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PRODUCT DETAIL

Tabrecta 200 mg filmom obalené tablety

Code 1529E
MA number EU/1/22/1650/003
Product Form: tbl flm 60x200 mg (blis.PCTFE/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
L01EX Other protein kinase inhibitors
L01EX17 Capmatinib
Shelf life: 36
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: 20.06.2022
Validity: 20.06.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 14.07.2022
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