| Code | 0668F | ||||||||||
| MA number | 59/0240/25-S | ||||||||||
| Product Form: | cps end 180x240 mg (blis. OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| 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: | 13.08.2025 |
| Validity: | 13.08.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Dimethyl fumarate STADA Arzneimittel tvrdé gastrorezistentné kapsuly_07_2025.pdf
|
| PIL: |
PIL_Dimethyl fumarate STADA Arzneimittel tvrdé gastrorezistentné kapsuly_07_2025.pdf
|
| Safety feature | Yes |
| Data update: | 14.08.2025 |
