Pluvicto

Medicinal product

(Invented) name

Pluvicto

Active substance (s)

Liutecio (177Lu) vipivotidas tetraksetanas

Strength

1000 MBq/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V10XX05, Liutecio ( 177Lu) vipivotidas tetraksetanas

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2022-12-09

Date of renewal

Documents

Pluvicto mokomoji medziaga pacientui.pdf

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

Solution for injection or infusion	1 ml
Liutecio (177Lu) vipivotidas tetraksetanas	1000 MBq

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
109964	96074	1096074	flakonas	7,5 - 12,5 ml N1		Receptinis	EU/1/22/1703/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-09	Registruotas