Kinpeygo

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budesonide

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

Overview

Kinpeygo is a medicine used to treat adults with primary immunoglobulin A nephropathy (IgAN) whose disease is at risk rapidly getting worse. IgAN is a disease where the kidneys gradually stop working and eventually fail, requiring patients to undergo dialysis or have a kidney transplant.

Kinpeygo is a ‘hybrid medicine’. It is similar to a ‘reference medicine’ containing the same active substance, but is used for a different disease and is given in a different way. The reference medicine for Kinpeygo is Entocort. 

IgAN is rare, and Kinpeygo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 November 2016. Further information on the orphan designation can be found here.

This EPAR was last updated on 23/11/2022

Authorisation details

Product details
Name
Kinpeygo
Agency product number
EMEA/H/C/005653
Active substance
budesonide, micronised
International non-proprietary name (INN) or common name
budesonide
Therapeutic area (MeSH)
Glomerulonephritis, IGA
Anatomical therapeutic chemical (ATC) code
A07EA06
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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Stada Arzneimittel AG
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
15/07/2022
Contact address

Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Product information

23/11/2022 Kinpeygo - EMEA/H/C/005653 - IB/0002

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:

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

Antidiarrheals, intestinal antiinflammatory / antiinfective agents

Therapeutic indication

Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

Assessment history

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