EU/3/17/1895: Orphan designation for the prevention of retinopathy of prematurity



On 17 July 2017, orphan designation (EU/3/17/1895) was granted by the European Commission to orphanix GmbH, Austria, for retinol for the prevention of retinopathy of prematurity.

The sponsor’s address was updated in March 2020.

Key facts

Active substance
Intended use
Prevention of retinopathy of prematurity
Orphan designation status
EU designation number
Date of designation

orphanix GmbH
Lederergasse 18/1
4020 Linz
Tel. +43 6769663799

Review of designation

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

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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