Sunitinib Zentiva

Medicinal product

(Invented) name

Sunitinib Zentiva

Active substance (s)

Sunitinibas

Strength

12,5 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/4973/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Sunitinibas	12,5 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
105549	91649	1091649	lizdinė plokštelė	N28		Receptinis	LT/1/20/4660/001	Netiekiama	2024-09-09	2025-03-31	No	-	-
105550	91650	1091650	dalomoji lizdinė plokštelė	N28×1		Receptinis	LT/1/20/4660/002	Netiekiama	-	-	No	-	-
105551	91651	1091651	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/20/4660/003	Netiekiama	-	-	No	-	-
105552	91652	1091652	buteliukas	N30		Receptinis	LT/1/20/4660/004	Netiekiama	-	-	No	-	-

Stadijos

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