Code | 9163D | ||||||||||
MA number | EU/1/21/1583/004 | ||||||||||
Product Form: | sol inj 10x5 ml/500 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Mylan Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 24 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 15.11.2021 |
Validity: | 15.11.2026 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 10.10.2023 |