| Code | 6128E | ||||||||||
| MA number | 21/0104/24-S | ||||||||||
| Product Form: | tbl flm 28x4 mg (blis.PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 10.05.2024 |
| Validity: | 10.05.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Fypalan_05.2024.pdf
|
| SPC: |
SPC_Fypalan_05.2024.pdf
|
| Safety feature | Yes |
| Data update: | 13.05.2024 |
