EU/3/09/671

About

On 8 October 2009, orphan designation (EU/3/09/671) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for pasireotide for the treatment of Cushing's disease.

Pasireotide in treatment of Cushing's disease has been authorised in the EU as Signifor since 24 April 2012.

The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.

Key facts

Active substance
pasireotide
Medicine name
Signifor
Disease / condition
Treatment of Cushing's disease
Date of decision
08/10/2009
Outcome
Positive
Orphan decision number
EU/3/09/671

Review of designation

During its meeting of 7-8 February 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/671 for Signifor (pasireotide) as an orphan medicinal product for the treatment of Cushing's disease. 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 satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained*.


*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 a comparable therapeutic indication cannot be placed on the market.

Sponsor's contact details

Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Tel. +41 61 324 11 11 (Switzerland)
E-mail: orphan.enquiries@novartis.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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