Ormeloxifene

Question

There are currently no plans to make ormeloxifene available. It is critical that medicines used in the United Kingdom are safe and effective and as such, medicines cannot be marketed in the UK without a marketing authorisation. These are granted by the Medicines and Healthcare products Regulatory Agency (MHRA), which assesses all medicines with regard to their quality, safety, and effectiveness. Ormeloxifene has not been licensed by the MHRA. It is the responsibility of the company to apply to the MHRA for a marketing authorisation. Should an application for it be received, the MHRA will consider this accordingly.

In England, most new licensed medicines are appraised by the National Institute for Health and Care Excellence (NICE) to determine whether they represent a clinically and cost-effective use of National Health Service resources. If the manufacturer of ormeloxifene seeks a licence from the MHRA, then it may be considered for evaluation by the NICE.