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PRODUCT DETAIL

Pepaxti 20 mg prášok na koncentrát na infúzny roztok

Code 1926E
MA number EU/1/22/1669/001
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
L01A ALKYLATING AGENTS
L01AA Nitrogen mustard analogues
L01AA10 Melphalan flufenamide
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: 17.08.2022
Validity: 17.08.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 05.01.2024
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