Preotact

RSS

parathyroid hormone (rDNA)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Preotact has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 02/07/2014

Authorisation details

Product details
Name
Preotact
Agency product number
EMEA/H/C/000659
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
Publication details
Marketing-authorisation holder
NPS Pharma Holdings Limited
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
24/04/2006
Contact address
Grand Canal House
1 Grand Canal Street Upper
Dublin
Dublin 4
IRELAND

Product information

16/05/2014 Preotact - EMEA/H/C/000659 - T/0022

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

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

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.

Assessment history

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