Vinorelbine Mylan [Vinorelbine Strides]

Medicinal product

(Invented) name

Vinorelbine Mylan [Vinorelbine Strides]

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

Mylan S.A.S., Prancūzija

Date of authorisation

2012-07-19

Date of renewal

Documents

3022_1_2 Vinorelbine Mylan RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2111/001/DC

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
42583	56350	1056350	buteliukas	1 ml N1		Receptinis	LT/1/12/3022/001	Netiekiama	-	-	No	-	-
42584	56351	1056351	buteliukas	5 ml N1		Receptinis	LT/1/12/3022/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-04-06	Išregistruotas
2012-07-19	Registruotas