| Code | 9523E | ||||||||||
| MA number | 59/0119/25-S | ||||||||||
| Product Form: | cps end 168x240 mg (blis. OPA/Al/PVC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| 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: | 11.04.2025 |
| Validity: | 11.04.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Dimetyl-fumarát G.L. Pharma 120 mg, 240 mg tvrdé gastrorezistentné kapsuly_ cps end_04/2025_REG.pdf
|
| PIL: |
PIL_Dimetyl-fumarát G.L. Pharma 120 mg, 240 mg tvrdé gastrorezistentné kapsuly_ cps end_04/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 15.04.2025 |
