Gemsol

Medicinal product

(Invented) name

Gemsol

Active substance (s)

Gemcitabinas

Strength

40 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

Sandoz d.d., Slovėnija

Date of authorisation

2010-12-15

Date of renewal

2017-06-13

Documents

2265 Gemsol konc inf PCS PL 2024 07 30.docx

2265 Pakuotės lapelis 2024 07 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/0359/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Gemcitabinas	40 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
38347	52003	1052003	flakonas	5 ml N1		Receptinis	LT/1/10/2265/001	Tiekiama	2025-07-07	-	No	-	-	Download
38348	52004	1052004	flakonas	5 ml N5		Receptinis	LT/1/10/2265/002	Netiekiama	-	-	No	-	-
38349	52005	1052005	flakonas	5 ml N10		Receptinis	LT/1/10/2265/003	Netiekiama	-	-	No	-	-
44144	57935	1057935	flakonas	25 ml N1		Receptinis	LT/1/10/2265/004	Netiekiama	2025-01-22	2025-09-30	Yes	2025-04-22	2025-09-30
44145	57936	1057936	flakonas	50 ml N1		Receptinis	LT/1/10/2265/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-13	Perregistruotas
2010-12-15	Registruotas