Medicinal product name Jyseleca
Pharmaceutical form Film-coated tablet
Strength 200 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
Risk minimisation measuresIzglītojošie materiāli ārstam Izglītojošie materiāli ārstam
Izglītojošie materiāli pacientam Izglītojošie materiāli pacientam
Vēstule veselības aprūpes speciālistam Vēstule veselības aprūpes speciālistam
ATC code L04AF04 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 N90: 3 × 30
(200 mg)
HDPE bottle    EU/1/20/1480/004  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/1/20/1480/004
Date of authorisation Sep 24, 2020
Marketing authorisation holder, country Galapagos N.V., Belgium