Gemcitabine Actavis

Medicinal product

(Invented) name

Gemcitabine Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2009-02-03

Date of renewal

2013-10-09

Documents

1450_1_3 Gemcitabine Actavis milt RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1237/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruošto infuzinio 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
23583	5155	1005155	flakonas	200 mg N1		Receptinis	LT/1/09/1450/001	Netiekiama	-	-	No	-	-	Download
40786	54523	1054523	flakonas	1 g N1		Receptinis	LT/1/09/1450/002	Netiekiama	-	-	No	-	-
40787	54524	1054524	flakonas	2 g N1		Receptinis	LT/1/09/1450/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-12-07	Išregistruotas
2013-10-09	Perregistruotas
2009-02-03	Registruotas