| Code | 5931E | ||||||||||
| MA number | 59/0075/24-S | ||||||||||
| Product Form: | cps end 56x240 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PE/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: | 01.05.2024 |
| Validity: | 01.05.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Dimethyl Fumarate Gedeon Richter tvrdé gastrorezistentné kapsuly_04_2024.pdf
|
| PIL: |
PIL_Dimethyl Fumarate Gedeon Richter tvrdé gastrorezistentné kapsuly_04_2024.pdf
|
| Safety feature | Yes |
| Data update: | 09.05.2024 |
