en

PRODUCT DETAIL

Datroway 100 mg prášok na koncentrát na infúzny roztok

Code 9556E
MA number EU/1/25/1915/001
Product Form: plc ifc 1x100 mg (liek.inj.skl.jantár.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Daiichi Sankyo Europe GmbH, Germany
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01F MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FX Other monoclonal antibodies and antibody drug conjugates
L01FX35 Datopotamab deruxtecan
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: 04.04.2025
Validity: 04.04.2030
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.04.2025
eu-flag.png sk-flag.png