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

2022-08-10

Date of renewal

Documents

5015_Cabazitaxel Teva.docx

5015_pakuotes lapelis_2022-08-10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/1209/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml infuzinio 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
109175	95281	1095281	flakonas	6 ml N1		Receptinis	LT/1/22/5015/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Išregistruotas
2022-08-10	Registruotas