Oxaliplatin Hospira

Medicinal product

(Invented) name

Oxaliplatin Hospira

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

Hospira UK Limited, Jungtinė Karalystė

Date of authorisation

2008-01-17

Date of renewal

Documents

0962_1_3 Oxaliplatin Hospira konc PZ 171215.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

UK/H/0971/001/R/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato 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
20504	23500	1023500	flakonas	flakonas (10 ml), N1		Receptinis	LT/1/08/0962/001	Netiekiama	-	-	No	-	-
20505	23501	1023501	flakonas	flakonas (20 ml), N1		Receptinis	LT/1/08/0962/002	Netiekiama	-	-	No	-	-
47024	60835	1060835	flakonas	flakonas (40 ml), N1		Receptinis	LT/1/08/0962/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-19	Išregistruotas
2008-01-17	Registruotas