Zejula

Medicinal product

(Invented) name

Zejula

Active substance (s)

Niraparibas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XK02, niraparib

Marketing authorisation holder

GlaxoSmithKline (Ireland) Limited , Airija

Date of authorisation

2017-11-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Niraparibas	100 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
98390	84492	1084492	dalomoji lizdinė plokštelė	N84x1		Receptinis	EU/1/17/1235/001	Netiekiama	-	-	No	-	-
98835	84939	1084939	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/17/1235/002	Netiekiama	-	-	No	-	-
98836	84940	1084940	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/17/1235/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-16	Registruotas