MHRA Approves Galenica’s Iron Replacement Product

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has become the first authority to approve the registration of Galencia’s Ferinject, an intravenous iron replacement product for the treatment of iron deficiency and anaemia.

Because the UK is a reference country in the decentralized drug registration process, Ferinject will be registered simultaneously in 18 European Union (EU) countries, Galencia said.

According to Galencia, Ferinject can be administered quickly and in high doses.

The first shipment of Ferinject in the EU is planned for later this year. Registration applications have also been submitted in Switzerland and the U.S., the company said.