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PRODUCT DETAIL

MYLOTARG 5 mg prášok na koncentrát na infúzny roztok

Code 7819C
MA number EU/1/18/1277/001
Product Form: plc ifc 1x5 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
L01F MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FX Other monoclonal antibodies and antibody drug conjugates
L01FX02 Gemtuzumab ozogamicin
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: 19.04.2018
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 16.12.2022
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