Medicinal product name GILENYA
Pharmaceutical form Capsule, hard
Strength 0.25 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Summary of product characteristics, package leaflet and labeling text  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code L04AE01 Immunosuppressants

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28
(0,25 mg)
PVC/PVDC/Al blister    EU/1/11/677/008  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/11/677/008
Date of authorisation Apr 28, 2011
Marketing authorisation holder, country Novartis Europharm Limited, Ireland