Weldinin

Medicinal product

(Invented) name

Weldinin

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2021-10-22

Date of renewal

Documents

4839 Pakuotės lapelis 2022 06 13.docx

4839 Weldinin PCS 2023 04 25.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5195/001/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
107459	93564	1093564	lizdinė plokštelė	N112 (kalendorinė)		Receptinis	LT/1/21/4839/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-30	Išregistruotas
2021-10-22	Registruotas