Kapruvia
difelikefalin
Table of contents
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.
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List item
Kapruvia : EPAR - Medicine Overview (PDF/121.54 KB)
First published: 28/04/2022
EMA/205469/2022 -
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Kapruvia : EPAR - Risk management plan summary (PDF/141.47 KB)
First published: 28/04/2022
Authorisation details
Product details | |
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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 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 | |
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Marketing-authorisation holder |
Vifor Fresenius Medical Care Renal Pharma France
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
25/04/2022
|
Contact address |
100-101 Terrasse Boieldieu |
Product information
21/07/2022 Kapruvia - EMEA/H/C/005612 - IB/0001
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).