Code | 7157E | ||||||||||
MA number | EU/1/24/1834/002 | ||||||||||
Product Form: | con inf 1x16 ml/400 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | FGK Representative Service GmbH, Germany | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 12 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 26.07.2024 |
Validity: | 26.07.2029 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 15.08.2024 |