Code | 4001E | ||||||||||
MA number | EU/1/23/1739/002 | ||||||||||
Product Form: | sol inj 10x5 ml/500 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Piramal Critical Care B.V, Netherland | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
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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: | 23.06.2023 |
Validity: | 23.06.2028 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 07.07.2023 |