Kapruvia

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difelikefalin

Authorised
This medicine is authorised for use in the European Union.

Overview

Kapruvia is a medicine used to treat moderate to severe pruritus (itching) in adults with chronic kidney disease who are on haemodialysis (treatment with a machine that filters toxins from the blood).

Kapruvia contains the active substance difelikefalin.

This EPAR was last updated on 21/07/2022

Authorisation details

Product details
Name
Kapruvia
Agency product number
EMEA/H/C/005612
Active substance
difelikefalin
International non-proprietary name (INN) or common name
difelikefalin
Therapeutic area (MeSH)
Pruritus
Anatomical therapeutic chemical (ATC) code
V03AX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Vifor Fresenius Medical Care Renal Pharma France
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
25/04/2022
Contact address

100-101 Terrasse Boieldieu
Tour Franklin La Defense 8
Paris La Defense
Cedex 92042
Paris
France

Product information

21/07/2022 Kapruvia - EMEA/H/C/005612 - IB/0001

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1).

Assessment history

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