| Code | 4511E | ||||||||||
| MA number | 59/0229/23-S | ||||||||||
| Product Form: | cps end 14x120 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: |
|
||||||||||
| 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_02.2025.pdf
|
| PIL: |
PIL_Dimethyl fumarate Glenmark_120mg_240mg_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 13.11.2023 |
