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PRODUCT DETAIL

Kadcyla 160 mg prášok na koncentrát na infúzny roztok

Code 7894A
MA number EU/1/13/885/002
Product Form: plc ifc 1x160 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Roche Registration GmbH, Germany
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01F MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FD HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
L01FD03 Trastuzumab emtansine
Shelf life: 48
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: 15.11.2013
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 10.04.2025
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