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GILENYA

0.5 Milligram Capsules Hard

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

Main Information

Trade NameGILENYA
Active SubstancesFINGOLIMOD
Strength0.5 Milligram
Dosage FormCapsules Hard
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/11/677/001-004

Group Information

ATC CodeL04AA27 Selective immunosuppressants

Status

Authorised/WithdrawnAuthorised
Licence Issued17/03/2011
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

Documents

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

Educational Materials - HCP

Prescriber Checklist

Educational Materials - Patient

Patient Reminder Card
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