Xorafia

Medicinal product

(Invented) name

Xorafia

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

LV System Service SIA, Latvija

Date of authorisation

2022-02-10

Date of renewal

Documents

LT_H_158_1_DC_Xorafia_PAR_SD+Summ+LT apzvalga.pdf

4902 Pakuotės lapelis 2022 06 09.docx

4902 Xorafia PCS PL 2022 06 09.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0158/001/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
108070	94174	1094174	lizdinė plokštelė	N112		Receptinis	LT/1/22/4902/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-10	Registruotas