Code | 4387E | ||||||||||
MA number | EU/1/23/1758/002 | ||||||||||
Product Form: | con inf 2(2x1)x10 ml/100 mg (liek.inj.skl. - viacnás.bal.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | BeiGene Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
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: | 15.09.2023 |
Validity: | 15.09.2028 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 21.09.2023 |