Oxaliplatin Kabi

Medicinal product

(Invented) name

Oxaliplatin Kabi

Active substance (s)

Oksaliplatina

Strength

5 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)

L01XA03, Oxaliplatin

Marketing authorisation holder

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

Date of authorisation

2011-05-11

Date of renewal

2017-07-27

Documents

1980 Pakuotės lapelis 2024 05 24.docx

1980 Oxaliplatin Kabi konc PCS 2025 04 13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0893/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml koncentrato infuziniam tirpalui yra	1 ml
Oksaliplatina	5 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
40805	54542	1054542	flakonas	10 ml N1		Receptinis	LT/1/10/1980/003	Tiekiama	-	-	No	-	-	Download
40806	54543	1054543	flakonas	20 ml N1		Receptinis	LT/1/10/1980/004	Tiekiama	-	-	No	-	-	Download
47594	61415	1061415	flakonas	40 ml N1		Receptinis	LT/1/10/1980/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-27	Perregistruotas
2011-05-11	Registruotas