Gemcitabine Ebewe

Medicinal product

(Invented) name

Gemcitabine Ebewe

Active substance (s)

Gemcitabinas

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)

L01BC05, Gemcitabine

Marketing authorisation holder

Ebewe Pharma Ges.m.b.H. Nfg. KG, Austrija

Date of authorisation

2010-03-05

Date of renewal

Documents

1893_1_9 Gemcitabine Ebewe RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Gemcitabinas	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
34856	5541	1005541	buteliukas	20 ml N1		Receptinis	LT/1/10/1893/001	Netiekiama	-	-	No	-	-
34857	37197	1037197	buteliukas	20 ml N5		Receptinis	LT/1/10/1893/002	Netiekiama	-	-	No	-	-
34858	37198	1037198	buteliukas	20 ml N10		Receptinis	LT/1/10/1893/003	Netiekiama	-	-	No	-	-
39852	5591	1005591	buteliukas	50 ml N1		Receptinis	LT/1/10/1893/004	Netiekiama	-	-	No	-	-
39853	53552	1053552	buteliukas	50 ml N5		Receptinis	LT/1/10/1893/005	Netiekiama	-	-	No	-	-
39854	53553	1053553	buteliukas	50 ml N10		Receptinis	LT/1/10/1893/006	Netiekiama	-	-	No	-	-
39855	5592	1005592	buteliukas	100 ml N1		Receptinis	LT/1/10/1893/007	Netiekiama	-	-	No	-	-
39856	53555	1053555	buteliukas	100 ml N5		Receptinis	LT/1/10/1893/008	Netiekiama	-	-	No	-	-
39857	53556	1053556	buteliukas	100 ml N10		Receptinis	LT/1/10/1893/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2010-03-05	Registruotas