Cabazitaxel Sandoz

Medicinal product

(Invented) name

Cabazitaxel Sandoz

Active substance (s)

Kabazitakselis

Strength

10 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

Sandoz d.d., Slovėnija

Date of authorisation

2020-10-23

Date of renewal

2024-11-21

Documents

4630_Cabazit_Sandoz_perr2024-11-21.docx

4630_pakuotes lapelis_2024-11-21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/1006/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Kabazitakselis	10 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
105178	91280	1091280	flakonas	4,5 ml N1		Receptinis	LT/1/20/4630/001	Netiekiama	-	-	No	-	-
105179	91281	1091281	flakonas	4,5 ml N5		Receptinis	LT/1/20/4630/002	Netiekiama	-	-	No	-	-
105180	91282	1091282	flakonas	6 ml N1		Receptinis	LT/1/20/4630/003	Tiekiama	-	-	No	-	-	Download
105181	91283	1091283	flakonas	6 ml N5		Receptinis	LT/1/20/4630/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-21	Perregistruotas
2020-10-23	Registruotas