Carboplatin Kabi

Medicinal product

(Invented) name

Carboplatin Kabi

Active substance (s)

Karboplatina

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)

L01XA02, Carboplatin

Marketing authorisation holder

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

Date of authorisation

2012-04-02

Date of renewal

2018-01-24

Documents

2880 Carboplatin Kabi PCS PL 2024 06 26.docx

2880 Pakuotės lapelis 2024 06 26.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4319/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato infuziniam tirpalui yra	1 ml
Karboplatina	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
43762	57538	1057538	flakonas	5 ml N1		Receptinis	LT/1/12/2880/001	Netiekiama	-	-	No	-	-
43763	57539	1057539	flakonas	15 ml N1		Receptinis	LT/1/12/2880/002	Tiekiama	-	-	No	-	-	Download
43764	57540	1057540	flakonas	45 ml N1		Receptinis	LT/1/12/2880/003	Netiekiama	-	-	No	-	-
43765	57541	1057541	flakonas	60 ml N1		Receptinis	LT/1/12/2880/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-01-24	Perregistruotas
2012-04-02	Registruotas