Gemcitabine Kabi

Medicinal product

(Invented) name

Gemcitabine Kabi

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

Fresenius Kabi Oncology Plc, Jungtinė Karalystė

Date of authorisation

2013-02-28

Date of renewal

Documents

3233_1_3 Gemcitabine Kabi 40 RPP 151202.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

NL/H/2447/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml 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
48562	62391	1062391	flakonas	5 ml N1 (200 mg/5 ml)		Receptinis	LT/1/13/3233/001	Netiekiama	-	-	No	-	-
48563	62392	1062392	flakonas	25 ml N1 (1000 mg/25 ml)		Receptinis	LT/1/13/3233/002	Netiekiama	-	-	No	-	-
48564	62393	1062393	flakonas	50 ml N1 (2000 mg/50 ml)		Receptinis	LT/1/13/3233/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-10-05	Išregistruotas
2013-02-28	Registruotas