Sunitinib Zentiva

Medicinal product

(Invented) name

Sunitinib Zentiva

Active substance (s)

Sunitinibas

Strength

50 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)

L01EX01, sunitinib

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2020-12-22

Date of renewal

2025-04-14

Documents

4660_61_pakuotes lapelis_2025-04-14.docx

4660_61_Sunit_Zentiva_perr2025-04-14.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4973/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Sunitinibas	50 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
105553	91653	1091653	lizdinė plokštelė	N28		Receptinis	LT/1/20/4661/001	Tiekiama	-	-	No	-	-
105554	91654	1091654	dalomoji lizdinė plokštelė	N28×1		Receptinis	LT/1/20/4661/002	Netiekiama	-	-	No	-	-
105555	91655	1091655	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/20/4661/003	Netiekiama	-	-	No	-	-
105556	91656	1091656	buteliukas	N30		Receptinis	LT/1/20/4661/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-30	Išregistruotas
2025-04-14	Perregistruotas
2020-12-22	Registruotas