Code | 9854D | ||||||||||
MA number | 19/0053/22-S | ||||||||||
Product Form: | sol ijf 50x5 ml (amp.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | LEO Pharma A/S , Denmark | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 08.04.2022 |
Validity: | 08.04.2027 |
PIL: |
|
SPC: |
|
Safety feature | Yes |
Data update: | 12.04.2022 |