Oksaliplatina EBEWE

Medicinal product

(Invented) name

Oksaliplatina EBEWE

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

Ebewe Pharma Ges.m.b.H. Nfg. KG, Austrija

Date of authorisation

2011-06-01

Date of renewal

Documents

0876_4_10 Oksaliplatina Ebewe konc RPP 160205.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

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
36259	38591	1038591	flakonas	10 ml N1		Receptinis	LT/1/07/0876/004	Netiekiama	-	-	No	-	-
36260	38592	1038592	flakonas	10 ml N5		Receptinis	LT/1/07/0876/005	Netiekiama	-	-	No	-	-
36261	38593	1038593	flakonas	10 ml N10		Receptinis	LT/1/07/0876/006	Netiekiama	-	-	No	-	-
47081	60893	1060893	flakonas	20 ml N1		Receptinis	LT/1/07/0876/007	Netiekiama	-	-	No	-	-
47082	60894	1060894	flakonas	40 ml N1		Receptinis	LT/1/07/0876/008	Netiekiama	-	-	No	-	-
47120	60933	1060933	flakonas	30 ml N1		Receptinis	LT/1/07/0876/009	Netiekiama	-	-	No	-	-
65011	79507	1079507	flakonas	50 ml N1		Receptinis	LT/1/07/0876/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2011-06-01	Registruotas