Gefzuris: Withdrawal of the marketing authorisation application



The applicant withdrew the marketing authorisation application for Gefzuris (gefapixant) on 14 July 2023. It was a duplicate of the application for another medicine, Lyfnua, which EMA’s human medicines committee (CHMP) was evaluating in parallel, and which is not affected by this withdrawal.

Further details are included in the withdrawal letter.

Key facts

Product number
International non-proprietary name (INN) or common name
  • gefapixant
Active substance
  • Gefapixant
Date of withdrawal
Company making the application
Merck Sharp & Dohme B.V. 
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.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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