Gemcitabine Mylan [Gemcitabine Strides]

Medicinal product

(Invented) name

Gemcitabine Mylan [Gemcitabine Strides]

Active substance (s)

Gemcitabinas

Strength

38 mg/ml

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC05, Gemcitabine

Marketing authorisation holder

Mylan S.A.S., Prancūzija

Date of authorisation

2012-07-19

Date of renewal

Documents

3018_1_2 Gemcitabine Mylan RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Gemcitabinas	38 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
41523	55282	1055282	buteliukas	200 mg N1		Receptinis	LT/1/12/3018/001	Netiekiama	-	-	No	-	-
41524	55283	1055283	buteliukas	1000 mg N1		Receptinis	LT/1/12/3018/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-05	Išregistruotas
2012-07-19	Registruotas