Fanaptum

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iloperidone

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

Overview

On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Fanaptum, intended for the treatment of schizophrenia. The company that applied for authorisation is Vanda Pharmaceuticals Ltd.

The company requested a re-examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.

This EPAR was last updated on 19/03/2018

Application details

Product details
Name
Fanaptum
Active substance
iloperidone
International non-proprietary name (INN) or common name
iloperidone
Therapeutic area (MeSH)
Schizophrenia
Anatomical therapeutic chemical (ATC) code
N05AX14
Application details
Marketing-authorisation applicant
Vanda Pharmaceuticals Ltd
Date of opinion
20/07/2017
Date of refusal of marketing authorisation
15/01/2018

Assessment history

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