Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Preotact
Auth. number : EU/1/06/339
INN : Parathyroid hormone
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H05 - Calcium homeostasis
Pharmacological subgroup: H05A - Parathyroid hormones
Chemical subgroup: H05AA - Parathyroid hormones
Chemical substance: H05AA03 - Parathyroid hormone
(See WHO ATC Index)
Indication: Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures.
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Marketing Authorisation Holder: NPS Pharma Holdings Limited
Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/04/2006 Centralised - Authorisation EMEA/H/C/659 (2006)1743 of 24/04/2006
29/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/II/1
11/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/IB/2
27/07/2007 Centralised - Variation EMEA/H/C/659/II/3 (2007)3679 of 24/07/2007
27/11/2007 Centralised - Notification EMEA/H/C/659/N/4
Updated with Decision(2011)2786 of 14/04/2011
29/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/II/5
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/II/6
31/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/IB/7
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/II/8
13/07/2010 Centralised - Variation (refusal) EMEA/H/C/659/IA/13
13/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/IA/12
22/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/IB/10
27/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/IA/11
08/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/659/II/9
27/10/2010 Centralised - Variation EMEA/H/C/659/IA/14
Updated with Decision(2011)2786 of 14/04/2011
18/04/2011 Centralised - Renewal EMEA/H/C/659/R/15 (2011)2786 of 14/04/2011
25/04/2012 Centralised - Variation EMEA/H/C/659/II/17 (2012)2817 of 20/04/2012
27/06/2013 Centralised - Variation EMEA/H/C/659/IA/21
Updated with Decision(2013)8705 of 29/11/2013
03/12/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/659/T/22 (2013)8705 of 29/11/2013
20/05/2014 Centralised - Withdrawal (2014)3418 of 16/05/2014