# Il-Ġurnal Uffiċjali C 311/2013

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2013.311.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 311 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5625 ta' Ottubru 2013 |

ISSN 1977-0987

doi:10.3000/19770987.C_2013.311.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 311

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5625 ta' Ottubru 2013

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2013/C 311/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Settembru 2013 sat-30 ta’ Settembru 2013(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2013/C 311/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Settembru 2013 sat-30 ta’ Settembru 2013(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 8 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2013/C 311/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Settembru 2013 sat-30 ta’ Settembru 2013(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

2013/C 311/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Settembru 2013 sat-30 ta’ Settembru 2013(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

8

| MT | |
| --- | --- |

MT

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 25.10.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 311/1 |
| --- | --- | --- | --- |

25.10.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 311/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Settembru 2013 sat-30 ta’ Settembru 2013

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1)
  )

2013/C 311/01

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.9.2013 | Procysbi | merkaptamina (ċisteamina bitartrat) | Raptor Pharmaceuticals Europe BV |
| Naritaweg 165, NL-1043 BW Amsterdam, Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

6.9.2013

Procysbi

merkaptamina (ċisteamina bitartrat)

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/13/861

Kapsula gastro-reżistenti, iebsa

A16AA04

10.9.2013

6.9.2013

Provenge

Ċelloli mononukleari tad-demm periferali awtologu attivati b'PAP-GM-CSF (Sipuleucel-T)

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

Dendreon UK Limited

41 Chalton Street, London NW1 1JD, United Kingdom

EU/1/13/867

Dispersjoni għal infużjoni

L03AX17

10.9.2013

10.9.2013

Inflectra

Infliximab

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

Hospira UK Limited

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

EU/1/13/854

Trab għal konċentrat għal soluzzjoni għall-infużjoni

L04AB02

12.9.2013

10.9.2013

Remsima

Infliximab

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

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

Trab għal konċentrat għal soluzzjoni għall-infużjoni

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

Konċentrat għal soluzzjoni għal infużjoni

Pending

16.9.2013

12.9.2013

Orphacol

Cholic acid

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

Laboratoires CTRS (Cell Therapies Research & Services)

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

EU/1/13/870

Kapsula, iebsa

A05AA03

16.9.2013

19.9.2013

Incresync

alogliptin / pioglitazone

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

Takeda Pharma A/S

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

EU/1/13/842

Pillola miksija b’rita

A10BD09

23.9.2013

19.9.2013

Tybost

cobicistat

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/872

Pillola miksija b’rita

V03AX03

23.9.2013

19.9.2013

Ultibro Breezhaler

indacaterol/glycopyrronium bromide

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

Novartis Europharm Limited

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

EU/1/13/862

Trab li jittieħed man-nifs, kapsula iebsa

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

Pillola miksija b’rita

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

Pillola miksija b’rita

A10BH04

23.9.2013

19.9.2013

Xoterna Breezhaler

indacaterol/glycopyrronium bromide

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

Novartis Europharm Limited

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

EU/1/13/863

Trab li jittieħed man-nifs, kapsula iebsa

R03AL04

23.9.2013

25.9.2013

EVARREST

Fibrinoġen Uman / Trombina Umana

| 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

Matriċi Siġillanti

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

Pillola miksija b’rita

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, iebsa

L01XE01

27.9.2013

27.9.2013

Ovaleap

Follitropin alfa

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/13/871

Soluzzjoni għall-injezzjoni

G03GA05

1.10.2013

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 6.9.2013 | Labazenit | LABORATOIRES SMB SA |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

6.9.2013

Labazenit

LABORATOIRES SMB SA

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

—

10.9.2013

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Neulasta | Amgen Europe B.V. |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

—   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.9.2013 | Rasitrio | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

3.9.2013

Rasitrio

Novartis Europharm Limited

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

EU/1/11/730

5.9.2013

Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (2)
  ): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.9.2013 | Apoquel | oclacitinib maleate | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

12.9.2013

Apoquel

oclacitinib maleate

Zoetis Belgium S.A.

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

EU/2/13/154

Pillola miksija b’rita

QD11AH90

16.9.2013

19.9.2013

Trifexis

Spinosad / Milbemycin oxime

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

Eli Lilly and Company Ltd

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

EU/2/13/155

Pilloli li tomgħodhom

QP54AB51

23.9.2013

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 12.9.2013 | Equip WNV | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

—   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 19.9.2013 | Netvax | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

19.9.2013

Netvax

Intervet International B.V.

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

EU/2/09/093

23.9.2013

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| 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)  ĠU L 136, 30.4.04, p. 1.

(2)  ĠU L 136, 30.4.04, p. 1.

---

| 25.10.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 311/8 |
| --- | --- | --- | --- |

25.10.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 311/8

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Settembru 2013 sat-30 ta’ Settembru 2013

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1)
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
   (2)
  )

2013/C 311/02

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 5.9.2013 | Okrido | Ara l-Anness I | Ara l-Anness I | 6.9.2013 |
| 24.9.2013 | Deltanil | Ara l-Anness II | Ara l-Anness II | 26.9.2013 |
| 13.9.2013 | Iron | Ara l-Anness III | Ara l-Anness III | 16.9.2013 |
| 18.9.2013 | Aprotinin | Ara l-Anness IV | Ara l-Anness IV | 19.9.2013 |
| 25.9.2013 | Cydectin | Ara l-Anness V | Ara l-Anness V | 26.9.2013 |
| 12.9.2013 | Targocid | Ara l-Anness VI | Ara l-Anness VI | 13.9.2013 |
| 5.9.2013 | Flupirtine | Ara l-Anness VII | Ara l-Anness VII | 6.9.2013 |
| 6.9.2013 | Doramectin | Ara l-Anness VIII | Ara l-Anness VIII | 9.9.2013 |
| 25.9.2013 | Diclofenac | Ara l-Anness IX | Ara l-Anness IX | 26.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | Ara l-Anness X | Ara l-Anness X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | Ara l-Anness XI | Ara l-Anness XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | Ara l-Anness XII | Ara l-Anness XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | Ara l-Anness XIII | Ara l-Anness XIII | 30.9.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

5.9.2013

Okrido

Ara l-Anness I

Ara l-Anness I

6.9.2013

24.9.2013

Deltanil

Ara l-Anness II

Ara l-Anness II

26.9.2013

13.9.2013

Iron

Ara l-Anness III

Ara l-Anness III

16.9.2013

18.9.2013

Aprotinin

Ara l-Anness IV

Ara l-Anness IV

19.9.2013

25.9.2013

Cydectin

Ara l-Anness V

Ara l-Anness V

26.9.2013

12.9.2013

Targocid

Ara l-Anness VI

Ara l-Anness VI

13.9.2013

5.9.2013

Flupirtine

Ara l-Anness VII

Ara l-Anness VII

6.9.2013

6.9.2013

Doramectin

Ara l-Anness VIII

Ara l-Anness VIII

9.9.2013

25.9.2013

Diclofenac

Ara l-Anness IX

Ara l-Anness IX

26.9.2013

27.9.2013

Ergot derivatives (dihydroergocristine)

Ara l-Anness X

Ara l-Anness X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

Ara l-Anness XI

Ara l-Anness XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

Ara l-Anness XII

Ara l-Anness XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

Ara l-Anness XIII

Ara l-Anness XIII

30.9.2013

—   Sospensjoni ta' awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 27.9.2013 | Ergot derivatives (dihydroergocristine) | Ara l-Anness X | Ara l-Anness X | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergocryptine) | Ara l-Anness XI | Ara l-Anness XI | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (nicergoline) | Ara l-Anness XII | Ara l-Anness XII | 30.9.2013 |
| 27.9.2013 | Ergot derivatives (dihydroergotamine) | Ara l-Anness XIII | Ara l-Anness XIII | 30.9.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

27.9.2013

Ergot derivatives (dihydroergocristine)

Ara l-Anness X

Ara l-Anness X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

Ara l-Anness XI

Ara l-Anness XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

Ara l-Anness XII

Ara l-Anness XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

Ara l-Anness XIII

Ara l-Anness XIII

30.9.2013

—   Tneħħija ta' sospensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 18.9.2013 | Aprotinin | Ara l-Anness IV | Ara l-Anness IV | 19.9.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

18.9.2013

Aprotinin

Ara l-Anness IV

Ara l-Anness IV

19.9.2013

---

(1)  ĠU L 311, 28.11.01, p. 67.

(2)  ĠU L 311, 28.11.01, p. 1.

---

ANNESS I

LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL-PRODOTT(I) MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT(I) / ID-DETENTUR(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | L-Applikant | Isem Ivvintat Isem | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Ġermanja | | Pharmapol Arzneimittelvertrieb-GmbH, |
| Kaddenbusch 11, 25578 Daegeling, |
| Germany |

Stat Membru

EU/EEA

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

L-Applikant

Isem Ivvintat Isem

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut (Konċentrat)

Ġermanja

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Soluzzjoni orali

Użu orali

Olanda

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

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Soluzzjoni orali

Użu orali

Ir-Renju Unit

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

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Soluzzjoni orali

Użu orali

---

ANNESS II

LISTA TA' ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI VETERINARJI, RAZEZ TAL-ANNIMALI, MOD TA' AMMINISTRAZZJONI, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru tal-UE/ŻEE | Applikant | Isem | INN | Qawwa | Għamla farmaċewtika | Speċi tal- annimali | Mod ta' amministrazzj oni |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Virbac |
| 1'ere Avenue, 2065m - LID |
| 06516 Carros CEDEX FRANCE |

Stat Membru tal-UE/ŻEE

Applikant

Isem

INN

Qawwa

Għamla farmaċewtika

Speċi tal- annimali

Mod ta' amministrazzj oni

Austria

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Belgium

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Belgium

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Soluzzjoni Spot-on

Għall-ifrat

Topical use

Bulgaria

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Cyprus

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Czech Republic

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Denmark

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Estonia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, kriipsususpensioon veistele ja lammastele

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

France

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

France

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Soluzzjoni Spot-on

Għall-ifrat

Topical use

Germany

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Germany

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Lösung zum Auftropfen für Rinder

Deltamethrin

10 mg/ml

Soluzzjoni Spot-on

Għall-ifrat

Topical use

Greece

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Hungary

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Iceland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Ireland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Italy

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Latvia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Lithuania

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Luxembourg

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

The Netherlands

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

The Netherlands

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Oplossing voor runderen

Deltamethrin

10 mg/ml

Soluzzjoni Spot-on

Għall-ifrat

Topical use

Poland

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Portugal

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Romania

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Slovakia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Slovenia

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

Spain

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

United Kingdom

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

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

Deltamethrin

10 mg/ml

Soluzzjoni għat- tferrigħ

Għall-ifrat u n-nagħaġ

Topical use

United Kingdom

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

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Solution for cattle

Deltamethrin

10 mg/ml

Soluzzjoni Spot-on

Għall-ifrat

Topical use

---

ANNESS III

LISTA TA’ ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  (fiż-ŻEE) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | INN | Isem ivvintat | Qawwa | Għamla farmaċewtika | Mnejn għandu jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Pharmacosmos A/S |
| Roervangsvej 30 |
| Holbaek DK-4300 |
| Denmark |

Stat Membru

(fiż-ŻEE)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

INN

Isem ivvintat

Qawwa

Għamla farmaċewtika

Mnejn għandu jingħata

L-Awstrija

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

L-Awstrija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Awstrija

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Awstrija

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Awstrija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Awstrija

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Belġju

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Cosmofer

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Belġju

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Belġju

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Belġju

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Bulgarija

| 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 (as Ferric carboxymaltose)

Ferinject

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Bulgarija

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ċipru

| 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 (as carboxymaltosum ferricum)

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ċipru

| 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 100 mg/ml

100 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ċipru

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ċipru

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ċipru

| 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 (as ferri oxidum saccharatum)

FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 mg/ml

20 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| 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 (as ferri oxidum saccharatum)

VENOFER

20 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| 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 (as ferri oxidum saccharatum)

FERROLOGIC 20 MG/ML

20 mg/ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

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

PHARMABIDE LTD

20, Lakonias str, 15234 Halandri

Athens - Greece

Ferrum (as ferri oxidum saccharatum)

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Ferrum (as ferri oxidum saccharatum)

FERION 20 MG/ML

20 mg/ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| 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 (as ferri natrii gluconas complex)

FERRLECIT

12,5 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| 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 (as carboxymaltosum ferricum)

FERINJECT

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Id-Danimarka

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Cosmofer

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Id-Danimarka

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Id-Danimarka

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Ferrioxidsaccharat

Ferion

20 mg/ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Id-Danimarka

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Id-Danimarka

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Id-Danimarka

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

MonoFer

100 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Id-Danimarka

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Estonja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Estonja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Estonja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Estonja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

L-Estonja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Estonja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Finlandja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Finlandja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Finlandja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Finlandja

| 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

Konċentrat għal soluzzjoni għall-infużjoni/soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Finlandja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Franza

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Franza

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Franza

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| 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

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Franza

| 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

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Franza

| 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

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Franza

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| 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 709mg/5ml

Konċentrat għal soluzzjoni għall-infużjoni/soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| 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/5ml

Konċentrat għal soluzzjoni għall-infużjoni/soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| 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

377-465mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Ġermanja

| 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

1 288,9mg/3.2ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| 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

2 013,9mg/5ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Ġermanja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Ġermanja

| 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/5ml

Konċentrat għal soluzzjoni għall-infużjoni/soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

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

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron hydroxide sucrose

REOXYL

100 mg/5 ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

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

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Iron hydroxide sucrose

FAREMIO

100 mg/5 ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

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

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Iron hydroxide sucrose

DEXTRIFER-S

100 mg/5 ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Greċja

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

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Iron hydroxide sucrose

FERROVIN

100 mg/5 ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron hydroxide sucrose

FERRINEMIA

100 mg/5 ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

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

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Iron hydroxide sucrose

IRONCROSE

20 mg/ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron III - hydroxide dextran

IRONATE

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Greċja

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

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Iron hydroxide sucrose

VENIRON

100 mg/5 ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Greċja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

L-Ungerija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Ungerija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Ungerija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Ungerija

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Iżlanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Iżlanda

| 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

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Iżlanda

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Irlanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Irlanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Irlanda

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Irlanda

| 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 (as Iron Carboxymaltose)

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Irlanda

| 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) as iron sucrose (iron (III)- hydroxide complex)

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

20 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Irlanda

| 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]equivalent to Fe(III)

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

20 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Italja

| 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

Konċentrat għal soluzzjoni għall-infużjoni/soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| 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

62,5mg/5ml

Soluzzjoni orali jew soluzzjoni għall-infużjoni

Użu orali

Użu għal ġol-vini

Il-Latvja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Latvja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Latvja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Latvja

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferrum

Monofer

100 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Litwanja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Litwanja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Litwanja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Litwanja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Litwanja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Lussemburgu

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| 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-50 mg/ml

50 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| 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-100 mg/5 ml

100 mg/5 ml

Soluzzjoni għall-perfużjoni

Użu għal ġol-vini

Il-Lussemburgu

| 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-20 mg/ml

20 mg/ml

Soluzzjoni għall-perfużjoni

Użu għal ġol-vini

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 as ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu parenterali

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu parenterali

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu parenterali

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu parenterali

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu parenterali

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni

Użu parenterali

In-Norveġja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu parenterali

Il-Polonja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Polonja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Polonja

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Ferri hydroxidum saccharum

Ferion

20 mg/ml

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Polonja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Polonja

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Ferri hydroxidum polyisomaltosum

Ferrum-Lek

50 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Polonja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Il-Portugall

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ir-Rumanija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Ir-Rumanija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Ir-Rumanija

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Ir-Repubblika Slovakka

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ir-Repubblika Slovakka

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Repubblika Slovakka

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Repubblika Slovakka

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Is-Slovenja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Is-Slovenja

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Is-Slovenja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Spanja

| 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

Konċentrat għal suspensjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

Spanja

| 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

Soluzzjoni għall-injezzjoni

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Iżvezja

| 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

Konċentrat għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Iżvezja

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

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron dextran

Cosmofer®

50 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Iżvezja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Iżvezja

| 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

Konċentrat għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Iżvezja

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

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose

Ferion

20 mg/ml

Konċentrat għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Iżvezja

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Olanda

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Renju Unit

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ir-Renju Unit

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Ir-Renju Unit

| 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

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

użu għal ġol-muskoli

Ir-Renju Unit

| 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

Soluzzjoni għall-injezzjoni

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Renju Unit

| 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

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

---

ANNESS IV

LISTA TAL-ISMIJIET IVVINTATI, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

Prodotti mediċinali li fihom aprotinin b’Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea

| Stat Membru
  (EU/EEA) | Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| AT - L-Awstrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| A-1160 Wien |
| L-Awstrija |

Stat Membru

(EU/EEA)

Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

AT - L-Awstrija

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

L-Awstrija

Trasylol 10 000 KIE/ml - Infusionsflasche

10 000 KIU/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

BE- Il-Belġju

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

Belgium Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

Il-Belġju

Trasylol

10 000 KIU/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

CZ - Ir-Repubblika Ċeka

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

Chemical Works of Gedeon Richter Plc.

Gyömrői út 19-21.

HU-1103 Budapest

L-Ungerija

Gordox

10 ku/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

CZ - Ir-Repubblika Ċeka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| 13353 Berlin |
| Il-Ġermanja |

Bayer Schering Pharma AG

Müllerstrasse 178

13353 Berlin

Il-Ġermanja

Trasylol 500 000 KIE

10 ku/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DE - Il-Ġermanja

Bayer Pharma Aktiengesellschaft

registered business address:

| Müllerstr. 178 |
| --- |
| 13353 Berlin |
| postal address: |
| 13342 Berlin |
| Il-Ġermanja |

Müllerstr. 178

13353 Berlin

postal address:

13342 Berlin

Il-Ġermanja

Trasynin 0,5

70.0 mg /50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DE - Il-Ġermanja

Bayer Pharma Aktiengesellschaft

registered business address:

| Müllerstr. 178 |
| --- |
| 13353 Berlin |
| postal address: |
| 13342 Berlin |
| Il-Ġermanja |

Müllerstr. 178

13353 Berlin

postal address:

13342 Berlin

Il-Ġermanja

Trasynin 1,0

140.0 mg /100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DE - Il-Ġermanja

Bayer Pharma Aktiengesellschaft

registered business address:

| Müllerstr. 178 |
| --- |
| 13353 Berlin |
| postal address: |
| 13342 Berlin |
| Il-Ġermanja |

Müllerstr. 178

13353 Berlin

postal address:

13342 Berlin

Il-Ġermanja

Trasynin 2,0

280.0 mg /200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DE - Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer Vital GmbH

51368 Leverkusen

Il-Ġermanja

Trasylol 0,5

70.0 mg /50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DE - Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer Vital GmbH

51368 Leverkusen

Il-Ġermanja

Trasylol 1,0

140.0 mg /100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DE - Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer Vital GmbH

51368 Leverkusen

Il-Ġermanja

Trasylol 2,0

280.0 mg /200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

DK - Id-Danimarka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| 13353 Berlin |
| Il-Ġermanja |

Bayer Schering Pharma AG

Müllerstrasse 170-178

13353 Berlin

Il-Ġermanja

Trasylol

10 000 KIE/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

EL - Il-Greċja

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

Bayer Hellas AG

18 - 20, Sorou Str.

151 25, Marousi Athens Il-Greċja

TRASYLOL

500 000 KIU / 50ML

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

ES - Spanja

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

QUIMICA FARMACEUTICA BAYER, S.L.

Av. Baix Llobregat, 3-5

Sant Joan Despi 08970

BARCELONA Spanja

TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA

10 000 K 10 000 KIU/ml IU/ml

Soluzzjoni għall-perfużjoni

Użu għal ġol-vini

FI - Il-Finlandja

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

51368 Leverkusen

Il-Ġermanja

TRASYLOL

10 000 KIU/ml

Soluzzjoni għall-injezzjoni / infużjoni

Użu għal ġol-vini

FR - Franza

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

BAYER SANTE 220,

avenue de la recherche 59120 LOOS

Franza

Trasylol

1 000 000 KUI / 100 mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

FR - Franza

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

BAYER SANTE 220,

avenue de la recherche 59120 LOOS

Franza

Trasylol

2 000 000 KUI / 200 mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

FR - Franza

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

BAYER SANTE 220,

avenue de la recherche 59120 LOOS

Franza

Trasylol

500 000 UIK / 50 mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

HU - L-Ungerija

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

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest

L-Ungerija

Gordox

100 000 KIU/10 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

HU - L-Ungerija

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

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest

L-Ungerija

Gordox

500 000 KIU/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

HU - L-Ungerija

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

Bayer Healthcare AG

Kaiser-Wilhelm-Allee, Bldg. E39

51368 Leverkusen

Il-Ġermanja

Trasylol

500 000 KIU / 50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

LU - Il-Lussemburgu

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

Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

Il-Belġju

TRASYLOL

50 000 KIU/50ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

LV – Il-Latvja

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

Gedeon Richter Ltd.

Gyomroi ut 19-21

Budapest HU-1103

L-Ungerija

Gordox 10 000 KSV/ml šķīdums infūzijām

10 000 KIU/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

MT-Malta

| Bayer Plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| Ir-Renju Unit |

Bayer Plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

Ir-Renju Unit

trading as Bayer Plc, Pharmaceutical Division

TRASYLOL

10 000 KIU/ML

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

NL - L-Olanda

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| L-Olanda |

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

L-Olanda

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

10 000 KIU/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

PL - Il-Polonja

| Bayer Pharma AG |
| --- |
| 13342 Berlin |
| Il-Ġermanja |

Bayer Pharma AG

13342 Berlin

Il-Ġermanja

Trasylol

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

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

PL - Il-Polonja

| Bayer Pharma AG |
| --- |
| 13342 Berlin |
| Il-Ġermanja |

Bayer Pharma AG

13342 Berlin

Il-Ġermanja

Trasylol

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

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

PL - Il-Polonja

| Bayer Pharma AG |
| --- |
| 13342 Berlin |
| Il-Ġermanja |

Bayer Pharma AG

13342 Berlin

Il-Ġermanja

Trasylol

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

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

PT - Il-Portugall

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

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Il-Portugall

Trasylol

500 000 U.I.C / 50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

PT - Il-Portugall

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

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Il-Portugall

Trasylol 1 000 000 UIC

1 000 000 U.I.C / 100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

PT - Il-Portugall

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

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Il-Portugall

Trasylol 2 000 000 UIC

2 000 000 U.I.C / 200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

SE - L-Isvezja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| 13353 Berlin |
| Il-Ġermanja |

Bayer Schering Pharma AG

Müllerstrasse 178

13353 Berlin

Il-Ġermanja

Trasylol

10 000 KIE/ml

Soluzzjoni għall-injezzjoni / infużjoni

Użu għal ġol-vini

SI - Is-Slovenja

| Bayer d.o.o. |
| --- |
| Bravničarjeva 13 |
| Ljubljana |
| Is-Slovenja |

Bayer d.o.o.

Bravničarjeva 13

Ljubljana

Is-Slovenja

TRASYLOL

10 000 KIU/ml

Soluzzjoni għall-injezzjoni u infużjoni

Użu għal ġol-vini

SK – Is-Slovakkja

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

Richter Gedeon Nyrt

Budapest 10

Pf. 27., H-1475

L-Ungerija

GORDOX

100 000 IU/10 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

UK - Ir-Renju Unit

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

Nordic Pharma Limited

Abbey House

1650 Arlington Business Park

Theale, Reading

Berkshire RG7 4SA

Ir-Renju Unit

Aprotinin 10,000 KIU/ml Injection

10,000 KIU/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

UK - Ir-Renju Unit

| Bayer plc |
| --- |
| Bayer House, |
| Strawberry Hill |
| Newbury, |
| Berkshire RG14 1JA |
| Ir-Renju Unit |

Bayer plc

Bayer House,

Strawberry Hill

Newbury,

Berkshire RG14 1JA

Ir-Renju Unit

Trasylol Solution

10,000 KIU/ML

Soluzzjoni għall-injezzjoni

Għal ġol-vini (injezzjoni u infużjoni)

---

ANNESS V

LISTA TA’ ISMIJIET, GĦAMLA FARMAĊEWTIKA, SAĦĦA TAL-PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI TA’ ANNIMAL, METODU TA’ AMMINISTRAZZJONI, DETENTUR TAL-AWTORIZZAZZJONI GĦAL-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

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

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

L-Awstrija

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

Floridsdorfer Hauptstraße 1

A - 1210 Wien

L-Awstrija

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Il-Belġju

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

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Il-Belġju

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Id-Danimarka

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Il-Finlandja |

Pfizer Oy, Animal Health

Tietokuja 4

00330 Helsinki

Il-Finlandja

Cydectin TriclaMox

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Franza

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

Pfizer Holding France

23-25 avenue du Docteur Lannelongue

F – 75668 Paris Cedex 14

Franza

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Il-Ġermanja

| Pfizer GmbH |
| --- |
| Linkstraße 10 |
| 10785 Berlin |
| Il-Ġermanja |

Pfizer GmbH

Linkstraße 10

10785 Berlin

Il-Ġermanja

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Il-Greċja

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

Pfizer Hellas AE

Mesogion Avenue 243

154 51 N. Psychiko

Athens

Il-Greċja

Cydectin TriclaMox

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

L-Irlanda

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

Pfizer Healthcare Ireland

Ringaskiddy

Co Cork

L-Irlanda

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo 71

04100 Latina

L-Italja

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Il-Lussemburgu

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

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Il-Belġju

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Il-Portugal

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

Laboratórios Pfizer, Lda

Lagoas Park – Edíficio 10

2740-271 Porto Salvo

Il-Portugal

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Is-Slovenja

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

Pfizer Luxembourg SARL

51, Avenue J.F.Kennedy

L-1855 Luxembourg

Il-Lussemburgu

Cydectin TriclaMox

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Spanja

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

Zoetis Spain, S.L.

Avda. de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spanja

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

Ir-Renju Unit

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich CT13 9NJ |
| Ir-Renju Unit |

Pfizer Ltd

Ramsgate Road

Sandwich CT13 9NJ

Ir-Renju Unit

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

Moxidectin

5,0 mg

Soluzzjoni pour-on

Topiku – fuq id-dahar tal-annimal

Baqar

Triclabendazole

200,0 mg

---

ANNESS VI

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU/EEA | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, isem tal-kumpanija, indirizz | Isem Ivvintat Isem | Qawwa | Għamla farmaċewtika | Mnejn jingħata | Kontenut (konċentrazzjoni) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | sanofi-aventis GmbH, |
| Leonard-Bernstein-Straße 10, |
| A-1220 Vienna, |
| L-Awstrija |

Stat Membru EU/EEA

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, isem tal-kumpanija, indirizz

Isem Ivvintat Isem

Qawwa

Għamla farmaċewtika

Mnejn jingħata

Kontenut (konċentrazzjoni)

L-Awstrija

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

L-Awstrija

Targocid 100 mg Trockenstechampullen mit Lösungsmittel

100 mg

trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni u soluzzjoni orali

għall-użu minn ġol-muskoli, għall-użu minn ġol-vini, għall-użu orali

100 mg/1.5 ml

L-Awstrija

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

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

L-Awstrija

Targocid 200 mg Trockenstechampullen mit Lösungsmittel

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni u soluzzjoni orali

għall-użu minn ġol-muskoli, għall-użu minn ġol-vini, għall-użu orali

200 mg/3 ml

L-Awstrija

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

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

L-Awstrija

Targocid 400 mg Trockenstechampullen mit Lösungsmittel

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni u soluzzjoni orali

għall-użu minn ġol-muskoli, għall-użu minn ġol-vini, għall-użu orali

400 mg/3 ml

Il-Belġju

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Il-Belġju

Targocid 200 mg, poeder en oplosmiddel voor oplossing voor injectie

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Il-Belġju

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Il-Belġju

Targocid 400 mg, poeder en oplosmiddel voor oplossing voor injectie

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Il-Bulgarija

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

sanofi-aventis Bulgaria EOOD

1303 Sofia,

103 Alexander Stamboliiski Blvd. fl.8.,

Il-Bulgarija

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

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

400 mg/3 ml

Ir-Repubblika Ċeka

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

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Ir-Repubblika Ċeka

Targocid 200 mg

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Ir-Repubblika Ċeka

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

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Ir-Repubblika Ċeka

Targocid 400 mg

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Id-Danimarka

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

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Id-Danimarka

Targocid

100 mg

trab għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

100 mg/1.5 ml

Id-Danimarka

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

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Id-Danimarka

Targocid

200 mg

trab għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Id-Danimarka

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

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Id-Danimarka

Targocid

400 mg

trab għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Il-Finlandja

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

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Il-Finlandja

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

200 mg

trab għal soluzzjoni għall-injezzjoni/infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Il-Finlandja

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

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Il-Finlandja

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

400 mg

trab għal soluzzjoni għall-injezzjoni/infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Franza

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

Franza

TARGOCID 100 mg, lyophilisat et solution pour usage parentéral

100 mg

trab u solvent għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

100 mg/1.5 ml

Franza

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

Franza

TARGOCID 200 mg, lyophilisat et solution pour usage parentéral

200 mg

trab u solvent għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

France

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

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

Franza

TARGOCID 400 mg, lyophilisat et solution pour usage parentéral

400 mg

trab u solvent għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Il-Ġermanja

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Il-Ġermanja

Targocid® 100 mg

100 mg

trab u solvent għal soluzzjoni għall-infużjoni/injezzjoni u soluzzjoni orali

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

100 mg/1.5 ml

Il-Ġermanja

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Il-Ġermanja

Targocid® 200 mg

200 mg

trab u solvent għal soluzzjoni għall-infużjoni/injezzjoni u soluzzjoni orali

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

200 mg/3 ml

Il-Ġermanja

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Il-Ġermanja

Targocid® 400 mg

400 mg

trab u solvent għal soluzzjoni għall-infużjoni/injezzjoni u soluzzjoni orali

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

400 mg/3 ml

Il-Ġermanja

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Il-Ġermanja

Teicoplanin Sanofi-Aventis 100 mg

100 mg

trab u solvent għal soluzzjoni għall-infużjoni/injezzjoni u soluzzjoni orali

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

100 mg/1.5 ml

Il-Ġermanja

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Il-Ġermanja

Teicoplanin Sanofi-Aventis 200 mg

200 mg

trab u solvent għal soluzzjoni għall-infużjoni/injezzjoni u soluzzjoni orali

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

200 mg/3 ml

Il-Ġermanja

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

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Il-Ġermanja

Teicoplanin Sanofi-Aventis 400 mg

400 mg

trab u solvent għal soluzzjoni għall-infużjoni/injezzjoni u soluzzjoni orali

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

400 mg/3 ml

Il-Greċja

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

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Il-Greċja

TARGOCID®

200 mg

Trab u solvent għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Il-Greċja

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

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Il-Greċja

TARGOCID®

400mg

Trab u solvent għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

L-Ungerija

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

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

L-Ungerija

Targocid 200 mg por és oldószer oldatos injekcióhoz

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Ungerija

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

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

L-Ungerija

Targocid 400 mg por és oldószer oldatos injekcióhoz

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

L-Irlanda

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

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

L-Irlanda

Targocid 200mg Powder and Solvent for Solution for Injection

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Irlanda

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

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

L-Irlanda

Targocid 400mg Powder and Solvent for Solution for Injection

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

L-Italja

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

L-Italja

TARGOSID

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Italja

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

L-Italja

TARGOSID

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

L-Italja

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

L-Italja

TEICOMID

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Italja

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

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

L-Italja

TEICOMID

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Il-Lussemburgu

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Il-Belġju

TARGOCID

200 mg

trab għal preparazzjonijiet injettabbli

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Il-Lussemburgu

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

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Il-Belġju

TARGOCID

400 mg

trab għal preparazzjonijiet injettabbli

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

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

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Olanda

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

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The L-Olanda

TARGOCID® 200

200 mg

trab għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Olanda

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

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

L-Olanda

TARGOCID® 400

400 mg

trab għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

In-Norveġja

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

sanofi-aventis Norge AS,

Strandveien 15,

PO Box 133, 1325 Lysaker,

In-Norveġja

TARGOCID®

400 mg

trab għal soluzzjoni għall-injezzjoni/infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Il-Polonja

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| Ir-Renju Unit |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

Ir-Renju Unit

TARGOCID

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni u infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Il-Polonja

| Aventis Pharma Ltd. |
| --- |
| One Onslow Street, |
| Guildford, Surrey |
| GU1 4YS, |
| Ir-Renju Unit |

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

Ir-Renju Unit

TARGOCID

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni u infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Il-Portugall

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

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Il-Portugall

Targosid

200 mg/3 ml

trab u solvent għal soluzzjoni għall-injezzjoni jew għall-infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Il-Portugall

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

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Il-Portugall

Targosid

400 mg/3 ml

trab u solvent għal soluzzjoni għall-injezzjoni jew għall-infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Ir-Rumanija

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

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

Ir-Renju Unit

TARGOCID® 200 mg

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Ir-Rumanija

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

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

Ir-Renju Unit

TARGOCID® 400 mg

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Ir-Repubblika Slovakka

| sanofi-aventis Pharma |
| --- |
| Slovakia s.r.o Einsteinova 24, |
| 85101 Bratislava, |
| Ir-Repubblika Slovakka |

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Ir-Repubblika Slovakka

Targocid 200

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

200 mg/3 ml

Ir-Repubblika Slovakka

| sanofi-aventis Pharma |
| --- |
| Slovakia s.r.o Einsteinova 24, |
| 85101 Bratislava, |
| Ir-Repubblika Slovakka |

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Ir-Repubblika Slovakka

Targocid 400

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini, għall-użu orali

400 mg/3 ml

Is-Slovenja

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

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Is-Slovenja

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

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Is-Slovenja

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

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Is-Slovenja

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

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Spanja

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

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Spanja

TARGOCID

200 mg

trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Spanja

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

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Spanja

TARGOCID

400 mg

trab u solvent għal soluzzjoni għall-injezzjoni jew infużjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

L-Isvezja

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma,, |
| L-Isvezja |

sanofi-aventis AB

Box 14142

167 14 Bromma,,

L-Isvezja

Targocid

200 mg

Trab għall-injezzjoni/infużjoni, soluzzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

L-Isvezja

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma, |
| L-Isvezja |

sanofi-aventis AB

Box 14142

167 14 Bromma,

L-Isvezja

Targocid

400 mg

Trab għall-injezzjoni/infużjoni, soluzzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

Ir-Renju Unit

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

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

One Onslow Street

Guildford

Surrey

GU1 4YS

Ir-Renju Unit

jew jopera bħala

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| Ir-Renju Unit |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

Ir-Renju Unit

TARGOCID®

200 mg

trab għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

200 mg/3 ml

Ir-Renju Unit

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

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

One Onslow Street

Guildford

Surrey

GU1 4YS

Ir-Renju Unit

jew jopera bħala

| Sanofi-aventis or Sanofi |
| --- |
| One Onslow Street |
| Guildford |
| Surrey |
| GU1 4YS |
| Ir-Renju Unit |

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

Ir-Renju Unit

TARGOCID®

400 mg

trab għall-injezzjoni

għall-użu minn ġol-muskoli/għall-użu minn ġol-vini

400 mg/3 ml

---

ANNESS VII

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦIDFIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  (fiż-ŻEE) | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem il-Prodott | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| Il-Bulgarija | Zentiva k.s. |
| 130 U kabelovn |
| Prague 10237 |
| Ir-Repubblika Ċeka |

Stat Membru

(fiż-ŻEE)

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem il-Prodott

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Bulgarija

Zentiva k.s.

130 U kabelovn

Prague 10237

Ir-Repubblika Ċeka

Flupizen

100 mg

kapsula, iebsa

użu orali

L-Estonja

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utre |
| L-Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utre

L-Olanda

KATADOLON

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

Flupirtinmaleat AbZ 100 mg Kapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Il-Ġermanja

Flupirtinmaleat AL 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Awegal inject

164,5 mg / 3 ml

soluzzjoni għall-injezzjoni

uża ġol-muskolu

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Katadolon inject

164,5 mg / 3 ml

Soluzzjoni għall-injezzjoni

uża ġol-muskolu

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Katadolon Kinderzäpfchen

75 mg

suppositorju

Użu fir-rektum

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Katadolon Zäpfchen

150 mg

suppositorju

Użu fir-rektum

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Trancopal Dolo

100 mg

kapsula

użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Trancopal Dolo Suppositorien

150 mg

suppositorju

Użu fir-rektum

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Katadolon S long

400 mg

pillola li terħi l-mediċina bil-mod

użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Katadolon

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Trancolong

400 mg

pillola li terħi l-mediċina bil-mod

użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Katadolon retard

400 mg

pillola li terħi l-mediċina bil-mod

użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Il-Ġermanja

Flupirtinmaleat Winthrop 400 mg Retardtabletten

400 mg

pillola li terħi l-mediċina bil-mod

użu orali

Il-Ġermanja

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

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

Flupirtinmaleat-CT 100 mg Hartkapsel

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

Flupin 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Il-Ġermanja

Dolokadin einmal täglich

400 mg

pillola li terħi l-mediċina bil-mod

użu orali

Il-Ġermanja

| Hormosan Pharma GmbH |
| --- |
| Wilhelmshöher Str. 106 |
| 60389 Frankfurt |
| Il-Ġermanja |

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Il-Ġermanja

Flupigamma 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

| Hormosan Pharma GmbH |
| --- |
| Wilhelmshöher Str. 106 |
| 60389 Frankfurt |
| Il-Ġermanja |

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Il-Ġermanja

Flupirtinmaleat-Hormosan 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Il-Ġermanja

Flupigil 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Il-Ġermanja

Flupigil 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

| Midas Pharma GmbH |
| --- |
| Rheinstr. 49 |
| 55218 Ingelheim |
| Il-Ġermanja |

Midas Pharma GmbH

Rheinstr. 49

55218 Ingelheim

Il-Ġermanja

Flupirtinmaleat Midas 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

Flupirtinmaleat-ratiopharm 100 mg Hartkapsel

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

Miflumal 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Il-Ġermanja

Flupirtinmaleat Vitapharma 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Il-Ġermanja

Flupivil 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Il-Ġermanja

Flupirtinmaleat Viatris 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Il-Ġermanja

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Il-Ġermanja

Flupimal 100 mg Hertkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Il-Ġermanja

Flupsadim 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Il-Ġermanja

Miphaflumix 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Il-Ġermanja

Fluporol 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

Il-Ġermanja

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

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Il-Ġermanja

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

kapsula, iebsa

użu orali

L-Ungerija

| ZENTIVA k.s. |
| --- |
| Ul. kabelovny 130, Dolní Mecholupy |
| 10237 Prague 10 |
| Ir-Repubblika Ċeka |

ZENTIVA k.s.

Ul. kabelovny 130, Dolní Mecholupy

10237 Prague 10

Ir-Repubblika Ċeka

Flupizen 100 mg kemény kapszula

100 mg

kapsula, iebsa

użu orali

L-Italja

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

MEDA PHARMA S.p.A.,

Viale Brenta 18, 20139 Milano

L-Italja

EFIRET

100 mg

kapsula, iebsa

użu orali

Il-Latvja

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

Teva Pharma B.V.,

Computerweg 10,

3542 DR Utrecht

L-Olanda

Katadolon 100 mg iebsa kapsulas

100 mg

kapsula, iebsa

użu orali

Il-Litwanja

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

L-Olanda

Katadolon

100 mg

kapsula, iebsa

użu orali

Il-Polonja

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

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Il-Polonja

Katadolon

100 mg

kapsula, iebsa

użu orali

Il-Portugall

| Midas Pharma GmbH |
| --- |
| Rheinstrasse, 49 |
| 55218 Ingelheim |
| Il-Ġermanja |

Midas Pharma GmbH

Rheinstrasse, 49

55218 Ingelheim

Il-Ġermanja

Flupirtina Midas

100 mg

kapsula, iebsa

użu orali

Il-Portugall

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

Sanofi-Aventis - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Il-Portugall

Flupirtina Winthrop

100 mg

kapsula, iebsa

użu orali

Il-Portugall

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

Meda Pharma - Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Il-Portugall

Metanor

100 mg

kapsula, iebsa

użu orali

Ir-Rumanija

| Zentiva k.s. |
| --- |
| U Kabelovny 130, Dolní Měcholupy |
| 102 37, Praga 10, |
| Ir-Repubblika Ċeka |

Zentiva k.s.

U Kabelovny 130, Dolní Měcholupy

102 37, Praga 10,

Ir-Repubblika Ċeka

FLUPIZEN 100 mg

100 mg

kapsula

użu orali

Ir-Repubblika Slovakka

| Zentiva k.s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Ir-Ir-Repubblika Ċeka |

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Ir-Ir-Repubblika Ċeka

Flupizen 100 mg tvrdé kapsuly

100 mg

kapsula, iebsa

użu orali

Ir-Repubblika Slovakka

| TEVA Pharmaceuticals Slovakia, s.r.o. |
| --- |
| Teslova 26 |
| 821 02 Bratislava |
| Ir-Repubblika Slovakka |

TEVA Pharmaceuticals Slovakia, s.r.o.

Teslova 26

821 02 Bratislava

Ir-Repubblika Slovakka

Katadolon

100 mg

kapsula, iebsa

użu orali

---

ANNESS VIII

LISTA TA’ ISMIJIET, GĦAMLA FARMAĊEWTIKA, SAĦĦA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI TA’ ANNIMAL, METODU TA’ AMMINISTRAZZJONI, PERJODI TA’ TIŻMIM, APPLICANT/DETENTURI TAL-AWTORIZZAZZJONI GĦAL-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ZEE | Sid l-Awtoriżżazzjoni tal-Kummerċ | ISem | INN | Saħħa | Għamla Farmaċewtika | Mod Ta’ Amministrazzjoni | Speċi |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Pfizer Corporation Austria Gesellschaft m.b.H. |
| Floridsdorfer Hauptstraße 1, |
| 1210 Wien |
| L-AWSTRIJA |

Stat Membru UE/ZEE

Sid l-Awtoriżżazzjoni tal-Kummerċ

ISem

INN

Saħħa

Għamla Farmaċewtika

Mod Ta’ Amministrazzjoni

Speċi

L-Awstrija

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

L-AWSTRIJA

Dectomax 1 % - Injektionslösung für Rinder und Schafe

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

L-Awstrija

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

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

L-AWSTRIJA

Dectomax S 10 mg/ml Injektionslösung für Schweine

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

L-Awstrija

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

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

L-AWSTRIJA

Dectomax Pour-On 5 mg/ml Lösung für Rinder

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Belġju

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

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

IL-BELĠJU

DECTOMAX

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

Il-Belġju

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

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

IL-BELĠJU

DECTOMAX POUR-ON

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Belġju

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

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

IL-BELĠJU

DECTOMAX SOLUTION INJECTABLE POUR PORCS

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

Il-Bulgarija

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

Pfizer S.A.,

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

37401 Amboise Cedex,

FRANZA

Дектомакс 1 % инжективен разтвор

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Bulgarija

| BIOVET AD |
| --- |
| 39 Petar Rakov str. |
| Peshtera 4550 |
| IL-BULGARIJA |

BIOVET AD

39 Petar Rakov str.

Peshtera 4550

IL-BULGARIJA

Ендектовет 1 % инжекционен разтвор за говеда, овце и свине

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Ċipru

| PFIZER HELLAS AE |
| --- |
| 243 Av Mesogeion |
| 15451, Athens |
| IL-GREĊJA |

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

IL-GREĊJA

DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Ir-Repubblika Ċeka

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| IR-REPUBBLIKA ĊEKA |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha

IR-REPUBBLIKA ĊEKA

DECTOMAX 10 mg/ml injekční roztok

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Ir-Repubblika Ċeka

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Id-Danimarka

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Dectomax Pour-On Vet.

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Id-Danimarka

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Dectomax Vet.

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, pigs

Id-Danimarka

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Prontax

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Id-Danimarka

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Prontax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

subcutaneous

Cattle

L-Estonja

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

Pfizer Animal Health S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

IL-BELĠJU

Dectomax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Estonja

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Finlandja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Il-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

Il-FINLANDJA

DECTOMAX vet 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, reindeer, pigs

Il-Finlandja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Prontax 5 mg/ml kertavaleluliuos

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Finlandja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Prontax 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Franza

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

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANZA

ZEARL

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

Franza

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

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANZA

ZEARL POUR ON

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Franza

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

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANZA

ZEARL PORCS

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

Franza

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Franza

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| IL-ĠERMANJA |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

IL-ĠERMANJA

Dectomax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| IL-ĠERMANJA |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

IL-ĠERMANJA

Dectomax Pour-On

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| IL-ĠERMANJA |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

IL-ĠERMANJA

Dectomax-S Injektionslösung

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

Il-Greċja

| PFIZER HELLAS AE |
| --- |
| 243 Av Mesogeion |
| 15451, Athens |
| IL-GREĊJA |

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

IL-GREĊJA

DECTOMAX ing sol

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Ungerija

| Pfizer Kft. |
| --- |
| Alkotás u. 53. |
| 1123 Budapest |
| L-Ungerija |

Pfizer Kft.

Alkotás u. 53.

1123 Budapest

L-Ungerija

Dectomax injekció A.U.V.

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Iżlanda

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Dectomax, vet.

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Iżlanda

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Prontax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Iżlanda

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| IL-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

IL-FINLANDJA

Prontax

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

IR-RENJU UNIT

Zearl Pour-On Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

IR-RENJU UNIT

Zearl 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

L-Irlanda

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

Dectomax 5 mg/ml Pour-On Solution for Cattle

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

L-Irlanda

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

L-ITALJA

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

L-ITALJA

DECTOMAX POUR ON 5 mg/ml

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Latvja

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

Pfizer Animal Health S.A.,

Rue Laid Burniat, 1,

1348 Louvain-la-Neuve,

IL-BELĠJU

Dectomax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Latvja

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

Dectomax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Litwanja

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

Pfizer S.A.,

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

37401 Amboise Cedex,

Franza

DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Litwanja

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Pajjiżi l-Baxxi

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| IL-PAJJIŻI L-BAXXI |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

IL-PAJJIŻI L-BAXXI

Dectomax Pour-On Oplossing voor Rundvee 5 mg/ml

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Pajjiżi l-Baxxi

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| IL-PAJJIŻI L-BAXXI |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

IL-PAJJIŻI L-BAXXI

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

In-Norveġja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Il-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

Il-FINLANDJA

Dectomax Pour-On vet

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

In-Norveġja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Il-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

Il-FINLANDJA

Dectomax vet

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

In-Norveġja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Il-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

Il-FINLANDJA

Prontax

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

In-Norveġja

| Pfizer Oy, Animal Health, |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Il-FINLANDJA |

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

Il-FINLANDJA

Prontax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Polonja

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

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

ul. Postępu 17 B

02-676 Warszawa

IL-POLONJA

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Il-Portugal

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

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

IL-PORTUGAL

Dectomax Pour-on

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Il-Portugal

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

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

IL-PORTUGAL

Dectomax solução injectável

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Ir-Rumanija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

DECTOMAX

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Ir-Rumanija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Ir-Rumanija

| Pfizer Limited |
| --- |
| Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| IR-RENJU UNIT |

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

IR-RENJU UNIT

PRONTAX 5 mg/ml Pour On Solution for Cattle

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Is-Slovakkja

| Pfizer Luxemburg SARL, o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 811 09 Bratislava |
| IS-SLOVAKKJA |

Pfizer Luxemburg SARL, o.z.

Pfizer AH

Pribinova 25

811 09 Bratislava

IS-SLOVAKKJA

Dectomax 10 mg/ml injekčný roztok

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Is-Slovenja

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

Pfizer Luxembourg SARL

51, Avenue J.F. Kennedy

L-1855 Luxembourg

IL-LUSSEMBURGU

DECTOMAX 10 mg/ml raztopina za injiciranje

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

Spanja

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPANJA

DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

Spanja

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPANJA

DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Spanja

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

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPANJA

DECTOMAX SOLUCION INYECTABLE

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

L-Isvezja

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLANDJA

Dectomax vet.

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, reindeer

L-Isvezja

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLANDJA

Dectomax Suis vet.

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

L-Isvezja

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLANDJA

Prontax

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep, pigs

L-Isvezja

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLANDJA

Dectomax pour-on vet.

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

L-Isvezja

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

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLANDJA

Prontax

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

Ir-Renju Unit

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

IR-RENJU UNIT

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

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

taħt il-ġilda, fil-muskolu

Cattle, sheep

Ir-Renju Unit

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

IR-RENJU UNIT

Dectomax 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Soluzzjoni għall-injezzjoni

fil-muskolu

Pigs

Ir-Renju Unit

| Elanco Animal Health |
| --- |
| Eli Lilly & Company Limited |
| Lilly House |
| Priestly Road |
| Basingstoke, Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

IR-RENJU UNIT

Dectomax Pour-on Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Soluzzjoni pour-on

topiku - fuq id-dahar tal-annimal

Cattle

---

ANNESS IX

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  UE/ZEE | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | INN | Isem Ivvintat Isem | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Pfizer Corporation Austria Ges.m.b.H |
| Floridsdorfer Hauptstraße 1, |
| 1210 Vienna |
| Austria |

Stat Membru

UE/ZEE

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

INN

Isem Ivvintat Isem

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

Diclofenac sodium

Misoprostol

Arthrotec forte - Manteltabletten

75 mg

0,2 mg

Pillola miksija

Użu orali

L-Awstrija

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

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

Diclofenac sodium

Misoprostol

Arthrotec - Manteltabletten

50 mg

0,2 mg

Pillola miksija

Użu orali

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Dedolor akut 75 mg – Kapseln

75 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Dedolor DRS 100 mg – Kapseln

100 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat DRS 75 mg – Kapseln

75 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 75 mg - Ampullen

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 50 mg – Kapseln

50 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 100 mg – Suppositorien

100 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

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

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat retard 100 mg – Kapseln

100 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal 50 mg - Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal rapid 50 mg - lösbare Tabletten

50 mg

Pillola li tinħall

Użu orali

L-Awstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal retard 150 mg - Tabletten

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal retard 75 mg - Tabletten

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 75 mg – Ampullen

75 mg/2 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 25 mg – Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 50 mg – Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 100 mg – Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 50 mg – Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene retard 100 mg - Kapseln

100 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene uno 150 mg - Retardtabletten

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten

50 mg

Pillola li tinħall

Użu orali

L-Awstrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac Genericon 75 mg - Ampullen

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Awstrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac "Genericon" 50 mg - Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac Genericon retard 100 mg Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" 25 mg-Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" 50 mg - Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

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

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Awstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" retard 100 mg - Tabletten

100 mg

Pillola

Użu orali

L-Awstrija

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

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" retard 75 mg - Tabletten

75 mg

Pillola

Użu orali

L-Awstrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclofenac G.L. 50 mg - Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac 1A Pharma retard 150 mg - Tabletten

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac 1A Pharma retard 75 mg - Tabletten

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclofenac G.L. retard 100 mg - Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 75 mg – Ampullen

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Awstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 50 mg – Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 150 mg - Retardtabletten

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 75 mg - Retardtabletten

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Awstrija

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac "Sandoz" retard 100 mg – Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Diclo-B „Lannacher“-Kapseln

50 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Diclo-B G.L.

50 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac sodium

Diclostad Ampullen

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Awstrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac Sodium

Diclostad 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac sodium

Diclostad retard 100 mg Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclovit-Kapseln

50 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Dolpasse 75 mg – Infusionslösung

75 mg/250 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Awstrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Dolpasse retard 100 mg - Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Ċitrat orphenadrine

Neodolpasse – Infusionslösung

75 mg/250 ml

30 mg/250 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Awstrija

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

MERCK GesmbH

Zimbagasse 5

1147 Vienna

Austria

Diclofenac sodium

Neurofenac - Kapseln

50 mg

Kapsula, iebsa

Użu orali

L-Awstrija

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenac sodium

Tratul retard 100 mg - Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 25 mg - Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 50 mg - Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 75 mg/3 ml - Injektionslösung

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 25 mg - Zäpfchen

25 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 100 mg - Zäpfchen für Erwachsene

100 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 50 mg - Zäpfchen für Erwachsene

50 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren retard 100 mg - Filmtabletten

100 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenac Acid

Tratul 50 mg - Kapseln

50 mg

Kapsula gastro-reżistenti, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac Acid

Voltaren dispers - lösliche Tabletten

46,5 mg

Pillola li tinħall

Użu orali

L-Awstrija

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

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac potassju

Diclobene rapid 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac potassju

Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen

50 mg

Trab għal soluzzjoni orali

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac potassju

Voltaren rapid 50 mg - Dragees

50 mg

Pillola miksija

Użu orali

Il-Belġju

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

ARTHROTEC 50

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Belġju

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

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

ARTHROTEC 75

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac potassju

CATAFLAM 50 MG

50 mg

Pillola miksija

Użu orali

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac potassju

CATAFLAM 50 MG

50 mg

Trab għal soluzzjoni orali

Użu orali

Il-Belġju

| 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

Pillola li tinxtered

Użu orali

Il-Belġju

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

APOTEX NV

Av. du Bourg. Etienne Demunter 5, box 8

1090 Jette

Belgium

Diclofenac sodium

DICLOFENAC APOTEX 100 MG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

APOTEX NV

Av. du Bourg. Etienne Demunter 5, box 8

1090 Jette

Belgium

Diclofenac sodium

DICLOFENAC APOTEX 75 MG

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Belġju

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 25 MG

25 mg

Pillola miksija

Użu orali

Il-Belġju

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 50 MG

50 mg

Pillola miksija

Użu orali

Il-Belġju

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 75 MG

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Belġju

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG RETARD 100 MG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG RETARD 75 MG

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

DICLOFENAC RETARD MYLAN 100 MG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

DICLOFENAC RETARD MYLAN 75 MG

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Belġju

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ 75 MG

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Belġju

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ RETARD 100 MG

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Belġju

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ RETARD 75 MG

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Belġju

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Belġju

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 100 MG RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Belġju

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 75 MG / 3 ML

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Belġju

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 75 MG RETARD

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac potassju

DICLOFENAC-K-TEVA 50 MG COMPR

50 mg

Pillola miksija b’rita

Użu orali

Il-Belġju

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

RATIOPHARM BELGIUM S.A.

Rue Saint-Lambert 141

1200 Woluwé-saint-lambert

Belgium

Diclofenac sodium

DICLOFENAC-RATIOPHARM 50 MG GASTRO-

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Belġju

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

LABORATORIA QUALIPHAR N.V/S.A

Rijksweg 9

2880 Bornem

Belgium

Diclofenac sodium

DICLOFENACUM NATRI QUALIPHAR 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Belġju

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

FLAMPHAR 50 MG

50 mg

Pillola

Użu orali

Il-Belġju

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

Daiichi Sankyo Belgium SA

Rue Fond Jean Pâques 5

B-1348 Louvain-la-Neuve

Belgium

Diclofenac sodium

MOTIFENE 75 MG

75 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Il-Belġju

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

POLYFLAM 75 MG

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Belġju

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

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG

50 mg

Pillola miksija

Użu orali

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 25

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 75 MG/3 ML

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN RETARD 100

100 mg

Pillola

Użu orali

Il-Belġju

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

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN RETARD 75 MG

75 mg

Pillola

Użu orali

Il-Belġju

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

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

Diclofenac potassju

VOLTATABS 12,5 MG(EX:ZYMAMED)

12,5 mg

Pillola miksija

Użu orali

Il-Bulgarija

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Bulgarija

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Bulgarija

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

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac sodium

Diclofenac Duo

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Bulgarija

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

Tchaikapharma Highquality Medicines

1 G. M. Dimitrov Blvd.

Sofia 1172

Bulgaria

Diclofenac sodium

Diclofenac-Tchaikapharma

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Bulgarija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Bulgarija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Bulgarija

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Bulgarija

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

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

Diclofenac sodium

Feloran

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Bulgarija

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

Actavis EAD

29 Atanas Dukov Str.

Sofia 1407

Bulgaria

Diclofenac sodium

Feloran Actavis

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Bulgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen SR

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Bulgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen DUO

75 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Il-Bulgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Bulgarija

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Bulgarija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Ċitrat orphenadrine

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassju

Voltfast

50 mg

Trab għal soluzzjoni orali

Użu orali

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Bulgarija

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Bulgarija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassju

Voltaren Dolo

12,5 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassju

Voltaren Dolo

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Bulgarija

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

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

Diclofenac sodium

Feloran

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ċipru

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL INJECTION 75 MG/3 ML

75 mg/3 ml

Injezzjoni

Użu għal ġol-muskoli

Ċipru

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL SUPPOSITORY 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

Ċipru

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL SUPPOSITORY 50 MG

50 mg

Suppositorju

Użu għal ġor-rektum

Ċipru

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL GASTRO-RESISTANT TABLET 25 MG

25 mg

Pillola

Użu orali

Ċipru

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL GASTRO-RESISTANT TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ARESTON TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassju

CATAFLAM ORAL DROPS 1.5 %

15 mg/ml

Qtar orali, soluzzjoni

Użu orali

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassju

CATAFLAM COATED TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

P.T.Hadjigeorgiou CO ltd,

P.O.Box 53158

3301 Lemesos

Cyprus

Diclofenac sodium

DICLAC INJECTION 75 MG/3 ML

75 mg/3 ml

Injezzjoni

Użu għal ġol-muskoli

Ċipru

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75 MG

75 mg

Pillola

Użu orali

Ċipru

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

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

Diclofenac sodium

DIFENE DUAL CAPSULE 100 MG

100 mg

Kapsula

Użu orali

Ċipru

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

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

Diclofenac sodium

DIFENE DUAL CAPSULE 75 MG

75 mg

Kapsula

Użu orali

Ċipru

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

Interpak ltd

Aharnon st

Industrial Estate

P.O. Box 51166

3502 Lemesos

Cyprus

Diclofenac sodium

NERITAN GASTRO RESISTANT TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Interpak ltd

Aharnon st

Industrial Estate

P.O. Box 51166

3502 Lemesos

Cyprus

Diclofenac sodium

NERITAN GASTRO RESISTANT TABLET 25 MG

25 mg

Pillola

Użu orali

Ċipru

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN SUPPOSITORY 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

Ċipru

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN SUSTAINED RELEASE TABLET 100 MG

100 mg

Pillola

Użu orali

Ċipru

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN GASTRO RESISTANT TABLET 25 MG

25 mg

Pillola

Użu orali

Ċipru

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

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN GASTRO RESISTANT TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Codal Synto ltd

33 Theklas Lysioti str.

P.O. Box 51785

Lemesos

Cyprus

Diclofenac sodium

TAKS INJECTION 75 MG/3 ML

75 mg/3 ml

Injezzjoni

Użu għal ġol-muskoli

Ċipru

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

Codal Synto ltd

33 Theklas Lysioti str.

P.O. Box 51785

Lemesos

Cyprus

Diclofenac sodium

TAKS GASTRO RESISTANT TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN INJECTION 75 MG/3 ML

75 mg/3 ml

Injezzjoni

Użu għal ġol-muskoli

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SUPPOSITORY 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SUPPOSITORY 50 MG

50 mg

Suppositorju

Użu għal ġor-rektum

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN GASTRO RESISTANT TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN D DISPERSIBLE TABLET 50 MG

50 mg

Pillola

Użu orali

Ċipru

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

Novartis Hellas S.A.C.I.

12th km

National Road No1

Metamorfosi Attiki

Athens

Greece

Diclofenac sodium

VOLTAREN DOLO FILM COATED TABLET 12,5 MG

12,5 mg

Pillola

Użu orali

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN FOR CHILDREN SUPPOSITORY 12,5 MG

12,5 mg

Suppositorju

Użu għal ġor-rektum

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN RETARD SUSTAINED RELEASE TABLET 100 MG

100 mg

Pillola

Użu orali

Ċipru

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

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SR SUSTAINED RELEASE TABLET 75 MG

75 mg

Pillola

Użu orali

Ir-Repubblika Ċeka

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Repubblika Ċeka

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL 50

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

APO-DICLO SR 100

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Repubblika Ċeka

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

APO-DICLO 25 MG

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

APO-DICLO 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

DICLOFENAC AL RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

DICLOFENAC AL 25

25 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

DICLOFENAC AL 50

50 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

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

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac sodium

DICLOFENAC DUO PHARMASWISS 75 MG

75 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Ir-Repubblika Ċeka

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Repubblika Ċeka

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM 100

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Repubblika Ċeka

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM 50

50 mg

Suppositorju

Użu għal ġor-rektum

Ir-Repubblika Ċeka

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM 50

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

DICUNO 25 MG POTAHOVANÉ TABLETY

25 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

DICUNO 50 MG POTAHOVANÉ TABLETY

50 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

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

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac sodium

DOLMINA INJ

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Repubblika Ċeka

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

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac sodium

DOLMINA 100 SR

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

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

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac sodium

DOLMINA 50

50 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

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

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

Diclofenac epolamine

FLECTOR EP RAPID 50 MG

50 mg

Granijiet għal soluzzjoni orali

Użu orali

Ir-Repubblika Ċeka

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

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

Diclofenac sodium

MONOFLAM 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Repubblika Ċeka

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

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

Diclofenac sodium

MONOFLAM 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

MYOGIT 25

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

MYOGIT 50

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

NAKLOFEN DUO TOBOLKY

75 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Ir-Repubblika Ċeka

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Ċitrat orphenadrine

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

OLFEN-100 SR

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Repubblika Ċeka

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

OLFEN-50

50 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

OLFEN-75

37,5 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Repubblika Ċeka

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

UNO

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac sodium

VERAL 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Repubblika Ċeka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac sodium

VERAL 100 RETARD

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Repubblika Ċeka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac sodium

VERAL 25 MG

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac sodium

VERAL 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac sodium

VERAL 75

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Repubblika Ċeka

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

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac sodium

VERAL 75 RETARD

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac sodium

VOLTAREN

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac sodium

VOLTAREN RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac sodium

VOLTAREN 50

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassju

VOLTAREN RAPID 50 MG TABLETY

50 mg

Pillola miksija

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassju

VOLTAREN ACTIGO

12,5 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassju

VOLTAREN ACTIGO EXTRA

25 mg

Pillola miksija

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassju

VOLTAREN RAPID 12,5 MG

12,5 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Praha 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassju

VOLTAREN RAPID 25 MG

25 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

Diclofenac

Diclodan

50 mg

Suppositorju

Użu għal ġor-rektum

Id-Danimarka

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

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

Diclofenac

Diclodan

100 mg

Suppositorju

Użu għal ġor-rektum

Id-Danimarka

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon

100 mg

Suppositorju

Użu għal ġor-rektum

Id-Danimarka

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon Rapid

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon Rapid

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac

Diklofenak "Mylan"

50 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diklofenak "Orifarm"

25 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diklofenak "Orifarm"

50 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Modifenac

75 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

25 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

50 mg

Suppositorju

Użu għal ġor-rektum

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Pillola

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Rapid

50 mg

Pillola

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Retard

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Id-Danimarka

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

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac

Diclofenac "BMM Pharma"

50 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac

Diclofenac "BMM Pharma"

25 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Diclofenac Rapid "Actavis"

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Diclofenac Rapid "Actavis"

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diclofenac Rapid "Orifarm"

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diclofenac Rapid "Orifarm"

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Teva Denmark A/S

Parallelvej 10-12

DK-2800 Kongens Lyngby

Denmark

Diclofenac

Diclofenac Rapid "Teva"

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

50 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Id-Danimarka

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Id-Danimarka

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

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

25 mg

Pillola gastro-reżistenti

Użu orali

Id-Danimarka

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Diclopax

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Diclopax

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac

Diklotab

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac

Diklotab

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac

Eeze

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Fenacta

12,5 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

50 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

25 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola

Użu orali

Id-Danimarka

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac

Misoprostol

Arthrotec Forte

75 mg

0,2 mg

Pillola

Użu orali

Id-Danimarka

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

DICLOBERL 75 MG/3 ML

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Estonia

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

DICLOBERL RETARD

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Estonja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

L-Estonja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN

100 mg

Suppositorju

Użu għal ġor-rektum

L-Estonja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN RETARD 100 MG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Estonja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

50 mg

Pillola gastro-reżistenti

Użu orali

L-Estonja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

50 mg

Suppositorju

Użu għal ġor-rektum

L-Estonja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Estonja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN SR

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Estonja

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac

ALMIRAL

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Estonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

OLFEN DEPOCAPS

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Estonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

OLFEN DEPOCAPS

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

CATAFLAM

50 mg

Pillola miksija

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN AKTI

12,5 mg

Pillola miksija b’rita

Użu orali

L-Estonja

| Pfizer Enterprises SARL |
| --- |
| Round-Point du Kirchberg |
| 51, Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| Luxembourg |

Pfizer Enterprises SARL

Round-Point du Kirchberg

51, Avenue J.F.Kennedy

L-1855 Luxembourg

Luxembourg

Diclofenac

Misoprostol

ARTHROTEC

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Estonja

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

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

Estonia

Diclofenac

DICLORAPID

75 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

L-Estonja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC- RATIOPHARM 50 MG

50 mg

Pillola gastro-reżistenti

Użu orali

L-Estonja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 50 MG

50 mg

Suppositorju

Użu għal ġor-rektum

L-Estonja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 100 MG

100 mg

Suppositorju

Użu għal ġor-rektum

L-Estonja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 75 MG/2 ML

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Estonja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM UNO

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Estonja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC 100

100 mg

Suppositorju

Użu għal ġor-rektum

L-Estonja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Estonja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC ID 75 MG

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Estonja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC ID 150 MG

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Estonja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC 100 MG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Estonja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

DICUNO

25 mg

Pillola miksija b’rita

Użu orali

L-Estonja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

DICUNO

50 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassju

Diclofenac Rapid Orifarm

50 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

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

ratiopharm Oy

P.O.Box 67

02631 Espoo

Finland

Diclofenac potassju

Diclomex Rapid

50 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

25 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

50 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

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

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassju

Eeze

25 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassju

Voltaren Rapid

25 mg

Pillola miksija

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassju

Voltaren Rapid

50 mg

Pillola miksija

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassju

Voltfast

50 mg

Trab għal soluzzjoni orali

Użu orali

Il-Finlandja

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diclofenac sodium

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola

Użu orali

Il-Finlandja

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diclofenac sodium

Misoprostol

Arthrotec Forte

75 mg

0,2 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Finlandja

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

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Finlandja

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

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Finlandja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclomex

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Finlandja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclomex

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Finlandja

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

Oy Stada Pharma Ab

P.O.Box 1310

00101 Helsinki

Finland

Diclofenac sodium

Motifene Dual

75 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren

25 mg/ml

Soluzzjoni għall-injezzjoni /Konċertrat għal soluzzjoni għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren Retard

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Franza

| Laboratoires Genevrier |
| --- |
| 280, rue de Goa |
| Les Trois Moulins - Parc de Sophia Antipolis |
| 06600 Antibes |
| France |

Laboratoires Genevrier

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

Diclofenac epolamine

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

25 mg

Granijiet għal soluzzjoni orali

Użu orali

Franza

| Laboratoires Genevrier |
| --- |
| 280, rue de Goa |
| Les Trois Moulins - Parc de Sophia Antipolis |
| 06600 Antibes |
| France |

Laboratoires Genevrier

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

Diclofenac epolamine

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

50 mg

Granijiet għal soluzzjoni orali

Użu orali

Franza

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé

12,5 mg

Pillola miksija b’rita

Użu orali

Franza

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

NOVARTIS SANTE FAMILIALE

14, boulevard Richelieu

92500 Rueil-Malmaison

France

Diclofenac potassju

VOLTARENDOLO 12,5 mg, comprimé enrobé

12,5 mg

Pillola miksija

Użu orali

Franza

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

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

Diclofenac sodium

DICLOFENAC ARROW 50 mg, comprimé gastro-résistant

50 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Diclofenac sodium

DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant

50 mg

Pillola miksija b’rita gastro-reżistenti

Użu orali

Franza

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Diclofenac sodium

DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant

50 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

CRISTERS

22 quai Gallieni

92150 Suresnes

France

Diclofenac sodium

DICLOFENAC CRISTERS 50 mg, comprimé gastro-résistant

50 mg

Pillola gastro-reżistenti

Użu orali

Franza

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Diclofenac sodium

DICLOFENAC EG 50 mg, comprimé gastro-résistant

50 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Diclofenac sodium

DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant

25 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Diclofenac sodium

DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant

50 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Diclofenac sodium

DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Franza

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

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Diclofenac sodium

DICLOFENAC TEVA 25 mg, comprimé enrobé gastro-résistant

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Franza

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

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Diclofenac sodium

DICLOFENAC TEVA 50 mg, comprimé enrobé gastro-résistant

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 100 mg, suppositoire

100 mg

Suppositorju

Użu għal ġor-rektum

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 25 mg, comprimé gastro-résistant

25 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 50 mg, comprimé enrobé gastro-résistant

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 75 mg/3 ml, solution injectable

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE ENFANT, suppositoire

25 mg

Suppositorju

Użu għal ġor-rektum

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée

100 mg

Pillola li terħi il-mediċina bil-mod miksija

Użu orali

Franza

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

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée

75 mg

Pillola li terħi il-mediċina bil-mod miksija

Użu orali

Franza

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

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

Diclofenac sodium

Misoprostol

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

50 mg

0,2 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

Diclofenac sodium

Misoprostol

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

75 mg

0,2 mg

Pillola gastro-reżistenti

Użu orali

Franza

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

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Diclofenac sodium

Xelaran Brausetablette 25 mg

25 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 100 retard - 1 A Pharma

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 25 - 1 A Pharma

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 50 - 1 A Pharma

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 75 SL - 1 A Pharma

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclofenac- 1 A Pharma 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclofenac- 1 A Pharma 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 25 mg Tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 50 mg Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 50 mg Trinktabletten

50 mg

Pillola li tinxtered

Użu orali

Il-Ġermanja

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclo Divido

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclo-Divido long

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclofenac-Actavis 100 mg

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclofenac-Actavis 50 mg

50 mg

Kapsula gastro-reżistenti

Użu orali

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac kalium

Diclo AL akut 12,5 mg

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 25

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 50 Supp.

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL i.m.

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac kalium

Diclofenac-Kalium AL 25 mg Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina dual 75 Kaps

75 mg

Kapsula

Użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina uno 100

100 mg

Kapsula

Użu orali

Il-Ġermanja

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Xelaran Brausetablette 50 mg

50 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 50 mg

Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl N 75

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclo dispers

50 mg

Pillola li tinxtered

Użu orali

Il-Ġermanja

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 100 retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 25

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 100 mg Retardtablette

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 50 mg magensaftresistente Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 75 mg SF Injektionslösung

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 100 mg Supp.

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 25 mg Tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Trinktabletten

50 mg

Pillola li tinxtered

Użu orali

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Supp.

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 75 mg/2 ml Ampullen

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac kalium

Diclo-CT akut 12,5 mg Filmtabletten

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Diclofenac sodium

Diclo-Denk 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Diclofenac sodium

DICLO-DENK 100 mg RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Diclofenac sodium

Diclofenac Atid 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Diclofenac sodium

Diclofenac Atid retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

DOCPHARM Arzneimittelvertrieb GmbH & Co.

Kommanditgesellschaft auf Aktien

Greschbachstr. 7

76229 Karlsruhe

Germany

Diclofenac sodium

Diclafenac PB retard 100 mg

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

| Dolorgiet GmbH & Co. KG |
| --- |
| Otto-von-Guericke-Str. 1 |
| 53757 Sankt Augustin |
| Germany |

Dolorgiet GmbH & Co. KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Diclofenac sodium

Dolgit-Diclo 100

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

| Dolorgiet GmbH & Co. KG |
| --- |
| Otto-von-Guericke-Str. 1 |
| 53757 Sankt Augustin |
| Germany |

Dolorgiet GmbH & Co. KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Diclofenac sodium

Dolgit-Diclo 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 25

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 50

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 75 akut

75 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Il-Ġermanja

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

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

Diclofenac sodium

Diclo-Weimer

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Diclofenac sodium

Diclofenac Natrium HERMES 25 mg Brausetabletten

25 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Diclofenac sodium

Diclofenac Natrium HERMES 50 mg Brausetabletten

50 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 100 Heumann Supp.

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 100 retard Heumenn

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 25 Heumenn

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 50 Heumann

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 50 Heumenn Supp.

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 150 mg ID

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 25

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 75 mg ID

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac Dispers

50 mg

Pillola li tinxtered

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac potassju

Diclac Dolo 12,5 mg

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac potassju

Diclac Dolo 25 mg

25 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

| HIKMA Farmaceutica (Portugal(, S.A. |
| --- |
| Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca |
| 2705-906 Terrugem SNT |
| Portugal |

HIKMA Farmaceutica (Portugal(, S.A.

Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca

2705-906 Terrugem SNT

Portugal

Diclofenac sodium

Diclofenac Hikma 75 mg

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

Diclofenac sodium

Jutafenac 100 mg Retardtabletten

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Kappler Pharma Consult GmbH

Fonyoder Str. 18

89340 Leipheim

Germany

Diclofenac potassju

Diclofen Kalium KPC 25 mg Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Diclofenac sodium

Diclo KSK 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Diclofenac sodium

Diclofenac MEDA 25 mg Brausetabletten

25 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Diclofenac sodium

Diclofenac MEDA 50 mg Brausetabletten

50 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 100 mg Retardtabletten

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac Mylan 100 mg Retardtabletten

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassju

Diclofenac NCH 25 mg

25 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassju

Optalidon Zahnschmerz mit Diclofenac 25 mg

25 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassju

Voltaren Dolo 12,5 mg

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassju

Voltaren Dolo 25 mg

25 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassju

Voltaren Dolo 25 mg

25 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassju

Voltaren Dolo Liquid 12,5 mg

12,5 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Codeine hemihydrate phosphate

Combaren 50 mg/50 mg Filmtabletten

50 mg

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 100 mg retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 25 mg Zäpfchen

25 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren Dispers

50 mg

Pillola li tinxtered

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac potassju

Voltaren K Migräne 50 mg

50 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Codeine hemihydrate phosphate

Voltaren Plus 50 mg/50 mg Filmtabletten

50 mg

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac colestyramine

Voltaren Resinat

140 mg

Kapsula, iebsa

Użu orali

Il-Ġermanja

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

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

Diclofenac sodium

Misoprostol

Arthotec

50 mg

0,2 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

Diclofenac sodium

Misoprostol

Arthotec forte

75 mg

0,2 mg

Pillola miksija

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 100 mg Retardkapseln

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 25 mg magensaftresistente Tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg Disperstabletten

50 mg

Pillola li tinxtered

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg magensaftresistente Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg SL Retardkapseln

75 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg/2 ml Injektionslösung

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassju

Diclofenac-ratiopharm Lösung bei Migräne

50 mg/1 ml

Qtar orali, soluzzjoni

Użu orali

Il-Ġermanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassju

Diclofenac-ratiopharm Schmerztabletten 12,5 mg

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

22946 Trittau

Germany

Diclofenac sodium

Diclofenac SF-Rotexmedica

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 100 mg Retardtabletten

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 25 mg magensaftresistente Tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 50 mg magensaftresistente Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz parenteral 75 mg Injektionslösung

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz Uno 150 mg Retardtabletten

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

sigapharm GmbH

Temmlerstr. 2

35039 Marburg/Lahn

Germany

Diclofenac sodium

Sigafenac 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 100 mg Retardtabletten

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 25 mg magensaftresistente Tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 50 mg magensaftresistente Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac Stada 50 mg Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA N 75 mg/3 ml Injektionslösung

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac potassju

Diclofenac-Kalium STADA 12,5 mg Filmtabletten

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac potassju

Diclofenac-Kalium STADA 25 mg Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

Diclofenac sodium

Allvoran 100 mg Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

Diclofenac sodium

Allvoran SF

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

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

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran S 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran S 50 mg

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

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

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran uno

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclo-Klinge 75 mg magensaftresistente Hartkapsel

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclo-Klinge 75 mg spezial

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac spezial 100 mg Klinge

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac spezial 75 mg Klinge

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler 25 mg Hartkapseln

25 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler SL 100 mg Retardkapseln

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

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

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler SL 75 mg Retardkapseln

75 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 100 mg Retardtabletten

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 100 mg Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 25 mg magensaftresistente Tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 50 mg magensaftresistente Tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| TEOFARMA S.R.L. |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 VALLE SALIMBENE (PV) |
| Italy |

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 75 mg/3 ml Injektionslösung

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

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

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Diclofenac sodium

Xelaran Brausetablette 25 mg

25 mg

Pillola li tfexfex

Użu orali

Il-Ġermanja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Diclotin 25 mg Filmtabletten

25 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Diclotin 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

Diclowal 100 mg retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL 75 mg

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Ġermanja

| Walter Ritter GmbH & Co. |
| --- |
| Spaldingstr. 110 B |
| 20097 Hamburg |
| Germany |

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL Supp.

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 50 mg

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam retard N

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Ġermanja

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 100 mg

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Ġermanja

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Wörwag Pharma GmbH & Co.KG |
| --- |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Greċja

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| Dilou 9, Peristeri |
| Attikis, 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9, Peristeri

Attikis, 12134

Greece

Diclofenac sodium

BATAFIL

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

| ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Greece |

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

| MEDICUS S.A |
| --- |
| Valaoritou 10 |
| Metamorfosi 14452 |
| Greece |

MEDICUS S.A

Valaoritou 10

Metamorfosi 14452

Greece

Diclofenac sodium

DIFEND

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

25 mg

Pillola miksija b’rita

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

100 mg

Pillola miksija b’rita rilaxx sostnut

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

75 mg

Pillola miksija b’rita rilaxx sostnut

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Pillola li tinxtered

Użu orali

Il-Greċja

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

| PHARMATHEN International S.A.Greece |
| --- |
| Dervenakiwn 4, Pallini |
| Attikis 15351 |
| Greece |

PHARMATHEN International S.A.Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

| D.A.S.T. BIOTECH Pharmaceutical Ltd |
| --- |
| Larissis 10 |
| Pallini 15351 |
| Greece |

D.A.S.T. BIOTECH Pharmaceutical Ltd

Larissis 10

Pallini 15351

Greece

Diclofenac sodium

FLEFARMIN

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

100 mg

Pillola miksija b’rita rilaxx sostnut

Użu orali

Il-Greċja

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

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

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

50 mg

Pillola miksija

Użu orali

Il-Greċja

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

25 mg

Pillola miksija

Użu orali

Il-Greċja

| ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Greece |

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

| ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Greece |

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Greċja

| Pfizer Hellas A.E. |
| --- |
| Messoghion Ave. 243 |
| Neo Psychiko 15451 |
| Greece |

Pfizer Hellas A.E.

Messoghion Ave. 243

Neo Psychiko 15451

Greece

Diclofenac sodium

Misoprostol

ARTHROTEC

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Greċja

| PHARMANEL COMMERCE PHARMACEUTICAL S.A. |
| --- |
| Marathonos Avenue 106, Gerakas 15344 |
| Greece |

PHARMANEL COMMERCE PHARMACEUTICAL S.A.

Marathonos Avenue 106, Gerakas 15344

Greece

Diclofenac sodium

FENOCLOF

75 mg

Kapsula li terħi il-mediċina b’mod modifikat

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassju

VOLTAREN ACTI-GO

25 mg

Pillola miksija

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassju

VOLTAREN ACTI-GO

50 mg

Pillola miksija

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassju

VOLTAREN ACTI-GO

12,5 mg

Pillola miksija

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassju

VOLTAREN FAST

50 mg

Trab għal soluzzjoni orali

Użu orali

Il-Greċja

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

Diclofenac sodium

DICLO DUO

75 mg

Kapsula li terħi il-mediċina b’mod modifikat

Użu orali

Il-Greċja

| PHARMASWISS HELLAS A.E. |
| --- |
| Pentelis Avenue 53 |
| Vrilissia 15235 |
| Greece |

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

Diclofenac sodium

COUNTERFLAME

75 mg

Kapsula gastro-reżistenti

Użu orali

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Greċja

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12th Km National Highway No 1, |
| Metamorfosi Attikis 144 51 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Greċja

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

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Greċja

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia, 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Greċja

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

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

50 mg

Suppositorju

Użu għal ġor-rektum

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM belsőleges szuszpenziós cseppek

15 mg/ml

Qtar orali, suspensjoni

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM 50 mg bevont tabletta

50 mg

Pillola miksija

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM-V 50 mg tabletta

50 mg

Pillola

Użu orali

L-Ungerija

| Sandoz Hungária Kft.,., |
| --- |
| Bartók Béla út 43.-47. |
| Budapest, 1114 |
| Hungary |

Sandoz Hungária Kft.,.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

Diclofenac

DICLAC 75 mg retard tabletta

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Ungerija

| Sandoz Hungária Kft.,., |
| --- |
| Bartók Béla út 43.-47. |
| Budapest, 1114 |
| Hungary |

Sandoz Hungária Kft.,.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

Diclofenac

DICLAC 150 mg retard tabletta

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Ungerija

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 50 mg végbélkúp

50 mg

Suppositorju

Użu għal ġor-rektum

L-Ungerija

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 50 mg gyomornedv-ellenálló filmtabletta

50 mg

Pillola gastro-reżistenti miksija b’rita

Użu orali

L-Ungerija

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 100 mg végbélkúp

100 mg

Suppositorju

Użu għal ġor-rektum

L-Ungerija

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

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 75 mg/3 ml oldatos injekció

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu parenterali,

Użu għal ġol-muskoli

L-Ungerija

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

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac

DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula

75 mg

Kapsula, iebsa

Użu orali

L-Ungerija

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| Bad Vilbel 61118 |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

Diclofenac

DICLOFENAC STADA 100 mg retard filmtabletta

100 mg

Pillola li terħi il-mediċina bil-modi miksija b’rita

Użu orali

L-Ungerija

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 25 mg filmtabletta

25 mg

Pillola miksija b’rita

Użu orali

L-Ungerija

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 100 mg retard kemény kapszula

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Ungerija

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 50 mg filmtabletta

50 mg

Pillola miksija b’rita

Użu orali

L-Ungerija

| ratiopharm Hungária |
| --- |
| Kereskedelmi Kft. Uzsoki u. 36/a |
| Budapest, 1145 |
| Hungary |

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM retard tabletta

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Ungerija

| TEVA Gyógyszergyár zRt. |
| --- |
| Pallagi út 13 |
| Debrecen 4042 |
| Hungary |

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

Diclofenac

DICLOFENAC-TEVA 100 mg végbélkúp

100 mg

Suppositorju

Użu għal ġor-rektum

L-Ungerija

| PANNONPHARMA Gyógyszergyártó Kft. |
| --- |
| PannonPharma út 1. |
| Pécsvárad 7720 |
| Hungary |

PANNONPHARMA Gyógyszergyártó Kft.

PannonPharma út 1.

Pécsvárad 7720

Hungary

Diclofenac

DICLOMEL SR 100 mg retard tabletta

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Ungerija

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

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Ċitrat orphenadrine

NEODOLPASSE oldatos infúzió

75 mg/250 ml

30 mg/250 ml

Soluzzjoni għall-infużjoni

Użu parenterali,

Użu għal ġol-vini

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 100 mg retard filmtabletta

100 mg

Pillola li terħi il-mediċina bil-modi miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 25 mg gyomornedv-ellenálló filmtabletta

25 mg

Pillola gastro-reżistenti miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 50 mg gyomornedv-ellenálló filmtabletta

50 mg

Pillola gastro-reżistenti miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 50 mg végbélkúp

50 mg

Suppositorju

Użu għal ġor-rektum

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 75 mg retard filmtabletta

75 mg

Pillola li terħi il-mediċina bil-modi miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 75 mg/3 ml oldatos injekció

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu parenterali; Użu għal ġol-muskoli; Użu għal ġol-vini; Użu għal infużjoni; Użu għal injezzjoni.

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 12,5 mg filmtabletta

12,5 mg

Pillola miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 12,5 mg lágy kapszula

12,5 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 25 mg bevont tabletta

25 mg

Pillola miksija

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| Budapest, 1114 |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac potassju

VOLTAREN DOLO 25 mg lágy kapszula

25 mg

Kapsula, ratba

Użu orali

L-Ungerija

| IBSA Pharma Információs és Szolgáltató Kft. |
| --- |
| Fodor u. 54/B. |
| Budapest 1124, |
| Hungary |

IBSA Pharma Információs és Szolgáltató Kft.

Fodor u. 54/B.

Budapest 1124,

Hungary

Diclofenac

FLECTOR RAPID 50 mg granulátum

50 mg

Granijiet

Użu orali

L-Ungerija

| TEVA Gyógyszergyár zRt. |
| --- |
| Pallagi út 13 |
| Debrecen 4042 |
| Hungary |

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

Diclofenac

FORTEDOL 50 mg filmtabletta

50 mg

Pillola miksija b’rita

Użu orali

L-Islanda

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac sodium

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola

Użu orali

L-Islanda

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

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac sodium

Misoprostol

Arthrotec Forte

75 mg

0,2 mg

Pillola

Użu orali

L-Islanda

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

ratiopharm GmbH

Graf-Arco Strasse 3

89079 Ulm

Germany

Diclofenacum INN natríum

Diclomex

50 mg

Pillola gastro-reżistenti

Użu orali

L-Islanda

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

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Pillola gastro-reżistenti

Użu orali

L-Islanda

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac sodium

Klofen L

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Islanda

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac sodium

Modifenac

75 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac sodium

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac sodium

Voltaren

25 mg

Pillola gastro-reżistenti

Użu orali

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac sodium

Voltaren

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac sodium

Voltaren

50 mg

Suppositorju

Użu għal ġor-rektum

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac sodium

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac potassju

Voltaren Dolo

12,5 mg

Pillola miksija b’rita

Użu orali

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac potassju

Voltaren Dolo

12,5 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac potassju

Voltaren Dolo

25 mg

Pillola miksija

Użu orali

L-Islanda

| Novaris Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Københawn Ø |
| Denmark |

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenac potassju

Voltaren Rapid

50 mg

Pillola miksija

Użu orali

L-Islanda

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Vóstar-S

25 mg

Pillola miksija b’rita

Użu orali

L-Islanda

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Vóstar-S

50 mg

Pillola miksija b’rita

Użu orali

L-Islanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 25 mg Gastro-Resistant Tablets

25 mg

Pillola gastro-reżistenti

Użu orali

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 50 mg Gastro-Resistant Tablets

50 mg

Pillola gastro-reżistenti

Użu orali

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 12,5 mg Suppositories

12,5 mg

Suppositorju

Użu għal ġor-rektum

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 100 mg Suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Ampoules 75 mg/3 ml, solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Retard 100 mg Film-coated Prolonged Release Tablets

100 mg

Pillola li terħi il-mediċina bil-modi miksija b’rita

Użu orali

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Retard 75 mg Film-coated Prolonged-release Tablets

75 mg

Pillola li terħi il-mediċina bil-modi miksija b’rita

Użu orali

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassju

Cataflam 25 mg Coated Tablets

25 mg

Pillola miksija

Użu orali

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassju

Cataflam 50 mg Coated Tablets

50 mg

Pillola miksija

Użu orali

L-Irlanda

| Novarits Pharmacetucials UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GU16 7SR |
| Surrey |
| United Kingdom |

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassju

Voltfast Sachets 50 mg Powder for Oral Solution

50 mg

Trab għal soluzzjoni orali

Użu orali

L-Irlanda

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassju

Diclofenac potassium NCH 12,5 mg Film-coated tablets

12,5 mg

Pillola miksija b’rita

Użu orali

L-Irlanda

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassju

Otriflu 12,5 mg Film-coated Tablets

12,5 mg

Pillola miksija b’rita

Użu orali

L-Irlanda

| Pinewood Laboratories Ltd |
| --- |
| (T/A Pinewood Heathcare) Ballymacarbry |
| Clonmel, Co. Tipperary |
| Ireland |

Pinewood Laboratories Ltd

(T/A Pinewood Heathcare) Ballymacarbry

Clonmel, Co. Tipperary

Ireland

Diclofenac sodium

Diclo 75 mg prolonged release tablets.

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Irlanda

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 75 mg Prolonged -Release Tablets

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Irlanda

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac Retard 100 mg Prolonged-release Tablets

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Irlanda

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 25 mg Gastro-resistant Tablets

25 mg

Pillola gastro-reżistenti

Użu orali

L-Irlanda

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 50 mg Gastro-resistant Tablets

50 mg

Pillola gastro-reżistenti

Użu orali

L-Irlanda

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 100 mg Suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

L-Irlanda

| Rowex Ltd |
| --- |
| Bantry, Co. Cork |
| Ireland |

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 25 mg/ml Solution for Injection 3 ml Ampoule

25 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Irlanda

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Diclofenac sodium

Arthrotec 50 modified release tablets

50 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Irlanda

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Diclofenac sodium

Arthrotec 75 modified-release tablets

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Irlanda

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 25 mg Capsules

25 mg

Kapsula

Użu orali

L-Irlanda

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 50 mg Capsules

50 mg

Kapsula

Użu orali

L-Irlanda

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 75 mg Dual Release Capsules

75 mg

Kapsula li jerħu l-mediċina doppju -mod

Użu orali

L-Irlanda

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 100 mg Dual Release Capsules

100 mg

Kapsula li jerħu l-mediċina doppju -mod

Użu orali

L-Irlanda

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion

75 mg/3 ml

Soluzzjoni għall-injezzjonii Konċentrat għal soluzzjoni għall-infużjonii

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Irlanda

| Astellas Pharma Co. Ltd |
| --- |
| 5 Waterside |
| Citywest Busniess Campus Naas Road |
| Dublin 24 |
| Ireland |

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 100 mg Suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

L-Irlanda

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

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Kyflam 50 mg Film Coated Tablet

50 mg

Pillola miksija b’rita

Użu orali

L-Irlanda

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac Sodium

Misoprostol

Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Irlanda

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac Sodium

Misoprostol

Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

50 mg

Pillola li tinħall

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

50 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Industria Farmaceutica Galenica Senese S.r.l. |
| --- |
| Via Cassia Nord |
| 351 Darvia - 53014 Siena |
| Italy |

Industria Farmaceutica Galenica Senese S.r.l.

Via Cassia Nord

351 Darvia - 53014 Siena

Italy

Diclofenac sodium

ALGOSENAC

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Bayer S.p.a. |
| --- |
| Viale Certosa, 130 |
| Milano - 20156 |
| Italy |

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

Diclofenac hydroxyethylpyrrolidine

BAIFENAC

50 mg

Granijiet

Użu orali

L-Italja

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

Diclofenac sodium

DEALGIC

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| CostanzaFarma srl |
| --- |
| Via Taranto 4 |
| 20142 Milano |
| Italy |

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

Diclofenac sodium

DEALGIC

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| DAICHI SANKYO Italia S.p.a. |
| --- |
| Via Paolo Di Dono 73 |
| 00142, Rome |
| Italy |

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodium

DEFLAMAT

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| DAICHI SANKYO Italia S.p.a. |
| --- |
| Via Paolo Di Dono 73 |
| 00142, Rome |
| Italy |

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodium

DEFLAMAT

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| DAICHI SANKYO Italia S.p.a. |
| --- |
| Via Paolo Di Dono 73 |
| 00142, Rome |
| Italy |

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodium

DEFLAMAT

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

Diclofenac sodium

DICLOFAN

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Crinos S.p.a. |
| --- |
| Via Pavia, 6 |
| Milano - 20136 |
| Italy |

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

Diclofenac sodium

DICLOFAN

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodium

DICLOFENAC

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodium

DICLOFENAC

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

50 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

25 mg

Pillola

Użu orali

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

50 mg

Pillola

Użu orali

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

150 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Alpha Biotech S.r.l. |
| --- |
| Via Ragazzi del 99 |
| 5, Bologna - 40133 |
| Italy |

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodium

DICLOFENAC ALPHA BIOTECH

25 mg/ml

Qtar orali, soluzzjoni

Użu orali

L-Italja

| Almus S.r.l. |
| --- |
| Via Cesarea, 11/10 |
| Genova - 16121 |
| Italy |

Almus S.r.l.

Via Cesarea, 11/10

Genova - 16121

Italy

Diclofenac sodium

DICLOFENAC ALMUS

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodium

DICLOFENAC ANGENERICO

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodium

DICLOFENAC ANGENERICO

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodium

DICLOFENAC ANGENERICO

50 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| Angenerico S.p.a. |
| --- |
| Via Nocera Umbra 75 |
| Roma - 00181 |
| Italy |

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodium

DICLOFENAC ANGENERICO

25 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC DOC

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC DOC GENERICI

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| Milano - 20124 |
| Italy |

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC DOC GENERICI

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC EG

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC EG

50 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC EG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| EG S.p.a |
| --- |
| Via Scarlatti, 31 |
| Milano - 20124 |
| Italy |

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC EG

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Germed Pharma S.p.a. |
| --- |
| Via Cantu, 11, Balsamo |
| Milano, 20092 |
| Italy |

Germed Pharma S.p.a.

Via Cantu, 11, Balsamo

Milano, 20092

Italy

Diclofenac sodium

DICLOFENAC GERMED

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodium

DICLOFENAC HEXAL

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodium

DICLOFENAC HEXAL

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodium

DICLOFENAC HEXAL

50 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| HEXAL S.p.a. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso, 16 |
| Brianza, Milano, 20041 |
| Italy |

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodium

DICLOFENAC HEXAL

25 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC MYLAN GENERICS

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Mylan S.p.a. |
| --- |
| Via Vittor Pisani, 20 |
| Milano - 20124 |
| Italy |

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

Diclofenac sodium

DICLOFENAC MYLAN GENERICS

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Sandoz S.p.a. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio, Varese - 21040 |
| Italy |

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodium

DICLOFENAC SODICO

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Biologici Italia Laboratories S.r.l. |
| --- |
| Via Serpero, 2 |
| Masate, Milano - 20060 |
| Italy |

Biologici Italia Laboratories S.r.l.

Via Serpero, 2

Masate, Milano - 20060

Italy

Diclofenac sodium

DICLOFENAC SODICO BIL

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

50 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

150 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

50 mg

Granijiet

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

50 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

25 mg/ml

Qtar orali, soluzzjoni

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

DICLOREUM

46,5 mg/ml

Qtar orali, soluzzjoni

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac hydroxyethylpyrrolidine

DIEP

25 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac hydroxyethylpyrrolidine

DIEP

25 mg

Granijiet għal suspensjoni orali

Użu orali

L-Italja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac potassju

EMINOCS

50 mg

Qtar orali, soluzzjoni

Użu orali

L-Italja

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

FENADOL

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Wellington Street Development Pharma Limited |
| --- |
| 47 Oaklands Drive Rathgar |
| Dublin 6 |
| Ireland |

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

Diclofenac sodium

FENDER

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Wellington Street Development Pharma Limited |
| --- |
| 47 Oaklands Drive Rathgar |
| Dublin 6 |
| Ireland |

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

Diclofenac sodium

FENDER

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

| Bayer S.p.a. |
| --- |
| Viale Certosa, 130 |
| Milano - 20156 |
| Italy |

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

Diclofenac hydroxyethylpyrrolidine

FLECTOR DOLORE

25 mg

Granijiet għal soluzzjoni orali

Użu orali

L-Italja

| Menarini Industrie Farmaceutiche Riunite S.r.l. |
| --- |
| Via Sette Santi 3, |
| Firenze 50131- Italy |

Menarini Industrie Farmaceutiche Riunite S.r.l.

Via Sette Santi 3,

Firenze 50131- Italy

Diclofenac sodium

FLOGOFENAC

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| FIDIA Farmaceutici S.p.a. |
| --- |
| Via Ponte della Fabbrica |
| 3/a, Abano Terme |
| Padova - 35031 |
| Italy |

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica

3/a, Abano Terme

Padova - 35031

Italy

Diclofenac potassju

ITAMIFAST

25 mg

Pillola miksija b’rita

Użu orali

L-Italja

| FIDIA Farmaceutici S.p.a. |
| --- |
| Via Ponte della Fabbrica |
| 3/a, Abano Terme |
| Padova - 35031 |
| Italy |

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica

3/a, Abano Terme

Padova - 35031

Italy

Diclofenac potassju

ITAMIFAST

50 mg

Pillola miksija b’rita

Użu orali

L-Italja

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

Diclofenac potassju

KAPPADI

25 mg

Pillola miksija b’rita

Użu orali

L-Italja

| Scandinavian Regulatory Services, AB |
| --- |
| Svardvagen 3B |
| Stockholm SE-182 33 |
| Sweden |

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

Diclofenac potassju

KAPPADI

50 mg

Pillola miksija b’rita

Użu orali

L-Italja

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodium

NOVAPIRINA

25 mg

Pillola miksija

Użu orali

L-Italja

| O. P. PHARMA S.r.l. |
| --- |
| Via Torino 51 |
| Milano - 20123 |
| Italy |

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

Diclofenac sodium

TRAULEN

100 mg

Pillola miksija b’rita

Użu orali

L-Italja

| O. P. PHARMA S.r.l. |
| --- |
| Via Torino 51 |
| Milano - 20123 |
| Italy |

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

Diclofenac sodium

TRAULEN

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

L-Italja

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodium

VOLTADVANCE

25 mg

Trab għal soluzzjoni orali

Użu orali

L-Italja

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodium

VOLTADVANCE

25 mg

Pillola miksija b’rita

Użu orali

L-Italja

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassju

VOLTFAST

50 mg

Pillola miksija

Użu orali

L-Italja

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassju

VOLTFAST

25 mg

Pillola miksija

Użu orali

L-Italja

| Novartis Pharma S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| Origgio - 21040 Varese |
| Italy |

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassju

VOLTFAST

50 mg

Granijiet għal soluzzjoni orali

Użu orali

L-Italja

| Altergon Italia S.r.l. |
| --- |
| Via Dell'Industria |
| Pietradefusi - 83030 Avellino |
| Italy |

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

Diclofenac

INFORCE

75 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal taħt il-ġilda

L-Italja

| Altergon Italia S.r.l. |
| --- |
| Via Dell'Industria |
| Pietradefusi - 83030 Avellino |
| Italy |

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

Diclofenac sodium

INDICAM

75 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal taħt il-ġilda

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodium

Misoprostol

MISOFENAC

50 mg

0,2 mg

Pillola

Użu orali

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodium

Misoprostol

MISOFENAC

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodium

Misoprostol

ARTROTEC

50 mg

0,2 mg

Pillola

Użu orali

L-Italja

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

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodium

Misoprostol

ARTROTEC

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Italja

| HEXAL AG S.p.a. |
| --- |
| Industriestrasse, 25, D-83607 |
| HOLZKIRCHEN |
| Germany |

HEXAL AG S.p.a.

Industriestrasse, 25, D-83607

HOLZKIRCHEN

Germany

Diclofenac sodium

DICLOFENAC HEXAL AG

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Italja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

DICLOFENAC RATIOPHARM

50 mg

Pillola gastro-reżistenti

Użu orali

L-Italja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

DICLOFENAC RATIOPHARM

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Latvja

| 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

Diclofenac sodium

Profenac 75 mg/3 ml solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Latvja

| 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

Diclofenac sodium

Profenac SR 100 mg prolonged-release tablets

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Latvja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg gastro-resistant tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Latvja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 25 mg gastro-resistant tablets

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Latvja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm uno 150 mg prolonged-release tablets

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Latvja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg/2 ml solution for injection

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Latvja

| 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

Diclofenac sodium

Diclogen 50 mg suppositories

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Latvja

| 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

Diclofenac sodium

Diclogen 100 mg suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Latvja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac sodium

Diclac 75 mg/3 ml solution for injection/infusion

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Latvja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac sodium

Diclac 100 mg modified release tablets

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Latvja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac sodium

Diclac ID 75 mg modified release tablets

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Latvja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac sodium

Diclac ID 150 mg modified release tablets

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Latvja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclomelan retard 100 mg sustained-release tablets

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Latvja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclomelan 50 mg gastro-resistant tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Latvja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclomelan 100 mg suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Latvja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Tiamina hydrochloride

Pyridoxine hydrochloride

Cyanocobalamine

Diclovit hard capsules

50 mg

50 mg

50 mg

0,25 mg

Kapsula, iebsa

Użu orali

Il-Latvja

| SIA Briz |
| --- |
| Rasas iela 5 |
| Riga, LV-1057 |
| Latvia |

SIA Briz

Rasas iela 5

Riga, LV-1057

Latvia

Diclofenac sodium

Feloran 75 mg/3 ml solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Latvja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Lidocainum hydrochloridum

Olfen 75 mg/20 mg/2 ml solution for injection

75 mg/2 ml

20 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Latvja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen Lactab 50 mg gastro-resistant tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Latvja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen Depocaps 100 mg prolonged-release capsules, hard

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Latvja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen Rectocaps 100 mg rectal capsules

100 mg

Kapsula għar-rektum

Użu għal ġor-rektum

Il-Latvja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen Depotabs 75 mg prolonged release tablets

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Latvja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno 25 mg film-coated tablets

25 mg

Pillola miksija b’rita

Użu orali

Il-Latvja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno 50 mg film-coated tablets

50 mg

Pillola miksija b’rita

Użu orali

Il-Latvja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 75 mg/3 ml solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Latvja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 100 mg suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Latvja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 50 mg gastro-resistant tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Latvja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl retard 100 mg prolonged release capsules

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Pharmaceutical Works POLPHARMA SA |
| --- |
| ul. Pelplińska 19 |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

Diclofenac sodium

Majamil retard 100 mg prolonged-release tablets

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Latvja

| A/S “Olainfarm” |
| --- |
| Rupnicu iela 5 |
| Olaine, LV – 2114 |
| Latvia |

A/S “Olainfarm”

Rupnicu iela 5

Olaine, LV – 2114

Latvia

Diclofenac potassju

Dikloferol 50 mg coated tablets

50 mg

Pillola miksija

Użu orali

Il-Latvja

| SIA PharmaSwiss Latvia |
| --- |
| Gertrudes iela 54 – 5 |
| Riga, LV 1011 |
| Latvia |

SIA PharmaSwiss Latvia

Gertrudes iela 54 – 5

Riga, LV 1011

Latvia

Diclofenac sodium

Diclorapid 75 mg gastro-resistant capsules, hard

75 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren 75 mg/3 ml solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassju

Voltaren Akti 12,5 mg film-coated tablets

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassju

Voltaren Akti 25 mg soft capsules

25 mg

Kapsula, ratba

Użu orali

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac sodium

Voltaren Retard 100 mg modified-release film-coated tablets

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassju

Cataflam 50 mg film-coated tablets

50 mg

Pillola miksija b’rita

Użu orali

Il-Latvja

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

Diclofenac sodium

Diclofenac 50 mg suppositories

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Latvja

| GlaxoSmithKline Latvia SIA |
| --- |
| Duntes iela 11 |
| Riga LV - 1013 |
| Latvia |

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

Diclofenac sodium

Diclofenac 100 mg suppositories

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Latvja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen SR 100 mg prolonged-release tablets

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Latvja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen 75 mg/3 ml solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Latvja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen 50 mg gastro-resistant tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Latvja

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

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 25 mg/ml solution for injection and infusion

25 mg/ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Latvja

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

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo CT 75 mg/2 ml solution for injection

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Litwanja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Litwanja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Litwanja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac ID

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Litwanja

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

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac ID

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB „PharmaSwiss“ |
| --- |
| Šeimyniškių g. 21B |
| LT-09200, Vilnius |
| Lithuania |

UAB „PharmaSwiss“

Šeimyniškių g. 21B

LT-09200, Vilnius

Lithuania

Diclofenac

DicloRapid

75 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

Il-Litwanja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Litwanja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Litwanja

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

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

| UAB „BERLIN CHEMIE MENARINI BALTIC“ |
| --- |
| Jasinskio g. 16 a, |
| 01112 Vilnius |
| Lithuania |

UAB „BERLIN CHEMIE MENARINI BALTIC“

Jasinskio g. 16 a,

01112 Vilnius

Lithuania

Diclofenac

Dicloberl retard

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Litwanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Litwanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Litwanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Litwanja

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

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm uno

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Litwanja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Litwanja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Litwanja

| UAB Corpus Medica |
| --- |
| Sukilėlių pr. 61 |
| LT-49333 Kaunas |
| Lithuania |

UAB Corpus Medica

Sukilėlių pr. 61

LT-49333 Kaunas

Lithuania

Diclofenac

FELORAN

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Litwanja

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

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Feloran

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Litwanja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Litwanja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Litwanja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

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

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen SR

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Litwanja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Depocaps

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Litwanja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Depotabs

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Litwanja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Lactab

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Litwanja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Rectocaps

100 mg

Kapsula għar-rektum

Użu għal ġor-rektum

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

25 mg

Pillola miksija

Użu orali

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

25 mg

Kapsula, ratba

Użu orali

Il-Litwanja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Cataflam

50 mg

Pillola miksija

Użu orali

Il-Litwanja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

25 mg

Pillola miksija b’rita

Użu orali

Il-Litwanja

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

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

50 mg

Pillola miksija b’rita

Użu orali

Il-Litwanja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Lidocaine

Olfen

75 mg/2 ml

20 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Litwanja

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

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Tiamina

Pyridoxine

Cyanocobalamine

Diclovit

50 mg

50 mg

50 mg

0,25 mg

Kapsula, iebsa

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassju

Cataflam

50 mg

Pillola miksija

Użu orali

Il-Lussemburgu

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac retard 100

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 75 mg/3 ml Injektionslösung

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Lussemburgu

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-100 Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Lussemburgu

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-25

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-50

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

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

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-50 Zäpfchen

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Lussemburgu

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG-25

25 mg

Pillola miksija

Użu orali

Il-Lussemburgu

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG-50

50 mg

Pillola miksija

Użu orali

Il-Lussemburgu

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG retard 75

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG retard 100

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

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

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG 75 mg/3 ml solution injectable

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Lussemburgu

| N.V. Eurogenerics S.A |
| --- |
| Esplanade Heysel b 22 |
| B-1020 Bruxelles |
| Belgium |

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG 100 suppositoire

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Lussemburgu

| Mylan bvba |
| --- |
| Rozendal Businesspark |
| Terhulpsesteenweg 6A |
| B-1560 Hoeilaart |
| Belgium |

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

Diclofenac Mylan-75 Retard

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Mylan bvba |
| --- |
| Rozendal Businesspark |
| Terhulpsesteenweg 6A |
| B-1560 Hoeilaart |
| Belgium |

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

Diclofenac Mylan-100 Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-100 Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Lussemburgu

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-25

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-50

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Lussemburgu

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Retard Ratiopharm-100

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Lussemburgu

| Daiichi Sankyo Belgium SA |
| --- |
| Rue Fond Jean Pâques 5 |
| B-1348 Louvain-la-Neuve |
| Belgium |

Daiichi Sankyo Belgium SA

Rue Fond Jean Pâques 5

B-1348 Louvain-la-Neuve

Belgium

Diclofenac sodium

Motifene-75

75 mg

Kapsula li terħi il-mediċina b'mod modifikat, iebsa

Użu orali

Il-Lussemburgu

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

Diclofenac sodium

Polyflam-50

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

| Socobom S.A |
| --- |
| Avenue Louise 149 b24 |
| B-1050 Bruxelles |
| Belgium |

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

Diclofenac sodium

Polyflam-75

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Continental Pharma |
| --- |
| Rijksweg, 12 |
| B-2870 Puurs |
| Belgium |

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

Arthrotec-50

50 mg

0,2 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Il-Lussemburgu

| Continental Pharma |
| --- |
| Rijksweg, 12 |
| B-2870 Puurs |
| Belgium |

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

Arthrotec-75

75 mg

0,2 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-100 Zäpfchen

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-25

25 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-50

50 mg

Pillola miksija gastro-reżistenti

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren injekt

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac colestyramine

Voltaren resinat

145,6 mg

Kapsula, iebsa

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren Retard-100

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Novartis Consumer Health S.A. |
| --- |
| Medialaan, 40 |
| B-1800 Vilvoorde |
| Belgium |

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

Diclofenac potassju

Voltatabs

12,5 mg

Pillola miksija

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassju

Cataflam

25 mg

Pillola miksija

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassju

Cataflam

50 mg

Pillola miksija

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassju

Catafast

50 mg

Trab għal soluzzjoni orali

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

12,5 mg

Suppositorju

Użu għal ġor-rektum

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Suppositorju

Użu għal ġor-rektum

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

25 mg

Pillola gastro-reżistenti

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Pillola li tinxtered

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Malta

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Malta

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

Fenadol

100 mg

Suppositorju

Użu għal ġor-rektum

Malta

| Proge Farm S.r.l. |
| --- |
| Largo Donegani 4/a |
| Novara - 28100 |
| Italy |

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

Fenadol

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac potassju

Areston

50 mg

Pillola miksija b’rita

Użu orali

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 25 mg tablets

25 mg

Pillola gastro-reżistenti

Użu orali

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 50 mg tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Malta

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni/għall-infużjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-75 Ampoules

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-25 Lactab

25 mg

Kapsula għar-rektum gastro-reżistenti

Użu orali

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-50 Lactab

50 mg

Kapsula għar-rektum gastro-reżistenti

Użu orali

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-100 Rectocaps

100 mg

Suppositorju

Użu għal ġor-rektum

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-75 SR Depotabs

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Malta

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-100 SR Depocaps

100 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Malta

| Remedica Ltd |
| --- |
| Limassol Industrial Estate |
| Aharnon Street |
| PO Box 51706 |
| CY-3508 Limassol |
| Cyprus |

Remedica Ltd

Limassol Industrial Estate

Aharnon Street

PO Box 51706

CY-3508 Limassol

Cyprus

Diclofenac sodium

Remethan 25 mg Tablets

25 mg

Pillola gastro-reżistenti

Użu orali

Malta

| DEMO SA Pharmaceutical Industry |
| --- |
| 21st km National Road |
| Athens-Lamia 14568 |
| Athens |
| Greece |

DEMO SA Pharmaceutical Industry

21st km National Road

Athens-Lamia 14568

Athens

Greece

Diclofenac sodium

Urigon 75 mg/3 ml solution for injection

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

In-Norveġja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassju

Diclofenackalium Orifarm

25 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassju

Diclofenackalium Orifarm

50 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Voltarol

12,5 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Voltarol

25 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Voltarol

12,5 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Voltarol

25 mg

Pillola miksija

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Cataflam

12,5 mg

Pillola miksija

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Cataflam

50 mg

Pillola miksija

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassju

Cataflam

50 mg

Trab għal soluzzjoni orali

Użu orali

In-Norveġja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

25 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

50 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Difenassium

25 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Difenassium

50 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Diclofenac Actavis

12,5 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac sodium

Modifenac

75 mg

Kapsula li terħi il-mediċina b'mod modifikat, iebsa

Użu orali

In-Norveġja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassju

DiclofenacKalium ratiopharm

50 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Pfizer AS |
| --- |
| Lilleakerveien 2B |
| 1324 Lysaker |
| Norway |

Pfizer AS

Lilleakerveien 2B

1324 Lysaker

Norway

Diclofenac sodium

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

In-Norveġja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac ratiopharm

25 mg

Pillola gastro-reżistenti

Użu orali

In-Norveġja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac ratiopharm

50 mg

Pillola gastro-reżistenti

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg

Pillola gastro-reżistenti

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg/ml

Soluzzjoni għall-infużjoni / Konċentrat għal soluzzjoni għall-infużjoni

Użu parenterali

In-Norveġja

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Pillola gastro-reżistenti

Użu orali

In-Norveġja

| BMM Pharma AB |
| --- |
| Blasieholmsgatan 2 |
| SE-111 48 Stockholm |
| Sweden |

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Pillola gastro-reżistenti

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg

Suppositorju

Użu għal ġor-rektum

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

50 mg

Suppositorju

Użu għal ġor-rektum

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37 A |
| 0484 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Vostar

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

Dicloreum

50 mg

Pillola gastro-reżistenti miksija b’rita

Użu orali

Il-Polonja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

Dicloreum

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Polonja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodium

Dicloreum retard

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl retard

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Berlin-Chemie AG |
| --- |
| (Menarini Group) |
| Glienicker Weg 125 |
| 12489 Berlin |
| Germany |

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 50

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

Diclofenac sodium

Diclofenac GSK

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| GlaxoSmithKline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka 189 |
| Poznań 60-322 |
| Poland |

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

Diclofenac sodium

Diclofenac GSK

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Polonja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen Duo

75 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen 100

100 mg

Kapsula għar-rektum

Użu għal ġor-rektum

Il-Polonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen 50

50 mg

Kapsula għar-rektum

Użu għal ġor-rektum

Il-Polonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Lidocaini hydrochloridum

Olfen 75

37,5 mg/ml

10 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Polonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen 100 SR

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen 25

25 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen 50

50 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassju

Voltaren Acti

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassju

Voltaren Express

12,5 mg

Kapsula, ratba

Użu orali

Il-Polonja

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassju

Voltaren Acti Forte

25 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassju

Voltaren Express Forte

25 mg

Kapsula, ratba

Użu orali

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassju

Cataflam 50

50 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren SR 100

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren SR 75

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

25 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenacum

Misoprostol

Arthrotec Forte

75 mg

0,2 mg

Pillola

Użu orali

Il-Polonja

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenac sodium

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola

Użu orali

Il-Polonja

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac sodium

DicloDuo

75 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio Retard 100

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 25

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Lidocainum

Dicloratio

75 mg/2 ml

20 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 50

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Olfen UNO

150 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 50

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclac

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclac 75 Duo

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclac 150 Duo

150 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclac 100

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclac 50

50 mg

Suppositorju

Użu għal ġor-rektum

Il-Polonja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

25 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

50 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| 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

Diclofenac sodium

Difadol

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Polonja

| 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

Diclofenac sodium

Majamil prolongatum

100 mg

Kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| 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

Diclofenac sodium

Majamil PPH

25 mg

Pillola gastro-reżistenti

Użu orali

Il-Polonja

| 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

Diclofenac sodium

Majamil PPH

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola

Użu orali

Il-Portugall

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Diclofenac

Misoprostol

Arthrotec 75

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina

Portugal

Diclofenac

Diclofenac Alter 50 mg Comprimidos

50 mg

Pillola miksija

Użu orali

Il-Portugall

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| Portugal |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Diclofenac

Diclofenac Generis 50 mg Comprimidos Revestidos

50 mg

Pillola miksija

Użu orali

Il-Portugall

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Portugall

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Campo de Besteiros |
| 3465-051 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Campo de Besteiros

3465-051 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal 75 mg/3 ml Solução injectável

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Portugall

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro Borges |
| Edíficio Arquiparque 1 |
| R/C Esqo |
| 1499-016 Algés |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro Borges

Edíficio Arquiparque 1

R/C Esqo

1499-016 Algés

Portugal

Diclofenac

Diclofenac Mylan

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Portugall

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Ratiopharm

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Ratiopharm 100 mg Supositórios

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Retard Ratiopharm

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Portugall

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura |
| Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura

Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Diclofenac

Diclofenac Sandoz 50 mg Comprimidos revestidos

50 mg

Pillola miksija

Użu orali

Il-Portugall

| Labesfal - Laboratórios Almiro S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Dolacen

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Portugall

| Laboratório B. A. Farma, Lda. |
| --- |
| Rua Prof. Sousa da Câmara, 207 - 211 |
| 1074-803 Lisboa |
| Portugal |

Laboratório B. A. Farma, Lda.

Rua Prof. Sousa da Câmara, 207 - 211

1074-803 Lisboa

Portugal

Diclofenac

Dorcalor

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Il-Portugall

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V Retard

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Portugall

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Portugall

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Portugall

| Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park |
| Edificio 5-A, Piso 2 |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Confar - Consórcio Farmacêutico, Lda. |
| --- |
| Rua Félix Correia, 1-B |
| 1500-271 Lisboa |
| Portugal |

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex 25

25 mg

Pillola miksija

Użu orali

Il-Portugall

| Confar - Consórcio Farmacêutico, Lda. |
| --- |
| Rua Félix Correia, 1-B |
| 1500-271 Lisboa |
| Portugal |

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex 50

50 mg

Pillola miksija

Użu orali

Il-Portugall

| Confar - Consórcio Farmacêutico, Lda. |
| --- |
| Rua Félix Correia, 1-B |
| 1500-271 Lisboa |
| Portugal |

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex R

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

100 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

50 mg

Pillola gastro-reżistenti

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren 75

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren Retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Il-Portugall

| Laboratório Normal - Produtos Farmacêuticos, Lda. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Cataflam

50 mg

Pillola miksija

Użu orali

Il-Portugall

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Otriflu

12,5 mg

Pillola miksija

Użu orali

Il-Portugall

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 12,5

12,5 mg

Pillola miksija b’rita

Użu orali

Il-Portugall

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 12,5

12,5 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Consumer Health |
| --- |
| Produtos Farmacêuticos e Nutrição, Lda. |
| Rua do Centro Empresarial, |
| Edf 8, Quinta da Beloura |
| 2710-693 Sintra |
| Portugal |

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 25

25 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren Rapid

50 mg

Pillola miksija

Użu orali

Il-Portugall

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V Dispersivel

46,5 mg

Pillola li tinxtered

Użu orali

Ir-Rumanija

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum

DICLOFENAC DUO PHARMASWISS 75 mg

75 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Rumanija

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum

DICLOREUM 150 mg

150 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Rumanija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 50 mg

50 mg

Kapsula gastro-reżistenti, ratba

Użu orali

Ir-Rumanija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca 400 632 |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOTARD® 100 mg

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Rumanija

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenacum

DICLAC® 75 ID

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Rumanija

| STADA HEMOFARM S.R.L. |
| --- |
| Str. Zugrav Nedelcu nr. 3, Timișoara |
| Județul Timiș |
| România |

STADA HEMOFARM S.R.L.

Str. Zugrav Nedelcu nr. 3, Timișoara

Județul Timiș

România

Diclofenacum

REFEN® RETARD

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Rumanija

| S.C. AC HELCOR PHARMA SRL |
| --- |
| Str. Victor Babeș nr. 50 |
| Baia-Mare |
| Jud. Maramureș 430092 |
| România |

S.C. AC HELCOR PHARMA SRL

Str. Victor Babeș nr. 50

Baia-Mare

Jud. Maramureș 430092

România

Diclofenacum

DICLOFENAC 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| SC ANTIBIOTICE SA |
| --- |
| Str. Valea Lupului nr. 1 |
| 6600-Iași |
| România |

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

Diclofenacum

CLAFEN 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| FARAN LABORATORIES S.A. |
| --- |
| 17 km Athens-Lamia |
| Achaias și Trizinas |
| 145 64 Nea Kifisia |
| Greece |

FARAN LABORATORIES S.A.

17 km Athens-Lamia

Achaias și Trizinas

145 64 Nea Kifisia

Greece

Diclofenacum

RHEUMAVEK

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® 50

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® 25

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca 400 632 |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOFENAC 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN RAPID®

50 mg

Pillola miksija

Użu orali

Ir-Rumanija

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Stefan Mihaileanu |
| nr. 31, sector 2; |
| Bucuresti |
| România |

S.C. ARENA GROUP S.A.

Str. Stefan Mihaileanu

nr. 31, sector 2;

Bucuresti

România

Diclofenacum

DICLOFENAC ARENA 50 mg

25 mg

Pillola miksija

Użu orali

Ir-Rumanija

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Stefan Mihaileanu |
| nr. 31, sector 2; |
| Bucuresti |
| România |

S.C. ARENA GROUP S.A.

Str. Stefan Mihaileanu

nr. 31, sector 2;

Bucuresti

România

Diclofenacum

DICLOFENAC ARENA 50 mg

50 mg

Pillola miksija

Użu orali

Ir-Rumanija

| S.C. MEDUMAN S.A. |
| --- |
| Str. Aleea Eroilor nr. 28 |
| Vișeu de Sus |
| Județul Maramureș 435700 |
| România |

S.C. MEDUMAN S.A.

Str. Aleea Eroilor nr. 28

Vișeu de Sus

Județul Maramureș 435700

România

Diclofenacum

N - DICLOFENAC

50 mg

Pillola miksija

Użu orali

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Rumanija

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum

DICLOFENAC AL I.M.

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Rumanija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL®

30 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Rumanija

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum

ALMIRAL

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Rumanija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca 400 632 |
| România |

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOFENAC 75 mg

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Rumanija

| STADA HEMOFARM S.R.L. |
| --- |
| Str. Zugrav Nedelcu nr. 3, Timișoara |
| Județul Timiș |
| România |

STADA HEMOFARM S.R.L.

Str. Zugrav Nedelcu nr. 3, Timișoara

Județul Timiș

România

Diclofenacum

REFEN 75 mg

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Rumanija

| FARAN LABORATORIES S.A. |
| --- |
| 17 km Athens-Lamia |
| Achaias și Trizinas |
| 145 64 Nea Kifisia |
| Greece |

FARAN LABORATORIES S.A.

17 km Athens-Lamia

Achaias și Trizinas

145 64 Nea Kifisia

Greece

Diclofenacum

RHEUMAVEK

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Rumanija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 120 mg

120 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| Gerot Pharmazeutika GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 60 mg

60 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| SC ANTIBIOTICE SA |
| --- |
| Str. Valea Lupului nr. 1 |
| 6600-Iași |
| România |

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

Diclofenacum

CLAFEN 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| Nuernberg D-90429 |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

50 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| S.C. MAGISTRA C&C S.R.L. |
| --- |
| B-dul Aurel Vlaicu nr. 82A |
| Constanța 900055 |
| România |

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82A

Constanța 900055

România

Diclofenacum

DICLOFENAC SODIC 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| S.C. MAGISTRA C&C S.R.L. |
| --- |
| B-dul Aurel Vlaicu nr. 82A |
| Constanța 900055 |
| România |

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82A

Constanța 900055

România

Diclofenacum

DICLOFENAC 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Ċitrat orphenadrine

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

Ir-Rumanija

| PFIZER EUROPE MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PFIZER EUROPE MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenacu

Misoprostol

ARTHROTEC 75

75 mg

0,2 mg

Pillola gastro-

reżistenti

Użu orali

Ir-Rumanija

| Lannacher Heilmittel Ges.m.b.H |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Tiamina hydrochloride

Pyridoxine hydrochloride

Cyanocobalamine

TRATUL PLUS

50 mg

50 mg

50 mg

0,25 mg

Pillola gastro-

reżistenti

Użu orali

Is-Slovakkja

| MEDOPHARM s.r.o., Lehárova 1808/11 |
| --- |
| 143 00, Praha 4 |
| Czech Republic |

MEDOPHARM s.r.o., Lehárova 1808/11

143 00, Praha 4

Czech Republic

Diclofenac

ALMIRAL

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Is-Slovakkja

| Medochemie Ltd |
| --- |
| 1-10 Constantinoupoleos str |
| P.O. Box 51409 |
| Limassol 3505 |
| Cyprus |

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac

ALMIRAL 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac

Diclac retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 150 mg retard

150 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

Diclofenac AL 25

25 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

Diclofenac AL 50

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb Daimler Strasse 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

diclofenac

Diclofenac AL retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| PharmaSwiss Česká republika s.r.o. |
| --- |
| Jankovcova 1569/2c |
| 170 00 Praha 7 - Holešovice |
| Czech Republic |

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac

Diclofenac Duo PharmaSwiss 75 mg

75 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Is-Slovakkja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 50 mg

50 mg

Suppositorju

Użu għal ġor-rektum

Is-Slovakkja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 100 mg

100 mg

Suppositorju

Użu orali

Is-Slovakkja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

diclofenac

DICLOREUM 75 mg

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Is-Slovakkja

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 25 mg filmom obalené tablety

25 mg

Pillola miksija b’rita

Użu orali

Is-Slovakkja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 50 mg filmom obalené tablety

50 mg

Pillola miksija b’rita

Użu orali

Is-Slovakkja

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac

Dolmina 50

50 mg

Pillola miksija b’rita

Użu orali

Is-Slovakkja

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Praha 10 - Dolní Měcholupy |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac

DOLMINA INJ

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Is-Slovakkja

| IBSA Slovakia s.r.o. |
| --- |
| Mytna 42 |
| 811 05 Bratislava |
| Slovak Republic |

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

Diclofenac

Flector EP Rapid 50 mg

50 mg

Granijiet

Użu orali

Is-Slovakkja

| Dr. R. Pfleger Chemische Fabrik GmbH |
| --- |
| Dr.Robert Pfleger Strasse 12 |
| D-96045 Bamberg |
| Germany |

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac

Myogit 50

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Is-Slovakkja

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 100 retard

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 75

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Is-Slovakkja

| Herbacos Recordati s.r.o. |
| --- |
| Štrossova 239 |
| 53003 Pardubice |
| Czech Republic |

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 75 retard

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 100

100 mg

Suppositorju

Użu għal ġor-rektum

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 50

50 mg

Pillola gastro-reżistenti

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 75 mg/3 ml

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Actigo Extra 25 mg

25 mg

Pillola miksija

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 12,5 mg

12,5 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 25 mg

25 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 50 mg

50 mg

Pillola miksija

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid Sachets

50 mg

Trab għal soluzzjoni orali

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Retard 100

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| Novartis s.r.o. |
| --- |
| Na Pankraci 1724/129 |
| 140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren SR 75

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Is-Slovakkja

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Kent, Sandwich CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenac

Misoprostol

ARTHROTEC FORTE

75 mg

0,2 mg

Pillola miksija b’rita

Użu orali

Is-Slovakkja

| Fresenius Kabi Austria GmbH |
| --- |
| Hafnerstrasse 36 |
| Graz A-8055 |
| Austria |

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac

Orphenadrine

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

Slovenja

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| 1000 Ljubljana |
| Slovenia |

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

Diclofenac

Diclo Duo 75 mg trde gastrorezistentne kapsule

75 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

Slovenja

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| 1000 Ljubljana |
| Slovenia |

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

Diclofenac

DicloJet 75 mg trde gastrorezistentne kapsule

75 mg

Kapsula gastro-reżistenti, iebsa

Użu orali

Slovenja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 25 mg filmsko obložene tablete

25 mg

Pillola miksija b’rita

Użu orali

Slovenja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 50 mg filmsko obložene tablete

50 mg

Pillola miksija b’rita

Użu orali

Slovenja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen 25 mg/ml raztopina za injiciranje

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Slovenja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diclofenac

Naklofen 50 mg gastrorezistentne tablete

50 mg

Pillola gastro-reżistenti

Użu orali

Slovenja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen 50 mg svečke

50 mg

Suppositorju

Użu għal ġor-rektum

Slovenja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen duo 75 mg trde kapsule

75 mg

Kapsula, iebsa

Użu orali

Slovenja

| Krka, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen SR 100 mg tablete s podaljšanim sproščanjem

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Slovenja

| Medias International d.o.o. |
| --- |
| Leskoškova cesta 9D |
| 1000 Ljubljana |
| Slovenia |

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

Diclofenac

Neodolpasse 75 mg/30 mg raztopina za infundiranje

2,5 mg/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

Slovenja

| Pliva Ljubljana d.o.o. |
| --- |
| pot k sejmišču 35 |
| 1231 Ljubljana Črnuče |
| Slovenia |

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Olfen 100 mg trde kapsule s podaljšanim sproščanjem

100 mg

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Slovenja

| Pliva Ljubljana d.o.o. |
| --- |
| pot k sejmišču 35 |
| 1231 Ljubljana Črnuče |
| Slovenia |

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Voltaren 12,5 mg svečke

12,5 mg

Suppositorju

Użu għal ġor-rektum

Slovenja

| Pliva Ljubljana d.o.o. |
| --- |
| pot k sejmišču 35 |
| 1231 Ljubljana Črnuče |
| Slovenia |

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Voltaren 25 mg svečke

25 mg

Suppositorju

Użu għal ġor-rektum

Slovenja

| Novartis Consumer Health GmbH |
| --- |
| Zielstattstrasse 40 |
| Munchen 81379 |
| Germany |

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac

Voltaren Dolo 12,5 mg filmsko obložene tablete

12,5 mg

Pillola miksija b’rita

Użu orali

Spanja

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 100 mg supositorios

100 mg

Suppositorju

Użu għal ġor-rektum

Spanja

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 50 mg comprimidos gastrorresistentes

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

DOLO-VOLTAREN 50 mg comprimidos dispersables

50 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN RETARD 75 mg comprimidos de liberación modificada

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Spanja

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN RETARD 100 mg comprimidos de liberación modificada

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Spanja

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Vía de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 75 mg/3 ml solución inyectable

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Spanja

| LABORATORIOS ALDO-UNION, S.A. |
| --- |
| Baronesa de Malda, 73 |
| 08950 Esplugues de Llobregat (Barcelona) |
| Spain |

LABORATORIOS ALDO-UNION, S.A.

Baronesa de Malda, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO ALDO-UNION comprimidos EFG

50 mg

Pillola

Użu orali

Spanja

| BEXAL FARMACEUTICA, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda. Osa Mayor, 4 - Area B |
| 28023 Aravaca (Madrid) |
| Spain |

BEXAL FARMACEUTICA, S.A.

Centro Empresarial Osa Mayor

Avda. Osa Mayor, 4 - Area B

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| LABORATORIOS STADA, S.L |
| --- |
| Frederic Mompou, 5 |
| 08960 Sant Just Desvern (Barcelona) |
| Spain |

LABORATORIOS STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO RETARD STADA 100 mg comprimidos EFG

100 mg

Pillola miksija b’rita

Użu orali

Spanja

| LABORATORIOS STADA, S.L |
| --- |
| Frederic Mompou, 5 |
| 08960 Sant Just Desvern (Barcelona) |
| Spain |

LABORATORIOS STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO STADA 50 mg comprimidos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| LABORATORIOS NORMON, S.A. |
| --- |
| Ronda de Valdecarrizo, 6 |
| 28760 Tres Cantos (Madrid) |
| Spain |

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Diclofenac sodium

DICLOFENACO NORMON 50 mg comprimidos dispersables EFG

50 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| LABORATORIOS NORMON, S.A. |
| --- |
| Ronda de Valdecarrizo, 6 |
| 28760 Tres Cantos (Madrid) |
| Spain |

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Diclofenac sodium

DICLOFENACO NORMON 50 mg comprimidos entéricos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN 50 mg comprimidos gastrorresistentes

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN RETARD 100 mg cápsulas duras de liberación prolongada

100 mg

Kapsula li terħi il-mediċina b'mod modifikat, iebsa

Użu orali

Spanja

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN DISPERSABLE comprimidos

50 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN supositorios

100 mg

Suppositorju

Użu għal ġor-rektum

Spanja

| FAES FARMA, S.A. |
| --- |
| Maximo Aguirre, 14 |
| 48940 Lamiaco-Lejona (Vizcaya) |
| Spain |

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN ampollas

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Spanja

| SIGMA TAU ESPAÑA, S.A. |
| --- |
| Bolivia, 15 |
| Polígono Industrial Azque |
| 28806 Alcalá de Henares (Madrid) |
| Spain |

SIGMA TAU ESPAÑA, S.A.

Bolivia, 15

Polígono Industrial Azque

28806 Alcalá de Henares (Madrid)

Spain

Diclofenac sodium

LUASE 50 mg comprimidos

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 75 mg solución inyectable EFG

75 mg/3 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Spanja

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DI-RETARD 100 mg comprimidos de liberación modificada

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Spanja

| LABORATORIOS LLORENS, S.A. |
| --- |
| Ciudad de Balaguer, 7-11 |
| 08022 Barcelona |
| Spain |

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 100 mg supositorios EFG

100 mg

Suppositorju

Użu orali

Spanja

| RATIOPHARM ESPAÑA, S.A. |
| --- |
| Avda. de Burgos, 16 D |
| 5a planta |
| 28036 Madrid |
| Spain |

RATIOPHARM ESPAÑA, S.A.

Avda. de Burgos, 16 D

5a planta

28036 Madrid

Spain

Diclofenac sodium

DICLOFENACO RATIOPHARM 50 mg comprimidos

50 mg

Pillola miksija

Użu orali

Spanja

| LABORATORIOS ALTER, S.A. |
| --- |
| Mateo Inurria, 30 |
| 28036 Madrid |
| Spain |

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Diclofenac sodium

DICLOFENACO ALTER 50 mg comprimidos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| PENSA PHARMA, S.A.U. |
| --- |
| Jorge Comín (médico pediatra), 3-bajos |
| 46015 Valencia |
| Spain |

PENSA PHARMA, S.A.U.

Jorge Comín (médico pediatra), 3-bajos

46015 Valencia

Spain

Diclofenac sodium

DICLOFENACO PENSA 50 mg comprimidos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| LABORATORIOS CINFA, S.A. |
| --- |
| Olaz-Chipi, 10 |
| Polígono Industrial Areta |
| 31620 Huarte-Pamplona (Navarra) |
| Spain |

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10

Polígono Industrial Areta

31620 Huarte-Pamplona (Navarra)

Spain

Diclofenac sodium

DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ 100 mg supositorios EFG

100 mg

Suppositorju

Użu għal ġor-rektum

Spanja

| SANDOZ FARMACEUTICA, S.A. |
| --- |
| Avda. Osa Mayor, 4 |
| 28023 Aravaca (Madrid) |
| Spain |

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Spanja

| LABORATORIOS RANBAXY, S.L. |
| --- |
| Passeig de Gracia, 9 |
| 08007 Barcelona |
| Spain |

LABORATORIOS RANBAXY, S.L.

Passeig de Gracia, 9

08007 Barcelona

Spain

Diclofenac sodium

DICLOFENACO MUNDOGEN 50 mg comprimidos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| GERMED FARMACEUTICA, S.L. |
| --- |
| Chile, 8-2a planta. Oficina 203 |
| 28290 Las Matas (Madrid) |
| Spain |

GERMED FARMACEUTICA, S.L.

Chile, 8-2a planta. Oficina 203

28290 Las Matas (Madrid)

Spain

Diclofenac sodium

DICLOFENACO EDIGEN 50 mg comprimidos EFG

50 mg

Pillola gastro-reżistenti

Użu orali

Spanja

| Pfizer S.L. |
| --- |
| Avda. de Europa, 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Pfizer S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Diclofenac sodium

Misoprostol

ARTROTEC

50 mg

0,2 mg

Pillola miksija b’rita

Użu orali

Spanja

| Pfizer S.L. |
| --- |
| Avda. de Europa, 20 B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Pfizer S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Diclofenac sodium

Misoprostol

NORMULEN

50 mg

0,2 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

50 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassju

Voltaren® T

12,5 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg/ml

Soluzzjoni għall-injezzjoni

Parenteral use

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassju

Voltaren® T

25 mg

Pillola miksija

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassju

Voltaren® T

50 mg

Pillola miksija

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassju

Voltaren® T

12,5 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassju

Voltaren® T

25 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

25 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Isvezja

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Diclofenac sodium

Misoprostol

Arthrotec forte

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Isvezja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diklofenak Sandoz

25 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| Kundl A-6250 |
| Austria |

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diklofenak Sandoz

50 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassju

Diclofenac T ratiopharm

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| ratiopharm GmbH |
| --- |
| Graf Arco Strasse 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassju

Diclofenac T ratiopharm

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak Orifarm

25 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak Orifarm

50 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassju

Eeze

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Evolan Pharma AB |
| --- |
| Box: 120 |
| 182 12 Danderyd |
| Sweden |

Evolan Pharma AB

Box: 120

182 12 Danderyd

Sweden

Diclofenac potassju

Diklofenak T Evolan

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak T Orifarm

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Orifarm Generics A/S |
| --- |
| PO 69, Energivej 15 |
| DK-5260 Odense S |
| Denmark |

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak T Orifarm

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Diclofenac potassju

Diklofenak T Actavis

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Actavis A/S |
| --- |
| Ornegardsvej 16 |
| 2820 Gentofte |
| Denmark |

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Diclofenac potassju

Diklofenak T Actavis

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Pillola gastro-reżistenti

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Diclofenac potassju

Instantin

50 mg

Trab għal soluzzjoni orali

Użu orali

L-Isvezja

| Meda OTC AB |
| --- |
| Östermalmsgatan 19 |
| 11426 Stockholm |
| Sweden |

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassju

Eezeneo

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Eezeneo

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Eeze

12,5 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Vitabalans OY |
| --- |
| Varastokatu 8 |
| FI-135 000 Hämeenlinna |
| Finland |

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassju

Dicuno

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Diklotab

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Diklotab

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Diklok

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Diklok

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Kappadi

25 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Mimer Medical |
| --- |
| Svärdvägen 3B |
| SE-182 33 Danderyd |
| Sweden |

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassju

Kappadi

50 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

100 mg

Suppositorju

Użu għal ġor-rektum

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

50 mg

Suppositorju

Użu għal ġor-rektum

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg

Suppositorju

Użu għal ġor-rektum

L-Isvezja

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

100 mg

Suppositorju

Użu għal ġor-rektum

L-Isvezja

| Mylan AB |
| --- |
| PO 230 33 |
| Ynglingagatan 14 |
| SE-104 35 Stockholm |
| Sweden |

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis Retard 75 mg, tabletten met gereguleerde afgifte

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 25 mg, zetpillen

25 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 50 mg, zetpillen

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Actavis B.V. |
| --- |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| The Netherlands |

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 100 mg, zetpillen

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Diclofenac Kalium Actavis 12,5 mg, filmomhulde tabletten

12,5 mg

Pillola miksija b’rita

Użu orali

L-Olanda

| Alfa Wassermann S.p.A. |
| --- |
| Via Enrico Fermi 1 |
| Alanno (PE) 65020 |
| Italy |

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac potassju

Eminocs 50 mg/ml, drank

50 mg

Qtar orali, soluzzjoni

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex retard 100 mg, tabletten met gereguleerde afgifte

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 25 mg, zetpillen

25 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 50 mg, zetpillen

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 100 mg, zetpillen

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 25 mg/ml, oplossing voor injectie

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 50 mg, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na zetpil CF 50 mg, zetpillen

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na zetpil CF 100 mg, zetpillen

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na retard CF 75 mg, tabletten met gereguleerde afgifte

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Centrafarm B.V. |
| --- |
| Nieuwe Donk 3 |
| 4879 AC Etten Leur |
| The Netherlands |

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na retard CF 100 mg, tabletten met gereguleerde afgifte

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar EC 25, maagsapresistente tabletten 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar EC 50, maagsapresistente tabletten 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar Retard 75, tabletten met gereguleerde afgifte 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar Retard 100, tabletten met gereguleerde afgifte 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 25, zetpillen 25 mg

25 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 50, zetpillen 50 mg

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Disphar International B.V. |
| --- |
| Winkelskamp 6 |
| 7255 PZ Hengelo |
| The Netherlands |

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 100, zetpillen 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium Manston 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium Manston 50 mg, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Manston Pharma Limited |
| --- |
| 3 Montpelier Avenue, Bexley |
| DA5 3AP Kent |
| United Kingdom |

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium retard Manston 100 mg, maagsapresistente tabletten

100 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Marel B.V. |
| --- |
| Archimedesweg 2 |
| 2333 CN Leiden |
| The Netherlands |

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Diclofenac potassju

Kruidvat Diclofenac kalium 12,5 mg, filmomhulde tabletten

12,5 mg

Pillola miksija b’rita

Użu orali

L-Olanda

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 mg, zetpillen

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 mg, zetpillen

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinselaan 142 |
| 4818 CP Breda |
| The Netherlands |

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassju

Voltaren K 12,5 mg, filmomhulde tabletten

12,5 mg

Pillola miksija b’rita

Użu orali

L-Olanda

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinselaan 142 |
| 4818 CP Breda |
| The Netherlands |

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassju

Voltaren K 25 mg, omhulde tabletten

25 mg

Pillola miksija

Użu orali

L-Olanda

| Novartis Consumer Health B.V. |
| --- |
| Claudius Prinselaan 142 |
| 4818 CP Breda |
| The Netherlands |

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassju

Otriflu, omhulde tabletten 12,5 mg

12,5 mg

Pillola miksija

Użu orali

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac potassju

Cataflam 50, omhulde tabletten 50 mg

50 mg

Pillola miksija

Użu orali

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren Retard 75 mg, tabletten met verlengde afgifte

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

L-Olanda

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle aan den IJssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

The Netherlands

Diclofenac sodium

Misoprostol

Arthrotec 50, tabletten

50 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle aan den IJssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

The Netherlands

Diclofenac sodium

Misoprostol

Arthrotec 75, tabletten 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 PCH, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 PCH, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 PCH, zetpillen 25 mg

25 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 PCH, zetpillen 50 mg

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 PCH, zetpillen 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na retard 75 PCH, tabletten met gereguleerde afgifte 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na Retard 100 PCH tabletten met gereguleerde afgifte 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenacnatrium Pharmacin 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenacnatrium Pharmacin 50 mg, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Pharmacin B.V. |
| --- |
| Molenvliet 103 |
| 3335 LH Zwijndrecht |
| The Netherlands |

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na ratiopharm retard 75 mg, tabletten met gereguleerde afgifte

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz retard 75, tabletten met gereguleerde afgite 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

L-Olanda

| Teva Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 mg Teva, zetpilen

25 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Teva Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 mg Teva, zetpilen

50 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Teva Nederland B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem |
| The Netherlands |

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 mg Teva, zetpilen

100 mg

Suppositorju

Użu għal ġor-rektum

L-Olanda

| Wise Pharmaceuticals Ltd. |
| --- |
| Hamwells Business Park Unit No. 7, Hardicker Street |
| M19 2RB Manchester |
| United Kingdom |

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No. 7, Hardicker Street

M19 2RB Manchester

United Kingdom

Diclofenac sodium

Diclofenacnatrium 25 mg, maagsapresistente tabletten

25 mg

Pillola gastro-reżistenti

Użu orali

L-Olanda

| Wise Pharmaceuticals Ltd. |
| --- |
| Hamwells Business Park Unit No. 7, Hardicker Street |
| M19 2RB Manchester |
| United Kingdom |

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No. 7, Hardicker Street

M19 2RB Manchester

United Kingdom

Diclofenac sodium

Diclofenacnatrium 50 mg, maagsapresistente tabletten

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassju

Voltarol Pain-Eze Extra Strength Tablets

25 mg

Pillola miksija

Użu orali

Ir-Renju Unit

| Novartis Consumer Health UK Limited |
| --- |
| Park View, Riverside Way |
| Watchmoor Park, Camberley |
| Surrey GU15 3YL |
| United Kingdom |

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassju

Voltarol Pain-Eze Tablets

12,5 mg

Pillola miksija

Użu orali

Ir-Renju Unit

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenac sodium

Arthrotec 50 Modified-Release tablets

50 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenac sodium

Arthrotec 75 Modified-Release tablets

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Injection 75 mg/3 ml

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac free acid

Voltarol Dispersible Tablets 50 mg

46,5 mg

Pillola għal soluzzjoni orali

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Retard Tablets 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol SR Tablets

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 12,5 mg

12,5 mg

Suppositorju

Użu għal ġor-rektum

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 25 mg

25 mg

Suppositorju

Użu għal ġor-rektum

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 50 mg

50 mg

Suppositorju

Użu għal ġor-rektum

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Tablets 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Tablets 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Rapid Tablets 25 mg

25 mg

Pillola miksija

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK ltd. |
| --- |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Rapid Tablets 50 mg

50 mg

Pillola miksija

Użu orali

Ir-Renju Unit

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon EX32 8NS |
| United Kingdom |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon EX32 8NS

United Kingdom

Diclofenac sodium

Flamatak MR Tablets 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| E Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

E Sussex BN22 9AG

United Kingdom

Diclofenac sodium

Teva UK Diclofenac Sodium Tablets 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| E Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

E Sussex BN22 9AG

United Kingdom

Diclofenac sodium

Teva UK Diclofenac Sodium Tablets 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Chatfield Pharmaceuticals Limited |
| --- |
| Kramer Mews |
| London SW5 9JL |
| United Kingdom |

Chatfield Pharmaceuticals Limited

Kramer Mews

London SW5 9JL

United Kingdom

Diclofenac sodium

Chatfield Pharms Diclofenac Sodium Tablets 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Mercury Pharma International Limited |
| --- |
| 4045 Kingswood Road |
| City West Business Park |
| Co Dublin, Ireland |

Mercury Pharma International Limited

4045 Kingswood Road

City West Business Park

Co Dublin, Ireland

Diclofenac sodium

Antigen Diclofenac Sodium Injection 2.5 % w/v

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Lagap Pharms Diclofenac Tablets 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Lagap Pharms Diclofenac Tablets 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan SR Modified Release Capsules 75 mg

75 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Ir-Renju Unit

| Sandoz Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley, GUI16 7SR |
| United Kingdom |

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan XL Modified Release Capsules 100 mg

100 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

Użu orali

Ir-Renju Unit

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Diclofenac sodium

Generics UK Diclofenac Sodium Tablets 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Generics (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Diclofenac sodium

Generics UK Diclofenac Sodium Tablets 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Waymade Plc |
| --- |
| Regency House |
| Miles Gray Road |
| Basildon, Essex SS14 3RF |
| United Kingdom |

Waymade Plc

Regency House

Miles Gray Road

Basildon, Essex SS14 3RF

United Kingdom

Diclofenac sodium

Rheumatac Retard Tablets 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Daichi-Sankyo UK Limited |
| --- |
| Chiltern Place |
| Chalfont Park |
| Gerrards Cross |
| Buckinghamshire SL9 0BG |
| United Kingdom |

Daichi-Sankyo UK Limited

Chiltern Place

Chalfont Park

Gerrards Cross

Buckinghamshire SL9 0BG

United Kingdom

Diclofenac sodium

Motifene Capsules 75 mg

75 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Chiesi Limited |
| --- |
| Cheadle Royal Business Park |
| Highfield, Cheadle |
| Cheshire SK8 3GY |
| United Kingdom |

Chiesi Limited

Cheadle Royal Business Park

Highfield, Cheadle

Cheshire SK8 3GY

United Kingdom

Diclofenac sodium

Volsaid Retard Tablets 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Chiesi Limited |
| --- |
| Cheadle Royal Business Park |
| Highfield, Cheadle |
| Cheshire SK8 3GY |
| United Kingdom |

Chiesi Limited

Cheadle Royal Business Park

Highfield, Cheadle

Cheshire SK8 3GY

United Kingdom

Diclofenac sodium

Volsaid Retard Tablets 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Econac Suppositories 100 mg

100 mg

Suppositorju

Użu għal ġor-rektum

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Econac Injection 75 mg/3 ml

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Solution for Injection 75 mg/3 ml

75 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Econac SR Prolonged Release Tablet 75 mg

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Econac XL Prolonged Release Tablet 100 mg

100 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Sodium Tablets 25 mg

25 mg

Pillola

Użu orali

Ir-Renju Unit

| Mercury Pharma Group Limited |
| --- |
| No. 1 Croydon |
| 12-16 Addiscombe Road |
| Croydon, Surrey CR0 0XT |
| United Kingdom |

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Sodium Tablets 75 mg

50 mg

Pillola

Użu orali

Ir-Renju Unit

| Co-Pharma Limited |
| --- |
| Unit 4, Metro Centre |
| Tolpits Lane, Watford |
| Hertfordshire WD18 9SS |
| United Kingdom |

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire WD18 9SS

United Kingdom

Diclofenac sodium

Diclo-XL 100

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Co-Pharma Limited |
| --- |
| Unit 4, Metro Centre |
| Tolpits Lane, Watford |
| Hertfordshire WD18 9SS |
| United Kingdom |

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire WD18 9SS

United Kingdom

Diclofenac sodium

Diclo-SR 75

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100 mg

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75 mg

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Diclofenac Sodium Tablets 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Dexcel Pharma Limited |
| --- |
| 7 Sopwith Way |
| Drayton Fields |
| Industrial Estate, Daventry |
| Northamptonshire NN11 8PB |
| United Kingdom |

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Diclofenac Sodium Tablets 75 mg

75 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Bristol Laboratories Limited |
| --- |
| Unit 3, Canal side |
| Northbridge Road, Berkhamsted |
| Hertfordshire HP4 1EG |
| United Kingdom |

Bristol Laboratories Limited

Unit 3, Canal side

Northbridge Road, Berkhamsted

Hertfordshire HP4 1EG

United Kingdom

Diclofenac sodium

Volraman 25 mg Gastro-resistant tablets

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Bristol Laboratories Limited |
| --- |
| Unit 3, Canal side |
| Northbridge Road, Berkhamsted |
| Hertfordshire HP4 1EG |
| United Kingdom |

Bristol Laboratories Limited

Unit 3, Canal side

Northbridge Road, Berkhamsted

Hertfordshire HP4 1EG

United Kingdom

Diclofenac sodium

Volraman 50 mg Gastro-resistant tablets

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Focus Pharmaceuticals Limited |
| --- |
| Unit 5, Faraday court |
| First Avenue, Centrum 100 |
| Burton upon trent |
| Staffordshire, DE14 2WX |
| United Kingdom |

Focus Pharmaceuticals Limited

Unit 5, Faraday court

First Avenue, Centrum 100

Burton upon trent

Staffordshire, DE14 2WX

United Kingdom

Diclofenac potassju

Adacium Rapid 50 mg Tablets

50 mg

Pillola miksija b’rita

Użu orali

Ir-Renju Unit

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac sodium

Misoprostol

Misofen 50 mg/200 mcg modified released tablets

50 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Morningside Healthcare Limited |
| --- |
| 115 Narborough Road |
| Leicester, LE3 0PA |
| United Kingdom |

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac sodium

Misoprostol

Misofen 75 mg/200 mcg modified released tablets

75 mg

0,2 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Crescent Pharma Limited |
| --- |
| Unit 3&4 |
| Quidhampton Business Units |
| Polhampton Lane, Overton |
| Hampshire, RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Unit 3&4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire, RG25 3ED

United Kingdom

Diclofenac

Crescent Pharma Diclofenac Tablets BP 25 mg

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Crescent Pharma Limited |
| --- |
| Unit 3&4 |
| Quidhampton Business Units |
| Polhampton Lane, Overton |
| Hampshire, RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Unit 3&4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire, RG25 3ED

United Kingdom

Diclofenac

Crescent Pharma Diclofenac Tablets BP 50 mg

50 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| Therabel pharma UK Limited |
| --- |
| Compass House, vision Park |
| Chivers, Histon |
| Cambridge CB24 9AD |
| United Kingdom |

Therabel pharma UK Limited

Compass House, vision Park

Chivers, Histon

Cambridge CB24 9AD

United Kingdom

Diclofenac sodium

Dyloject 75 mg/2 ml solution for injection

75 mg/2 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli, Użu għal ġol-vini

Ir-Renju Unit

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

Diclofenac sodium

Diclomax SR

75 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Galen Limited |
| --- |
| Seagoe Industrial Estate |
| Craigavon |
| Armagh BT 63 5AU |
| United Kingdom |

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

Diclofenac sodium

Diclomax Retard

100 mg

Kapsula li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Doble action pain relief

12,5 mg

Pillola

Użu orali

Ir-Renju Unit

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Diclofenac potassium 12,5 mg Tablets

12,5 mg

Pillola

Użu orali

Ir-Renju Unit

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Diclofenac potassium 25 mg Tablets

25 mg

Pillola miksija b’rita

Użu orali

Ir-Renju Unit

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| IS-220 Hafnarfjördur |
| Iceæand |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassju

Diclofenac potassium 50 mg Tablets

50 mg

Pillola miksija b’rita

Użu orali

Ir-Renju Unit

| Chelonia Healthcare Limited |
| --- |
| Boumpoulinas 11 |
| 3rd, Nicosia |
| CY-1060 |
| Cyprus |

Chelonia Healthcare Limited

Boumpoulinas 11

3rd, Nicosia

CY-1060

Cyprus

Diclofenac sodium

Diclofenac sodium 25 mg Tablets

25 mg

Pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| RI Pharma Limited |
| --- |
| First floor, 6 St John's Court |
| Upper Fforest Way |
| Swansea Enterprise Park |
| Swansea SA6 8QQ |
| United Kingdom |

RI Pharma Limited

First floor, 6 St John's Court

Upper Fforest Way

Swansea Enterprise Park

Swansea SA6 8QQ

United Kingdom

Diclofenac sodium

Slofenac 75 mg SR

75 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| RI Pharma Limited |
| --- |
| First floor, 6 St John's Court |
| Upper Fforest Way |
| Swansea Enterprise Park |
| Swansea SA6 8QQ |
| United Kingdom |

RI Pharma Limited

First floor, 6 St John's Court

Upper Fforest Way

Swansea Enterprise Park

Swansea SA6 8QQ

United Kingdom

Diclofenac sodium

Slofenac 100 mg SR

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

Diclofenac sodium

Enstar SR 75 mg Tablets

75 mg

Pillola li terħi il-mediċina bil-mod

Użu orali

Ir-Renju Unit

| Ennogen Pharma Limited |
| --- |
| Unit G4, Riverside Way |
| Dartford, DA1 5BS |
| United Kingdom |

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

Diclofenac sodium

Enstar XL 100 mg Tablets

100 mg

Pillola li terħi il-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| Aptil Pharma limited |
| --- |
| 9th Floor |
| CP House |
| 97-107 Uxbridge Road |
| London W5 5TL |
| United Kingdom |

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassju

Diclofenac potassium 12,5 mg Tablets

12,5 mg

Pillola miksija b’rita

Użu orali

Ir-Renju Unit

| Aptil Pharma limited |
| --- |
| 9th Floor |
| CP House |
| 97-107 Uxbridge Road |
| London W5 5TL |
| United Kingdom |

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassju

Diclofenac potassium 25 mg Tablets

25 mg

Pillola miksija b’rita

Użu orali

Ir-Renju Unit

| Aptil Pharma limited |
| --- |
| 9th Floor |
| CP House |
| 97-107 Uxbridge Road |
| London W5 5TL |
| United Kingdom |

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassju

Diclofenac potassium 50 mg Tablets

50 mg

Pillola miksija b’rita

Użu orali

---

ANNESS X

LISTA TAL-ISMIJIET, FORMA FARMAĊEWTIKA, QAWWA TAL-PRODOTT(I) MEDIĊINALI, MOD TA' AMMINISTRAZZJONI, ID-DETENTUR(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru (fl-EEA) | Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem (Ivvintat) | Qawwa | Forma Farmaċewtika | Mod ta' amministrazzjoni |
| --- | --- | --- | --- | --- | --- |
| Awstrija | WABOSAN |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Awstrija |

Stat Membru (fl-EEA)

Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem (Ivvintat)

Qawwa

Forma Farmaċewtika

Mod ta' amministrazzjoni

Awstrija

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Awstrija

Ergomed retard - Kapseln

2.5 mg (1:1:1)

kapsuli li jtawwlu l-effett, rotob

użu orali

Awstrija

| WABOSAN |
| --- |
| Arzneimittelvertriebs |
| GmbH, Anton Anderer |
| Platz 6/1, A-1210 Vienna |
| Awstrija |

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Awstrija

Ergomed - Tropfen

1 mg/ml (1:1:1)

qtar orali, soluzzjoni

użu orali

Repubblika Ċeka

| TEVA Czech Industries s.r.o. |
| --- |
| Ostravská 29 |
| 747 70 Opava-Komárov |
| Repubblika Ċeka |

TEVA Czech Industries s.r.o.

Ostravská 29

747 70 Opava-Komárov

Repubblika Ċeka

ERSILAN

1mg/ml

Qtar orali, soluzzjoni

użu orali

Franza

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Franza |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Franza

ISKEDYL FORT, comprimé

2.40 mg/19.20 mg

pillola

użu orali

Franza

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Franza |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Franza

ISKEDYL, comprimé

0.60 mg / 4.80 mg

pillola

użu orali

Franza

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Franza |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Franza

ISKEDYL, soluzzjoni buvable en flacon

0.10 g / 0.80 g

soluzzjoni orali

użu orali

Franza

| PIERRE FABRE MEDICAMENT |
| --- |
| 45, place Abel Gance |
| 92100 Boulogne |
| Billancourt |
| Franza |

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

Franza

ISKEDYL, soluzzjoni injectable en ampoule

0.3125 mg /6.25 mg

soluzzjoni għall-injezzjoni

IV/IM

Greċja

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greċja |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greċja

DIERTINA

3mg/cap

kapsuli, rotob

użu orali

Greċja

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greċja |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greċja

DIERTINA

6MG/SINGLE DOSE

trab għal soluzzjoni orali għal doża waħda

użu orali

Greċja

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |
| Greċja |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greċja

DIERTINA

6MG/TAB

pillola

użu orali

Greċja

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, |
| GLYFADA, 16674 |
| Greċja |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150,

GLYFADA, 16674

Greċja

ERGOFIL

6MG/TAB

pillola

użu orali

Greċja

| GENEPHARM A.E. |
| --- |
| 18TH Km MARATHONOS |
| AVENUE, PALLINI, |
| ATTIKIS, 15351 |
| Greċja |

GENEPHARM A.E.

18TH Km MARATHONOS

AVENUE, PALLINI,

ATTIKIS, 15351

Greċja

MEMOTIL / GENEPHARM

6MG/TAB

pillola

użu orali

Greċja

| ANTOR LTD |
| --- |
| P. MAVROMIHALI 1 |
| VRILISSIA 15235 |
| Greċja |

ANTOR LTD

P. MAVROMIHALI 1

VRILISSIA 15235

Greċja

THRIOLAN

6MG/TAB

pillola

użu orali

Greċja

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, |
| ARGYROUPOLI, 16452 |
| Greċja |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22,

ARGYROUPOLI, 16452

Greċja

FENITINA

6MG/TAB

pillola

użu orali

Greċja

| PHARMACEUTICAL INDUSTRY PROEL EPAM. |
| --- |
| G. KORONIS |
| DILOU 9, PERISTERI, |
| ATTIKIS, 12134 |
| Greċja |

PHARMACEUTICAL INDUSTRY PROEL EPAM.

G. KORONIS

DILOU 9, PERISTERI,

ATTIKIS, 12134

Greċja

BEYTINA

6MG/TAB

pillola

użu orali

Greċja

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, |
| GERAKAS, 15344 |
| Greċja |

FINIXFARM EPE

DERVENAKION 38 & SAHINI,

GERAKAS, 15344

Greċja

CRISTIL

6MG/TAB

pillola

użu orali

Greċja

| S.J.A. PHARM O.E. |
| --- |
| ARKOLEON 11, KATO |
| PATISSIA, 10445 |
| Greċja |

S.J.A. PHARM O.E.

ARKOLEON 11, KATO

PATISSIA, 10445

Greċja

AGIOBITA

6MG/TAB

pillola

użu orali

Lussemburgu

| Pierre Fabre Médicaments |
| --- |
| 45, PLACE ABEL GANCE |
| F 92654 BOULOGNE |
| CEDEX |
| Franza |

Pierre Fabre Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE

CEDEX

Franza

Iskedyl Fort

2.40 mg/19.20 mg

pilloli

użu orali

Portugall

| Daiichi Sankyo |
| --- |
| Portugal,Lda. PRT |
| Lagoas Park, Edifício 11 |
| 2740-270 Porto Salvo |
| Portugall |

Daiichi Sankyo

Portugal,Lda. PRT

Lagoas Park, Edifício 11

2740-270 Porto Salvo

Portugall

Diertina

3 mg

Kapsula iebsa

użu orali

Spanja

| LABORATORIOS DAVUR, S.L. |
| --- |
| Teide, 4 - planta baja Polígono Empresarial La Marina |
| 28703 San Sebastian de los Reyes (Madrid) |
| Spanja |

LABORATORIOS DAVUR, S.L.

Teide, 4 - planta baja Polígono Empresarial La Marina

28703 San Sebastian de los Reyes (Madrid)

Spanja

ERGODAVUR GOTAS

1 mg (monodose suchet)

qtar orali, soluzzjoni

użu orali

Spanja

| TORA LABORATORIES |
| --- |
| S.L. Ferraz 80, 5o |
| 28008 Madrid |
| Spanja |

TORA LABORATORIES

S.L. Ferraz 80, 5o

28008 Madrid

Spanja

DIERTINE FORTE

2 mg/ ml

qtar orali, soluzzjoni

użu orali

---

ANNESS XI

SEMMI L-ISEM (IJIET) FORMOLA (I) FARMAĊEWTIKU (I) FORMA (I) TA 'DROGA (I), IR-ROTTA (I) TA' KIF JINGĦATA, ID-DETENTUR TAL-AWTORIZZAZZJONI FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  (fil-ŻEE) | Awtorizzazzjoni detentur suq | Speċjalità Isem | dożaġġ | forma tad-dożaġġ | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| Franza | CHIESI |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| Franza |

Stat Membru

(fil-ŻEE)

Awtorizzazzjoni detentur suq

Speċjalità Isem

dożaġġ

forma tad-dożaġġ

Mnejn jingħata

Franza

CHIESI

11, avenue Dubonnet

92400 Courbevoie

Franza

VASOBRAL, pillola mmarkata

4 mg/40 mg

pillola

orali

Franza

| CHIESI |
| --- |
| 11, avenue Dubonnet |
| 92400 Courbevoie |
| Franza |

CHIESI

11, avenue Dubonnet

92400 Courbevoie

Franza

VASOBRAL, soluzzjoni orali f'kunjett

0.10 g/1 g ta 100 ml

soluzzjoni orali

orali

---

ANNESS XII

LISTA’ TA’ ISMIJIET, GĦAMLA/GĦAMLA FARMAĊEWTIKA/GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL-PRODOTT(I) MEDIĊINALI, MNEJN JINGĦATA, DETENTUR(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru (fiż-ŻEE) | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem (Ivvintat) | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Kwizda Pharma GmbH |
| Effingergasse 21 |
| 1160 Vienna |
| Austria |

Stat Membru (fiż-ŻEE)

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem (Ivvintat)

Qawwa

Għamla farmaċewtika

Mnejn jingħata

L-Awstrija

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 10 mg - Tabletten

10 mg

pillola

użu orali

L-Awstrija

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Austria |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 20 mg - Filmtabletten

20 mg

pillola miksija b’rita

użu orali

L-Awstrija

| Kwizda Pharma GmbH |
| --- |
| Effingergasse 21 |
| 1160 Vienna |
| Austria |

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 30 mg - Filmtabletten

30 mg

pillola miksija b’rita

użu orali

L-Awstrija

| Rösch & Handel |
| --- |
| Scheringgasse 2/Objekt 2 |
| 1140 Vienna |
| Austria |

Rösch & Handel

Scheringgasse 2/Objekt 2

1140 Vienna

Austria

Nicergin - Filmtabletten

30 mg

pillola miksija b’rita

użu orali

L-Awstrija

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Vienna |
| Austria |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Sermion 30 mg - Filmtabletten

30 mg

pillola miksija b’rita

użu orali

Il-Bulgarija

| Pfizer Enterprises SARL |
| --- |
| Avenue J.F.Kennedy 51 |
| L-1855 |
| Luxembourg |

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luxembourg

Sermion

4 mg/4 ml

trab u solvent għal soluzzjoni għal injezzjoni

użu għal ġol-muskoli u użu għal ġol-vini

Il-Bulgarija

| Pfizer Enterprises SARL |
| --- |
| Avenue J.F.Kennedy 51 |
| L-1855 |
| Luxembourg |

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luxembourg

Sermion

30 mg

pilloli miksija b’rita

użu orali

Ir-Repubbika Ċeka

| Pfizer, spol. s r.o., Praha |
| --- |
| Stroupežnického 17 |
| 150 00 Prague 5 |
| Czech Republic |

Pfizer, spol. s r.o., Praha

Stroupežnického 17

150 00 Prague 5

Czech Republic

SERMION

30mg

Pillola miksija b’rita

użu orali

Franza

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 10 mg, gélule

10 mg

kapsula, iebsa

użu orali

Franza

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 5 mg, gélule

5 mg

kapsula, iebsa

użu orali

Franza

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 5 mg, poudre pour solution pour perfusion

5 mg

trab għal soluzzjoni għal infużjoni

użu għal ġol-vini

Franza

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

NICERGOLINE BIOGARAN 10 mg, gélule

10 mg

kapsula, iebsa

użu orali

Franza

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

NICERGOLINE BIOGARAN 5 mg, gélule

5 mg

kapsula, iebsa

użu orali

Franza

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

NICERGOLINE EG 10 mg, gélule

10 mg

kapsula, iebsa

użu orali

Franza

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

NICERGOLINE EG 5 mg, gélule

5 mg

kapsula, iebsa

użu orali

Franza

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE MYLAN 10 mg, gélule

10 mg

kapsula, iebsa

użu orali

Franza

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE MYLAN 5 mg, gélule

5 mg

kapsula, iebsa

użu orali

Franza

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE QUALIMED 10 mg, gélule

10 mg

kapsula, iebsa

użu orali

Franza

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE QUALIMED 5 mg, gélule

5 mg

kapsula, iebsa

użu orali

Franza

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

NICERGOLINE TEVA 10 mg, gélule

10 mg

kapsula, iebsa

użu orali

Franza

| TEVA SANTE |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

NICERGOLINE TEVA 5 mg, gélule

5 mg

kapsula, iebsa

użu orali

L-Ungerija

| Pfizer Kft. |
| --- |
| Alkotás u. 53., MOM Park F épület |
| 1123 Budapest |
| Hungary |

Pfizer Kft.

Alkotás u. 53., MOM Park F épület

1123 Budapest

Hungary

SERMION 30 mg filmtabletta

30 mg

pillola miksija b’rita

użu orali

L-Italja

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

10 mg/ml

trab u solvent għal soluzzjoni orali

użu orali

L-Italja

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

5 mg

pillola miksija

użu orali

L-Italja

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

10 mg

pillola miksija

użu orali

L-Italja

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

30 mg

pillola miksija b’rita

użu orali

L-Italja

| Pfizer Italia srl |
| --- |
| Via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

30 mg

pillola li tinħall

użu orali

L-Italja

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italy |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italy

NICERGOLINA ANGENERICO

10 mg/ml

trab u solvent għal soluzzjoni orali

użu orali

L-Italja

| Angenerico spa |
| --- |
| Via Nocera Umbra, |
| 75 00181 Roma |
| Italy |

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italy

NICERGOLINA ANGENERICO

30 mg

pillola

użu orali

L-Italja

| Sandoz spa |
| --- |
| Largo Umberto Boccioni, |
| 1 21040 Origgio - Varese |
| Italy |

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italy

NICERGOLINA SANDOZ

30 mg

pillola effervexxenti

użu orali

L-Italja

| Sandoz spa |
| --- |
| Largo Umberto Boccioni, |
| 1 21040 Origgio - Varese |
| Italy |

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italy

NICERGOLINA SANDOZ

30 mg

pillola

użu orali

L-Italja

| EG spa |
| --- |
| Via Scarlatti Domenico, |
| 31 20124 Milano |
| Italy |

EG spa

Via Scarlatti Domenico,

31 20124 Milano

Italy

NICERGOLINA EG

30 mg

pillola

użu orali

Il-Latvja

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

10 mg

pilloli miksija b’rita

użu orali

Il-Latvja

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

30 mg

kapsuli, ibsin

użu orali

Il-Latvja

| Pfizer Italia S.r.l., |
| --- |
| Via Isonzo 71, |
| 04100 Latina, |
| Italy |

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italy

Sermion

5 mg

pilloli miksija b’rita

użu orali

Il-Latvja

| Pfizer Italia S.r.l., |
| --- |
| Via Isonzo 71, |
| 04100 Latina, |
| Italy |

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italy

Sermion

10 mg

pilloli miksija b’rita

użu orali

Il-Litwanja

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

4 mg

Trab u solvent għal soluzzjoni għal injezzjoni

użu għal ġol-muskoli u użu għal ġol-vini

Il-Litwanja

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT) |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT)

Italy

Sermion

5 mg

Pillola miksija

użu orali

Il-Litwanja

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

10 mg

Pillola miksija

użu orali

Il-Litwanja

| Pfizer Italia S.r.l., |
| --- |
| Borgo San Michele S.S. 156 Km. 50 |
| Latina (LT), |
| Italy |

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

30 mg

Pillola miksija b’rita

użu orali

Il-Litwanja

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

30 mg

Kapsula, iebsa

użu orali

Il-Litwanja

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| 1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

10 mg

Pillola miksija b’rita

użu orali

Il-Polonja

| Farmaceutyczna Spółdzielnia Pracy FILOFARM |
| --- |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poland |

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Nicergolin

10 mg

pillola

użu orali

Il-Polonja

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| CT13 9 NJ Kent, Sandwich |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

CT13 9 NJ Kent, Sandwich

United Kingdom

Nicergolin

10 mg

pillola miksija

użu orali

Il-Polonja

| Pfizer Italia S.r.l. |
| --- |
| Borgo San Michele SS 156 Km 50 |
| Latina |
| Italy |

Pfizer Italia S.r.l.

Borgo San Michele SS 156 Km 50

Latina

Italy

Nicergolin

4 mg

trab u solvent għal soluzzjoni għal injezzjoni

użu għal ġol-muskoli u użu għal ġol-vini

Il-Portugall

| Laboratórios Pfizer, |
| --- |
| Lda. PRT Lagoas Park, |
| Edifício 10 Porto Salvo |
| Portugal |

Laboratórios Pfizer,

Lda. PRT Lagoas Park,

Edifício 10 Porto Salvo

Portugal

Sermion 30

30 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romania |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 5 mg

5 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romania |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 10 mg

10 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| S.C. LABORMED PHARMA S.A. |
| --- |
| Bd. Theodor Pallady nr. 44 B, |
| sector 3, București, |
| Romania |

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 30 mg

30 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 5 mg

5 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 10 mg

10 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București, |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 30 mg

30 mg

Pillola miksija b’rita

użu orali

Ir-Rumanija

| HEXAL AG |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Germany |

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 10

10 mg

Pillola miksija

użu orali

Ir-Rumanija

| Hexal AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Germany |

Hexal AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 15

15 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

użu orali

Ir-Rumanija

| HEXAL AG, |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Germany |

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 30 UNO

30 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

użu orali

Spanja

| PFIZER, S.L. |
| --- |
| Avenida de Europa, |
| 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) |
| Spain |

PFIZER, S.L.

Avenida de Europa,

20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)

Spain

SERMION 5 mg

5 mg

pillola miksija

użu orali

---

ANNESS XIII

LISTA TA’ ISMIJIET, GĦAMLA FARMAĊEWTIĊA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL-PRODOTT(I) MEDIĊINALI, MNEJN JINGĦATA, DETENTUR(I) TAL-AWTORIZZAZZJONI TAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  (fl-EEA) | Detentur tal-Awtorizzazzjoni tat-tqegħid fis-Suq | Isem (Ivvintat) | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| Awstria | Boehringer Ingelheim |
| RCV GmbH & Co KG, |
| Dr. Boehringer-Gasse 5-11, |
| A-1121 Vienna |
| Austria |

Stat Membru

(fl-EEA)

Detentur tal-Awtorizzazzjoni tat-tqegħid fis-Suq

Isem (Ivvintat)

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Awstria

Boehringer Ingelheim

RCV GmbH & Co KG,

Dr. Boehringer-Gasse 5-11,

A-1121 Vienna

Austria

Effortil comp. - Tropfen

2 mg/ml, 10 mg/ml

qtar orali, soluzzjoni

użu mill-ħalq

Awstria

| 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 li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Awstria

| 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 li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Awstria

Amdipharm Ltd.

3, Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot 2,5 mg - Pillolaten

2,5 mg

pillola

użu mill-ħalq

Awstria

| 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

qtar orali, soluzzjoni

użu mill-ħalq

Awstria

| 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 li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Awstria

| 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 li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Belġju

| Amdipharm Limited |
| --- |
| Burlington Road, 3 |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Burlington Road, 3

Dublin 4

Ireland

Dihydergot Forte

2,5 mg

pillola

użu mill-ħalq

Belġju

| 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

pillola

użu mill-ħalq

Finlandja

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

ORSTANORM

2,5 mg

pillola

użu mill-ħalq

Franċia

| 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

pillola li terħi l-mediċina b’mod modifikat

użu mill-ħalq

Franċia

| 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

qtar orali, soluzzjoni

użu mill-ħalq

Franċia

| 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

soluzzjoni orali

użu mill-ħalq

Franċja

| 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

kapsula iebsa

użu mill-ħalq

Franċja

| 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

lajofiliżejt orali

użu mill-ħalq

Franċja

| 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

kapsula ratba

użu mill-ħalq

Franċja

| 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

soluzzjoni orali

użu mill-ħalq

Franċja

| 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

pillola

użu mill-ħalq

Ġermanja

| 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

Soluzzjoni

użu mill-ħalq

Ġermanja

| 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

Soluzzjoni

użu mill-ħalq

Ġermanja

| 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

Soluzzjoni

użu mill-ħalq

Ġermanja

| 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 li terħi l-mediċina b’mod modifikat

użu mill-ħalq

Ġermanja

| 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 li terħi l-mediċina b’mod modifikat

użu mill-ħalq

Ġermanja

| 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 li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Ġermanja

| 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

Soluzzjoni

użu mill-ħalq

Greċja

| Amdipharm Ltd. |
| --- |
| 3 Burlington Road, |
| Temple Chambers, |
| Dublin 4 |
| Ireland |

Amdipharm Ltd.

3 Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot

2,5 mg

Pillola

użu mill-ħalq

Italja

| 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

Soluzzjoni orali

użu mill-ħalq

Italja

| 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

Pillola

użu mill-ħalq

Italja

| 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 li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Lussemburgu

| 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

Soluzzjoni orali

użu mill-ħalq

Lussemburgu

| 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

Pilloli

użu mill-ħalq

Polonja

| Farmaceutyczna |
| --- |
| Spółdzielnia Pracy |
| FILOFARM |
| ul. Pułaskiego 39 |
| 85-619 Bydgoszcz |
| Poland |

Farmaceutyczna

Spółdzielnia Pracy

FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Dihydroergotaminum Filofarm

2 mg/g

oral solution

użu mill-ħalq

Polonja

| 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

pillola

użu mill-ħalq

Portugal

| Laboratórios Azevedos – |
| --- |
| Indústria Farmacêutica, |
| S.A. PRT |
| Edifícios Azevedos – |
| Estrada Nacional 117-2, Alfragide |
| 2614-504Amadora |
| Portugal |

Laboratórios Azevedos –

Indústria Farmacêutica,

S.A. PRT

Edifícios Azevedos –

Estrada Nacional 117-2, Alfragide

2614-504Amadora

Portugal

Seglor Retard

5 mg

Kapsula li terħi l-mediċina b’mod modifikat, iebsa

użu mill-ħalq

Slovenja

| LEK farmacevtska |
| --- |
| družba d.d., |
| Verovskova 57, |
| SI-1526 Ljubljana, |
| Slovenia |

LEK farmacevtska

družba d.d.,

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

Ditamin 2,5 mg pillolae

2,5 mg

pillola

użu mill-ħalq

Spanja

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DIHYDERGOT COMPRIMIDOS

1 mg

pillola

użu mill-ħalq

Svezja

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

2,5 mg

Pilloli

użu mill-ħalq

Svezja

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

5 mg

Pilloli

użu mill-ħalq

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