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PRODUCT DETAIL

Braftovi 75 mg tvrdé kapsuly

Code 9991C
MA number EU/1/18/1314/004
Product Form: cps dur 168x75 mg (blis.PA/Al/PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EC B-Raf serine-threonine kinase (BRAF) inhibitors
L01EC03 Encorafenib
Shelf life: 36
Container: blister PA/Al/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: 07.11.2018
Validity: 20.09.2023
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 10.02.2022
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