Oxaliplatin CSC

Medicinal product

(Invented) name

Oxaliplatin CSC

Active substance (s)

Oksaliplatina

Strength

5 mg/ml

Pharmaceutical form

milteliai 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

CSC Pharmaceuticals Hendels Ges.m.b.H, Italija

Date of authorisation

2012-10-19

Date of renewal

Documents

3106_01-02 Oxaliplatin_CSC_DP.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1086/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruošto tirpalo 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
44519	58314	1058314	flakonas	50 mg N1		Receptinis	LT/1/12/3106/001	Netiekiama	-	-	No	-	-
54100	68088	1068088	flakonas	100 mg N1		Receptinis	LT/1/12/3106/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-04	Išregistruotas
2012-10-19	Registruotas