Cisplatin Kabi

Medicinal product

(Invented) name

Cisplatin Kabi

Active substance (s)

Cisplatina

Strength

1 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)

L01XA01, Cisplatin

Marketing authorisation holder

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

Date of authorisation

2014-05-26

Date of renewal

2019-07-25

Documents

3563_01-04 pakuotes lapelis_2019-07-25.docx

3563_1-4 Cisplatin Kabi_perr20190725.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0827/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato infuziniam tirpalui yra	1 ml
Cisplatina	1 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
54901	68926	1068926	flakonas	10 ml N1		Receptinis	LT/1/14/3563/001	Netiekiama	-	-	No	-	-	Download
59188	73412	1073412	flakonas	20 ml N1		Receptinis	LT/1/14/3563/002	Netiekiama	-	-	No	-	-
59189	73413	1073413	flakonas	50 ml N1		Receptinis	LT/1/14/3563/003	Netiekiama	-	-	No	-	-
59190	73414	1073414	flakonas	100 ml N1		Receptinis	LT/1/14/3563/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2019-07-25	Perregistruotas
2014-05-26	Registruotas