Refusal of orphan designation for the treatment of non-traumatic subarachnoid haemorrhage


Table of contents


On 15 March 2018, the Committee for Orphan Medicinal Products (COMP) adopted a negative opinion on the orphan designation application for melatonin for the treatment of non-traumatic subarachnoid haemorrhage. A negative decision was issued by the European Commission on 16 April 2018

The sponsor applied for orphan designation on the basis of the seriousness and the rarity of the condition, as well as an assumption of potential benefit over currently available methods of treatment.

The negative opinion was based on the following reason:

  • the sponsor has not provided sufficient evidence to show that melatonin might be of significant benefit for patients with non-traumatic subarachnoid haemorrhage, compared with the authorised medicine nimodipine. The laboratory models used to assess significant benefit of the medicine did not adequately represent the condition.

Requests for designation as an orphan medicinal product are made for investigational products. Absence of orphan designation does not preclude the development of this product, including its use in clinical trials. A marketing authorisation can still be obtained if quality, safety and efficacy are demonstrated.

Key facts

Active substance
Intended use
Treatment of non-traumatic subarachnoid haemorrhage
Orphan designation status
EU designation number
Date of refusal of designation
Therapicon Srl
Via dei Grimani 10
20144 Milan
Tel. +39 02 433 042
Fax +39 02 481 952 24

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • 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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