Medicinal product name Fingolimod Norameda 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 20-01-2022
Summary of product characteristicsMS Word document 20-01-2022
Risk minimisation measuresIzglītojošie materiāli ārstam Izglītojošie materiāli ārstam
Izglītojošie materiāli pacientam Izglītojošie materiāli pacientam
ATC code L04AE01 Immunosuppressants

Medicinal products (7)

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    20-0078-01 Labelling text Labelling text Jan 20, 2022
 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    20-0078-02 Labelling text Labelling text Jan 20, 2022
 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    20-0078-03 Labelling text Labelling text Jan 20, 2022
 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/Al unit-dose blister    20-0078-04 Labelling text Labelling text Jan 20, 2022
 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 unit-dose blister    20-0078-05 Labelling text Labelling text Jan 20, 2022
 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 unit-dose blister    20-0078-06 Labelling text Labelling text Jan 20, 2022
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N100: 100 × 1
(0,5 mg)
OPA/Al/PVC/Al unit-dose blister    20-0078-07 Labelling text Labelling text Jan 20, 2022

Registration information

Marketing authorisation No. 20-0078
Date of authorisation Jun 9, 2020
Marketing authorisation holder, country Norameda UAB, Lithuania