Gemzar

Medicinal product

(Invented) name

Gemzar

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

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

1997-03-12

Date of renewal

2012-10-30

Documents

1461_1_2 Gemzar milt inf RPP 190328.docx

1461_1_2 Pakuotės lapelis 190328.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0713/002

Marketing authorisation procedure

Savitarpio pripažinimo 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
3376	3036	1003036	flakonas	N1		Receptinis	LT/1/97/1461/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-28	Išregistruotas
2012-10-30	Perregistruotas
1997-03-12	Registruotas