Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Parareg
Auth. number : EU/1/04/293
Active substance : 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: Dompé Biotec S.p.A.
Via San Martino, 12, I-20122 Milano, Italia
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/575 (2004)4248 of 22/10/2004
28/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/575/IA/2
03/02/2005 Centralised - Variation EMEA/H/C/575/IB/1
Updated with Decision(2005)3264 of 16/08/2005
18/08/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/575/T/3 (2005)3264 of 16/08/2005
02/03/2006 Centralised - Variation EMEA/H/C/575/II/4 (2006)686 of 28/02/2006
31/03/2006 Centralised - Variation EMEA/H/C/575/II/5 (2006)1331 of 29/03/2006
20/04/2006 Centralised - Variation EMEA/H/C/575/IB/6
Updated with Decision(2006)3293 of 13/07/2006
17/07/2006 Centralised - Variation EMEA/H/C/575/II/7 (2006)3293 of 13/07/2006
06/09/2007 Centralised - Variation EMEA/H/C/575/II/8, 9 (2007)4193 of 31/08/2007
02/01/2008 Centralised - Variation EMEA/H/C/575/II/10 (2007)6870 of 21/12/2007
14/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/575/IA/13
19/03/2008 Centralised - Variation EMEA/H/C/575/II/12 (2008)1141 of 17/03/2008
20/06/2008 Centralised - Variation EMEA/H/C/575/II/11 (2008)3077 of 18/06/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/575/IB/14
31/10/2008 Centralised - Variation EMEA/H/C/575/II/15 (2008)6537 of 29/10/2008
09/12/2008 Centralised - Withdrawal (2008)8249 of 05/12/2008