EU/3/09/670

About

On 8 October 2009, orphan designation (EU/3/09/670) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for pasireotide for the treatment of acromegaly.

Pasireotide in treatment of acromegaly has been authorised in the EU as Signifor since 19 November 2014.

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

The sponsorship was transferred to Recordati Rare Diseases, France in May 2020.

Key facts

Active substance
pasireotide
Medicine name
Signifor
Disease / condition
Treatment of acromegaly
Date of first decision
08/10/2009
Outcome
Positive
EU designation number
EU/3/09/670

Review of designation

During its meeting of 7 to 9 October 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/670 for Signifor (pasireotide) as an orphan medicinal product for the treatment of acromegaly. The COMP assessed whether, at the time of addition of a new indication to the 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. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with acromegaly. 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

Recordati Rare Diseases   
Immeuble Le Wilson
70 Avenue Du General De Gaulle
92800 Puteaux
France
Tel. +33 1 4773 9527
E-mail: RRDinfo@recordati.com

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.

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