Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mimpara   
Auth. number : EU/1/04/292
INN : Cinacalcet
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H05 - Calcium homeostasis
Pharmacological subgroup: H05B - Anti-parathyroid hormones
Chemical subgroup: H05BX - Other anti-parathyroid agents
Chemical substance: H05BX01 - Cinacalcet
(See WHO ATC Index)
Indication: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Reduction of hypercalcaemia in patients with parathyroid carcinoma.
Marketing Authorisation Holder: Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, 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 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
26/10/2004 Centralised - Authorisation EMEA/H/C/570 (2004)4250 of 22/10/2004
28/01/2005 Centralised - Variation EMEA/H/C/570/IA/2
03/02/2005 Centralised - Variation EMEA/H/C/570/IB/1
Updated with Decision(2005)3536 of 13/09/2005
14/09/2005 Centralised - Variation (2005)3536 of 13/09/2005
02/03/2006 Centralised - Variation EMEA/H/C/570/II/3 (2006)703 of 28/02/2006
31/03/2006 Centralised - Variation EMEA/H/C/570/II/4 (2006)1332 of 29/03/2006
20/04/2006 Centralised - Variation EMEA/H/C/570/IB/5
Updated with Decision(2006)3292 of 13/07/2006
17/07/2006 Centralised - Variation EMEA/H/C/570/II/6 (2006)3292 of 13/07/2006
06/09/2007 Centralised - Variation EMEA/H/C/570/II/7, 8 (2007)4191 of 31/08/2007
27/12/2007 Centralised - Variation EMEA/H/C/570/II/9 (2007)6863 of 21/12/2007
14/02/2008 Centralised - Variation EMEA/H/C/570/IA/12
19/03/2008 Centralised - Variation EMEA/H/C/570/II/11 (2008)1140 of 17/03/2008
23/06/2008 Centralised - Variation EMEA/H/C/570/II/10 (2008)3090 of 19/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/570/IB/13
31/10/2008 Centralised - Variation EMEA/H/C/570/II/14 (2008)6536 of 29/10/2008
04/03/2009 Centralised - Variation EMEA/H/C/570/IA/17
04/03/2009 Centralised - Variation EMEA/H/C/570/IA/19
04/03/2009 Centralised - Variation EMEA/H/C/570/IA/18
01/04/2009 Centralised - Variation EMEA/H/C/570/II/15 (2009)2469 of 27/03/2009
07/07/2009 Centralised - Variation EMEA/H/C/570/II/16 (2009)5481 of 02/07/2009
31/07/2009 Centralised - Variation EMEA/H/C/570/IA/22
02/09/2009 Centralised - Variation EMEA/H/C/570/II/21 (2009)6748 of 31/08/2009
25/09/2009 Centralised - Renewal EMEA/H/C/570/R/20 (2009)7455 of 23/09/2009
20/04/2010 Centralised - Variation EMEA/H/C/570/IB/23
27/08/2010 Centralised - Variation EMEA/H/C/570/IA/24/G
Updated with Decision(2010)7630 of 28/10/2010
04/11/2010 Centralised - Variation (2010)7630 of 28/10/2010
07/12/2010 Centralised - Variation EMEA/H/C/570/IA/25/G
Updated with Decision(2011)1155 of 18/02/2011
22/02/2011 Centralised - Variation (2011)1155 of 18/02/2011
28/06/2011 Centralised - Variation EMEA/H/C/570/IA/27/G
Updated with Decision(2012)596 of 30/01/2012
01/02/2012 Centralised - Variation (2012)596 of 30/01/2012
23/02/2012 Centralised - Variation EMEA/H/C/570/II/29 (2012)1268 of 21/02/2012
20/11/2012 Centralised - Variation EMEA/H/C/570/N/36
Updated with Decision(2013)9481 of 13/12/2013
13/12/2012 Centralised - Variation EMEA/H/C/570/II/38
Updated with Decision(2013)9481 of 13/12/2013
05/07/2013 Centralised - Variation EMEA/H/C/570/IB/43
Updated with Decision(2013)9481 of 13/12/2013
12/09/2013 Centralised - Variation EMEA/H/C/570/N/45
Updated with Decision(2013)9481 of 13/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/570/II/42
Updated with Decision(2013)9481 of 13/12/2013
17/12/2013 Centralised - Variation (2013)9481 of 13/12/2013
27/05/2014 Centralised - Variation EMEA/H/C/570/N/49
24/07/2014 Centralised - Variation EMEA/H/C/570/II/48