Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Forsteo   
Auth. number : EU/1/03/247
INN : Teriparatide
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: H05AA02 - Teriparatide
(See WHO ATC Index)
Indication: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland

  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 continues to be 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
12/06/2003 Centralised - Authorisation EMEA/H/C/425 (2003)1884 of 10/06/2003
21/11/2003 Centralised - Variation EMEA/H/C/425/I/1
22/01/2004 Centralised - Variation EMEA/H/C/425/N/2 (2004)141 of 20/01/2004
30/07/2004 Centralised - Variation EMEA/H/C/425/N/3
Updated with Decision(2005)1390 of 27/04/2005
29/04/2005 Centralised - Variation EMEA/H/C/425/II/4 (2005)1390 of 27/04/2005
12/05/2005 Centralised - Variation EMEA/H/C/425/II/6
12/05/2005 Centralised - Variation EMEA/H/C/425/II/5
30/06/2005 Centralised - Variation EMEA/H/C/425/IA/8
26/07/2005 Centralised - Variation EMEA/H/C/425/IA/9
Updated with Decision(2005)3438 of 05/09/2005
01/09/2005 Centralised - Variation EMEA/H/C/425/IB/10
05/09/2005 Centralised - Variation EMEA/H/C/425/II/7 (2005)3438 of 05/09/2005
25/06/2007 Centralised - Variation EMEA/H/C/425/II/11 (2007)3138 of 21/06/2007
27/06/2007 Centralised - Variation EMEA/H/C/425/II/12
23/08/2007 Centralised - Variation EMEA/H/C/425/II/14 (2007)4017 of 21/08/2007
26/02/2008 Centralised - Variation EMEA/H/C/425/II/15
04/04/2008 Centralised - Variation EMEA/H/C/425/II/13, 17 (2008)1315 of 02/04/2008
23/04/2008 Centralised - Variation EMEA/H/C/425/II/16 (2008)1660 of 21/04/2008
22/05/2008 Centralised - Renewal EMEA/H/C/425/R/18 (2008)2021 of 20/05/2008
27/02/2009 Centralised - Variation EMEA/H/C/425/II/19 (2009)1383 of 25/02/2009
05/06/2009 Centralised - Variation EMEA/H/C/425/II/20
01/09/2009 Centralised - Variation EMEA/H/C/425/II/21 (2009)6726 of 28/08/2009
21/01/2010 Centralised - Variation EMEA/H/C/425/IA/22
18/03/2010 Centralised - Variation EMEA/H/C/425/IB/23
Updated with Decision(2010)7540 of 25/10/2010
27/10/2010 Centralised - Variation (2010)7540 of 25/10/2010
20/12/2010 Centralised - Variation EMEA/H/C/425/IA/26/G
Updated with Decision(2011)247 of 24/03/2011
27/01/2011 Centralised - Variation EMEA/H/C/425/II/24/G
30/03/2011 Centralised - Variation (2011)247 of 24/03/2011
25/04/2011 Centralised - Variation EMEA/H/C/425/II/27/G
01/06/2011 Centralised - Variation EMEA/H/C/425/II/25/G (2011)3872 of 27/05/2011
28/07/2011 Centralised - Variation EMEA/H/C/425/II/29 (2011)5525 of 26/07/2011
08/03/2012 Centralised - Variation EMEA/H/C/425/N/30
Updated with Decision(2013)936 of 13/02/2013
15/02/2013 Centralised - Renewal EMEA/H/C/425/R/31 (2013)936 of 13/02/2013
19/02/2014 Centralised - Variation EMEA/H/C/425/N/36