Orphan designation: melatonin Treatment of perinatal asphyxia, 02/04/2012 Positive

Overview

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-12-978https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-12-978
Retrieved on: 
Mardi, avril 9, 2024
Information
Tags: 
Eurostat, Diagnosis, Civil service commission, Research, Brain, Disability studies, Survival, Asphyxia, Patient, Committee, Knowledge, Regulation, Child, Melatonin, EMA, IRIS, Thermoregulation, Intellectual, European, COMP, Oxygen, Safety, European Commission, Placenta, Hypothermia, Blood, Umbilical cord, Marketing, Perinatal asphyxia, Pharmaceutical industry
Geotags: 
EUROPEAN UNION, RARE, EC, ITALY, ICELAND, EU, NORWAY, UNITED KINGDOM, LIECHTENSTEIN
Résumé
Key Points: 
  • 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:
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