# Službeni list C 350/2013

| | ISSN 1977-1088
  doi:10.3000/19771088.C_2013.350.hrv |
| --- | --- |
| Službeni list
  Europske unije | C 350 |
| | |
| Hrvatsko izdanje | Informacije i objave | 5629. studenoga 2013. |

ISSN 1977-1088

doi:10.3000/19771088.C_2013.350.hrv

Službeni list

Europske unije

C 350

Hrvatsko izdanje

Informacije i objave

5629. studenoga 2013.

---

| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2013/C 350/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2013. do 30. rujna 2013.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 1 |
| 2013/C 350/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2013. do 31. listopada 2013.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 26 |
| 2013/C 350/03 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2013. do 31. listopada 2013.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 30 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2013/C 350/01

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

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

1

2013/C 350/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2013. do 31. listopada 2013.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

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

26

2013/C 350/03

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2013. do 31. listopada 2013.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

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

30

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

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 29.11.2013 | HR | Službeni list Europske unije | C 350/1 |
| --- | --- | --- | --- |

29.11.2013

HR

Službeni list Europske unije

C 350/1

---

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

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

2013/C 350/01

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

| Datum odluke | Naziv(i) lijeka | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 25.9.2013. | Sandimmun | Vidi Prilog I | Vidi Prilog I | 26.9.2013. |
| 25.9.2013. | Sandimmun Neoral | Vidi Prilog II | Vidi Prilog II | 26.9.2013. |

Datum odluke

Naziv(i) lijeka

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

25.9.2013.

Sandimmun

Vidi Prilog I

Vidi Prilog I

26.9.2013.

25.9.2013.

Sandimmun Neoral

Vidi Prilog II

Vidi Prilog II

26.9.2013.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

DODATAK I.

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

| Država članica EU/EGP | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene | Sastav
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Država članica EU/EGP

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Sastav

(koncentracija)

Austrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun

50 mg – Konzentrat zur Infusionsbereitung

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Belgija

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Češka Republika

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Danska

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Francuska

| 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

Otopina za infuziju

U venu

50 mg/ml

Njemačka

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Kapsule, meke

Kroz usta

Njemačka

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Kapsule, meke

Kroz usta

Njemačka

| 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

Oralna otopina

Kroz usta

100 mg/ml

Njemačka

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Njemačka

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 25 mg Weichkapseln

25 mg

Kapsule, meke

Kroz usta

Njemačka

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 50 mg Weichkapseln

50 mg

Kapsule, meke

Kroz usta

Njemačka

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 100 mg Weichkapseln

100 mg

Kapsule, meke

Kroz usta

Grčka

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Grčka

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Mađarska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Island

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Irska

| 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

Kapsule, meke

Kroz usta

Irska

| 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

Kapsule, meke

Kroz usta

Irska

| 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

Kapsule, meke

Kroz usta

Irska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Irska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Italija

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Kapsule, meke

Kroz usta

Luksemburg

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Kapsule, meke

Kroz usta

Luksemburg

| 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

Oralna otopina

Kroz usta

100 mg/ml

Luksemburg

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Nizozemska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Norveška

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Portugal

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Slovačka Republika

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Slovenija

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Španjolska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Španjolska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Švedska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Oralna otopina

Kroz usta

100 mg/ml

Ujedinjeno Kraljevstvo

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

---

DODATAK II.

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

| Država članica EU/EGP | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene | Sastav
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Država članica EU/EGP

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Sastav

(koncentracija)

Austrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 10 mg Kapseln

10 mg

Kapsule, meke

Kroz usta

Austrija

| 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

Kapsule, meke

Kroz usta

Austrija

| 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

Kapsule, meke

Kroz usta

Austrija

| 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

Kapsule, meke

Kroz usta

Austrija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Belgija

| 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

Kapsule

Kroz usta

Belgija

| 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

Kapsule

Kroz usta

Belgija

| 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

Kapsule

Kroz usta

Belgija

| 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

Kapsule

Kroz usta

Belgija

| 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

Oral solution

Kroz usta

100 mg/ml

Bugarska

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

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 25 mg capsule

25 mg

Kapsule, meke

Kroz usta

Bugarska

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

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 50 mg capsule

50 mg

Kapsule, meke

Kroz usta

Bugarska

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

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg capsule

100 mg

Kapsule, meke

Kroz usta

Bugarska

| 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

Oralna otopina

Kroz usta

100 mg/ml – 50ml

Cipar

| 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

Kapsule, meke

Kroz usta

Cipar

| 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

Kapsule, meke

Kroz usta

Cipar

| 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

Kapsule, meke

Kroz usta

Cipar

| 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

Oralna otopina

Kroz usta

100 mg/ml

Češka Republika

| 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

Kapsule, meke

Kroz usta

Češka Republika

| 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

Kapsule, meke

Kroz usta

Češka Republika

| 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

Kapsule, meke

Kroz usta

Češka Republika

| 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

Oralna otopina

Kroz usta

100 mg/ml

Danska

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

10 mg

Kapsule, meke

Kroz usta

Danska

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

25 mg

Kapsule, meke

Kroz usta

Danska

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

50 mg

Kapsule, meke

Kroz usta

Danska

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg

Kapsule, meke

Kroz usta

Danska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsule, meke

Kroz usta

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsule, meke

Kroz usta

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsule, meke

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsule, meke

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsule, meke

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsule, meke

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg/ml

Oralna otopina

Kroz usta

100 mg/ml

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Kapsule, meke

Kroz usta

Francuska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Njemačka

| 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

Kapsule, meke

Kroz usta

Njemačka

| 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

Kapsule, meke

Kroz usta

Njemačka

| 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

Kapsule, meke

Kroz usta

Njemačka

| 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

Kapsule, meke

Kroz usta

Njemačka

| 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

Oralna otopina

Kroz usta

100 mg/ml

Grčka

| 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

Kapsule, meke

Kroz usta

Grčka

| 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

Kapsule, meke

Kroz usta

Grčka

| 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

Kapsule, meke

Kroz usta

Grčka

| 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

Oralna otopina

Kroz usta

100 mg/ml

Mađarska

| 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

Kapsule, meke

Kroz usta

Mađarska

| 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

Kapsule, meke

Kroz usta

Mađarska

| 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

Kapsule, meke

Kroz usta

Mađarska

| 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

Kapsule, meke

Kroz usta

Mađarska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Island

| 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

Kapsule, meke

Kroz usta

Island

| 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

Kapsule, meke

Kroz usta

Island

| 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

Kapsule, meke

Kroz usta

Island

| 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

Oralna otopina

Kroz usta

100 mg/ml

Irska

| 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

Kapsule, meke

Kroz usta

Irska

| 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

Kapsule, meke

Kroz usta

Irska

| 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

Kapsule, meke

Kroz usta

Irska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Kapsule, meke

Kroz usta

Italija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Latvija

| 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

Kapsule, meke

Kroz usta

Latvija

| 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

Kapsule, meke

Kroz usta

Latvija

| 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

Kapsule, meke

Kroz usta

Litva

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsule, meke

Kroz usta

Litva

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo, |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo,

Finland

Sandimmun Neoral

50 mg

Kapsule, meke

Kroz usta

Litva

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsule, meke

Kroz usta

Luksemburg

| 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

Kapsule, meke

Kroz usta

Luksemburg

| 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

Kapsule, meke

Kroz usta

Luksemburg

| 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

Kapsule, meke

Kroz usta

Luksemburg

| 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

Kapsule, meke

Kroz usta

Luksemburg

| 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

Oralna otopina

Kroz usta

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

Kapsule, meke

Kroz usta

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

Kapsule, meke

Kroz usta

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

Oralna otopina

Kroz usta

100 mg/ml

Nizozemska

| 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

Kapsule, meke

Kroz usta

Nizozemska

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

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg, capsules

100 mg

Kapsule, meke

Kroz usta

Nizozemska

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

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg/ml, drank

100 mg/ml

Oralna otopina

Kroz usta

100 mg/ml

Norveška

| 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

Kapsule, meke

Kroz usta

Norveška

| 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

Kapsule, meke

Kroz usta

Norveška

| 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

Kapsule, meke

Kroz usta

Norveška

| 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

Oralna otopina

Kroz usta

100 mg/ml

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

10 mg

Kapsule, meke

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

25 mg

Kapsule, meke

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

50 mg

Kapsule, meke

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg

Kapsule, meke

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg/ml

Oralna otopina

Kroz usta

100 mg/ml

Portugal

| 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

Kapsule, meke

Kroz usta

Portugal

| 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

Kapsule, meke

Kroz usta

Portugal

| 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

Kapsule, meke

Kroz usta

Portugal

| 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

Oralna otopina

Kroz usta

100 mg/ml

Rumunjska

| 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

Kapsule, meke

Kroz usta

Rumunjska

| 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

Kapsule, meke

Kroz usta

Rumunjska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Slovačka Republika

| 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

Kapsule, meke

Kroz usta

Slovačka Republika

| 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

Kapsule, meke

Kroz usta

Slovačka Republika

| 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

Kapsule, meke

Kroz usta

Slovačka Republika

| 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

Oralna otopina

Kroz usta

100 mg/ml

Slovenija

| 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

Kapsule, meke

Kroz usta

Slovenija

| 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

Kapsule, meke

Kroz usta

Slovenija

| 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

Kapsule, meke

Kroz usta

Slovenija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Španjolska

| 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

Kapsule, meke

Kroz usta

Španjolska

| 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

Kapsule, meke

Kroz usta

Španjolska

| 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

Kapsule, meke

Kroz usta

Španjolska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Švedska

| 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

Kapsule, meke

Kroz usta

Švedska

| 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

Kapsule, meke

Kroz usta

Švedska

| 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

Kapsule, meke

Kroz usta

Švedska

| 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

Kapsule, meke

Kroz usta

Švedska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Kapsule, meke

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Oralna otopina

Kroz usta

100 mg/ml

---

| 29.11.2013 | HR | Službeni list Europske unije | C 350/26 |
| --- | --- | --- | --- |

29.11.2013

HR

Službeni list Europske unije

C 350/26

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2013. do 31. listopada 2013.

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

2013/C 350/02

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

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.10.2013. | Defitelio | defibrotid | Gentium S.p.A. |
| Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), |
| Italia |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

18.10.2013.

Defitelio

defibrotid

Gentium S.p.A.

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

Italia

EU/1/13/878

Koncentrat za otopinu za infuziju

B01AX01

22.10.2013.

18.10.2013.

Grastofil

filgrastim

| 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

otopina za injekciju ili infuziju

L03AA02

22.10.2013.

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 2.10.2013. | Myocet | Teva Pharma B.V. |
| Computerweg 10, NL-3542 DR Utrecht, |
| Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 25.10.2013. | Clopidogrel ratiopharm | Archie Samuel s.r.o. |
| Slunná 16, CZ-61700 Brno, |
| Česká republika |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

25.10.2013.

Clopidogrel ratiopharm

Archie Samuel s.r.o.

Slunná 16, CZ-61700 Brno,

Česká republika

EU/1/09/554

28.10.2013.

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 11.10.2013. | Equip WNV | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, |
| Belgique |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

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

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

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK-LONDON E14 4H

---

(1)  SL L 136, 30.4.2004., str. 1.

---

| 29.11.2013 | HR | Službeni list Europske unije | C 350/30 |
| --- | --- | --- | --- |

29.11.2013

HR

Službeni list Europske unije

C 350/30

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2013. do 31. listopada 2013.

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

2013/C 350/03

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

| Datum odluke | Naziv(i) lijeka | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 2.10.2013. | Suifertil 4 mg/ml | Vidi Prilog I | Vidi Prilog I | 3.10.2013. |
| 9.10.2013. | Methylphenidate Hexal | Vidi Prilog II | Vidi Prilog II | 11.10.2013. |
| 9.10.2013. | Methylphenidate Sandoz | Vidi Prilog III | Vidi Prilog III | 10.10.2013. |
| 18.10.2013. | Dexadreson 2 mg/ml | Vidi Prilog IV | Vidi Prilog IV | 21.10.2013. |
| 18.10.2013. | Micotil 300 | Vidi Prilog V | Vidi Prilog V | 21.10.2013. |
| 31.10.2013. | Sandimmun | Vidi Prilog VI | Vidi Prilog VI | 4.11.2013. |
| 31.10.2013. | Sandimmun Neoral | Vidi Prilog VII | Vidi Prilog VII | 4.11.2013. |

Datum odluke

Naziv(i) lijeka

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

2.10.2013.

Suifertil 4 mg/ml

Vidi Prilog I

Vidi Prilog I

3.10.2013.

9.10.2013.

Methylphenidate Hexal

Vidi Prilog II

Vidi Prilog II

11.10.2013.

9.10.2013.

Methylphenidate Sandoz

Vidi Prilog III

Vidi Prilog III

10.10.2013.

18.10.2013.

Dexadreson 2 mg/ml

Vidi Prilog IV

Vidi Prilog IV

21.10.2013.

18.10.2013.

Micotil 300

Vidi Prilog V

Vidi Prilog V

21.10.2013.

31.10.2013.

Sandimmun

Vidi Prilog VI

Vidi Prilog VI

4.11.2013.

31.10.2013.

Sandimmun Neoral

Vidi Prilog VII

Vidi Prilog VII

4.11.2013.

—   Obustava nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 11.10.2013. | Ketoconazole | Vidi Prilog VIII | Vidi Prilog VIII | 14.10.2013. |

Datum odluke

Naziv(i) lijeka

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

11.10.2013.

Ketoconazole

Vidi Prilog VIII

Vidi Prilog VIII

14.10.2013.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

DODATAK I.

POPIS IMENOM, FARMACEUTSKI OBLIK, JAČINA VETERINARSKOG LIJEKA, ŽIVOTINJSKE VRSTE, PUT PRIMJENE, PODNOSITELJ ZAHTJEVA U DRŽAVAMA ČLANICAMA

| Članica EU/EEA | Podnositelj | Naziv | Djelatna tvar | Jačina | Farmaceutski oblik | Ciljna vrsta životinja | Način primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | aniMedica GmbH |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

Članica EU/EEA

Podnositelj

Naziv

Djelatna tvar

Jačina

Farmaceutski oblik

Ciljna vrsta životinja

Način primjene

Austrija

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml Lösung zum Eingeben für Schweine

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Francuska

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Synchroplan 4 mg/ml solution buvable porcins

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Njemačka

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Mađarska

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

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

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Nizozemska

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml orale oplossing voor varkens

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Poljska

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Rumunjska

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Španjolska

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml solución oral para porcino

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

Velika Britanija

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Njemačka |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Njemačka

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oralna otopina

Svinje (spolno zrele nazimice)

Kroz usta, Posipanjem hrane

---

DODATAK II.

POPIS S IMENIMA, FARMACEUTSKIM OBLICIMA, JAČINAMA LIJEKOVA, PUTOVIMA PRIMJENE, PODNOSITELJIMA ZAHTJEVA / NOSITELJIMA ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica EU/EEA | Nositelj odobrenja, ime tvrtke, adresa | Podnositelj zahtjeva Ime tvrtke, adresa | (Izumljeno) Ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- | --- |
| Danska | Hexal A/S |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Država članica EU/EEA

Nositelj odobrenja, ime tvrtke, adresa

Podnositelj zahtjeva Ime tvrtke, adresa

(Izumljeno) Ime

Jačina

Farmaceutski oblik

Put primjene

Danska

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate „Hexal”

18 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate „Hexal”

36 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate „Hexal”

54 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 18 mg Retardtabletten

18 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 36 mg Retardtabletten

36 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 54 mg Retardtabletten

54 mg

tableta s produljenim oslobađanjem

kroz usta

Irska

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

Rowex Ltd

Bantry

Co. Cork

Ireland

Metidate XL 54 mg Prolonged-Release Tablets

54 mg

tableta s produljenim oslobađanjem

kroz usta

Irska

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

Rowex Ltd

Bantry

Co. Cork

Ireland

Metidate XL 18 mg Prolonged-Release Tablets

18 mg

tableta s produljenim oslobađanjem

kroz usta

Irska

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

Rowex Ltd

Bantry

Co. Cork

Ireland

Metidate XL 36 mg Prolonged-Release Tablets

36 mg

tableta s produljenim oslobađanjem

kroz usta

---

DODATAK III.

POPIS S IMENIMA, FARMACEUTSKIM OBLICIMA, JAČINAMA LIJEKOVA, PUTOVIMA PRIMJENE, PODNOSITELJIMA ZAHTJEVA / NOSITELJIMA ODOBRENJA U DRŽAVAMA ČLANICAMA

| Država članica EU/EEA | Nositelj odobrenja, ime tvrtke, adresa | Podnositelj zahtjeva Ime tvrtke, adresa | (Izumljeno) Ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- | --- |
| Belgija | | Sandoz A/S |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Država članica EU/EEA

Nositelj odobrenja, ime tvrtke, adresa

Podnositelj zahtjeva Ime tvrtke, adresa

(Izumljeno) Ime

Jačina

Farmaceutski oblik

Put primjene

Belgija

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 18 mg tabletten met verlengde afgifte

18 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 36 mg tabletten met verlengde afgifte

36 mg

tableta s produljenim oslobađanjem

kroz usta

Belgija

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 54 mg tabletten met verlengde afgifte

54 mg

tableta s produljenim oslobađanjem

kroz usta

Cipar

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Methylphenidate Sandoz

18 mg

tableta s produljenim oslobađanjem

kroz usta

Cipar

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Methylphenidate Sandoz

36 mg

tableta s produljenim oslobađanjem

kroz usta

Cipar

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Methylphenidate Sandoz

54 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate „Sandoz”

18 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate „Sandoz”

36 mg

tableta s produljenim oslobađanjem

kroz usta

Danska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate „Sandoz”

54 mg

tableta s produljenim oslobađanjem

kroz usta

Finska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

18 mg

tableta s produljenim oslobađanjem

kroz usta

Finska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

36 mg

tableta s produljenim oslobađanjem

kroz usta

Finska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

54 mg

tableta s produljenim oslobađanjem

kroz usta

Francuska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 18 mg, comprimé à liberation prolongée

18 mg

tableta s produljenim oslobađanjem

kroz usta

Francuska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 36 mg, comprimé à libération prolongée

36 mg

tableta s produljenim oslobađanjem

kroz usta

Francuska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 54 mg, comprimé à librétaion prolongée

54 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten

18 mg

tableta s produljenim oslobađanjem

kroz usta

Njemača

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten

36 mg

tableta s produljenim oslobađanjem

kroz usta

Njemačka

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten

54 mg

tableta s produljenim oslobađanjem

kroz usta

Island

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz, 18 mg, forðatöflur

18 mg

tableta s produljenim oslobađanjem

kroz usta

Island

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz, 36 mg, forðatöflur

36 mg

tableta s produljenim oslobađanjem

kroz usta

Island

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz, 54 mg, forðatöflur

54 mg

tableta s produljenim oslobađanjem

kroz usta

Luxemburg

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 18 mg comprimé à libération prolongée

18 mg

tableta s produljenim oslobađanjem

kroz usta

Luxemburg

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 36 mg comprimé à libération prolongée

36 mg

tableta s produljenim oslobađanjem

kroz usta

Luxembuurg

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 54 mg comprimé à libération prolongée

54 mg

tableta s produljenim oslobađanjem

kroz usta

Malta

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 18 mg Prolonged-release Tablets

18 mg

tableta s produljenim oslobađanjem

kroz usta

Malta

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 36 mg Prolonged-release Tablets

36 mg

tableta s produljenim oslobađanjem

kroz usta

Malta

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 54 mg Prolonged-release Tablets

54 mg

tableta s produljenim oslobađanjem

kroz usta

Norveška

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz 18 mg depottabletter

18 mg

tableta s produljenim oslobađanjem

kroz usta

Norveška

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz 36 mg depottabletter

36 mg

tableta s produljenim oslobađanjem

kroz usta

Norveška

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz 54 mg depottabletter

54 mg

tableta s produljenim oslobađanjem

kroz usta

Poljska

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Difumenil

18 mg

tableta s produljenim oslobađanjem

kroz usta

Poljska

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Difumenil

36 mg

tableta s produljenim oslobađanjem

kroz usta

Poljeska

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Difumenil

54 mg

tableta s produljenim oslobađanjem

kroz usta

Portugal

| 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

tableta s produljenim oslobađanjem

kroz usta

Portugal

| 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

tableta s produljenim oslobađanjem

kroz usta

Portugal

| 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

tableta s produljenim oslobađanjem

kroz usta

Španjolska

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

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

Metilfenidato Sandoz 18 mg comprimidos de liberación prolongada EFG

18 mg

tableta s produljenim oslobađanjem

kroz usta

Španjolska

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

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

Metilfenidato Sandoz 36 mg comprimidos de liberación prolongada EFG

36 mg

tableta s produljenim oslobađanjem

kroz usta

Španjolska

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

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

Metilfenidato Sandoz 54 mg comprimidos de liberación prolongada EFG

54 mg

tableta s produljenim oslobađanjem

kroz usta

Švedska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

18 mg

tableta s produljenim oslobađanjem

kroz usta

Švedska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

36 mg

tableta s produljenim oslobađanjem

kroz usta

Švedksa

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

54 mg

tableta s produljenim oslobađanjem

kroz usta

Nizozemska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte

18 mg

tableta s produljenim oslobađanjem

kroz usta

Nizozemska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte

36 mg

tableta s produljenim oslobađanjem

kroz usta

Nizozemska

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte

54 mg

tableta s produljenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 18 mg Prolonged-release Tablets

18 mg

tableta s produljenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 36 mg Prolonged-release Tablets

36 mg

tableta s produljenim oslobađanjem

kroz usta

Ujedinjeno Kraljevstvo

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 54 mg Prolonged-release Tablets

54 mg

tableta s produljenim oslobađanjem

kroz usta

---

DODATAK IV.

POPIS IMENA, FARMACEUTSKOG OBLIKA, JAČINE VMP, CILJNIH VRSTA, NOSITELJA ODOBRENJA DRŽAVA ČLANICA

| Države članice EU/EEA | Nositelj odobrenja | Ime | INN | Jačina | Farmaceutski oblik | Ciljne vrste |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Intervet GmbH |
| Siemensstraße 107 |
| AT-1210 Wien |
| AUSTRIJA |

Države članice EU/EEA

Nositelj odobrenja

Ime

INN

Jačina

Farmaceutski oblik

Ciljne vrste

Austrija

Intervet GmbH

Siemensstraße 107

AT-1210 Wien

AUSTRIJA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Austrija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Belgija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

RAPIDEXON 2 mg/ML SOLUTION INJECTABLE

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Belgija

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Cipar

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

DEXADRESON INJECTION 2 MG/ML

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Češka

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

Dexadreson, 2 mg/ml Injekční roztok

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Češka

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

RAPIDEXON 2 mg/ml injekční roztok

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Danska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

Dexadreson Vet

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Danska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Dexaject

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Denmark

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Finska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon vet

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Francuska

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

Intervet

Rue Olivier De Serres

Angers Technopole

49071 Beaucouze Cedex

FRANCUSKA

Dexadreson

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Francuska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml solution injectable

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Francuska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Francuska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Njemačka

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

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

NJEMAČKA

Hexadreson

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Njemačka

| Albrecht GmbH |
| --- |
| Hauptstr. 6-8 |
| 88326 Aulendorf |
| NJEMAČKA |

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

NJEMAČKA

Rapidexon Albrecht 2 mg/ml

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Njemačka

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Grčka

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

DEXADRESON

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Grčka

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

RAPIDEXON

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Mađarska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

Dexadreson injekció A.U.V.

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Mađarska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Mađarska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml injekció A.U.V.

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Island

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Dexaject

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Irska

| Intervet Ireland Ltd. |
| --- |
| Magna Drive, Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRSKA |

Intervet Ireland Ltd.

Magna Drive, Magna Business Park

Citywest Road

Dublin 24

IRSKA

Dexadresson 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Irska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Irska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Italija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

Dexadreson

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Latvija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

Dexacortin

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Litvanija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Litvanija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

RAPIDEXON 2 mg/ml, solution for injection

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Litvanija

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Nizozemska

| Intervet Nederland B.V. |
| --- |
| p.o. box 50 |
| 5830 AB Boxmeer |
| NIZOZEMSKA |

Intervet Nederland B.V.

p.o. box 50

5830 AB Boxmeer

NIZOZEMSKA

Dexadreson

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Nizozemska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Nizozemska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Nizozemska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Dexa-ject

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Norveška

| Intervet AB |
| --- |
| Box 7121 |
| 192 07 Sollentuna |
| SVEDSKA |

Intervet AB

Box 7121

192 07 Sollentuna

SVEDSKA

Dexadreson vet.

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Poljska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Poljska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

RAPIDEXON 2 mg/ml roztwór do wstrzykiwań

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Poljska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Portugal

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml, solução injectável

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Portugal

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

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém,

PORTUGAL

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Rumunjska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

DEXADRESON

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Slovačka

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

Dexadreson 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Slovačka

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Slovenija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

RAPIDEXON 2 mg/ml raztopina za injiciranje

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Slovenija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| NIZOZEMSKA |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Španjolska

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml solución inyectable

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Španjolska

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

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, Km 4,1

43330 Riudoms, Tarragona

ŠPANJOLSKA

Dexavex

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Španjolska

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Švedska

| Intervet AB |
| --- |
| Box 7121 |
| 192 07 Sollentuna |
| ŠVEDSKA |

Intervet AB

Box 7121

192 07 Sollentuna

ŠVEDSKA

Dexadreson vet.

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Velika Britanija

| Intervet UK Ltd |
| --- |
| Walton Manor, Walton |
| Milton Keynes MK7 7AJ |
| VELIKA BRITANIJA |

Intervet UK Ltd

Walton Manor, Walton

Milton Keynes MK7 7AJ

VELIKA BRITANIJA

Dexadreson 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Velika Britanija

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| NIZOZEMSKA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

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

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

Velika Britanija

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| NIZOZEMSKA |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

NIZOZEMSKA

Rapidexon 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Otopina za injekciju

Goveda, konji, svinje, psi i mačke

---

DODATAK V.

POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA VETERINARSKO MEDICINSKOG PROIZVODA, ŽIVOTINJSKIH VRSTA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U DRŽAVAMA ČLANICAMA

| Država članica EU/EEZ | Nositelj odobrenja za stavljanje lijeka u promet | Naziv | Međunarodni nezaštićeni naziv | Jačina | Farmaceutski oblik | Životinjske vrste | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| AUSTRIJA |

Država članica EU/EEZ

Nositelj odobrenja za stavljanje lijeka u promet

Naziv

Međunarodni nezaštićeni naziv

Jačina

Farmaceutski oblik

Životinjske vrste

Put primjene

Austrija

Richter Pharma AG

Feldgasse 19

4600 Wels

AUSTRIJA

Micotil 300 mg/ml - Injektionslösung für Rinder

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Belgija

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

ELI LILLY BENELUX N.V.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIJA

Micotil 300 mg/ml

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda, ovce

Supkutana injekcija

Češka Republika

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

EIi Lílly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Wien

AUSTRIJA

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

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Njemačka

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

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

NJEMAČKA

Micotil 300

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Francuska

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

LILLY FRANCE

13 Rue Pages

92158 Suresnes Cedex

FRANCUSKA

MICOTIL 300

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Grčka

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

Eli Lilly Regional Operations GesmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

AUSTRIJA

MICOTIL 300

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda, ovce

Supkutana injekcija

Španjolska

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

ELANCO VALQUÍMICA S.A,

Avenida de la Industria 30

28108 Alcobendas

Madrid

ŠPANJOLSKA

Micotil 300

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Mađarska

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health Kölblgasse 8-10

1030 Vienna

AUSTRIJA

Micotil 300 injekció

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Irska

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| UJEDINJENO KRALJEVSTVO |

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

UJEDINJENO KRALJEVSTVO

Micotil 300mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda, ovce

Supkutana injekcija

Italija

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

ELI LILLY ITALIA S.p.A.

Via A. Gramsci, 731/733 Sesto Fiorentino

ITALIJA

Micotil 300

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda, ovce, zečevi

Supkutana injekcija

Nizozemska

| Eli Lilly Nederland B.V./Elanco AnimalHealth |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NIZOZEMSKA |

Eli Lilly Nederland B.V./Elanco AnimalHealth

Grootslag 1-5

3991 RA Houten

NIZOZEMSKA

MICOTIL 300 INJECTIE

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda, ovce

Supkutana injekcija

Portugal

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

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, 5 – piso 4

Linda-a-Pastora

2790-326 QUEIJAS

PORTUGAL

Micotil 300 mg/ml solução injectável

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda

Supkutana injekcija

Ujedinjeno Kraljevstvo

| Eli Lilly & Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestley Road |
| Basingstoke |
| RG24 9NL |
| UJEDINJENO KRALJEVSTVO |

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke

RG24 9NL

UJEDINJENO KRALJEVSTVO

Micotil 300 mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Otopina za injekciju

Goveda, ovce

Supkutana injekcija

---

DODATAK VI.

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

| Država članica EU/EGP | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene | Sastav
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Država članica EU/EGP

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Sastav

(koncentracija)

Austrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun

50 mg – Konzentrat zur Infusionsbereitung

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Belgija

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Češka Republika

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Danska

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

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Francuska

| 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, meka

Kroz usta

Francuska

| 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, meka

Kroz usta

Francuska

| 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, meka

Kroz usta

Francuska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Francuska

| 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

Otopina za infuziju

U venu

50 mg/ml

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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

Oralna otopina

Kroz usta

100 mg/ml

Njemačka

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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, meka

Kroz usta

Grčka

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Grčka

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Mađarska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Island

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Irska

| 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, meka

Kroz usta

Irska

| 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, meka

Kroz usta

Irska

| 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, meka

Kroz usta

Irska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Irska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Italija

| 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, meka

Kroz usta

Italija

| 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, meka

Kroz usta

Italija

| 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, meka

Kroz usta

Italija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Italija

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Luksemburg

| 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, meka

Kroz usta

Luksemburg

| 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, meka

Kroz usta

Luksemburg

| 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

Oralna otopina

Kroz usta

100 mg/ml

Luksemburg

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Nizozemska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Norveška

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun

50 mg/ml

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Portugal

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Slovačka Republika

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Slovenija

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Španjolska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Španjolska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Švedska

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Oralna otopina

Kroz usta

100 mg/ml

Ujedinjeno Kraljevstvo

| 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

Koncentrat za otopinu za infuziju

U venu

50 mg/ml

---

DODATAK VII.

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

| Država članica EU/EGP | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene | Sastav
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Država članica EU/EGP

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Sastav

(koncentracija)

Austrija

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 10 mg Kapseln

10 mg

Kapsula, meka

Kroz usta

Austrija

| 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, meka

Kroz usta

Austrija

| 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, meka

Kroz usta

Austrija

| 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, meka

Kroz usta

Austrija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Belgija

| 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

Kroz usta

Belgija

| 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

Kroz usta

Belgija

| 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

Kroz usta

Belgija

| 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

Kroz usta

Belgija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Bugarska

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

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 25 mg capsule

25 mg

Kapsula, meka

Kroz usta

Bugarska

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

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 50 mg capsule

50 mg

Kapsula, meka

Kroz usta

Bugarska

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

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg capsule

100 mg

Kapsula, meka

Kroz usta

Bugarska

| 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

Oralna otopina

Kroz usta

100 mg/ml – 50 ml

Cipar

| 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, meka

Kroz usta

Cipar

| 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, meka

Kroz usta

Cipar

| 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, meka

Kroz usta

Cipar

| 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

Oralna otopina

Kroz usta

100 mg/ml

Češka Republika

| 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, meka

Kroz usta

Češka Republika

| 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, meka

Kroz usta

Češka Republika

| 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, meka

Kroz usta

Češka Republika

| 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

Oralna otopina

Kroz usta

100 mg/ml

Danska

| 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, meka

Kroz usta

Danska

| 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, meka

Kroz usta

Danska

| 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, meka

Kroz usta

Danska

| 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, meka

Kroz usta

Danska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, meka

Kroz usta

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsula, meka

Kroz usta

Estonija

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

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, meka

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, meka

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Kapsula, meka

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, meka

Kroz usta

Finska

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

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg/ml

Oralna otopina

Kroz usta

100 mg/ml

Francuska

| 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, meka

Kroz usta

Francuska

| 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, meka

Kroz usta

Francuska

| 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, meka

Kroz usta

Francuska

| 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, meka

Kroz usta

Francuska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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, meka

Kroz usta

Njemačka

| 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

Oralna otopina

Kroz usta

100 mg/ml

Grčka

| 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, meka

Kroz usta

Grčka

| 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, meka

Kroz usta

Grčka

| 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, meka

Kroz usta

Grčka

| 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

Oralna otopina

Kroz usta

100 mg/ml

Mađarska

| 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, meka

Kroz usta

Mađarska

| 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, meka

Kroz usta

Mađarska

| 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, meka

Kroz usta

Mađarska

| 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, meka

Kroz usta

Mađarska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Island

| 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, meka

Kroz usta

Island

| 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, meka

Kroz usta

Island

| 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, meka

Kroz usta

Island

| 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

Oralna otopina

Kroz usta

100 mg/ml

Irska

| 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, meka

Kroz usta

Irska

| 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, meka

Kroz usta

Irska

| 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, meka

Kroz usta

Irska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Italija

| 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, meka

Kroz usta

Italija

| 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, meka

Kroz usta

Italija

| 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, meka

Kroz usta

Italija

| 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, meka

Kroz usta

Italija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Latvija

| 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, meka

Kroz usta

Latvija

| 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, meka

Kroz usta

Latvija

| 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, meka

Kroz usta

Litva

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Kapsula, meka

Kroz usta

Litva

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo, |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo,

Finland

Sandimmun Neoral

50 mg

Kapsula, meka

Kroz usta

Litva

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Kapsula, meka

Kroz usta

Luksemburg

| 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, meka

Kroz usta

Luksemburg

| 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, meka

Kroz usta

Luksemburg

| 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, meka

Kroz usta

Luksemburg

| 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, meka

Kroz usta

Luksemburg

| 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

Oralna otopina

Kroz usta

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, meka

Kroz usta

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, meka

Kroz usta

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

Oralna otopina

Kroz usta

100 mg/ml

Nizozemska

| 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, meka

Kroz usta

Nizozemska

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

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg, capsules

100 mg

Kapsula, meka

Kroz usta

Nizozemska

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

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg/ml, drank

100 mg/ml

Oralna otopina

Kroz usta

100 mg/ml

Norveška

| 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, meka

Kroz usta

Norveška

| 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, meka

Kroz usta

Norveška

| 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, meka

Kroz usta

Norveška

| 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

Oralna otopina

Kroz usta

100 mg/ml

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

10 mg

Kapsula, meka

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

25 mg

Kapsula, meka

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

50 mg

Kapsula, meka

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg

Kapsula, meka

Kroz usta

Poljska

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg/ml

Oralna otopina

Kroz usta

100 mg/ml

Portugal

| 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, meka

Kroz usta

Portugal

| 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, meka

Kroz usta

Portugal

| 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, meka

Kroz usta

Portugal

| 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

Oralna otopina

Kroz usta

100 mg/ml

Rumunjska

| 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, meka

Kroz usta

Rumunjska

| 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, meka

Kroz usta

Rumunjska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Slovačka Republika

| 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, meka

Kroz usta

Slovačka Republika

| 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, meka

Kroz usta

Slovačka Republika

| 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, meka

Kroz usta

Slovačka Republika

| 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

Oralna otopina

Kroz usta

100 mg/ml

Slovenija

| 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, meka

Kroz usta

Slovenija

| 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, meka

Kroz usta

Slovenija

| 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, meka

Kroz usta

Slovenija

| 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

Oralna otopina

Kroz usta

100 mg/ml

Španjolska

| 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, meka

Kroz usta

Španjolska

| 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, meka

Kroz usta

Španjolska

| 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, meka

Kroz usta

Španjolska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Švedska

| 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, meka

Kroz usta

Švedska

| 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, meka

Kroz usta

Švedska

| 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, meka

Kroz usta

Švedska

| 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, meka

Kroz usta

Švedska

| 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

Oralna otopina

Kroz usta

100 mg/ml

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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, meka

Kroz usta

Ujedinjeno Kraljevstvo

| 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

Oralna otopina

Kroz usta

100 mg/ml

---

DODATAK VIII.

POPIS NAZIVA, FARMACEUTSKIH OBLIKA, DOZA LIJEKA, PUTEVA PRIMJENE, NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U ZEMLJAMA ČLANICAMA

| Zemlja članica (u EGP-u) | Nositelj odobrenja za stavljanje lijeka u promet | Zaštićeno ime | Doza | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Belgija | Janssen-Cilag NV |
| Antwerpseweg 15-17 |
| 2340 Beerse |
| Belgium |

Zemlja članica (u EGP-u)

Nositelj odobrenja za stavljanje lijeka u promet

Zaštićeno ime

Doza

Farmaceutski oblik

Put primjene

Belgija

Janssen-Cilag NV

Antwerpseweg 15-17

2340 Beerse

Belgium

Nizoral 200 mg tabletten

200 mg

Tableta

Primjena kroz usta

Bugarska

| 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

Tableta

Primjena kroz usta

Cipar

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

Aegis Ltd

17 Athinon street

2081 Lefkosia

Cyprus

KETOZAL TABLETS 200 mg

200 mg

Tableta

Primjena kroz usta

Cipar

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

Remedica ltd

Aharnon street

3508 Lemesos

Cyprus

KETROZOL TABLETS 200 mg

200 mg

Tableta

Primjena kroz usta

Cipar

| 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

Tableta

Primjena kroz usta

Cipar

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

Medochemie ltd

1-10 Constantinoupoleos street

3505 Lemesos

Cyprus

TINUVIN TABLETS 200 mg

200 mg

Tableta

Primjena kroz usta

Cipar

| 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

Tableta

Primjena kroz usta

Češka Republika

| 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

Tableta

Primjena kroz usta

Estonija

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

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

NIZORAL

200 mg

Tableta

Primjena kroz usta

Finska

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

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

NIZORAL

200 mg

Tableta

Primjena kroz usta

Francuska

| 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

Tableta

Primjena kroz usta

Grčka

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

Coup ABEE

Agias Barbaras 53-55

Dafni 15235

Greece

MYCOFEBRIN

200 mg

Tableta

Primjena kroz usta

Grčka

| 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

Tableta

Primjena kroz usta

Grčka

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

Rafarm AEBE

Korinthou 12

Neo Psychiko 15451

Greece

ILGEM

200 mg

Tableta

Primjena kroz usta

Grčka

| 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

Tableta

Primjena kroz usta

Grčka

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

Bros ltd

Avgis & Galinis 15

Nea Kifissia

Athens

Greece

EBERSEPT

200 mg

Tableta

Primjena kroz usta

Mađarska

| 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

Tableta

Primjena kroz usta

Island

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

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral

200 mg

Tableta

Primjena kroz usta

Latvija

| 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

Tableta

Primjena kroz usta

Litva

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

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral

200 mg

Tableta

Primjena kroz usta

Luksemburg

| 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

Tableta

Primjena kroz usta

Norveška

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

Janssen-Cilag AS

Postboks 144

1325 Lysaker

Norway

Fungoral

200 mg

Tableta

Primjena kroz usta

Poljska

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

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

Ketokonazol

200 mg

Tableta

Primjena kroz usta

Portugal

| 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

Tableta

Primjena kroz usta

Rumunjska

| 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

Tableta

Primjena kroz usta

Rumunjska

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

Terapia SA

Str. Fabricii nr. 124

Cluj-Napoca

Romania

NIZORAL 200 mg

200 mg

Tableta

Primjena kroz usta

Rumunjska

| 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

Tableta

Primjena kroz usta

Rumunjska

| 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

Tableta

Primjena kroz usta

Rumunjska

| 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

Tableta

Primjena kroz usta

Slovačka Republika

| 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

Tableta

Primjena kroz usta

Španjolska

| 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

Tableta

Primjena kroz usta

Španjolska

| 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

Tableta

Primjena kroz usta

Španjolska

| 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

Tableta

Primjena kroz usta

Švedska

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

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral®

200 mg

Tableta

Primjena kroz usta

Nizozemska

| 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

Tableta

Primjena kroz usta

Velika Britanija

| 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

Tableta

Primjena kroz usta

---