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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Preotact
|
| Auth. number : | EU/1/06/339 |
| INN : | Parathyroid hormone |
| ATC: | H - Systemic hormonal prep, excluding sex hormones H05 - Calcium homeostasis H05A - Parathyroid hormones H05AA - Parathyroid hormones H05AA03 - Parathyroid hormone (See WHO ATC Index) |
| Indication: | Treatment of osteoporosis in postmenopausal women at high risk of fractures |
| Marketing Authorisation Holder: | Nycomed Danmark ApS
Langebjerg 1, DK-4000 Roskilde, Danmark |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | EMEA/H/C/659/II/1 | ||||
| 11/04/2007 | Centralised - Variation | 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 - Variation | EMEA/H/C/659/N/4 | ||||
| Updated with Decision(2011)2786 of 14/04/2011 | ||||||
| 29/04/2008 | Centralised - Variation | EMEA/H/C/659/II/5 | ||||
| 02/10/2008 | Centralised - Variation | EMEA/H/C/659/II/6 | ||||
| 31/03/2009 | Centralised - Variation | EMEA/H/C/659/IB/7 | ||||
| 25/03/2010 | Centralised - Variation | EMEA/H/C/659/II/8 | ||||
| 13/07/2010 | Centralised - Variation | EMEA/H/C/659/IA/13 | ||||
| 13/07/2010 | Centralised - Variation | EMEA/H/C/659/IA/12 | ||||
| 22/07/2010 | Centralised - Variation | EMEA/H/C/659/IB/10 | ||||
| 27/07/2010 | Centralised - Variation | EMEA/H/C/659/IA/11 | ||||
| 08/10/2010 | Centralised - Variation | 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 | - | (2011)2786 of 14/04/2011 | |||
| 25/04/2012 | Centralised - Variation | EMEA/H/C/659/II/17 | (2012)2817 of 20/04/2012 |