Oxaliplatin Mylan [Oxaliplatin Strides]

Medicinal product

(Invented) name

Oxaliplatin Mylan [Oxaliplatin Strides]

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

Mylan S.A.S., Prancūzija

Date of authorisation

2013-02-08

Date of renewal

Documents

3200_1_3 Oxaliplatin Mylan konc RPP 170224.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1977/001/DC

Marketing authorisation procedure

Decentralizuota 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
40239	53976	1053976	flakonas	N1 (50 mg/10 ml)		Receptinis	LT/1/13/3200/001	Netiekiama	-	-	No	-	-
40240	53977	1053977	flakonas	N1 (100 mg/20 ml)		Receptinis	LT/1/13/3200/002	Netiekiama	-	-	No	-	-
40241	53978	1053978	flakonas	N1 (200 mg/40 ml)		Receptinis	LT/1/13/3200/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2013-02-08	Registruotas