Code | 2618E |
MA number | EU/1/22/1700/001 |
Product Form: | dis inj 1-6x1 ml (liek.inj.COC) |
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances |
Type of procedure: | EU Orphan |
Shelf life: | 48 |
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: | 16.12.2022 |
Validity: | 16.12.2027 |
SmPC + PL: |
|
Safety feature | No |
Data update: | 14.03.2023 |