Vinorelbine Accord

Medicinal product

(Invented) name

Vinorelbine Accord

Active substance (s)

Vinorelbinas

Strength

10 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01CA04, Vinorelbine

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2016-11-22

Date of renewal

2020-10-23

Documents

4008 Pakuotės lapelis 2025 03 28.docx

4008 Vinorelbine Accord PCS PL 2025 03 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/1300/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Vinorelbinas	10 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
67174	81718	1081718	flakonas	1 ml N1		Receptinis	LT/1/16/4008/001	Netiekiama	-	-	No	-	-
67175	81719	1081719	flakonas	5 ml N1		Receptinis	LT/1/16/4008/002	Netiekiama	2025-03-07	2025-04-30	No	-	-

Stadijos

Data	Stadija
2020-10-23	Perregistruotas
2016-11-22	Registruotas