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PRODUCT DETAIL

TEPMETKO 225 mg filmom obalené tablety

Code 9782D
MA number EU/1/21/1596/001
Product Form: tbl flm 60x225 mg (blis.Al/PVC-PE-PVDC-PE-PVC)
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
L01EX21 Tepotinib
Shelf life: 36
Container: blister PVC/PE/PVDC/PE/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: 16.02.2022
Validity: 16.02.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 04.03.2022
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