EU/3/14/1309

About

On 22 August 2014, orphan designation (EU/3/14/1309) was granted by the European Commission to NDA Group AB, Sweden, for 17α,21-dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione for the treatment of Duchenne muscular dystrophy.

The sponsorship was transferred to ReveraGen BioPharma Limited, United Kingdom, in May 2015.

The sponsorship was transferred to Pharma Gateway AB, Sweden, in January 2019.

Key facts

Active substance
17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione
Disease / condition
Treatment of Duchenne muscular dystrophy
Date of decision
22/08/2014
Outcome
Positive
Orphan decision number
EU/3/14/1309

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

Pharma Gateway AB
Johanneslundsvägen 2
194 81 Upplands Väsby
Sweden
Tel. +46 8 590 778 00
E-mail: info@pharmagateway.eu

Patients' organisations

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;

How useful was this page?

Add your rating