EU/3/18/2068: Orphan designation for the treatment of growth hormone deficiency

Somapacitan

Overview

On 24 August 2018, orphan designation (EU/3/18/2068) was granted by the European Commission to Novo Nordisk A/S, Denmark, for somapacitan for the treatment of growth hormone deficiency.

Somapacitan has been authorised in the EU as Sogroya since 31 March 2021. 

Key facts

Active substance
Somapacitan
Intended use
Treatment of growth hormone deficiency
Orphan designation status
Positive
EU designation number
EU/3/18/2068
Date of designation
24/08/2018
Sponsor

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Tel. +45 44 44 88 88
E-mail: webmasters@novonordisk.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Somapacitan at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

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.

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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