| Code | 6975E | ||||||||||
| MA number | 87/0188/24-S | ||||||||||
| Product Form: | cps dur 60x1x2 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: |
|
||||||||||
| 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 |
