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PRODUCT DETAIL

Tivdak 40 mg prášok na koncentrát na infúzny roztok

Code 9557E
MA number EU/1/25/1911/001
Product Form: plc ifc 1x40 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Pfizer Europe MA EEIG, Belgium
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
L01FX23 Tisotumab vedotin
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: 28.03.2025
Validity: 28.03.2030
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.04.2025
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