Francija

| 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

peroralna raztopina

peroralna uporaba

Francija

| 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

trda kapsula

peroralna uporaba

Francija

| 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

peroralni liofilizat

peroralna uporaba

Francija

| 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

mehka kapsula

peroralna uporaba

Francija

| 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

peroralna raztopina

peroralna uporaba

Francija

| 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

peroralna uporaba

Nemčija

| 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

raztopina

peroralna uporaba

Nemčija

| 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

raztopina

peroralna uporaba

Nemčija

| 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

raztopina

peroralna uporaba

Nemčija

| 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 podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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 podaljšanim sproščanjem

peroralna uporaba

Nemčija

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Nemčija

| 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

raztopina

peroralna uporaba

Grčija

| 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

peroralna uporaba

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

peroralna raztopina

peroralna uporaba

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

peroralna uporaba

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 prirejenim sproščanjem, trda

peroralna uporaba

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

peroralna raztopina

peroralna uporaba

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

tableta

peroralna uporaba

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

peroralna raztopina

peroralna uporaba

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

peroralna uporaba

Portugalska

| 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 podaljšanim sproščanjem, trda

peroralna uporaba

Slovenija

| LEK farmacevtska |
| --- |
| družba d.d., |
| Verovškova 57, |
| SI-1526 Ljubljana, |
| Slovenia |

LEK farmacevtska

družba d.d.,

Verovškova 57,

SI-1526 Ljubljana,

Slovenia

Ditamin 2,5 mg tablete

2,5 mg

tableta

peroralna uporaba

Španija

| 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

peroralna uporaba

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

tableta

peroralna uporaba

Švedska

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

5 mg

tableta

peroralna uporaba

---