Gefzuris

Application withdrawn

The application for this medicine has been withdrawn

gefapixant

Overview

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

• Name of medicine:
  Gefzuris
• Active substance:
  gefapixant
• International non-proprietary name (INN) or common name:
  gefapixant
• Therapeutic area (MeSH):
  Cough
• Anatomical therapeutic chemical (ATC) code:
  R05DB29
• EMA product number:
  EMEA/H/C/005884
• Marketing authorisation applicant:
  Merck Sharp & Dohme B.V.
• Withdrawal of application:
  14/07/2023

All documents

Withdrawal assessment report for Gefzuris

Adopted Reference Number: EMA/357359/2023

Withdrawal letter: Gefzuris