Zejula

Medicinal product

(Invented) name

Zejula

Active substance (s)

Niraparibas

Strength

100 mg

Pharmaceutical form

plėvele dengtos tabletės

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

Film coated tablet	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
108837	94943	1094943	lizdinė plokštelė	N56		Receptinis	EU/1/17/1235/004	Netiekiama	-	-	No	-	-
108838	94944	1094944	lizdinė plokštelė	N84		Receptinis	EU/1/17/1235/005	Netiekiama	-	-	No	-	-
112500	98620	1098620	lizdinė plokštelė	N56 (vaikų sunkiai atidaromos)		Receptinis	EU/1/17/1235/006	Netiekiama	-	-	No	-	-
112501	98621	1098621	lizdinė plokštelė	N84 (vaikų sunkiai atidaromos)		Receptinis	EU/1/17/1235/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-16	Registruotas