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PRODUCT DETAIL

Dimtelzo 120 mg

Code 4708E
MA number 59/0244/23-S
Product Form: cps end 14x120 mg (blis.OPA/Al//PVC//Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AX Other immunosuppressants
L04AX07 Dimethyl fumarate
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 21.11.2023
Validity: 21.11.2028
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Dimtelzo_120mg_240mg_10 2023.pdf  
PIL: PIL_Dimtelzo_120mg_240mg_10 2023.pdf  
Safety feature Yes
Data update: 05.12.2023
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