Medicinal product name Fingolimod Medochemie 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 leafletMS Word document 25-01-2022
Summary of product characteristicsMS Word document 25-01-2022
Risk minimisation measuresIzglītojošie materiāli ārstam Izglītojošie materiāli ārstam
Izglītojošie materiāli pacientam Izglītojošie materiāli pacientam
ATC code L04AE01 Immunosuppressants

Medicinal products (19)

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)
OPA/Al/PVC/Al blister    20-0112-01 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(0,5 mg)
OPA/Al/PVC/Al blister    20-0112-02 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10: 10 × 1
(0,5 mg)
OPA/Al/PVC/Al perforated unit dose blister    20-0112-03 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28
(0,5 mg)
OPA/Al/PVC/Al blister    20-0112-04 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28: 28 × 1
(0,5 mg)
OPA/Al/PVC/Al perforated unit dose blister    20-0112-05 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30
(0,5 mg)
OPA/Al/PVC/Al blister    20-0112-06 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30: 30 × 1
(0,5 mg)
OPA/Al/PVC/Al perforated unit dose blister    20-0112-07 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N98
(0,5 mg)
OPA/Al/PVC/Al blister    20-0112-08 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N98: 98 × 1
(0,5 mg)
OPA/Al/PVC/Al perforated unit dose blister    20-0112-09 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N7
(0,5 mg)
OPA/Al/PVC//paper/PET/Al blister    20-0112-10 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(0,5 mg)
OPA/Al/PVC//paper/PET/Al blister    20-0112-11 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10: 10 × 1
(0,5 mg)
OPA/Al/PVC//paper/PET/Al unit-dose blister    20-0112-12 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28
(0,5 mg)
OPA/Al/PVC//paper/PET/Al blister    20-0112-13 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28: 28 × 1
(0,5 mg)
OPA/Al/PVC//paper/PET/Al unit-dose blister    20-0112-14 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30
(0,5 mg)
OPA/Al/PVC//paper/PET/Al blister    20-0112-15 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30: 30 × 1
(0,5 mg)
OPA/Al/PVC//paper/PET/Al unit-dose blister    20-0112-16 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N98
(0,5 mg)
OPA/Al/PVC//paper/PET/Al blister    20-0112-17 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N98: 98 × 1
(0,5 mg)
OPA/Al/PVC//paper/PET/Al unit-dose blister    20-0112-18 Labelling text Labelling text Sep 7, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N7: 7 × 1
(0,5 mg)
OPA/Al/PVC//paper/PET/Al perforated unit dose blister    20-0112-19 Labelling text Labelling text Sep 7, 2021

Registration information

Marketing authorisation No. 20-0112
Date of authorisation Sep 18, 2020
Marketing authorisation holder, country Medochemie Ltd., Cyprus