| Code | 0344F | ||||||||||
| MA number | EU/1/25/1930/001 | ||||||||||
| Product Form: | sus por 1x140 ml (fľ.PET jantár.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Italfarmaco S.p.A, Italy | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | bottle polyethylene terephtalate (PET) | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 06.06.2025 |
| Validity: | 06.06.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 24.06.2025 |
