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Public - List of Opinions on Orphan Medicinal Product Designation

This list provides all orphan medicine designations and amendments for which opinions were adopted by EMA’s Committee for Orphan Medicinal Products (COMP). Following their adoption, opinions are forwarded to the European Commission for final decision and the designated medicinal products are listed on the EC website . Additional information on the orphan designation is published in the COMP meeting minutes .
Medicines being developed for rare diseases can be granted an orphan designation, which allows the developer to receive scientific and regulatory support from EMA towards a future application for marketing authorisation.
An orphan designation does not mean that the medicine is or will ever be available or authorised for use. 
Sponsors of orphan designations are invited to update the email address of the contact person (last column) directly in the IRIS Industry portal, whenever necessary. There is no need to inform EMA of the change.