Gemcitabine SanoSwiss

Medicinal product

(Invented) name

Gemcitabine SanoSwiss

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

UAB SanoSwiss, Lietuva

Date of authorisation

2013-12-31

Date of renewal

2018-09-28

Documents

Gemcitabine_SanoSwiss_AR.pdf

3475 Gemcitabine SanoSwiss 20233 12 19.docx

3475 Pakuotės lapelis 2023 12 19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Viename 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
56403	70501	1070501	flakonas	N1		Receptinis	LT/1/13/3475/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-09-28	Perregistruotas
2013-12-31	Registruotas