Register of Medicinal Products

PLUVICTO

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1891942
Name of medicinal product:	PLUVICTO
Active substances:	Lutetium(177Lu)vipivotide tetraxetan Estonian, English, Latin
ATC code:	V10XX05
Dosage form:	solution for injection/infusion
Route of administration:	intravenous use
Strengh:
Amount in package:	1TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:	Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).
Safety features:	Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):	EST
Labelling:
Last imported to Estonia:	Never imported to Estonia
:	This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines

Marketing authorization holder:	Novartis Europharm Limited
Marketing authorization number:	EU/1/22/1703
Marketing authorization issued on:	December 9, 2022
Marketing authorization expires on:	December 12, 2027
Marketing authorization procedure type:	Centralised

Reference price:
Under reference price:
Reference price of daily dose:

Description	Additional condition
Ei ole lubatud väljastada korduvretsepti

Entry/Changing date: February 13, 2023

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere