| Code | 9165D | ||||||||||
| MA number | EU/1/21/1582/002 | ||||||||||
| Product Form: | pl iol 4x110 mg + 4x12 ml solv. (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Amivas Ireland Ltd, Ireland | ||||||||||
| Therapeutic Class: | 25 - ANTIPARASITICA (ANTIPROTOZOICA, ANTIMALARICA) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| 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: | 22.11.2021 |
| Validity: | 22.11.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 03.02.2022 |
