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PRODUCT DETAIL

Erbitux 5 mg/ml infúzny roztok

Code 46252
MA number EU/1/04/281/005
Product Form: sol inf 1x100 ml/500 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
L01FE EGFR (Epidermal Growth Factor Receptor) inhibitors
L01FE01 Cetuximab
Shelf life: 48
Container: glass container
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: 29.06.2004
SmPC + PL: European Medicines Agency's database
Dokument: DHCP Erbitux 30 12 2013.pdf  
Safety feature Yes
Data update: 19.05.2023
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