EU/3/12/1087: Orphan designation for the treatment of growth hormone deficiency

Recombinant modified human growth hormone

Overview

On 24 January 2013, orphan designation (EU/3/12/1087) was granted by the European Commission to Richardson Associates Regulatory Affairs Ltd, United Kingdom, for recombinant modified human growth hormone for the treatment of growth-hormone deficiency.

The sponsorship was transferred to Richardson Associates Regulatory Affairs Ltd, Ireland, in December 2018.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in April 2020.

Recombinant modified human growth hormone has been authorised in the EU as Ngenla since 14 February 2022.

This medicine is now known as somatrogon.

Key facts

Active substance
Recombinant modified human growth hormone
Intended use
Treatment of growth hormone deficiency
Orphan designation status
Positive
EU designation number
EU/3/12/1087
Date of designation
24/01/2013
Sponsor

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Brussels-Capital Region
Belgium
E-mail: orphan_enquiries@pfizer.com

Review of designation

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

The Committee for Orphan Medicinal Products reviewed the orphan designation of Ngenla 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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