# Il-Ġurnal Uffiċjali C 350/2013

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2013.350.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 350 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5629 ta' Novembru 2013 |

ISSN 1977-0987

doi:10.3000/19770987.C_2013.350.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 350

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5629 ta' Novembru 2013

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2013/C 350/01 | 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(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 1 |
| 2013/C 350/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2013 sal-31 ta’ Ottubru 2013(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 26 |
| 2013/C 350/03 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2013 sal-31 ta’ Ottubru 2013(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 30 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

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

Il-Kummissjoni Ewropea

2013/C 350/01

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(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)

1

2013/C 350/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2013 sal-31 ta’ Ottubru 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)

26

2013/C 350/03

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2013 sal-31 ta’ Ottubru 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/K

jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

30

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

MT

---

IV Informazzjoni

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

Il-Kummissjoni Ewropea

| 29.11.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 350/1 |
| --- | --- | --- | --- |

29.11.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 350/1

---

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

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

2013/C 350/01

—   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 |
| --- | --- | --- | --- | --- |
| 25.9.2013 | Sandimmun | Ara l-Anness I | Ara l-Anness I | 26.9.2013 |
| 25.9.2013 | Sandimmun Neoral | Ara l-Anness II | Ara l-Anness II | 26.9.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

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

Stat Membru kkonċernat

Data ta' notifika

25.9.2013

Sandimmun

Ara l-Anness I

Ara l-Anness I

26.9.2013

25.9.2013

Sandimmun Neoral

Ara l-Anness II

Ara l-Anness II

26.9.2013

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

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 Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Kontenut
  (konċentrazzjoni) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Stat Membru EU/EEA

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Kontenut

(konċentrazzjoni)

L-Awstrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun

50 mg – Konzentrat zur Infusionsbereitung

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B-1800 Vilvoorde

Belgium

SANDIMMUN

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

25 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 50 mg Weichkapseln

50 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

250 mg/5 ml amp

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

50 mg/ml amp

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun 50 mg/ml koncentrátum oldatos infúzióhoz

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 |
| Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003

Köbenhavn S

Denmark

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

25 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg/1 ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

25 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni fil-vini

Użu għal ġol-vini

50 mg/ml

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Intravenous

50 mg/ml

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

ls-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun 50 mg/ml

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 50 mg/ml concentrado para solución para perfusión

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 250 mg/5 ml concentrado para solución para perfusión

250 mg/5 ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 100 mg

100 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Oral Solution

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Concentrate for Solution for Infusion 50 mg/ml

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

---

ANNESS II

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 Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Kontenut
  (konċentrazzjoni) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Stat Membru EU/EEA

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Kontenut

(konċentrazzjoni)

L-Awstrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 10 mg Kapseln

10 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 25 mg Kapseln

25 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 50 mg Kapseln

50 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg Kapseln

100 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg/ml - Trinklösung

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 10 mg

10 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg

100 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 25 mg

25 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 50 mg

50 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 25 mg capsule

25 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 50 mg capsule

50 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg capsule

100 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg/ml oral solution

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml – 50ml

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 25 mg

25 mg

Kapsula, ratba

Użu orali

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 50 mg

50 mg

Kapsula, ratba

Użu orali

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 100 mg

100 mg

Kapsula, ratba

Użu orali

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral Oral Solution 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

10 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

25 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

50 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

25 mg/cap

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

50 mg/cap

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

100 mg/cap

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

500 mg/5ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 10 mg lágy kapszula

10 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 25 mg lágy kapszula

25 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 50 mg lágy kapszula

50 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg lágy kapszula

100 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg/ml belsőleges oldat

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S

Denmark

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S

Denmark

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S

Denmark

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S

Denmark

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

25 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

50 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 25 mg mīkstās kapsulas

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

Sandimmun Neoral 50 mg mīkstās kapsulas

50 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

Sandimmun Neoral 100 mg mīkstās kapsulas

100 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

Sandimmun Neoral

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

Sandimmun Neoral

50 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

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 25 mg, capsules

25 mg

Kapsula, ratba

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

Neoral 100 mg, capsules

100 mg

Kapsula, ratba

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

Neoral 100 mg/ml, drank

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Rumanija

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL capsule moi, 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Rumanija

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL, capsule moi, 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Rumanija

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL, solutie orala, 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 25 mg mehke kapsule

25 mg

Kapsula, ratba

Użu orali

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 50 mg mehke kapsule

50 mg

Kapsula, ratba

Użu orali

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg mehke kapsule

100 mg

Kapsula, ratba

Użu orali

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg/ml peroralna raztopina

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 25 mg cápsulas blandas

25 mg

Kapsula, ratba

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 50 mg cápsulas blandas

50 mg

Kapsula, ratba

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg cápsulas blandas

100 mg

Kapsula, ratba

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg/ml solución oral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 10 mg

10 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 100 mg

100 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Oral solution

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

---

| 29.11.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 350/26 |
| --- | --- | --- | --- |

29.11.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 350/26

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2013 sal-31 ta’ Ottubru 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 350/02

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.10.2013 | Defitelio | defibrotide | Gentium S.p.A. |
| Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), |
| Italia |

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

18.10.2013

Defitelio

defibrotide

Gentium S.p.A.

Piazza XX Settembre, 2, I-22079 Villa Guardia (CO),

Italia

EU/1/13/878

Konċentrat għal soluzzjoni għal infużjoni

B01AX01

22.10.2013

18.10.2013

Grastofil

filgrastimas

| Apotex Europe B.V. |
| --- |
| Darwinweg 20, NL- 2333 CR Leiden, |
| Nederland |

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden,

Nederland

EU/1/13/877

Soluzzjoni għall-injezzjoni jew infużjoni

L03AA02

22.10.2013

—   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 |
| --- | --- | --- | --- | --- |
| 2.10.2013 | Myocet | Teva Pharma B.V. |
| Computerweg 10, NL-3542 DR Utrecht, |
| Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

2.10.2013

Myocet

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht,

Nederland

EU/1/00/141

4.10.2013

2.10.2013

Spedra

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

Menarini International Operations Luxembourg S.A.

1, avenue de la Gare - L-1611

Luxembourg

EU/1/13/841

4.10.2013

2.10.2013

Zonegran

| Eisai Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, |
| United Kingdom |

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN,

United Kingdom

EU/1/04/307

4.10.2013

4.10.2013

ATryn

| GTC Biotherapeutics UK Limited |
| --- |
| 10 Norwich Street, London EC4A 1BD, |
| United Kingdom |

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD,

United Kingdom

EU/1/06/355

8.10.2013

4.10.2013

Ganfort

| Allergan Pharmaceuticals Ireland, (514125) |
| --- |
| Castlebar Road, Westport, County Mayo, |
| Ireland |

Allergan Pharmaceuticals Ireland, (514125)

Castlebar Road, Westport, County Mayo,

Ireland

EU/1/06/340

8.10.2013

9.10.2013

Biograstim

| AbZ-Pharma GmbH |
| --- |
| Graf -Arco-Straße 3, D-89079 Ulm, |
| Deutschland |

AbZ-Pharma GmbH

Graf -Arco-Straße 3, D-89079 Ulm,

Deutschland

EU/1/08/450

11.10.2013

9.10.2013

Biopoin

| Teva GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, |
| Deutschland |

Teva GmbH

Graf-Arco-Straße 3, D-89079 Ulm,

Deutschland

EU/1/09/565

11.10.2013

9.10.2013

Bridion

| 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/1/08/466

18.10.2013

9.10.2013

Revestive

| NPS Pharma Holdings Limited |
| --- |
| Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, |
| Ireland |

NPS Pharma Holdings Limited

Grand Canal House, 1 Grand Canal Street Upper, Dublin 4,

Ireland

EU/1/12/787

11.10.2013

11.10.2013

Foscan

| Biolitec Pharma Ltd |
| --- |
| United Drug House, Magna Drive, Dublin 24, |
| Ireland |

Biolitec Pharma Ltd

United Drug House, Magna Drive, Dublin 24,

Ireland

EU/1/01/197

14.10.2013

18.10.2013

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

22.10.2013

18.10.2013

Viread

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

Gilead Sciences International Limited

Cambridge CB21 6GT,

United Kingdom

EU/1/01/200

22.10.2013

24.10.2013

ADCETRIS

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

Takeda Pharma A/S

Langebjerg 1, DK-4000 Roskilde,

Danmark

EU/1/12/794

28.10.2013

24.10.2013

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Straße 76, D-35041 Marburg, |
| Deutschland |

Novartis Vaccines and Diagnostics GmbH

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

Deutschland

EU/1/07/394

28.10.2013

31.10.2013

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse,

België

EU/1/11/720

17.10.2013

31.10.2013

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse,

België

EU/1/11/720

4.11.2013

31.10.2013

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH,

United Kingdom

EU/1/11/698

5.11.2013

—   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 |
| --- | --- | --- | --- | --- |
| 25.10.2013 | Clopidogrel ratiopharm | Archie Samuel s.r.o. |
| Slunná 16, CZ-61700 Brno, |
| Česká republika |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

25.10.2013

Clopidogrel ratiopharm

Archie Samuel s.r.o.

Slunná 16, CZ-61700 Brno,

Česká republika

EU/1/09/554

28.10.2013

—   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 |
| --- | --- | --- | --- | --- |
| 11.10.2013 | 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

11.10.2013

Equip WNV

Zoetis Belgium S.A.

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

Belgique

EU/2/08/086

15.10.2013

18.10.2013

Advocate

| Bayer Animal Health GmbH |
| --- |
| D-51368 Leverkusen, |
| Deutschland |

Bayer Animal Health GmbH

D-51368 Leverkusen,

Deutschland

EU/2/03/039

22.10.2013

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, 30.4.2004, p. 1.

---

| 29.11.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 350/30 |
| --- | --- | --- | --- |

29.11.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 350/30

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2013 sal-31 ta’ Ottubru 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 350/03

—   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 |
| --- | --- | --- | --- | --- |
| 2.10.2013 | Suifertil 4 mg/ml | Ara l-Anness I | Ara l-Anness I | 3.10.2013 |
| 9.10.2013 | Methylphenidate Hexal | Ara l-Anness II | Ara l-Anness II | 11.10.2013 |
| 9.10.2013 | Methylphenidate Sandoz | Ara l-Anness III | Ara l-Anness III | 10.10.2013 |
| 18.10.2013 | Dexadreson 2 mg/ml | Ara l-Anness IV | Ara l-Anness IV | 21.10.2013 |
| 18.10.2013 | Micotil 300 | Ara l-Anness V | Ara l-Anness V | 21.10.2013 |
| 31.10.2013 | Sandimmun | Ara l-Anness VI | Ara l-Anness VI | 4.11.2013 |
| 31.10.2013 | Sandimmun Neoral | Ara l-Anness VII | Ara l-Anness VII | 4.11.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

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

Stat Membru kkonċernat

Data ta' notifika

2.10.2013

Suifertil 4 mg/ml

Ara l-Anness I

Ara l-Anness I

3.10.2013

9.10.2013

Methylphenidate Hexal

Ara l-Anness II

Ara l-Anness II

11.10.2013

9.10.2013

Methylphenidate Sandoz

Ara l-Anness III

Ara l-Anness III

10.10.2013

18.10.2013

Dexadreson 2 mg/ml

Ara l-Anness IV

Ara l-Anness IV

21.10.2013

18.10.2013

Micotil 300

Ara l-Anness V

Ara l-Anness V

21.10.2013

31.10.2013

Sandimmun

Ara l-Anness VI

Ara l-Anness VI

4.11.2013

31.10.2013

Sandimmun Neoral

Ara l-Anness VII

Ara l-Anness VII

4.11.2013

—   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 |
| --- | --- | --- | --- | --- |
| 11.10.2013 | Ketoconazole | Ara l-Anness VIII | Ara l-Anness VIII | 14.10.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

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

Stat Membru kkonċernat

Data ta' notifika

11.10.2013

Ketoconazole

Ara l-Anness VIII

Ara l-Anness VIII

14.10.2013

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI TA’ ANNIMALI, MNEJN JINGĦATA, APPLIKANT TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Applikant | Isem | Sustanza Attiva | Qawwa | Għamla farmaċewtika | Speċi ta’ annimali | l-metodu ta' amministrazzjoni |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | aniMedica GmbH |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

Stat Membru

Applikant

Isem

Sustanza Attiva

Qawwa

Għamla farmaċewtika

Speċi ta’ annimali

l-metodu ta' amministrazzjoni

L-Awstrija

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml Lösung zum Eingeben für Schweine

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

Franza

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Synchroplan 4 mg/ml solution buvable porcins

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

Il-Ġermanja

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

Hungary

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml belsőleges oldat sertések részére A.U.V.

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

The Netherlands

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml orale oplossing voor varkens

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

Poland

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

Romania

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

Spain

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml solución oral para porcino

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

United Kingdom

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Il-Ġermanja |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Il-Ġermanja

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Soluzzjoni orali

Ħnieżer (ħnieżer nisa żgħar sesswalment maturi)

Użu orali, Użu għal biex tagħmel kisja ta’ mediċina fuq l-ikel

---

ANNESS II

LISTA TA’ ISMIJIET, FORMA FARMAĊEWTIKA, DOŻAR TA’ PRODOTTI MEDIĊINALI, ROTTOT TA’ ADMINISTRAZJONI, APPLIKANTI/DETENTURI TA’ L- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ F’STATI MEMBRI

| Stat Membru EU/EEA | Detenturi ta’ l- awtorizzazzjoni għat-tqegħid fis-suq Isem tal-Kumpanija, Indirizz | Applikant Isem tal-Kumpanija, Indirizz | (Ivvintat) Isem | Dożar | Forma Farmaċewtika | Rotta ta’ administrazzjoni |
| --- | --- | --- | --- | --- | --- | --- |
| Danimarka | Hexal A/S |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Stat Membru EU/EEA

Detenturi ta’ l- awtorizzazzjoni għat-tqegħid fis-suq Isem tal-Kumpanija, Indirizz

Applikant Isem tal-Kumpanija, Indirizz

(Ivvintat) Isem

Dożar

Forma Farmaċewtika

Rotta ta’ administrazzjoni

Danimarka

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate “Hexal”

18 mg

Pillola Prolonged-release

Oral use

Danimarka

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate “Hexal”

36 mg

Pillola Prolonged-release

Oral use

Danimarka

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate “Hexal”

54 mg

Pillola Prolonged-release

Oral use

Ġermanja

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidathydrochlorid HEXAL 18 mg Retardtabletten

18 mg

Pillola Prolonged-release

Oral use

Ġermanja

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidathydrochlorid HEXAL 36 mg Retardtabletten

36 mg

Pillola Prolonged-release

Oral use

Ġermanja

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidathydrochlorid HEXAL 54 mg Retardtabletten

54 mg

Pillola Prolonged-release

Oral use

Irlanda

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |
| Irlanda |

Rowex Ltd

Bantry

Co. Cork

Irlanda

Metidate XL 54 mg Pillola Prolonged-releases

54 mg

Pillola Prolonged-release

Oral use

Irlanda

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |
| Irlanda |

Rowex Ltd

Bantry

Co. Cork

Irlanda

Metidate XL 18 mg Pillola Prolonged-releases

18 mg

Pillola Prolonged-release

Oral use

Irlanda

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |
| Irlanda |

Rowex Ltd

Bantry

Co. Cork

Irlanda

Metidate XL 36 mg Pillola Prolonged-releases

36 mg

Pillola Prolonged-release

Oral use

---

ANNESS III

LISTA TA’ ISMIJIET, FORMA FARMAĊEWTIKA, DOŻAR TA’ PRODOTTI MEDIĊINALI, ROTTOT TA’ ADMINISTRAZJONI, APPLIKANTI/DETENTURI TA’ L- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ F’STATI MEMBRI

| Stat Membru EU/EEA | Detenturi ta’ l- awtorizzazzjoni għat-tqegħid fis-suq Isem tal-Kumpanija, Indirizz | Applikant Isem tal-Kumpanija, Indirizz | (Ivvintat) Isem | Dożar | Forma Farmaċewtika | Rotta ta’ administrazzjoni |
| --- | --- | --- | --- | --- | --- | --- |
| Belġju | | Sandoz A/S |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Stat Membru EU/EEA

Detenturi ta’ l- awtorizzazzjoni għat-tqegħid fis-suq Isem tal-Kumpanija, Indirizz

Applikant Isem tal-Kumpanija, Indirizz

(Ivvintat) Isem

Dożar

Forma Farmaċewtika

Rotta ta’ administrazzjoni

Belġju

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat Sandoz 18 mg tabletten met verlengde afgifte

18 mg

Pillola Prolonged-release

Oral use

Belġju

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat Sandoz 36 mg tabletten met verlengde afgifte

36 mg

Pillola Prolonged-release

Oral use

Belġju

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat Sandoz 54 mg tabletten met verlengde afgifte

54 mg

Pillola Prolonged-release

Oral use

Ċipru

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Awstrija

Methylphenidate Sandoz

18 mg

Pillola Prolonged-release

Oral use

Ċipru

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Awstrija

Methylphenidate Sandoz

36 mg

Pillola Prolonged-release

Oral use

Ċipru

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Awstrija

Methylphenidate Sandoz

54 mg

Pillola Prolonged-release

Oral use

Danimarka

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate “Sandoz”

18 mg

Pillola Prolonged-release

Oral use

Danimarka

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate “Sandoz”

36 mg

Pillola Prolonged-release

Oral use

Danimarka

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate “Sandoz”

54 mg

Pillola Prolonged-release

Oral use

Finlandja

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz

18 mg

Pillola Prolonged-release

Oral use

Finlandja

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz

36 mg

Pillola Prolonged-release

Oral use

Finlandja

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz

54 mg

Pillola Prolonged-release

Oral use

France

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Méthylphénidate Sandoz LP 18 mg, comprimé à liberation prolongée

18 mg

Pillola Prolonged-release

Oral use

France

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Méthylphénidate Sandoz LP 36 mg, comprimé à libération prolongée

36 mg

Pillola Prolonged-release

Oral use

France

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Méthylphénidate Sandoz LP 54 mg, comprimé à librétaion prolongée

54 mg

Pillola Prolonged-release

Oral use

Germany

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten

18 mg

Pillola Prolonged-release

Oral use

Germany

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten

36 mg

Pillola Prolonged-release

Oral use

Germany

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten

54 mg

Pillola Prolonged-release

Oral use

Islanda

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz, 18 mg, forðatöflur

18 mg

Pillola Prolonged-release

Oral use

Islanda

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz, 36 mg, forðatöflur

36 mg

Pillola Prolonged-release

Oral use

Islanda

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz, 54 mg, forðatöflur

54 mg

Pillola Prolonged-release

Oral use

Luxembourg

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat Sandoz 18 mg comprimé à libération prolongée

18 mg

Pillola Prolonged-release

Oral use

Luxembourg

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat Sandoz 36 mg comprimé à libération prolongée

36 mg

Pillola Prolonged-release

Oral use

Luxembourg

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat Sandoz 54 mg comprimé à libération prolongée

54 mg

Pillola Prolonged-release

Oral use

Malta

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Matoride XL 18 mg Pillola Prolonged-releases

18 mg

Pillola Prolonged-release

Oral use

Malta

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Matoride XL 36 mg Pillola Prolonged-releases

36 mg

Pillola Prolonged-release

Oral use

Malta

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Matoride XL 54 mg Pillola Prolonged-releases

54 mg

Pillola Prolonged-release

Oral use

Norway

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz 18 mg depottabletter

18 mg

Pillola Prolonged-release

Oral use

Norway

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz 36 mg depottabletter

36 mg

Pillola Prolonged-release

Oral use

Norway

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz 54 mg depottabletter

54 mg

Pillola Prolonged-release

Oral use

Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Awstrija

Difumenil

18 mg

Pillola Prolonged-release

Oral use

Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Awstrija

Difumenil

36 mg

Pillola Prolonged-release

Oral use

Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Awstrija

Difumenil

54 mg

Pillola Prolonged-release

Oral use

Portugall

| Sandoz Farmacêutica Lda. |
| --- |
| Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

Metilfenidato Sandoz

18 mg

Pillola Prolonged-release

Oral use

Portugall

| Sandoz Farmacêutica Lda. |
| --- |
| Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

Metilfenidato Sandoz

36 mg

Pillola Prolonged-release

Oral use

Portugall

| Sandoz Farmacêutica Lda. |
| --- |
| Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

Metilfenidato Sandoz

54 mg

Pillola Prolonged-release

Oral use

Spanja

| Sandoz Farmacéutica, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda Osa Mayor no 4 |
| 28023 – Aravaca, Madrid |
| Spanja |

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spanja

Metilfenidato Sandoz 18 mg comprimidos de liberación prolongada EFG

18 mg

Pillola Prolonged-release

Oral use

Spanja

| Sandoz Farmacéutica, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda Osa Mayor no 4 |
| 28023 – Aravaca, Madrid |
| Spanja |

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spanja

Metilfenidato Sandoz 36 mg comprimidos de liberación prolongada EFG

36 mg

Pillola Prolonged-release

Oral use

Spanja

| Sandoz Farmacéutica, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda Osa Mayor no 4 |
| 28023 – Aravaca, Madrid |
| Spanja |

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spanja

Metilfenidato Sandoz 54 mg comprimidos de liberación prolongada EFG

54 mg

Pillola Prolonged-release

Oral use

Svezja

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz

18 mg

Pillola Prolonged-release

Oral use

Svezja

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz

36 mg

Pillola Prolonged-release

Oral use

Svezja

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylphenidate Sandoz

54 mg

Pillola Prolonged-release

Oral use

Olanda

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte

18 mg

Pillola Prolonged-release

Oral use

Olanda

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte

36 mg

Pillola Prolonged-release

Oral use

Olanda

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte

54 mg

Pillola Prolonged-release

Oral use

Ir-Renju Unit

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Matoride XL 18 mg Pillola Prolonged-releases

18 mg

Pillola Prolonged-release

Oral use

Ir-Renju Unit

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Matoride XL 36 mg Pillola Prolonged-releases

36 mg

Pillola Prolonged-release

Oral use

Ir-Renju Unit

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danimarka

Matoride XL 54 mg Pillola Prolonged-releases

54 mg

Pillola Prolonged-release

Oral use

---

ANNESS IV

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

| Stat Membru UE/ŻEE | Detenturi ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Isem | INN | Qawwa | Għamla farmaċewtika | Speċi ta’ l-annimal |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Intervet GmbH |
| Siemensstraße 107 |
| AT-1210 Wien |
| L-AWSTRIJA |

Stat Membru UE/ŻEE

Detenturi ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Isem

INN

Qawwa

Għamla farmaċewtika

Speċi ta’ l-annimal

L-Awstrija

Intervet GmbH

Siemensstraße 107

AT-1210 Wien

L-AWSTRIJA

Hexadreson 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Hunde

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Awstrija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Katzen und Hunde

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Belġju

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

RAPIDEXON 2 MG/ML SOLUTION INJECTABLE

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Belġju

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

DEXA-JECT 2 MG/ML oplossing voor injectie voor runderen, paarden, varkens, honden en katten

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Ċipru

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

DEXADRESON INJECTION 2 MG/ML

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Ir-Repubblika Ċeka

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Dexadreson, 2 mg/ml Injekční roztok

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Ir-Repubblika Ċeka

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

RAPIDEXON 2 mg/ml injekční roztok

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Denmark

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Dexadreson Vet

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel

Id-Danimarka

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexaject

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Id-Danimarka

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Finlandja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon vet

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Franza

| Intervet |
| --- |
| Rue Olivier De Serres |
| Angers Technopole |
| 49071 Beaucouze Cedex |
| FRANZA |

Intervet

Rue Olivier De Serres

Angers Technopole

49071 Beaucouze Cedex

FRANZA

Dexadreson

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, mogħoż, ħniezer, klieb u qtates

Franza

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml solution injectable

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Franza

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Cortadex 2 mg/ml solution injectable pour bovins, porcins, chiens et chats

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, ħniezer, klieb u qtates

Franza

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject 2 mg/ml solution injectable pour bovins, chevaux, porcins, chiens et chats

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Ġermanja

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| IL-ĠERMANJA |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

IL-ĠERMANJA

Hexadreson

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Ġermanja

| Albrecht GmbH |
| --- |
| Hauptstr. 6-8 |
| 88326 Aulendorf |
| IL-ĠERMANJA |

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

IL-ĠERMANJA

Rapidexon Albrecht 2 mg/ml

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Ġermanja

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Greċja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

DEXADRESON

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Greċja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

RAPIDEXON

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Ungerija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Dexadreson injekció A.U.V.

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Ungerija

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject 2 mg/ml injekció szarvasmarhák, lovak, sertések, kutyák és macskák részére A.U.V.

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Ungerija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml injekció A.U.V.

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Iżlanda

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexaject

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Irlanda

| Intervet Ireland Ltd. |
| --- |
| Magna Drive,MagnaBusinessPark |
| Citywest Road |
| Dublin24 |
| L-IRLANDA |

Intervet Ireland Ltd.

Magna Drive,MagnaBusinessPark

Citywest Road

Dublin24

L-IRLANDA

Dexadresson 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Irlanda

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Irlanda

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Italja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Dexadreson

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, mogħoż, ħniezer, klieb u qtates

Il-Latvja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Dexacortin

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, ħniezer, klieb u qtates

Il-Litwanja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

DEXACORTIN 2 mg/ml solution for injection for cattle, swine, dogs and cats

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, ħniezer, klieb u qtates

Il-Litwanja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

RAPIDEXON 2 mg/ml, solution for injection

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Litwanja

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

DEXA-JECT 2 mg/ml solution for injection for cattle, horse, pigs, dogs and cats

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Pajjiżi l-Baxxi

| Intervet Nederland B.V. |
| --- |
| p.o. box 50 |
| 5830 AB Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet Nederland B.V.

p.o. box 50

5830 AB Boxmeer

IL-PAJJIŻI L-BAXXI

Dexadreson

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar

Il-Pajjiżi l-Baxxi

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar

Il-Pajjiżi l-Baxxi

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Pajjiżi l-Baxxi

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

In-Norveġja

| Intervet AB |
| --- |
| Box 7121 |
| 192 07 Sollentuna |
| L-ISVEZJA |

Intervet AB

Box 7121

192 07 Sollentuna

L-ISVEZJA

Dexadreson vet.

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Polonja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

DEXACORTIN 2 mg/ml roztwór do wstrzykiwań dla bydła, świń, psów i kotów

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, ħniezer, klieb u qtates

Il-Polonja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

RAPIDEXON 2 mg/ml roztwór do wstrzykiwań

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Polonja

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject 2 mg/ml roztwór do wstrzykiwań dla bydła, koni, świń, psów i kotów

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Portugal

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml, solução injectável

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Il-Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém, |
| IL-PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém,

IL-PORTUGAL

Dexacortin 2 mg/ml solução injectável para bovinos, suínos, cães e gatos

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, ħniezer, klieb u qtates

Ir-Rumanija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

DEXADRESON

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, mogħoż, ħniezer, klieb u qtates

Is-Slovakkja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

Dexadreson 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Is-Slovakkja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Is-Slovenja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

RAPIDEXON 2 mg/ml raztopina za injiciranje

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Is-Slovenja

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| IL-PAJJIŻI L-BAXXI |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

IL-PAJJIŻI L-BAXXI

DEXACORTIN 2 mg/ml, raztopina za injiciranje za govedo, prašiče, pse in mačke

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, ħniezer, klieb u qtates

Spanja

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IL-PAJJIŻI L-BAXXI |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IL-PAJJIŻI L-BAXXI

Rapidexon 2 mg/ml solución inyectable

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Spanja

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, Km 4,1 |
| 43330 Riudoms, Tarragona |
| SPANJA |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, Km 4,1

43330 Riudoms, Tarragona

SPANJA

Dexavex

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Spanja

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IL-PAJJIŻI L-BAXXI |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IL-PAJJIŻI L-BAXXI

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

L-Isvezja

| Intervet AB |
| --- |
| Box 7121 |
| 192 07 Sollentuna |
| L-ISVEZJA |

Intervet AB

Box 7121

192 07 Sollentuna

L-ISVEZJA

Dexadreson vet.

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Ir-Renju Unit

| Intervet UK Ltd |
| --- |
| Walton Manor, Walton |
| Milton Keynes MK7 7AJ |
| IR-RENJU UNIT |

Intervet UK Ltd

Walton Manor, Walton

Milton Keynes MK7 7AJ

IR-RENJU UNIT

Dexadreson 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Ir-Renju Unit

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IR-RENJU UNIT |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

IR-RENJU UNIT

Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs and Cats

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

Ir-Renju Unit

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| IR-RENJU UNIT |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

IR-RENJU UNIT

Rapidexon 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, żwiemel, ħniezer, klieb u qtates

---

ANNESS V

LISTA TA’ ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI TA’ ANNIMAL, MNEJN JINGĦATA, ID-DETENTURI TA’ L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Detenturi ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Isem | INN | Qawwa | Għamla farmaċewtika | Speċi ta’ l-annimal | Mnejn għandu jingħata |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| L-AWSTRIJA |

Stat Membru UE/ŻEE

Detenturi ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Isem

INN

Qawwa

Għamla farmaċewtika

Speċi ta’ l-annimal

Mnejn għandu jingħata

L-Awstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

L-AWSTRIJA

Micotil 300 mg/ml - Injektionslösung für Rinder

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

Il-Belġju

| ELI LILLY BENELUX N.V. |
| --- |
| Division Elanco Animal Health |
| Stoofstraat 52 |
| 1000 Brussel |
| IL-BELĠJU |

ELI LILLY BENELUX N.V.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

IL-BELĠJU

Micotil 300 mg/ml

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar, nagħaġ

Injezzjoni taħt il-ġilda

Ir-Repubblika Ċeka

| EIi Lílly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Wien |
| L-AWSTRIJA |

EIi Lílly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Wien

L-AWSTRIJA

Micotil 300 mg/ml injekční roztok pro skot (telata, mladý skot)

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

Il-Ġermanja

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

IL-ĠERMANJA

Micotil 300

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

Franza

| LILLY FRANCE |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANZA |

LILLY FRANCE

13 Rue Pages

92158 Suresnes Cedex

FRANZA

MICOTIL 300

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

Il-Greċja

| Eli Lilly Regional Operations GesmbH |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| L-AWSTRIJA |

Eli Lilly Regional Operations GesmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

L-AWSTRIJA

MICOTIL 300

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar, nagħaġ

Injezzjoni taħt il-ġilda

Spanja

| ELANCO VALQUÍMICA S.A, |
| --- |
| Avenida de la Industria 30 |
| 28108 Alcobendas |
| Madrid |
| SPANJA |

ELANCO VALQUÍMICA S.A,

Avenida de la Industria 30

28108 Alcobendas

Madrid

SPANJA

Micotil 300

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

L-Ungerija

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health Kölblgasse 8-10 |
| 1030 Vienna |
| L-AWSTRIJA |

Eli Lilly Regional Operations GmbH

Elanco Animal Health Kölblgasse 8-10

1030 Vienna

L-AWSTRIJA

Micotil 300 injekció

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

L-Irlanda

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| IR-RENJU UNIT |

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

IR-RENJU UNIT

Micotil 300mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar, nagħaġ

Injezzjoni taħt il-ġilda

L-Italja

| ELI LILLY ITALIA S.p.A. |
| --- |
| Via A. Gramsci, 731/733 Sesto Fiorentino |
| L-ITALJA |

ELI LILLY ITALIA S.p.A.

Via A. Gramsci, 731/733 Sesto Fiorentino

L-ITALJA

Micotil 300

Tilmicosin

300 mg/ml

Soluzzjoni għall-injezzjoni

Baqar, nagħaġ, fniek

Injezzjoni taħt il-ġilda

Il-Pajjiżi l-Baxxi

| Eli Lilly Nederland B.V./Elanco AnimalHealth |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| IL-PAJJIŻI L-BAXXI |

Eli Lilly Nederland B.V./Elanco AnimalHealth

Grootslag 1-5

3991 RA Houten

IL-PAJJIŻI L-BAXXI

MICOTIL 300 INJECTIE

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar, nagħaġ

Injezzjoni taħt il-ġilda

Il-Portugall

| Lilly Portugal – Produtos Farmacêuticos, Lda. |
| --- |
| Rua Cesário Verde, 5 – piso 4 |
| Linda-a-Pastora |
| 2790-326 QUEIJAS |
| IL-PORTUGALL |

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, 5 – piso 4

Linda-a-Pastora

2790-326 QUEIJAS

IL-PORTUGALL

Micotil 300 mg/ml solução injectável

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar

Injezzjoni taħt il-ġilda

Ir-Renju Unit

| Eli Lilly & Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestley Road |
| Basingstoke |
| RG24 9NL |
| IR-RENJU UNIT |

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke

RG24 9NL

IR-RENJU UNIT

Micotil 300 mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Soluzzjoni għal injezzjoni

Baqar, nagħaġ

Injezzjoni taħt il-ġilda

---

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 Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Kontenut
  (konċentrazzjoni) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Stat Membru EU/EEA

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Kontenut

(konċentrazzjoni)

L-Awstrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun

50 mg – Konzentrat zur Infusionsbereitung

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B-1800 Vilvoorde

Belgium

SANDIMMUN

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

25 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 50 mg Weichkapseln

50 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

250 mg/5 ml amp

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

50 mg/ml amp

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun 50 mg/ml koncentrátum oldatos infúzióhoz

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 |
| Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003

Köbenhavn S

Denmark

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

25 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg/1 ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

25 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni fil-vini

Użu għal ġol-vini

50 mg/ml

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Intravenous

50 mg/ml

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

ls-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun 50 mg/ml

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 50 mg/ml concentrado para solución para perfusión

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 250 mg/5 ml concentrado para solución para perfusión

250 mg/5 ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 100 mg

100 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Oral Solution

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Concentrate for Solution for Infusion 50 mg/ml

50 mg/ml

Konċentrat għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

50 mg/ml

---

ANNESS VII

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 Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Kontenut
  (konċentrazzjoni) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Stat Membru EU/EEA

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Kontenut

(konċentrazzjoni)

L-Awstrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 10 mg Kapseln

10 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 25 mg Kapseln

25 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 50 mg Kapseln

50 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg Kapseln

100 mg

Kapsula, ratba

Użu orali

L-Awstrija

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

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg/ml - Trinklösung

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 10 mg

10 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg

100 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 25 mg

25 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 50 mg

50 mg

Kapsula

Użu orali

Il-Belġju

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 25 mg capsule

25 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 50 mg capsule

50 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg capsule

100 mg

Kapsula, ratba

Użu orali

Il-Bulgarija

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg/ml oral solution

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml – 50 ml

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 25 mg

25 mg

Kapsula, ratba

Użu orali

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 50 mg

50 mg

Kapsula, ratba

Użu orali

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 100 mg

100 mg

Kapsula, ratba

Użu orali

Ċipru

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral Oral Solution 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

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

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Id-Danimarka

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Estonja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Finlandja

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

10 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

25 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

50 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg

Kapsula, ratba

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Ġermanja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

25 mg/cap

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

50 mg/cap

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

100 mg/cap

Kapsula, ratba

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

500 mg/5 ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 10 mg lágy kapszula

10 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 25 mg lágy kapszula

25 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 50 mg lágy kapszula

50 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg lágy kapszula

100 mg

Kapsula, ratba

Użu orali

L-Ungerija

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg/ml belsőleges oldat

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

25 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

50 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg

Kapsula, ratba

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

L-Italja

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Latvja

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 25 mg mīkstās kapsulas

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

Sandimmun Neoral 50 mg mīkstās kapsulas

50 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

Sandimmun Neoral 100 mg mīkstās kapsulas

100 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

Sandimmun Neoral

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

Sandimmun Neoral

50 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

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Kapsula, ratba

Użu orali

Il-Lussemburgu

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 25 mg, capsules

25 mg

Kapsula, ratba

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

Neoral 100 mg, capsules

100 mg

Kapsula, ratba

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

Neoral 100 mg/ml, drank

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

In-Norveġja

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Polonja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

Il-Portugall

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Rumanija

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL capsule moi, 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Rumanija

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL,capsule moi, 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Rumanija

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL, solutie orala, 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Kapsula, ratba

Użu orali

Is-Slovakkja

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

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 25 mg mehke kapsule

25 mg

Kapsula, ratba

Użu orali

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 50 mg mehke kapsule

50 mg

Kapsula, ratba

Użu orali

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg mehke kapsule

100 mg

Kapsula, ratba

Użu orali

Is-Slovenja

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg/ml peroralna raztopina

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 25 mg cápsulas blandas

25 mg

Kapsula, ratba

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 50 mg cápsulas blandas

50 mg

Kapsula, ratba

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg cápsulas blandas

100 mg

Kapsula, ratba

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg/ml solución oral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

10 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

25 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

50 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg

Kapsula, ratba

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 10 mg

10 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 25 mg

25 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 50 mg

50 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 100 mg

100 mg

Kapsula, ratba

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Oral solution

100 mg/ml

Soluzzjoni orali

Użu orali

100 mg/ml

---

ANNESS VIII

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

| Stati Membri (fl-EEA) | Detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem Inventat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| Il-Belġju | Janssen-Cilag NV |
| Antwerpseweg 15-17 |
| 2340 Beerse |
| Belgium |

Stati Membri (fl-EEA)

Detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem Inventat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Belġju

Janssen-Cilag NV

Antwerpseweg 15-17

2340 Beerse

Belgium

Nizoral 200 mg tabletten

200 mg

Pillola

Użu orali

Il-Bulgarija

| Jonson & Jonson D.O.O., |
| --- |
| Smartinska cesta 53, |
| 1000 Ljubljana, |
| Slovenia |

Jonson & Jonson D.O.O.,

Smartinska cesta 53,

1000 Ljubljana,

Slovenia

NIZORAL

200 mg

Pillola

Użu orali

Ċipru

| Aegis Ltd |
| --- |
| 17 Athinon street |
| 2081 Lefkosia |
| Cyprus |

Aegis Ltd

17 Athinon street

2081 Lefkosia

Cyprus

KETOZAL TABLETS 200 mg

200 mg

Pillola

Użu orali

Ċipru

| Remedica ltd |
| --- |
| Aharnon street |
| 3508 Lemesos |
| Cyprus |

Remedica ltd

Aharnon street

3508 Lemesos

Cyprus

KETROZOL TABLETS 200 mg

200 mg

Pillola

Użu orali

Ċipru

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beers |
| Belgium |

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beers

Belgium

NIZORAL TABLETS 200 mg

200 mg

Pillola

Użu orali

Ċipru

| Medochemie ltd |
| --- |
| 1-10 Constantinoupoleos street |
| 3505 Lemesos |
| Cyprus |

Medochemie ltd

1-10 Constantinoupoleos street

3505 Lemesos

Cyprus

TINUVIN TABLETS 200 mg

200 mg

Pillola

Użu orali

Ċipru

| CDL Pharmaceutical Products ltd |
| --- |
| Agiou Spyridonos 12 |
| 7102 Larnaca |
| Cyprus |

CDL Pharmaceutical Products ltd

Agiou Spyridonos 12

7102 Larnaca

Cyprus

VAFLUSON TABLETS 200 mg

200 mg

Pillola

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s.r.o. |
| --- |
| Karla Engliše 3201/6 |
| 15000 Praha 5 |
| Czech Republic |

Janssen-Cilag s.r.o.

Karla Engliše 3201/6

15000 Praha 5

Czech Republic

NIZORAL

200 mg

Pillola

Użu orali

L-Estonja

| UAB Johnson & Johnson |
| --- |
| Gelezinio Vilko g. 18A |
| 08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

NIZORAL

200 mg

Pillola

Użu orali

Il-Finlandja

| Janssen-Cilag Oy |
| --- |
| Vaisalantie 2 |
| 02130 Espoo |
| Finland |

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

NIZORAL

200 mg

Pillola

Użu orali

Franza

| Janssen Cilag |
| --- |
| 1, rue Camille Desmoulins TSA |
| 91003 92787 Issy-les-Moulineaux |
| Cedex 9 |
| France |

Janssen Cilag

1, rue Camille Desmoulins TSA

91003 92787 Issy-les-Moulineaux

Cedex 9

France

NIZORAL 200 mg, comprimé

200 mg

Pillola

Użu orali

Il-Greċja

| Coup ABEE |
| --- |
| Agias Barbaras 53-55 |
| Dafni 15235 |
| Greece |

Coup ABEE

Agias Barbaras 53-55

Dafni 15235

Greece

MYCOFEBRIN

200 mg

Pillola

Użu orali

Il-Greċja

| Demo ABEE |
| --- |
| 21ST Km National Highway |
| Athens - Lamia |
| Kryoneri 14568 |
| Greece |

Demo ABEE

21ST Km National Highway

Athens - Lamia

Kryoneri 14568

Greece

AQUARIUS

200 mg

Pillola

Użu orali

Il-Greċja

| Rafarm AEBE |
| --- |
| Korinthou 12 |
| Neo Psychiko 15451 |
| Greece |

Rafarm AEBE

Korinthou 12

Neo Psychiko 15451

Greece

ILGEM

200 mg

Pillola

Użu orali

Il-Greċja

| Angelini Pharma Hellas ABEE |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Athens |
| Greece |

Angelini Pharma Hellas ABEE

Achaias & Trizinias

Nea Kifissia 14564

Athens

Greece

SOSTATIN

200 mg

Pillola

Użu orali

Il-Greċja

| Bros ltd |
| --- |
| Avgis & Galinis 15 |
| Nea Kifissia |
| Athens |
| Greece |

Bros ltd

Avgis & Galinis 15

Nea Kifissia

Athens

Greece

EBERSEPT

200 mg

Pillola

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| West Gate Business Park |
| Tó Park |
| 2045, Törökbálint |
| Hungary |

Janssen-Cilag Kft.

West Gate Business Park

Tó Park

2045, Törökbálint

Hungary

NIZORAL 200 mg tabletta

200 mg

Pillola

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| 192 07 Sollentuna |
| Sweden |

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral

200 mg

Pillola

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Gelezinio Vilko g. 18A |
| 08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral 200 mg tablets

200 mg

Pillola

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Gelezinio Vilko g. 18A |
| 08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral

200 mg

Pillola

Użu orali

Il-Lussemburgu

| Janssen Cilag NV |
| --- |
| 15-17 Antwerpseweg |
| B-2340 Beerse |
| Belgium |

Janssen Cilag NV

15-17 Antwerpseweg

B-2340 Beerse

Belgium

Nizoral 200 mg comprimés

200 mg

Pillola

Użu orali

In-Norveġja

| Janssen-Cilag AS |
| --- |
| Postboks 144 |
| 1325 Lysaker |
| Norway |

Janssen-Cilag AS

Postboks 144

1325 Lysaker

Norway

Fungoral

200 mg

Pillola

Użu orali

Il-Polonja

| Polfarmex S.A. |
| --- |
| Józefów 9 |
| 99-300 Kutno |
| Poland |

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

Ketokonazol

200 mg

Pillola

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Nizale

200 mg

Pillola

Użu orali

Ir-Rumanija

| S.C. Arena Group S.A. |
| --- |
| Str. Ștefan Mihăileanu nr. 31 Sector 2, București |
| România |

S.C. Arena Group S.A.

Str. Ștefan Mihăileanu nr. 31 Sector 2, București

România

KETOCONAZOL ARENA 200 mg

200 mg

Pillola

Użu orali

Ir-Rumanija

| Terapia SA |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca |
| Romania |

Terapia SA

Str. Fabricii nr. 124

Cluj-Napoca

Romania

NIZORAL 200 mg

200 mg

Pillola

Użu orali

Ir-Rumanija

| S.C. Magistra C&C |
| --- |
| Str. Aurel Vlaicu nr. 82A |
| 8700 Constanța |
| România |

S.C. Magistra C&C

Str. Aurel Vlaicu nr. 82A

8700 Constanța

România

KETOCONAZOL 200 mg

200 mg

Pillola

Użu orali

Ir-Rumanija

| S.C. Slavia Pharm S.R.L. |
| --- |
| Bd.Theodor Pallady nr. 44C |
| Sector 3 |
| București |
| România |

S.C. Slavia Pharm S.R.L.

Bd.Theodor Pallady nr. 44C

Sector 3

București

România

KETOCONAZOL 200 mg

200 mg

Pillola

Użu orali

Ir-Rumanija

| A.C. Helcor s.r.l. |
| --- |
| Str. Dr. Victor Babeș nr. 50 |
| Baia Mare |
| România |

A.C. Helcor s.r.l.

Str. Dr. Victor Babeș nr. 50

Baia Mare

România

KETOSTIN 200 mg

200 mg

Pillola

Użu orali

ls-Slovakkja

| Johnson & Johnson s.r.o. |
| --- |
| Karadžičova 12 |
| 821 08 Bratislava |
| Slovak Republic |

Johnson & Johnson s.r.o.

Karadžičova 12

821 08 Bratislava

Slovak Republic

NIZORAL

200 mg

Pillola

Użu orali

Spanja

| Zeus, S.L. |
| --- |
| Collado mediano, s/n |
| 28230 Las Rozas |
| Madrid |
| Spain |

Zeus, S.L.

Collado mediano, s/n

28230 Las Rozas

Madrid

Spain

FUNGO ZEUS 200 mg comprimidos

200 mg

Pillola

Użu orali

Spanja

| Janssen-Cilag, S.A. |
| --- |
| Po de Las Doce Estrellas 5-7 |
| 28042 Madrid |
| Spain |

Janssen-Cilag, S.A.

Po de Las Doce Estrellas 5-7

28042 Madrid

Spain

FUNGAREST comprimidos

200 mg

Pillola

Użu orali

Spanja

| Ratiopharm Espana, S.A. |
| --- |
| C/ Anabel Segura, 11 |
| Edificio Albatros B 1a planta |
| 28108 Alcobendas (Madrid) |
| Spain |

Ratiopharm Espana, S.A.

C/ Anabel Segura, 11

Edificio Albatros B 1a planta

28108 Alcobendas (Madrid)

Spain

Ketoconazol ratiopharm 200 mg comprimidos

200 mg

Pillola

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| 192 07 Sollentuna |
| Sweden |

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral®

200 mg

Pillola

Użu orali

L-Olanda

| Janssen-Cilag B.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| 5026 RH TILBURG |
| The Netherlands |

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH TILBURG

The Netherlands

Nizoral tabletten 200 mg

200 mg

Pillola

Użu orali

Ir-Renju Unit

| Janssen-Cilag Limited |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire HP12 4EG |
| United Kingdom |

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Nizoral 200 mg tablets

200 mg

Pillola

Użu orali

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