Dexxience

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betrixaban

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

Overview

On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience, intended for the prevention of venous thromboembolism. The company that applied for authorisation is Portola Pharma UK Limited.

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 26 July 2018.

This EPAR was last updated on 09/10/2018

Application details

Product details
Name
Dexxience
Active substance
betrixaban maleate
International non-proprietary name (INN) or common name
betrixaban
Therapeutic area (MeSH)
Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01AF
Application details
Marketing-authorisation applicant
Portola Pharma UK Limited
Date of opinion
26/07/2018
Date of refusal of marketing authorisation
20/09/2018

Assessment history

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