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.

Key facts

Active substance
Recombinant modified human growth hormone
Disease / condition
Treatment of growth hormone deficiency
Date of first decision
EU designation number

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

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles

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.

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