Preotact
Withdrawn
This medicine's authorisation has been withdrawn
parathyroid hormone (rDNA)
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 24 April 2006 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Preotact (PTH(parathyroid hormone)) for treatment of osteoporosis in postmenopausal women who are at high risk of fractures. The marketing authorisation holder (MAH) responsible for Preotact was NPS Pharma Holdings Limited (NPS Pharma).
The European Commission was notified by a letter dated 21 March 2014 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Preotact for commercial reasons. Preotact was not marketed anywhere in the European Union. On 16 May 2014 the European Commission issued a decision to withdraw the marketing authorisation for Preotact.
Pursuant to this decision the European Public Assessment Report for Preotact is updated to reflect that the marketing authorisation is no longer valid.
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).
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 homeostasisTherapeutic 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.
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