Vinorelbine Actavis

Medicinal product

(Invented) name

Vinorelbine Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2008-05-12

Date of renewal

Documents

1132_1_4 Vinorelbine Actavis konc II PL 180330.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2801/001/

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato 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
21736	24589	1024589	flakonas	1 ml, N1		Receptinis	LT/1/08/1132/001	Netiekiama	-	-	No	-	-	Download
30065	32533	1032533	flakonas	1 ml, N10		Receptinis	LT/1/08/1132/002	Netiekiama	-	-	No	-	-
30066	32534	1032534	flakonas	5 ml, N1		Receptinis	LT/1/08/1132/003	Netiekiama	-	-	No	-	-
30067	32535	1032535	flakonas	5 ml, N10		Receptinis	LT/1/08/1132/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-28	Išregistruotas
2008-05-12	Registruotas