Gembin

Medicinal product

(Invented) name

Gembin

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2010-11-24

Date of renewal

2016-01-04

Documents

2236_1_3 Pakuotės lapelis 201112.docx

2236_1_3 Gembin 40mg_ml konc inf PCS PL 201112.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/1644/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato 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
32881	35261	1035261	buteliukas	5 ml N1		Receptinis	LT/1/10/2236/001	Netiekiama	-	-	No	-	-	Download
32882	35262	1035262	buteliukas	25 ml N1		Receptinis	LT/1/10/2236/002	Netiekiama	-	-	No	-	-
32883	35263	1035263	buteliukas	50 ml N1		Receptinis	LT/1/10/2236/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-28	Išregistruotas
2016-01-04	Perregistruotas
2010-11-24	Registruotas