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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021
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17/09/2021
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23/07/2021