Oxaliplatin Mylan

Medicinal product

(Invented) name

Oxaliplatin Mylan

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

Mylan S.A.S., Prancūzija

Date of authorisation

2013-02-08

Date of renewal

Documents

3200_4_5 Oxaliplatin Mylan milt RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2063/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml paruošto infuzinio 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
41784	55546	1055546	flakonas	20 ml N1 (50 mg)		Receptinis	LT/1/13/3200/004	Netiekiama	-	-	No	-	-
41785	55547	1055547	flakonas	50 ml N1 (100 mg)		Receptinis	LT/1/13/3200/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-05	Išregistruotas
2013-02-08	Registruotas