EU/3/03/156 - orphan designation for treatment of adrenal insufficiency

prasterone
OrphanHuman

Overview

On 28 July, orphan designation (EU/3/03/156) was granted by the European Commission to Medicom Healthcare BV, the Netherlands, for prasterone (Fidelin) for the treatment of adrenal insufficiency.

EU/3/03/156: Public summary of positive opinion for orphan designation of prasterone for the treatment of adrenal insufficiency

Adopted Reference Number: EMEA/COMP/1257/03

English (EN) (142.18 KB - PDF)

First published: Last updated:
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Key facts

Active substance
prasterone
Intended use
Treatment of adrenal insufficiency
Orphan designation status
Positive
EU designation number
EU/3/03/156
Date of designation
Sponsor

Medicom Healthcare BV
De Nort 1B
NL-3931 NE Woudenberg
The Netherlands

EMA list of opinions on orphan medicinal product designation

EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

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.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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