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PRODUCT DETAIL

Zejula 100 mg tvrdé kapsuly

Code 6171C
MA number EU/1/17/1235/001
Product Form: cps dur 84x1x100 mg (blis.PCTFE/PVC/Al-jednotk.bal.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XK Poly (ADP-ribose) polymerase (PARP) inhibitors
L01XK02 Niraparib
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: 16.11.2017
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 04.08.2022
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