Decision

2 March 2017: Monofer & Diafer (iron isomaltoside) Promotional and Patient Materials

Published 28 April 2017

Vifor Pharma UK Ltd. complained about a series of promotional and patient materials for Monofer (iron isomaltoside) issued by Pharmacosmos UK Ltd. They considered that ‘One visit’ promotional materials and a patient leaflet exaggerated the benefits of the product and minimised the potential adverse effects.

MHRA did not uphold the complaint. The dose required for iron correction could be administered in one visit and other claims were consistent with the SPC for Monofer.