Code | 4634C | ||||||||||
MA number | EU/1/17/1200/001 | ||||||||||
Product Form: | plc ifc 1x1 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 60 | ||||||||||
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: | 29.06.2017 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 22.05.2023 |