Overview

The European Medicines Agency has decided to reset the evaluation procedure for Syfovre to day 180 of the initial assessment procedure and convene a new ad-hoc expert group (AHEG). This decision follows the appellate judgment in Case C-291/22 P published on 14 March 2024 by the Court of Justice which had implications for EMA's organisation of Scientific Advisory Groups and AHEGs.

Further information is available in the March and April CHMP meeting highlights.

For a list of all the human medicines EMA is currently evaluating, see Medicines under evaluation. EMA publishes an updated list monthly.

Key facts

Name of medicine
Syfovre
International non-proprietary name (INN) or common name
pegcetacoplan
Therapeutic area (MeSH)
  • Macular Degeneration
  • Geographic Atrophy
EMA product number
EMEA/H/C/005954
Marketing authorisation applicant
Apellis Netherlands B.V.

Topics

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