Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zometa   
Auth. number : EU/1/01/176
INN : zoledronic acid
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M05 - Drugs for treatment of bone diseases
Pharmacological subgroup: M05B - Drugs affecting bone structure and mineralization
Chemical subgroup: M05BA - Biphosphonates
Chemical substance: M05BA08 - Zoledronic acid
(See WHO ATC Index)
Indication:
  • Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
  • Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

  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
22/03/2001 Centralised - Authorisation EMEA/H/C/336 (2001)619 of 20/03/2001
07/01/2002 Centralised - Variation EMEA/H/C/336/I/4
23/07/2002 Centralised - Variation EMEA/H/C/336/II/1 (2002)2856 of 19/07/2002
25/03/2003 Centralised - Variation EMEA/H/C/336/X/2 (2003)1032 of 24/03/2003
30/04/2003 Centralised - Variation EMEA/H/C/336/II/6
06/06/2003 Centralised - Variation EMEA/H/C/336/II/3 (2003)1840 of 04/06/2003
16/06/2004 Centralised - Variation EMEA/H/C/336/IB/8
20/09/2004 Centralised - Variation EMEA/H/C/336/N/7
Updated with Decision(2004)4331 of 04/11/2004
08/11/2004 Centralised - Variation EMEA/H/C/336/II/9 (2004)4331 of 04/11/2004
02/02/2005 Centralised - Variation EMEA/H/C/336/IA/12
02/02/2005 Centralised - Variation EMEA/H/C/336/IA/11
24/03/2005 Centralised - Variation EMEA/H/C/336/II/10 (2005)1009 of 22/03/2005
22/09/2005 Centralised - Variation EMEA/H/C/336/IA/14
15/11/2005 Centralised - Variation EMEA/H/C/336/IA/15
03/01/2006 Centralised - Variation EMEA/H/C/336/II/13 (2005)6011 of 23/12/2005
26/04/2006 Centralised - Renewal EMEA/H/C/336/R/16 (2006)1758 of 24/04/2006
06/06/2006 Centralised - Variation EMEA/H/C/336/II/17 (2006)2248 of 01/06/2006
20/07/2006 Centralised - Variation EMEA/H/C/336/IB/19
05/09/2006 Centralised - Variation EMEA/H/C/336/IB/20
23/10/2006 Centralised - Variation EMEA/H/C/336/II/18 (2006)5078 of 19/10/2006
19/02/2007 Centralised - Variation EMEA/H/C/336/N/22
Updated with Decision(2007)2439 of 04/06/2007
21/05/2007 Centralised - Variation EMEA/H/C/336/IA/25
06/06/2007 Centralised - Variation EMEA/H/C/336/II/24 (2007)2439 of 04/06/2007
23/10/2007 Centralised - Variation EMEA/H/C/336/II/26 (2007)5226 of 19/10/2007
09/04/2008 Centralised - Variation EMEA/H/C/336/IB/27
08/07/2008 Centralised - Variation EMEA/H/C/336/II/28 (2008)3504 of 04/07/2008
16/10/2008 Centralised - Variation EMEA/H/C/336/IA/29
23/03/2009 Centralised - Variation EMEA/H/C/336/II/30
16/07/2009 Centralised - Variation EMEA/H/C/336/II/33 (2009)5765 of 14/07/2009
29/09/2009 Centralised - Variation EMEA/H/C/336/II/32
27/01/2010 Centralised - Variation EMEA/H/C/336/II/31 (2010)524 of 25/01/2010
24/02/2011 Centralised - Variation EMEA/H/C/336/IG/41/G
01/07/2011 Referral EMEA/H/C/336/A-20/36 (2011)4800 of 29/06/2011
30/08/2011 Centralised - Variation EMEA/H/C/336/X/35 (2011)6187 of 24/08/2011
21/02/2012 Centralised - Variation EMEA/H/C/336/IB/42
Updated with Decision(2012)7640 of 24/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/336/II/45 (2012)7640 of 24/10/2012
29/05/2013 Centralised - Modification EMEA/H/C/336/PSU/35 (2013)3220 of 27/05/2013
24/10/2013 Centralised - Variation EMEA/H/C/336/II/51