Medicinal product name Fingolimod Zentiva 0.5 mg hard capsules
Pharmaceutical form Capsule, hard
Strength 0.5 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Package leafletPDF 03-08-2023
Summary of product characteristicsMS Word document 14-09-2021
ATC code L04AE01 Immunosuppressants
Information for Marketing authorisation holdersView

Medicinal products (6)

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 N7
(0,5 mg)
PVC/PVDC/Al blister    20-0145-01 Labelling text Labelling text Sep 14, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28
(0,5 mg)
PVC/PVDC/Al blister    20-0145-02 Labelling text Labelling text Sep 14, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30
(0,5 mg)
PVC/PVDC/Al blister    20-0145-03 Labelling text Labelling text Sep 14, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N56
(0,5 mg)
PVC/PVDC/Al blister    20-0145-04 Labelling text Labelling text Sep 14, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N90
(0,5 mg)
PVC/PVDC/Al blister    20-0145-05 Labelling text Labelling text Sep 14, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N98
(0,5 mg)
PVC/PVDC/Al blister    20-0145-06 Labelling text Labelling text Sep 14, 2021

Registration information

Marketing authorisation No. 20-0145
Date of authorisation Dec 4, 2020
Marketing authorisation holder, country Zentiva, k.s., Czech Republic