Gemcitabine Kabi

Medicinal product

(Invented) name

Gemcitabine Kabi

Active substance (s)

Gemcitabinas

Strength

38 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 Polska Sp.z.o.o., Lenkija

Date of authorisation

2014-12-11

Date of renewal

2019-10-01

Documents

3233 Gemcitabine Kabi PCS PL 2024 05 22.docx

3233 Pakuotės lapelis 2024 05 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/2447/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename koncentrato ml 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
56689	70792	1070792	flakonas	5,26 ml N1		Receptinis	LT/1/13/3233/004	Netiekiama	-	-	No	-	-	Download
60846	75136	1075136	flakonas	26,3 ml N1		Receptinis	LT/1/13/3233/005	Netiekiama	-	-	No	-	-
60847	75137	1075137	flakonas	52,6 ml N1		Receptinis	LT/1/13/3233/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-01	Perregistruotas
2014-12-11	Registruotas