| Code | 0860F | ||||||||||
| MA number | EU/1/25/1955/001 | ||||||||||
| Product Form: | sol inf 1x500 ml (fľ.skl.) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Recordati Rare Diseases, France | ||||||||||
| Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | glass bottle | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 28.07.2025 |
| Validity: | 28.07.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 08.01.2026 |
