Natpar

RSS

parathyroid hormone

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 20/02/2019

Authorisation details

Product details
Name
Natpar
Agency product number
EMEA/H/C/003861
Active substance
parathyroid hormone
International non-proprietary name (INN) or common name
parathyroid hormone
Therapeutic area (MeSH)
Hypoparathyroidism
Anatomical therapeutic chemical (ATC) code
H05AA03
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Shire Pharmaceuticals Ireland Ltd
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
24/04/2017
Contact address

Block 2-3, Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 Y754 
Ireland

Product information

15/01/2019 Natpar - EMEA/H/C/003861 - PSUSA/00010591/201804

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CALCIUM HOMEOSTASIS

Therapeutic indication

Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

Assessment history

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