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PRODUCT DETAIL

ONIVYDE pegylated liposomal 4,3 mg/ml koncentrát na infúznú disperziu

Code 1535C
MA number EU/1/16/1130/001
Product Form: con dsf 1x10 ml/43 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01C PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01CE Topoisomerase 1 inhibitors
L01CE02 Irinotecan
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 - known active substance
MA issued: 14.10.2016
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 12.10.2022
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