Gemcitabine Accord

Medicinal product

(Invented) name

Gemcitabine Accord

Active substance (s)

Gemcitabinas

Strength

100 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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2012-04-06

Date of renewal

2017-07-10

Documents

2889 Pakuotės lapelis 2024 12 05.docx

2889 Gemcitabine Accord konc PCS 2024 11 25, PL 2024 12 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2136/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml yra	1 ml
Gemcitabinas	100 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
44191	57982	1057982	flakonas	2 ml N1		Receptinis	LT/1/12/2889/001	Netiekiama	-	-	No	-	-
44192	57983	1057983	flakonas	10 ml N1		Receptinis	LT/1/12/2889/002	Netiekiama	-	-	No	-	-
44193	57984	1057984	flakonas	15 ml N1		Receptinis	LT/1/12/2889/003	Netiekiama	-	-	No	-	-
44194	57985	1057985	flakonas	20 ml N1		Receptinis	LT/1/12/2889/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-10	Perregistruotas
2012-04-06	Registruotas