Feraccru - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

ferric maltol

Opinion

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Feraccru. The marketing authorisation holder for this medicinal product is Norgine B.V.

The CHMP adopted a change to the existing indication as follows:

Feraccru is indicated in adults for the treatment of iron deficiency in adults and adolescents aged 12 years and older.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Feraccru (VR/0000268118)

Adopted Reference Number: EMADOC-1700519818-2994500

Key facts

• Name of medicine:
  Feraccru
• EMA product number:
  EMEA/H/C/002733
• Active substance:
  ferric maltol
• International non-proprietary name (INN) or common name:
  ferric maltol
• Therapeutic area (MeSH):
  Anemia, Iron-Deficiency
• Anatomical therapeutical chemical (ATC) code:
  B03AB
• Marketing authorisation holder:
  Norgine B.V.
• Date of opinion:
  26/03/2026
• Status:
  Positive