Gemcit

Medicinal product

(Invented) name

Gemcit

Active substance (s)

Gemcitabinas

Strength

38 mg/ml

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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2009-05-19

Date of renewal

2017-10-25

Documents

1546 Pakuotės lapelis 2023 12 08.docx

1546 Gemcit 38mg_ml milt inf PCS PL 2023 12 08.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2244/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruošto infuzinio tirpalo yra	1 ml
Gemcitabinas	38 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
30512	5504	1005504	buteliukas	200 mg N1		Receptinis	LT/1/09/1546/001	Netiekiama	-	-	No	-	-	Download
36156	5560	1005560	buteliukas	1000 mg N1		Receptinis	LT/1/09/1546/002	Netiekiama	-	-	No	-	-
36157	38489	1038489	buteliukas	1500 mg N1		Receptinis	LT/1/09/1546/003	Netiekiama	-	-	No	-	-
42228	55993	1055993	buteliukas	2000 mg N1		Receptinis	LT/1/09/1546/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-12	Išregistruotas
2017-10-25	Perregistruotas
2009-05-19	Registruotas