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PRODUCT DETAIL

Odomzo 200 mg tvrdé kapsuly

Code 5907B
MA number EU/1/15/1030/001
Product Form: cps dur 10x1x200 mg (blis.PCTFE/PVC/Al-perf.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XJ Hedgehog pathway inhibitors
L01XJ02 Sonidegib
Shelf life: 60
Container: blister PCTFE/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 14.08.2015
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 29.05.2022
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