Orphan designation: melatonin Treatment of perinatal asphyxia, 02/04/2012 Positive
Overview
- Overview
On 2 April 2012, orphan designation (EU/3/12/978) was granted by the European Commission to Dr Nicola J Robertson, United Kingdom, for melatonin for the treatment of perinatal asphyxia. - At the time of orphan designation, there was no treatment for perinatal asphyxia authorised in the EU.
- Key facts
- Active substance
- melatonin
- Intended use
- Treatment of perinatal asphyxia
- Orphan designation status
- Positive
- EU designation number
- EU/3/12/978
- Date of designation
- Sponsor
UCL Research Limited
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation. - 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: