Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 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.01003001.xml










29.11.2013   


EN


Official Journal of the European Union


C 350/30





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2013

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

2013/C 350/03
—   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




2.10.2013


Suifertil 4 mg/ml


See Annex I


See Annex I


3.10.2013




9.10.2013


Methylphenidate Hexal


See Annex II


See Annex II


11.10.2013




9.10.2013


Methylphenidate Sandoz


See Annex III


See Annex III


10.10.2013




18.10.2013


Dexadreson 2 mg/ml


See Annex IV


See Annex IV


21.10.2013




18.10.2013


Micotil 300


See Annex V


See Annex V


21.10.2013




31.10.2013


Sandimmun


See Annex VI


See Annex VI


4.11.2013




31.10.2013


Sandimmun Neoral


See Annex VII


See Annex VII


4.11.2013







—   Suspension 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




11.10.2013


Ketoconazole


See Annex VIII


See Annex VIII


14.10.2013






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES













Member State EU/EEA


Applicant


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml Lösung zum Eingeben für Schweine


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




France







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Synchroplan 4 mg/ml solution buvable porcins


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




Germany







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml Oral Solution for Pigs


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




Hungary







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






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


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




The Netherlands







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml orale oplossing voor varkens


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




Poland







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml Oral Solution for Pigs


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




Romania







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml Oral Solution for Pigs


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




Spain







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml solución oral para porcino


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing




United Kingdom







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Suifertil 4 mg/ml Oral Solution for Pigs


Altrenogest


4 mg/ml


Oral solution


Pigs (sexually mature gilts)


For oral use as a top-dressing







ANNEX II

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












Member State EU/EEA


Marketing authorisation holder company name, address


Applicant company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Denmark







Hexal A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate ‘Hexal’


18 mg


Prolonged-release tablet


Oral use




Denmark







Hexal A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate ‘Hexal’


36 mg


Prolonged-release tablet


Oral use




Denmark







Hexal A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate ‘Hexal’


54 mg


Prolonged-release tablet


Oral use




Germany


 







Hexal A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidathydrochlorid HEXAL 18 mg Retardtabletten


18 mg


Prolonged-release tablet


Oral use




Germany


 







Hexal A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidathydrochlorid HEXAL 36 mg Retardtabletten


36 mg


Prolonged-release tablet


Oral use




Germany


 







Hexal A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidathydrochlorid HEXAL 54 mg Retardtabletten


54 mg


Prolonged-release tablet


Oral use




Ireland







Rowex Ltd




Bantry




Co. Cork




Ireland






 


Metidate XL 54 mg Prolonged-Release Tablets


54 mg


Prolonged-release tablet


Oral use




Ireland







Rowex Ltd




Bantry




Co. Cork




Ireland






 


Metidate XL 18 mg Prolonged-Release Tablets


18 mg


Prolonged-release tablet


Oral use




Ireland







Rowex Ltd




Bantry




Co. Cork




Ireland






 


Metidate XL 36 mg Prolonged-Release Tablets


36 mg


Prolonged-release tablet


Oral use







ANNEX III

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












Member State EU/EEA


Marketing authorisation holder company name, address


Applicant company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Belgium


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat Sandoz 18 mg tabletten met verlengde afgifte


18 mg


Prolonged-release tablet


Oral use




Belgium


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat Sandoz 36 mg tabletten met verlengde afgifte


36 mg


Prolonged-release tablet


Oral use




Belgium


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat Sandoz 54 mg tabletten met verlengde afgifte


54 mg


Prolonged-release tablet


Oral use




Cyprus







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




Austria






 


Methylphenidate Sandoz


18 mg


Prolonged-release tablet


Oral use




Cyprus







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




Austria






 


Methylphenidate Sandoz


36 mg


Prolonged-release tablet


Oral use




Cyprus







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




Austria






 


Methylphenidate Sandoz


54 mg


Prolonged-release tablet


Oral use




Denmark







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate ‘Sandoz’


18 mg


Prolonged-release tablet


Oral use




Denmark







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate ‘Sandoz’


36 mg


Prolonged-release tablet


Oral use




Denmark







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate ‘Sandoz’


54 mg


Prolonged-release tablet


Oral use




Finland







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz


18 mg


Prolonged-release tablet


Oral use




Finland







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz


36 mg


Prolonged-release tablet


Oral use




Finland







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz


54 mg


Prolonged-release tablet


Oral use




France


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Méthylphénidate Sandoz LP 18 mg, comprimé à liberation prolongée


18 mg


Prolonged-release tablet


Oral use




France


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Méthylphénidate Sandoz LP 36 mg, comprimé à libération prolongée


36 mg


Prolonged-release tablet


Oral use




France


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Méthylphénidate Sandoz LP 54 mg, comprimé à librétaion prolongée


54 mg


Prolonged-release tablet


Oral use




Germany


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten


18 mg


Prolonged-release tablet


Oral use




Germany


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten


36 mg


Prolonged-release tablet


Oral use




Germany


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten


54 mg


Prolonged-release tablet


Oral use




Iceland







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz, 18 mg, forðatöflur


18 mg


Prolonged-release tablet


Oral use




Iceland







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz, 36 mg, forðatöflur


36 mg


Prolonged-release tablet


Oral use




Iceland







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz, 54 mg, forðatöflur


54 mg


Prolonged-release tablet


Oral use




Luxembourg


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat Sandoz 18 mg comprimé à libération prolongée


18 mg


Prolonged-release tablet


Oral use




Luxembourg


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat Sandoz 36 mg comprimé à libération prolongée


36 mg


Prolonged-release tablet


Oral use




Luxembourg


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat Sandoz 54 mg comprimé à libération prolongée


54 mg


Prolonged-release tablet


Oral use




Malta


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Matoride XL 18 mg Prolonged-release Tablets


18 mg


Prolonged-release tablet


Oral use




Malta


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Matoride XL 36 mg Prolonged-release Tablets


36 mg


Prolonged-release tablet


Oral use




Malta


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Matoride XL 54 mg Prolonged-release Tablets


54 mg


Prolonged-release tablet


Oral use




Norway







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz 18 mg depottabletter


18 mg


Prolonged-release tablet


Oral use




Norway







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz 36 mg depottabletter


36 mg


Prolonged-release tablet


Oral use




Norway







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






 


Methylphenidate Sandoz 54 mg depottabletter


54 mg


Prolonged-release tablet


Oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




Austria






 


Difumenil


18 mg


Prolonged-release tablet


Oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




Austria






 


Difumenil


36 mg


Prolonged-release tablet


Oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




Austria






 


Difumenil


54 mg


Prolonged-release tablet


Oral use




Portugal







Sandoz Farmacêutica Lda.




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




2710-693 Sintra




Portugal






 


Metilfenidato Sandoz


18 mg


Prolonged-release tablet


Oral use




Portugal







Sandoz Farmacêutica Lda.




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




2710-693 Sintra




Portugal






 


Metilfenidato Sandoz


36 mg


Prolonged-release tablet


Oral use




Portugal







Sandoz Farmacêutica Lda.




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




2710-693 Sintra




Portugal






 


Metilfenidato Sandoz


54 mg


Prolonged-release tablet


Oral use




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


Prolonged-release tablet


Oral use




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


Prolonged-release tablet


Oral use




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


Prolonged-release tablet


Oral use




Sweden


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidate Sandoz


18 mg


Prolonged-release tablet


Oral use




Sweden


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidate Sandoz


36 mg


Prolonged-release tablet


Oral use




Sweden


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylphenidate Sandoz


54 mg


Prolonged-release tablet


Oral use




The Netherlands


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte


18 mg


Prolonged-release tablet


Oral use




The Netherlands


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte


36 mg


Prolonged-release tablet


Oral use




The Netherlands


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte


54 mg


Prolonged-release tablet


Oral use




United Kingdom


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Matoride XL 18 mg Prolonged-release Tablets


18 mg


Prolonged-release tablet


Oral use




United Kingdom


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Matoride XL 36 mg Prolonged-release Tablets


36 mg


Prolonged-release tablet


Oral use




United Kingdom


 







Sandoz A/S




Edvard Thomsens Vej 14




DK-2300 København S




Denmark






Matoride XL 54 mg Prolonged-release Tablets


54 mg


Prolonged-release tablet


Oral use







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Applicant/marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species




Austria







Intervet GmbH




Siemensstraße 107




AT-1210 Wien




AUSTRIA






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Austria







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Belgium







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






RAPIDEXON 2 MG/ML SOLUTION INJECTABLE


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Belgium







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Cyprus







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






DEXADRESON INJECTION 2 MG/ML


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Czech republic







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






Dexadreson, 2 mg/ml Injekční roztok


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Czech republic







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






RAPIDEXON 2 mg/ml injekční roztok


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Denmark







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






Dexadreson Vet


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses




Denmark







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






Dexaject


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Denmark







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Finland







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon vet


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




France







Intervet




Rue Olivier De Serres




Angers Technopole




49071 Beaucouze Cedex




FRANCE






Dexadreson


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, goat, pigs, dogs and cats.




France







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml solution injectable


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




France







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, pigs, dogs and cats




France







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Germany







Intervet Deutschland GmbH




Feldstr. 1a




D-85716 Unterschleißheim




GERMANY






Hexadreson


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Germany







Albrecht GmbH




Hauptstr. 6-8




88326 Aulendorf




GERMANY






Rapidexon Albrecht 2 mg/ml


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Germany







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






Dexa-ject 2 mg/ml


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Greece







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






DEXADRESON


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Greece







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






RAPIDEXON


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Hungary







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






Dexadreson injekció A.U.V.


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Hungary







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Hungary







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml injekció A.U.V.


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Iceland







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






Dexaject


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Ireland







Intervet Ireland Ltd.




Magna Drive, Magna Business Park




Citywest Road




Dublin 24




IRELAND






Dexadresson 2 mg/ml solution for injection


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Ireland







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml solution for injection


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Ireland







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Italy







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






Dexadreson


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, goat, pigs, dogs and cats.




Latvia







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






Dexacortin


Dexamethasone


2 mg/ml


Solution for injection


Cattle, pigs, dogs and cats




Lithuania







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, pigs, dogs and cats




Lithuania







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






RAPIDEXON 2 mg/ml, solution for injection


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Lithuania







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




The Netherlands







Intervet Nederland B.V.




p.o. box 50




5830 AB Boxmeer




THE NETHERLANDS






Dexadreson


Dexamethasone


2 mg/ml


Solution for injection


Cattle




The Netherlands







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon


Dexamethasone


2 mg/ml


Solution for injection


Cattle




The Netherlands







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




The Netherlands







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






Dexa-ject


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Norway







Intervet AB




Box 7121




192 07 Sollentuna




SWEDEN






Dexadreson vet.


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Poland







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, pigs, dogs and cats.




Poland







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






RAPIDEXON 2 mg/ml roztwór do wstrzykiwań


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Poland







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Portugal







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml, solução injectável


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




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


Solution for injection


Cattle, pigs, dogs and cats




Romania







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






DEXADRESON


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, goat, pigs, dogs and cats




Slovakia







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






Dexadreson 2 mg/ml injekčný roztok


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Slovakia







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml injekčný roztok


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Slovenia







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






RAPIDEXON 2 mg/ml raztopina za injiciranje


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Slovenia







Intervet International B.V.




Wim de Körverstraat 35




5831, AN Boxmeer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, pigs, dogs and cats




Spain







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml solución inyectable


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Spain







S.P. Veterinaria, S.A.




Ctra. Reus-Vinyols, Km 4,1




43330 Riudoms, Tarragona




SPAIN






Dexavex


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Spain







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






Dexa-ject 2 mg/ml


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




Sweden







Intervet AB




Box 7121




192 07 Sollentuna




SWEDEN






Dexadreson vet.


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




United Kingdom







Intervet UK Ltd




Walton Manor, Walton




Milton Keynes MK7 7AJ




UNITED KINGDOM






Dexadreson 2 mg/ml Solution for Injection


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




United Kingdom







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




THE NETHERLANDS






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


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats




United Kingdom







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




THE NETHERLANDS






Rapidexon 2 mg/ml Solution for Injection


Dexamethasone


2 mg/ml


Solution for injection


Cattle, horses, pigs, dogs and cats







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES













Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Richter Pharma AG




Feldgasse 19




4600 Wels




AUSTRIA






Micotil 300 mg/ml - Injektionslösung für Rinder


Tilmicosin


300 mg/ml


Solution for injection


Cattle


Subcutaneous injection




Belgium







ELI LILLY BENELUX N.V.




Division Elanco Animal Health




Stoofstraat 52




1000 Brussel




BELGIUM






Micotil 300 mg/ml


Tilmicosin


300 mg/ml


Solution for injection


Cattle, sheep


Subcutaneous injection




Czech Republic







EIi Lílly Regional Operations GmbH




Elanco Animal Health




Kölblgasse 8-10




1030 Wien




AUSTRIA






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


Tilmicosin


300 mg/ml


Solution for injection


Cattle


Subcutaneous injection




Germany







Lilly Deutschland GmbH




Teichweg 3




35396 Gießen




GERMANY






Micotil 300


Tilmicosin


300 mg/ml


Solution for injection


Cattle


Subcutaneous injection




France







LILLY FRANCE




13 Rue Pages




92158 Suresnes Cedex




FRANCE






MICOTIL 300


Tilmicosin


300 mg/ml


Solution for injection


Cattle


Subcutaneous injection




Greece







Eli Lilly Regional Operations GesmbH




Elanco Animal Health




Kölblgasse 8-10




1030 Vienna




AUSTRIA






MICOTIL 300


Tilmicosin


300 mg/ml


Solution for injection


Cattle, sheep


Subcutaneous injection




Spain







ELANCO VALQUÍMICA S.A,




Avenida de la Industria 30




28108 Alcobendas




Madrid




SPAIN






Micotil 300


Tilmicosin


300 mg/ml


Solution for injection


Cattle


Subcutaneous injection




Hungary







Eli Lilly Regional Operations GmbH




Elanco Animal Health Kölblgasse 8-10




1030 Vienna




AUSTRIA






Micotil 300 injekció


Tilmicosin


300 mg/ml


Solution for injection


Cattle


Subcutaneous injection




Ireland







Eli Lilly and Company Ltd




Priestley Road




Basingstoke




Hampshire




RG24 9NL




UNITED KINGDOM






Micotil 300 mg/ml Solution for Injection


Tilmicosin


300 mg/ml


Solution for injection


Cattle, sheep


Subcutaneous injection




Italy







ELI LILLY ITALIA S.p.A.




Via A. Gramsci, 731/733 Sesto Fiorentino




ITALY






Micotil 300


Tilmicosin


300 mg/ml


Solution for injection


Cattle, sheep rabbit


Subcutaneous injection




The Netherlands







Eli Lilly Nederland B.V./Elanco AnimalHealth




Grootslag 1-5




3991 RA Houten




THE NETHERLANDS






MICOTIL 300 INJECTIE


Tilmicosin


300 mg/ml


Solution for injection


Cattle, sheep


Subcutaneous injection




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


Solution for injection


Cattle


Subcutaneous injection




United Kingdom







Eli Lilly & Company Ltd




Elanco Animal Health




Lilly House




Priestley Road




Basingstoke




RG24 9NL




UNITED KINGDOM






Micotil 300 mg/ml Solution for Injection


Tilmicosin


300 mg/ml


Solution for injection


Cattle, sheep


Subcutaneous injection







ANNEX VI

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 VII

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







ANNEX VIII

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











Member State (in EEA)


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Belgium







Janssen-Cilag NV




Antwerpseweg 15-17




2340 Beerse




Belgium






Nizoral 200 mg tabletten


200 mg


Tablet


Oral use




Bulgaria







Jonson & Jonson D.O.O.,




Smartinska cesta 53,




1000 Ljubljana,




Slovenia






NIZORAL


200 mg


Tablet


Oral use




Cyprus







Aegis Ltd




17 Athinon street




2081 Lefkosia




Cyprus






KETOZAL TABLETS 200 mg


200 mg


Tablet


Oral use




Cyprus







Remedica ltd




Aharnon street




3508 Lemesos




Cyprus






KETROZOL TABLETS 200 mg


200 mg


Tablet


Oral use




Cyprus







Janssen-Cilag International NV




Turnhoutseweg 30




B-2340 Beers




Belgium






NIZORAL TABLETS 200 mg


200 mg


Tablet


Oral use




Cyprus







Medochemie ltd




1-10 Constantinoupoleos street




3505 Lemesos




Cyprus






TINUVIN TABLETS 200 mg


200 mg


Tablet


Oral use




Cyprus







CDL Pharmaceutical Products ltd




Agiou Spyridonos 12




7102 Larnaca




Cyprus






VAFLUSON TABLETS 200 mg


200 mg


Tablet


Oral use




Czech Republic







Janssen-Cilag s.r.o.




Karla Engliše 3201/6




15000 Praha 5




Czech Republic






NIZORAL


200 mg


Tablet


Oral use




Estonia







UAB Johnson & Johnson




Gelezinio Vilko g. 18A




08104 Vilnius




Lithuania






NIZORAL


200 mg


Tablet


Oral use




Finland







Janssen-Cilag Oy




Vaisalantie 2




02130 Espoo




Finland






NIZORAL


200 mg


Tablet


Oral use




France







Janssen Cilag




1, rue Camille Desmoulins TSA




91003 92787 Issy-les-Moulineaux




Cedex 9




France






NIZORAL 200 mg, comprimé


200 mg


Tablet


Oral use




Greece







Coup ABEE




Agias Barbaras 53-55




Dafni 15235




Greece






MYCOFEBRIN


200 mg


Tablet


Oral use




Greece







Demo ABEE




21ST Km National Highway




Athens - Lamia




Kryoneri 14568




Greece






AQUARIUS


200 mg


Tablet


Oral use




Greece







Rafarm AEBE




Korinthou 12




Neo Psychiko 15451




Greece






ILGEM


200 mg


Tablet


Oral use




Greece







Angelini Pharma Hellas ABEE




Achaias & Trizinias




Nea Kifissia 14564




Athens




Greece






SOSTATIN


200 mg


Tablet


Oral use




Greece







Bros ltd




Avgis & Galinis 15




Nea Kifissia




Athens




Greece






EBERSEPT


200 mg


Tablet


Oral use




Hungary







Janssen-Cilag Kft.




West Gate Business Park




Tó Park




2045, Törökbálint




Hungary






NIZORAL 200 mg tabletta


200 mg


Tablet


Oral use




Iceland







Janssen-Cilag AB




Box 7073




192 07 Sollentuna




Sweden






Fungoral


200 mg


Tablet


Oral use




Latvia







UAB Johnson & Johnson




Gelezinio Vilko g. 18A




08104 Vilnius




Lithuania






Nizoral 200 mg tablets


200 mg


Tablet


Oral use




Lithuania







UAB Johnson & Johnson




Gelezinio Vilko g. 18A




08104 Vilnius




Lithuania






Nizoral


200 mg


Tablet


Oral use




Luxembourg







Janssen Cilag NV




15-17 Antwerpseweg




B-2340 Beerse




Belgium






Nizoral 200 mg comprimés


200 mg


Tablet


Oral use




Norway







Janssen-Cilag AS




Postboks 144




1325 Lysaker




Norway






Fungoral


200 mg


Tablet


Oral use




Poland







Polfarmex S.A.




Józefów 9




99-300 Kutno




Poland






Ketokonazol


200 mg


Tablet


Oral use




Portugal







Janssen Farmacêutica Portugal, Lda.




Estrada Consiglieri Pedroso, 69 A




Queluz de Baixo




2734-503 Barcarena




Portugal






Nizale


200 mg


Tablet


Oral use




Romania







S.C. Arena Group S.A.




Str. Ștefan Mihăileanu nr. 31 Sector 2, București




România






KETOCONAZOL ARENA 200 mg


200 mg


Tablet


Oral use




Romania







Terapia SA




Str. Fabricii nr. 124




Cluj-Napoca




Romania






NIZORAL 200 mg


200 mg


Tablet


Oral use




Romania







S.C. Magistra C&C




Str. Aurel Vlaicu nr. 82A




8700 Constanța




România






KETOCONAZOL 200 mg


200 mg


Tablet


Oral use




Romania







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




Bd.Theodor Pallady nr. 44C




Sector 3




București




România






KETOCONAZOL 200 mg


200 mg


Tablet


Oral use




Romania







A.C. Helcor s.r.l.




Str. Dr. Victor Babeș nr. 50




Baia Mare




România






KETOSTIN 200 mg


200 mg


Tablet


Oral use




Slovak Republic







Johnson & Johnson s.r.o.




Karadžičova 12




821 08 Bratislava




Slovak Republic






NIZORAL


200 mg


Tablet


Oral use




Spain







Zeus, S.L.




Collado mediano, s/n




28230 Las Rozas




Madrid




Spain






FUNGO ZEUS 200 mg comprimidos


200 mg


Tablet


Oral use




Spain







Janssen-Cilag, S.A.




Po de Las Doce Estrellas 5-7




28042 Madrid




Spain






FUNGAREST comprimidos


200 mg


Tablet


Oral use




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


Tablet


Oral use




Sweden







Janssen-Cilag AB




Box 7073




192 07 Sollentuna




Sweden






Fungoral®


200 mg


Tablet


Oral use




The Netherlands







Janssen-Cilag B.V.




Dr. Paul Janssenweg 150




5026 RH TILBURG




The Netherlands






Nizoral tabletten 200 mg


200 mg


Tablet


Oral use




United Kingdom







Janssen-Cilag Limited




50-100 Holmers Farm Way




High Wycombe




Buckinghamshire HP12 4EG




United Kingdom






Nizoral 200 mg tablets


200 mg


Tablet


Oral use