EU/3/13/1210

About

On 16 January 2014, orphan designation (EU/3/13/1210) was granted by the European Commission to NPS Pharma UK Ltd, United Kingdom, for recombinant human parathyroid hormone for the treatment of hypoparathyroidism.

The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland, in January 2016.

Recombinant human parathyroid hormone has been authorised in the EU as Natpar since 24 April 2017.

Key facts

Active substance
Recombinant human parathyroid hormone
Disease / condition
Treatment of hypoparathyroidism
Date of first decision
16/01/2014
Outcome
Positive
EU designation number
EU/3/13/1210

Review of designation

On 6 March 2017, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/13/1210 for Natpar (parathyroid hormone) as an orphan medicinal product for the treatment of hypoparathyroidism. 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. 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 treatment of hypoparathyroidism. The COMP recommended that the orphan designation of the medicine be maintained1


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

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
Ireland
Tel. +353 1 429 7700
Fax +353 1 429 7722
E-mail: medinfoemea@shire.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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