| Code | 5648E | ||||||||||
| MA number | EU/1/23/1787/001 | ||||||||||
| Product Form: | dis inf 1-Xx1,5 ml-20 ml (liek.inj.COC) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Vertex Pharmaceuticals (Ireland) Limited, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 09.02.2024 |
| Validity: | 12.02.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | No |
| Data update: | 05.03.2025 |
