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PRODUCT DETAIL

ELAHERE 5 mg/ml koncentrát na infúzny roztok

Code 8425E
MA number EU/1/24/1866/001
Product Form: con inf 1x20 ml/100 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: AbbVie Deutschland GmbH & Co. KG, Germany
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
L01FX26 Mirvetuximab soravtansine
Shelf life: 60
Container: glass vial
Route of admin.: Intravenous use
Legal basis: Article 8(3) application - new active substance
MA issued: 14.11.2024
Validity: 14.11.2029
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 17.12.2024
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