EU/3/18/2127

About

On 11 January 2019, orphan designation (EU/3/18/2127) was granted by the European Commission to Therapicon S.r.l., Italy, for melatonin for the treatment of perinatal asphyxia.

The sponsorship was transferred to Worphmed S.r.l. Italy, in June 2019.

Key facts

Active substance
melatonin
Disease / condition
Treatment of perinatal asphyxia
Date of first decision
11/01/2019
Outcome
Positive
EU designation number
EU/3/18/2127

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Worphmed S.r.l.
Via Malachia Marchesi de Taddei 21
20146 Milan
Italy
Tel. +39 (02) 433042
E-mail: rare@worphmed.eu

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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