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Questions & Answers

On 22 February 2018, 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 Shield TX (UK) Ltd.

The CHMP adopted an extension to the existing indication as follows1:

Feraccru is indicated in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD) (see section 5.1).

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

1Removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Feraccru (English only) 2018-02-23  

Key facts

Product details for Feraccru
INN or common name

ferric maltol

Therapeutic area Anemia, Iron-Deficiency
Active substance

ferric maltol

Date opinion adopted22/02/2018
Company name

Shield TX (UK) Ltd

Application typePost authorisation