Sorafenib Zentiva

Medicinal product

(Invented) name

Sorafenib Zentiva

Active substance (s)

Sorafenibas

Strength

200 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)

L01EX02, sorafenib

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2020-07-30

Date of renewal

2025-03-28

Documents

4602_Sorafenib Zentiva_perr2025-03-28+KR3082.docx

4602_pakuotes lapelis_2025-03-28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4878/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Sorafenibas	200 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
104791	90892	1090892	dalomoji lizdinė plokštelė	N112×1		Receptinis	LT/1/20/4602/001	Tiekiama	-	-	No	-	-
106358	92459	1092459	lizdinė plokštelė	N112		Receptinis	LT/1/20/4602/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-28	Perregistruotas
2020-07-30	Registruotas