Cabazitaxel Fresenius Kabi

Medicinal product

(Invented) name

Cabazitaxel Fresenius Kabi

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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2022-09-16

Date of renewal

Documents

5031 Cabazitaxel Fresenius Kabi PCS PL 2024 11 28.docx

5031 Pakuotės lapelis 2024 11 28.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/3243/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 koncentrato mililitre yra:	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
109425	95531	1095531	flakonas	3 ml N1		Receptinis	LT/1/22/5031/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-16	Registruotas