Gemcitabine Accord

Medicinal product

(Invented) name

Gemcitabine Accord

Active substance (s)

Gemcitabinas

Strength

2000 mg

Pharmaceutical form

milteliai 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

2013-02-28

Date of renewal

2019-12-13

Documents

1940_3 Gemcitabine Accord 2000 milt inf II PL 200403.docx

1940_1_3 Pakuotės lapelis 200403.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

IE/H/0753/003

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Gemcitabinas	2000 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
40506	54243	1054243	flakonas	N1		Receptinis	LT/1/10/1940/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-29	Išregistruotas
2019-12-13	Perregistruotas
2013-02-28	Registruotas