Nouryant

RSS

istradefylline

Refused
This medicine was refused authorisation for use in the European Union.

Overview

After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Nouryant. The medicine was intended for the treatment of Parkinson’s disease.

The Agency issued its opinion after re-examination on 11 November 2021. The Agency had issued its initial opinion on 22 July 2021. The company that applied for authorisation of Nouryant is Kyowa Kirin Holdings B.V.

This EPAR was last updated on 19/01/2022

Application details

Product details
Name
Nouryant
Active substance
Istradefylline
International non-proprietary name (INN) or common name
istradefylline
Therapeutic area (MeSH)
Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04
Application details
Marketing-authorisation applicant
Kyowa Kirin Holdings B.V.
Date of opinion
22/07/2021
Date of refusal of marketing authorisation
06/01/2022

Assessment history

How useful was this page?

Add your rating