Code | 6977E | ||||||||||
MA number | 87/0191/24-S | ||||||||||
Product Form: | cps dur 60x1x20 mg (blis.OPA/Al/PVC-Al - jednotk.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Dipharma Arzneimittel GmbH, Germany | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
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: | 15.08.2024 |
Validity: | 15.08.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
SPC: | SPC_Nitisinone Dipharma 2 mg a 20 mg_07 2024.pdf |
PIL: | PIL_Nitisinone Dipharma 2 mg a 20 mg_07 2024.pdf |
Safety feature | Yes |
Data update: | 03.09.2024 |