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GILENYA



Novartis Europharm LimitedEU/1/11/677/001-004

Main Information

Trade NameGILENYA
Active SubstancesFingolimod
Dosage FormCapsule, hard
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/11/677/001-004

Group Information

ATC CodeL04AA Selective immunosuppressants
L04AA27 fingolimod

Status

License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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