Eleber

Medicinal product

(Invented) name

Eleber

Active substance (s)

Kabazitakselis

Strength

60 mg

Pharmaceutical form

koncentratas ir tirpiklis infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01CD04, Cabazitaxel

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2021-05-17

Date of renewal

2025-09-19

Documents

4744_Eleber_perr2025-09-19.docx

4744_pakuotes lapelis_2025-09-19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0420/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone (1,5 ml koncentrato) yra:	1.5 ml
Kabazitakselis	60 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
106536	92637	1092637	flakonas	1,5 ml ir tirpiklio flakonas (4,5 ml) N1		Receptinis	LT/1/21/4744/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-19	Perregistruotas
2021-05-17	Registruotas