| Code | 6978E | ||||||||||
| MA number | 87/0189/24-S | ||||||||||
| Product Form: | cps dur 1x60x5 mg (fľ.HDPE) | ||||||||||
| 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 5 mg a 10 mg_07 2024.pdf
|
| PIL: |
PIL_Nitisinone Dipharma 5 mg a 10 mg_07 2024.pdf
|
| Safety feature | Yes |
| Data update: | 03.09.2024 |
