Cabazitaxel Accord

Medicinal product

(Invented) name

Cabazitaxel Accord

Active substance (s)

Kabazitakselis

Strength

20 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)

L01CD04, Cabazitaxel

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-08-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Kabazitakselis	20 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
104964	91066	1091066	flakonas	3 ml N1		Receptinis	EU/1/20/1448/001	Tiekiama	2026-01-01	-	No	-	-

Stadijos

Data	Stadija
2020-08-28	Registruotas