EU/3/12/1087

About

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.

Key facts

Active substance
Recombinant modified human growth hormone
Disease / condition
Treatment of growth-hormone deficiency
Date of decision
24/01/2013
Outcome
Positive
Orphan decision number
EU/3/12/1087

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

22 Northumberland Road
Ballsbridge
Dublin 4 D04 ED73
Ireland
Tel. + +353 6641177
E-mail: info@richardsonassociatesra.com

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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