Gemcitabine Actavis

Medicinal product

(Invented) name

Gemcitabine Actavis

Active substance (s)

Gemcitabinas

Strength

40 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)

L01BC05, Gemcitabine

Marketing authorisation holder

Actavis Group PTC ehf., Islandija

Date of authorisation

2011-11-22

Date of renewal

2016-01-04

Documents

2701_1-3 Gemcitabine_Actavis_perr0104.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/1646/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Gemcitabinas	40 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
32904	35284	1035284	flakonas	5 ml N1		Receptinis	LT/1/11/2701/001	Netiekiama	-	-	No	-	-
32905	35285	1035285	flakonas	25 ml N1		Receptinis	LT/1/11/2701/002	Netiekiama	-	-	No	-	-
32906	35286	1035286	flakonas	50 ml N1		Receptinis	LT/1/11/2701/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-12-07	Išregistruotas
2016-01-04	Perregistruotas
2011-11-22	Registruotas