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 | |
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Marketing-authorisation applicant |
Vanda Pharmaceuticals Ltd
|
Date of opinion |
09/11/2017
|
Date of refusal of marketing authorisation |
15/01/2018
|