Oxaliplatin Accord

Medicinal product

(Invented) name

Oxaliplatin Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2010-08-13

Date of renewal

2016-05-27

Documents

2144 Pakuotės lapelis 2025 10 07.docx

2144 Oxaliplatin Accord II PL 2025 10 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0756/001

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
31739	34154	1034154	flakonas	10 ml N1		Receptinis	LT/1/10/2144/001	Netiekiama	-	-	No	-	-
32298	34690	1034690	flakonas	20 ml N1		Receptinis	LT/1/10/2144/002	Tiekiama	-	-	No	-	-
45733	59535	1059535	flakonas	40 ml, N1		Receptinis	LT/1/10/2144/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-27	Perregistruotas
2010-08-13	Registruotas