Oxaliplatin Actavis

Medicinal product

(Invented) name

Oxaliplatin Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2011-09-15

Date of renewal

Documents

0997_3_5 Pakuotės lapelis 190729.docx

0997_3_5 Oxaliplatin Actavis konc inf PCS PL 190729.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3039/001

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
40519	54256	1054256	flakonas	10 ml N1		Receptinis	LT/1/08/0997/003	Netiekiama	-	-	No	-	-
40520	54257	1054257	flakonas	20 ml N1		Receptinis	LT/1/08/0997/004	Netiekiama	-	-	No	-	-
40521	54258	1054258	flakonas	40 ml N1		Receptinis	LT/1/08/0997/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-05	Išregistruotas
2011-09-15	Registruotas