Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2013-11-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013350EN.01000101.xml










29.11.2013   


EN


Official Journal of the European Union


C 350/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2013/C 350/01
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




25.9.2013


Sandimmun


See Annex I


See Annex I


26.9.2013




25.9.2013


Sandimmun Neoral


See Annex II


See Annex II


26.9.2013






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Invented Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




AT-1020 Wien




Austria






Sandimmun
50 mg – Konzentrat zur Infusionsbereitung


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Belgium







N.V. Novartis Pharma S.A.




Medialaan 40, bus 1




B-1800 Vilvoorde




Belgium






SANDIMMUN


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Prague 4 - Nusle




Czech Republic






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 Copenhagen




Denmark






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Finland







Novartis Finland OY




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




France







Novartis Pharma S.A.S.




2-4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






SANDIMMUN


25 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2-4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






SANDIMMUN


50 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2- 4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






SANDIMMUN


100 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2- 4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






SANDIMMUN


100 mg/ml


Oral solution


Oral use


100 mg/ml




France







Novartis Pharma S.A.S.




2- 4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






SANDIMMUN


50 mg/ml


Solution for infusion


Intravenous use


50 mg/ml




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 25 mg Weichkapseln


25 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 100 mg Weichkapseln


100 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 100 mg/ml Lösung zum Einnehmen


100 mg/ml


Oral solution


Oral use


100 mg/ml




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Immunosporin 25 mg Weichkapseln


25 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Immunosporin 50 mg Weichkapseln


50 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Immunosporin 100 mg Weichkapseln


100 mg


Capsule, soft


Oral use


 




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


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Greece







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




National Road No. 1 (12th Km)




Metamorphosis




GR-144 51 Athens




Greece






SANDIMMUN


50 mg/ml amp


Concentrate for solution for infusion


Intravenous use


50 mg/ml




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


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Iceland







Novartis Healthcare A/S




Edward Thomsens Vej 14 2003




Köbenhavn S




Denmark






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun


25 mg


Capsule, soft


Oral use


 




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun


50 mg


Capsule, soft


Oral use


 




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun


100 mg


Capsule, soft


Oral use


 




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun


100 mg/ml


Oral Solution


Oral use


100 mg/ml




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun


50 mg/1 ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






SANDIMMUN


25 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






SANDIMMUN


50 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






SANDIMMUN


100 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






SANDIMMUN


100 mg/ml


Oral solution


Oral use


100 mg/ml




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






SANDIMMUN


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 25 mg Weichkapseln


25 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 100 mg Weichkapseln


100 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 100 mg/ml Lösung zum Einnehmen


100 mg/ml


Oral solution


Oral use


100 mg/ml




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




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


Concentrate for solution for intravenous infusion


Intravenous use


50 mg/ml




Norway







Novartis Norge AS




Nydalen Alle 37A




P.O Box 4284




Nydalen, N-0401 Oslo




Norway






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Poland







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous


50 mg/ml




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


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Slovak Republic







Novartis s.r.o.




Na Pankráci 1724/129




Prague 140 00




Czech Republic






Sandimmun 50 mg/ml


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Slovenia







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




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


Concentrate for solution for infusion


Intravenous use


50 mg/ml




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


Concentrate for solution for infusion


Intravenous use


50 mg/ml




Sweden







Novartis Sverige AB




Kemistvägen 1B / Box 1150




SE-183 11 Täby




Sweden






Sandimmun


50 mg/ml


Concentrate for solution for infusion


Intravenous use


50 mg/ml




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






SANDIMMUN Soft Gelatin Capsules 25 mg


25 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






SANDIMMUN Soft Gelatin Capsules 50 mg


50 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






SANDIMMUN Soft Gelatin Capsules 100 mg


100 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






SANDIMMUN Oral Solution


100 mg/ml


Oral solution


Oral use


100 mg/ml




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


Concentrate for solution for infusion


Intravenous use


50 mg/ml







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Invented Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




AT-1020 Wien




Austria






Sandimmun - Neoral 10 mg Kapseln


10 mg


Capsule, soft


Oral use


 




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




AT-1020 Wien




Austria






Sandimmun - Neoral 25 mg Kapseln


25 mg


Capsule, soft


Oral use


 




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




AT-1020 Wien




Austria






Sandimmun - Neoral 50 mg Kapseln


50 mg


Capsule, soft


Oral use


 




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




AT-1020 Wien




Austria






Sandimmun - Neoral 100 mg Kapseln


100 mg


Capsule, soft


Oral use


 




Austria







Novartis Pharma GmbH




Stella-Klein-Löw-Weg 17




AT-1020 Wien




Austria






Sandimmun - Neoral 100 mg/ml - Trinklösung


100 mg/ml


Oral solution


Oral use


100 mg/ml




Belgium







N.V. Novartis Pharma S.A.




Medialaan 40,




B-1800 Vilvoorde




Belgium






Neoral - Sandimmun 10 mg


10 mg


Capsule


Oral use


 




Belgium







N.V. Novartis Pharma S.A.




Medialaan 40,




B-1800 Vilvoorde




Belgium






Neoral-Sandimmun 100 mg


100 mg


Capsule


Oral use


 




Belgium







N.V. Novartis Pharma S.A.




Medialaan 40,




B-1800 Vilvoorde




Belgium






Neoral - Sandimmun 25 mg


25 mg


Capsule


Oral use


 




Belgium







N.V. Novartis Pharma S.A.




Medialaan 40,




B-1800 Vilvoorde




Belgium






Neoral - Sandimmun 50 mg


50 mg


Capsule


Oral use


 




Belgium







N.V. Novartis Pharma S.A.




Medialaan 40,




B-1800 Vilvoorde




Belgium






Neoral-Sandimmun 100 mg/ml


100 mg/ml


Oral solution


Oral use


100 mg/ml




Bulgaria







Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg




Germany






Sandimmun Neoral 25 mg capsule


25 mg


Capsule, soft


Oral use


 




Bulgaria







Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg




Germany






Sandimmun Neoral 50 mg capsule


50 mg


Capsule, soft


Oral use


 




Bulgaria







Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg




Germany






Sandimmun Neoral 100 mg capsule


100 mg


Capsule, soft


Oral use


 




Bulgaria







Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg




Germany






Sandimmun Neoral 100 mg/ml oral solution


100 mg/ml


Oral solution


Oral use


100 mg/ml – 50 ml




Cyprus







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun Neoral 25 mg


25 mg


Capsule, soft


Oral use


 




Cyprus







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun Neoral 50 mg


50 mg


Capsule, soft


Oral use


 




Cyprus







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun Neoral 100 mg


100 mg


Capsule, soft


Oral use


 




Cyprus







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


Oral Solution


Oral use


100 mg/ml




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Prague 4 - Nusle




Czech Republic






Sandimmun Neoral 25 mg


25 mg


Capsule, soft


Oral use


 




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Prague 4 - Nusle




Czech Republic






Sandimmun Neoral 50 mg


50 mg


Capsule, soft


Oral use


 




Czech Republic







Novartis s.r.o.




Na Pankráci 1724/129




140 00 Prague 4 - Nusle




Czech Republic






Sandimmun Neoral 100 mg


100 mg


Capsule, soft


Oral use


 




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


Oral solution


Oral use


100 mg/ml




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 Copenhagen




Denmark






Sandimmun Neoral


10 mg


Capsule, soft


Oral use


 




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 Copenhagen




Denmark






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 Copenhagen




Denmark






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 Copenhagen




Denmark






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




DK-2100 Copenhagen




Denmark






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Estonia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Finland







Novartis Finland OY




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Finland







Novartis Finland OY




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Finland







Novartis Finland OY




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Finland







Novartis Finland OY




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




France







Novartis Pharma S.A.S.




2-4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






NEORAL


10 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2- 4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






NEORAL


25 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2-4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






NEORAL


50 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2-4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






NEORAL


100 mg


Capsule, soft


Oral use


 




France







Novartis Pharma S.A.S.




2-4, rue Lionel Terray




92500 RUEIL-MALMAISON,




France






NEORAL


100 mg/ml


Oral solution


Oral use


100 mg/ml




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 10 mg Weichkapseln


10 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 25 mg Weichkapseln


25 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 50 mg Weichkapseln


50 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 100 mg Weichkapseln


100 mg


Capsule, soft


Oral use


 




Germany







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen


100 mg/ml


Oral solution


Oral use


100 mg/ml




Greece







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




National Road No. 1 (12th Km)




Metamorphosis




GR-144 51 Athens




Greece






SANDIMMUN NEORAL


25 mg/cap


Capsule, soft


Oral use


 




Greece







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




National Road No. 1 (12th Km)




Metamorphosis




GR-144 51 Athens




Greece






SANDIMMUN NEORAL


50 mg/cap


Capsule, soft


Oral use


 




Greece







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




National Road No. 1 (12th Km)




Metamorphosis




GR-144 51 Athens




Greece






SANDIMMUN NEORAL


100 mg/cap


Capsule, soft


Oral use


 




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


Oral solution


Oral use


100 mg/ml




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47




H-1114 Budapest




Hungary






Sandimmun Neoral 10 mg lágy kapszula


10 mg


Capsule, soft


Oral use


 




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47




H-1114 Budapest




Hungary






Sandimmun Neoral 25 mg lágy kapszula


25 mg


Capsule, soft


Oral use


 




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47




H-1114 Budapest




Hungary






Sandimmun Neoral 50 mg lágy kapszula


50 mg


Capsule, soft


Oral use


 




Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47




H-1114 Budapest




Hungary






Sandimmun Neoral 100 mg lágy kapszula


100 mg


Capsule, soft


Oral use


 




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


Oral solution


Oral use


100 mg/ml




Iceland







Novartis Healthcare A/S




Edward Thomsens Vej 14 2003 Köbenhavn S




Denmark






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Iceland







Novartis Healthcare A/S




Edward Thomsens Vej 14 2003 Köbenhavn S




Denmark






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Iceland







Novartis Healthcare A/S




Edward Thomsens Vej 14 2003 Köbenhavn S




Denmark






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Iceland







Novartis Healthcare A/S




Edward Thomsens Vej 14 2003 Köbenhavn S




Denmark






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral


25 mg


Capsule, soft


Oral use


 




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral


50 mg


Capsule, soft


Oral use


 




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral


100 mg


Capsule, soft


Oral use


 




Ireland







Novartis Pharmaceuticals UNITED KINGDOM Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






Sandimmun Neoral


10 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Italy







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex, RH12 5AB




United Kingdom






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral 25 mg mīkstās kapsulas


25 mg


Capsule, soft


Oral use


 




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral 50 mg mīkstās kapsulas


50 mg


Capsule, soft


Oral use


 




Latvia







Novartis Finland OY




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral 100 mg mīkstās kapsulas


100 mg


Capsule, soft


Oral use


 




Lithuania







Novartis Finland Oy




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Lithuania







Novartis Finland Oy




Metsänneidonkuja 10




FIN-02130 Espoo,




Finland






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Lithuania







Novartis Finland Oy




Metsänneidonkuja 10




FIN-02130 Espoo




Finland






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 10 mg Weichkapseln


10 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 25 mg Weichkapseln


25 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 50 mg Weichkapseln


50 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 100 mg Weichkapseln


100 mg


Capsule, soft


Oral use


 




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen


100 mg/ml


Oral solution


Oral use


100 mg/ml




Malta







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Malta







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Malta







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Sandimmun Neoral


100 mg/ml


Oral Solution


Oral use


100 mg/ml




Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Neoral 25 mg, capsules


25 mg


Capsule, soft


Oral use


 




Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Neoral 100 mg, capsules


100 mg


Capsule, soft


Oral use


 




Netherlands







Novartis Pharma B.V.




Raapopseweg 1




6824 DP Arnhem




The Netherlands






Neoral 100 mg/ml, drank


100 mg/ml


Oral Solution


Oral use


100 mg/ml




Norway







Novartis Norge AS




Nydalen Alle 37A




P.O Box 4284




Nydalen, N-0401 Oslo




Norway






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Norway







Novartis Norge AS




Nydalen Alle 37A




P.O Box 4284




Nydalen, N-0401 Oslo




Norway






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Norway







Novartis Norge AS




Nydalen Alle 37A




P.O Box 4284




Nydalen, N-0401 Oslo




Norway






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Norway







Novartis Norge AS




Nydalen Alle 37A




P.O Box 4284




Nydalen, N-0401 Oslo




Norway






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




Poland







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral


10 mg


Capsule, soft


Oral use


 




Poland







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Poland







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Poland







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Poland







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




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


Capsule, soft


Oral use


 




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


Capsule, soft


Oral use


 




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


Capsule, soft


Oral use


 




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


Oral solution


Oral use


100 mg/ml




Romania







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






SANDIMMUN NEORAL capsule moi, 25 mg


25 mg


Capsule, soft


Oral use


 




Romania







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






SANDIMMUN NEORAL, capsule moi, 50 mg


50 mg


Capsule, soft


Oral use


 




Romania







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






SANDIMMUN NEORAL, solutie orala, 100 mg/ml


100 mg/ml


Oral solution


Oral use


100 mg/ml




Slovak Republic







Novartis s.r.o.




Na Pankráci 1724/129




Prague 140 00




Czech Republic






Sandimmun Neoral 25 mg


25 mg


Capsule, soft


Oral use


 




Slovak Republic







Novartis s.r.o.




Na Pankráci 1724/129




Prague 140 00




Czech Republic






Sandimmun Neoral 50 mg


50 mg


Capsule, soft


Oral use


 




Slovak Republic







Novartis s.r.o.




Na Pankráci 1724/129




Prague 140 00




Czech Republic






Sandimmun Neoral 100 mg


100 mg


Capsule, soft


Oral use


 




Slovak Republic







Novartis s.r.o.




Na Pankráci 1724/129




Prague 140 00




Czech Republic






Sandimmun Neoral 100 mg/ml


100 mg/ml


Oral solution


Oral use


100 mg/ml




Slovenia







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral 25 mg mehke kapsule


25 mg


Capsule, soft


Oral use


 




Slovenia







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral 50 mg mehke kapsule


50 mg


Capsule, soft


Oral use


 




Slovenia







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral 100 mg mehke kapsule


100 mg


Capsule, soft


Oral use


 




Slovenia







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Sandimmun Neoral 100 mg/ml peroralna raztopina


100 mg/ml


Oral solution


Oral use


100 mg/ml




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes, 764




E-08013 Barcelona




Spain






Sandimmun Neoral 25 mg cápsulas blandas


25 mg


Capsule, soft


Oral use


 




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes, 764




E-08013 Barcelona




Spain






Sandimmun Neoral 50 mg cápsulas blandas


50 mg


Capsule, soft


Oral use


 




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes, 764




E-08013 Barcelona




Spain






Sandimmun Neoral 100 mg cápsulas blandas


100 mg


Capsule, soft


Oral use


 




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


Oral solution


Oral use


100 mg/ml




Sweden







Novartis Sverige AB




Kemistvägen 1B / Box 1150




SE-183 11 Täby




Sweden






Sandimmun Neoral


10 mg


Capsule, soft


Oral use


 




Sweden







Novartis Sverige AB




Kemistvägen 1B / Box 1150




SE-183 11 Täby




Sweden






Sandimmun Neoral


25 mg


Capsule, soft


Oral use


 




Sweden







Novartis Sverige AB




Kemistvägen 1B / Box 1150




SE-183 11 Täby




Sweden






Sandimmun Neoral


50 mg


Capsule, soft


Oral use


 




Sweden







Novartis Sverige AB




Kemistvägen 1B / Box 1150




SE-183 11 Täby




Sweden






Sandimmun Neoral


100 mg


Capsule, soft


Oral use


 




Sweden







Novartis Sverige AB




Kemistvägen 1B / Box 1150




SE-183 11 Täby




Sweden






Sandimmun Neoral


100 mg/ml


Oral solution


Oral use


100 mg/ml




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral Soft Gelatin Capsules 10 mg


10 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral Soft Gelatin Capsules 25 mg


25 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral Soft Gelatin Capsules 50 mg


50 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral Soft Gelatin Capsules 100 mg


100 mg


Capsule, soft


Oral use


 




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Neoral Oral solution


100 mg/ml


Oral Solution


Oral use


100 mg/ml