This is a summary of the European public assessment report (EPAR) for Natpar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Natpar.
For practical information about using Natpar, patients should read the package leaflet or contact their doctor or pharmacist.
Natpar : EPAR - Summary for the public (PDF/78.87 KB)
First published: 26/04/2017
Last updated: 26/04/2017
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Shire Pharmaceuticals Ireland Ltd
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22/08/2018 Natpar - EMEA/H/C/003861 - N/0011
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.