Gemcitabine Accord

Medicinal product

(Invented) name

Gemcitabine Accord

Active substance (s)

Gemcitabinas

Strength

1000 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

2010-03-31

Date of renewal

2019-12-13

Documents

1940_1_2 Gemcitabine Accord 200;1000 milt inf II PL 200403.docx

1940_1_3 Pakuotės lapelis 200403.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0753/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Gemcitabinas	1000 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
22412	25188	1025188	flakonas	N1		Receptinis	LT/1/10/1940/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-29	Išregistruotas
2019-12-13	Perregistruotas
2010-03-31	Registruotas