Preotact

Withdrawn

This medicine's authorisation has been withdrawn

parathyroid hormone (rDNA)

Overview

The marketing authorisation for Preotact has been withdrawn at the request of the marketing authorisation holder.

Preotact : EPAR - Summary for the public

Product information

Preotact : EPAR - Product Information

Latest procedure affecting product information: T/0022

16/05/2014

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Preotact : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Calcium homeostasis

Therapeutic indication

Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).

A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

Authorisation details

• EMA product number:
  EMEA/H/C/000659
• Marketing authorisation holder:
  NPS Pharma Holdings Limited

  Grand Canal House; 1 Grand Canal Street Upper; Dublin; Dublin 4; IRELAND

• Marketing authorisation issued:
  24/04/2006
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Preotact : EPAR - Scientific Discussion

Preotact : EPAR - Procedural steps taken before authorisation