Cabazitaxel Teva

Medicinal product

(Invented) name

Cabazitaxel Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2020-09-30

Date of renewal

Documents

4611_1 Pakuotės lapelis 210306.docx

4611_1 Cabazitaxel Teva konc inf II PL 210306.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/1027/001/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
105068	91171	1091171	flakonas	6 ml N1		Receptinis	LT/1/20/4611/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-29	Išregistruotas
2020-09-30	Registruotas