EU/3/15/1586

About

This medicine is now known as cenegermin.

On 14 December 2015, orphan designation (EU/3/15/1586) was granted by the European Commission to Dompé farmaceutici S.p.A., Italy, for recombinant human nerve growth factor for the treatment of neurotrophic keratitis.

Recombinant human nerve growth factor has been authorised in the EU as Oxervate since 6 July 2017.

Key facts

Active substance
Recombinant human nerve growth factor (cenegermin)
Disease / condition
Treatment of neurotrophic keratitis
Date of first decision
14/12/2015
Outcome
Positive
EU designation number
EU/3/15/1586

Review of designation

On 19 May 2017, the Committee for Orphan Medicinal Products (COMP) completed its review of the designation EU/3/15/1586 for Oxervate (cenegermin, previously known as recombinant human nerve growth factor) as an orphan medicinal product for the treatment neurotrophic keratitis. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained.1


[1]The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

Dompé farmaceutici S.p.A.
Via Santa Lucia 6
20122 Milano
Italy
Tel. +39 02 583831
Fax +39 02 58383215
E-mail: info@dompe.com

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;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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