Gemcitabine medac

Medicinal product

(Invented) name

Gemcitabine medac

Active substance (s)

Gemcitabinas

Strength

38 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01BC05, Gemcitabine

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2016-04-04

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

UK/H/5735//001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Gemcitabinas	38 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
61425	75744	1075744	flakonas	200 mg N1	Receptinis	LT/1/16/3896/001	Netiekiama	-	-	No	-	-
65413	79917	1079917	flakonas	200 mg N5	Receptinis	LT/1/16/3896/002	Netiekiama	-	-	No	-	-
65414	79918	1079918	flakonas	1000 mg N1	Receptinis	LT/1/16/3896/003	Netiekiama	-	-	No	-	-
65415	79919	1079919	flakonas	1000 mg N5	Receptinis	LT/1/16/3896/004	Netiekiama	-	-	No	-	-
65416	79920	1079920	flakonas	2000 mg N1	Receptinis	LT/1/16/3896/005	Netiekiama	-	-	No	-	-
65417	79921	1079921	flakonas	2000 mg N5	Receptinis	LT/1/16/3896/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-07	Išregistruotas
2016-04-04	Registruotas