Natpar

Withdrawn

This medicine's authorisation has been withdrawn

parathyroid hormone

Overview

On 1 July 2026, the European Commission withdrew the marketing authorisation for Natpar (parathyroid hormone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharmaceuticals International AG Ireland Branch, which notified the European Commission of its decision to permanently discontinue the marketing of the product due to unresolved supply issues that are specific to the product.  

Natpar was granted marketing authorisation in the EU on 24 April 2017 for the treatment of hypoparathyroidism. 

Therapeutic alternatives are available throughout the EU. Patients using Natpar are advised to consult their doctor.

Natpar : EPAR - Summary for the public

Product information

Natpar : EPAR - Product Information

Natpar : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Natpar
• Active substance:
  parathyroid hormone
• International non-proprietary name (INN) or common name:
  parathyroid hormone
• Therapeutic area (MeSH):
  Hypoparathyroidism
• Anatomical therapeutic chemical (ATC) code:
  H05AA03

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003861
• Conditional 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.

• Orphan:

  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.

• Marketing authorisation holder:
  Takeda Pharmaceuticals International AG Ireland Branch

  Block 2 Miesian Plaza; 50-58 Baggot Street Lower; Dublin 2; Co Dublin; D02 HW68; Ireland

• Opinion adopted:
  23/02/2017
• Marketing authorisation issued:
  24/04/2017
• Withdrawal of marketing authorisation:
  01/07/2026
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

Natpar : EPAR - Procedural steps taken and scientific information after authorisation

Natpar : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Natpar-H-C-PSUSA-00010591-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/126024/2019

Initial marketing authorisation documents

Natpar : EPAR - Public assessment report

Reference Number: EMA/180882/2017

CHMP summary of positive opinion for Natpar

Reference Number: EMA/CHMP/99882/2017