Code | 7558E | ||||||||||
MA number | 59/0243/24-S | ||||||||||
Product Form: | cps end 28x1x120 mg (blis.OPA/Al/PVC/Al - jednotk.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
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: | 16.10.2024 |
Validity: | 16.10.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Dimetyl-fumarát STADA tvrdé gastrorezistentné kapsuly _09_2024.pdf |
SPC: | SPC_Dimetyl-fumarát STADA tvrdé gastrorezistentné kapsuly _09_2024.pdf |
Safety feature | Yes |
Data update: | 25.10.2024 |