Refusal of orphan designation for the treatment of retinopathy of prematurity


Table of contents


Melatonin has not been designated as an orphan medicine for the treatment of retinopathy of prematurity in the European Union, despite an application from the sponsor.

Absence of orphan designation does not preclude the development of this medicine, including its use in clinical trials. The medicine can be authorised if its quality, safety and efficacy are demonstrated.

During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:

Key facts

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

Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351
53014 Monteroni D'arbia (SI)

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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