| Code | 3903B | ||||||||||
| MA number | 21/0140/15-S | ||||||||||
| Product Form: | cps dur 90x300 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 21.04.2015 |
| PIL: |
PIL_Pragiola_04.2024.pdf
|
| SPC: |
SPC_Pragiola_04.2024.pdf
|
| Safety feature | Yes |
| Data update: | 11.04.2024 |
