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PRODUCT DETAIL

Dimethyl fumarate Glenmark 120 mg

Code 6747E
MA number 59/0229/23-S
Product Form: cps end 56x120 mg (blis.PVC/PVDC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Glenmark Pharmaceuticals s.r.o., Czechia
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AX Other immunosuppressants
L04AX07 Dimethyl fumarate
Shelf life: 24
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 13.10.2023
Validity: 13.10.2028
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Dimethyl fumarate Glenmark_120mg_240mg_07.2024.pdf  
PIL: PIL_Dimethyl fumarate Glenmark_120mg_240mg_07.2024.pdf  
Safety feature Yes
Data update: 28.06.2024
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