Nouryant

istradefylline

Table of contents

Opinion

Update as of 2 August 2021:

The applicant for Nouryant has requested a re-examination of EMA’s July 2021 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.

 

The European Medicines Agency has recommended the refusal of the marketing authorisation for Nouryant, a medicine intended for the treatment of Parkinson’s disease.

The Agency issued its opinion on 22 July 2021. The company that applied for authorisation, Kyowa Kirin Holdings B.V., may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Name
Nouryant
Agency product number
EMEA/H/C/005308
International non-proprietary name (INN) or common name
  • istradefylline
Active substance
  • Istradefylline
Therapeutic area
Parkinson Disease
Date opinion adopted
22/07/2021
Company name
Kyowa Kirin Holdings B.V.
Status
Negative
Application type
Initial authorisation

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