eflornithine / sulindac

Table of contents


Update as of 22 July 2021:

The applicant for Flynpovi has requested a re-examination of EMA’s June 2021 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.


The European Medicines Agency has recommended the refusal of the marketing authorisation for Flynpovi, a medicine intended for the treatment of familial adenomatous polyposis.

The Agency issued its opinion on 24 June. The company that applied for authorisation, Cancer Prevention Pharma (Ireland) Limited, may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • eflornithine
  • sulindac
Active substance
  • Eflornithine hydrochloride
  • Sulindac
Therapeutic area
Adenomatous Polyposis Coli

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
Company name
Cancer Prevention Pharma (Ireland) Limited
Application type
Initial authorisation

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