Belviq: Withdrawal of the marketing authorisation application

lorcaserin hydrochloride

Overview

On 3 May 2013, Arena Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Belviq, a medicine intended for helping to achieve weight control in obese and overweight patients.

Key facts

Name
Belviq
Product number
EMEA/H/C/002597
International non-proprietary name (INN) or common name
  • lorcaserin hydrochloride
Active substance
  • lorcaserin hydrochloride
Date of withdrawal
03/05/2013
Company making the application
Arena Pharmaceutical Enterprises Limited
Withdrawal type
Initial authorisation

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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