Gemcitabine medac

Medicinal product

(Invented) name

Gemcitabine medac

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)

ATC code (s)

L01BC05, Gemcitabine

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2009-05-19

Date of renewal

2017-12-27

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5507/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 paruošto tirpalo mililitre yra	1 ml
Gemcitabinas	38 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
26454	5196	1005196	buteliukas	200 mg N1	Receptinis	LT/1/09/1580/001	Netiekiama	-	-	No	-	-	Download
28874	5195	1005195	buteliukas	1000 mg N1	Receptinis	LT/1/09/1580/002	Netiekiama	-	-	No	-	-
28875	5194	1005194	buteliukas	1500 mg N1	Receptinis	LT/1/09/1580/003	Netiekiama	-	-	No	-	-

Stadijos