ONIVYDE pegylated liposomal [ONIVYDE]

Medicinal product

(Invented) name

ONIVYDE pegylated liposomal [ONIVYDE]

Active substance (s)

Irinotekanas

Strength

4,3 mg/ml

Pharmaceutical form

koncentratas infuzinei dispersijai

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01CE02, Irinotecan

Marketing authorisation holder

Les Laboratoires Servier, Prancūzija

Date of authorisation

2016-10-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for dispersion for infusion	1 ml
Irinotekanas	4,3 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
66918	81458	1081458	flakonas	10 ml N1		Receptinis	EU/1/16/1130/001	Netiekiama	2025-01-01	2025-12-31	Yes	2025-01-01	2025-12-31

Stadijos

Data	Stadija
2016-10-14	Registruotas