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PRODUCT DETAIL

Padcev 20 mg prášok na koncentrát na infúzny roztok

Code 0517E
MA number EU/1/21/1615/001
Product Form: plc ifc 1x20 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
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
L01FX13 Enfortumab vedotin
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: 13.04.2022
Validity: 13.04.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 22.04.2022
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