Oxaliplatin Hospira

Medicinal product

(Invented) name

Oxaliplatin Hospira

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

Hospira UK Limited, Jungtinė Karalystė

Date of authorisation

2007-01-10

Date of renewal

2011-09-15

Documents

0628_1_2 Oxaliplatin Hospira PCS PL keit.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

EE/H/0102/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml 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
19257	22617	1022617	flakonas	50 mg N1		Receptinis	LT/1/06/0628/001	Netiekiama	-	-	No	-	-
19258	22618	1022618	flakonas	100 mg N1		Receptinis	LT/1/06/0628/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2011-09-15	Perregistruotas
2007-01-10	Registruotas