Code | 8588D | ||||||||||
MA number | EU/1/21/1570/001 | ||||||||||
Product Form: | plc ifc 1x200 mg (liek.inj.skl.) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Incyte Biosciences Distribution B.V., Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
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: | 26.08.2021 |
Validity: | 01.09.2024 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 27.07.2023 |