On 13 May 2011, orphan designation (EU/3/11/865) was granted by the European Commission to ORS Oxford Ltd, United Kingdom, for 9-cis-retinyl acetate for the treatment of retinitis pigmentosa. The sponsorship was transferred to QLT Ophthalmics (UK), Ltd, United Kingdom, in November 2011.

The sponsorship was transferred to Granzer Regulatory Consulting & Services, Germany in May 2019.

Key facts

Active substance
9-cis-Retinyl acetate
Disease / condition
Treatment of retinitis pigmentosa
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

Granzer Regulatory Consulting & Services
Kistlerhofstrasse 172c
81379 Munich
Tel: + 49 89-780 68 98 55

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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