Melatonin has not been designated as an orphan medicine for the treatment of retinopathy of prematurity in the European Union, despite an application from the sponsor.
Absence of orphan designation does not preclude the development of this medicine, including its use in clinical trials. The medicine can be authorised if its quality, safety and efficacy are demonstrated.
Treatment of retinopathy of prematurity
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Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: