Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aclasta   
Auth. number : EU/1/05/308
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: Treatment of Pagets disease of the bone.
Treatment of osteoporosis in post-menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture.
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
19/04/2005 Centralised - Authorisation EMEA/H/C/595 (2005)1246 of 15/04/2005
16/06/2005 Centralised - Variation EMEA/H/C/595/N/1
20/09/2005 Centralised - Variation EMEA/H/C/595/IA/2
31/01/2006 Centralised - Variation EMEA/H/C/595/IA/4
02/03/2006 Centralised - Variation EMEA/H/C/595/IB/5
Updated with Decision(2006)4342 of 26/09/2006
08/06/2006 Centralised - Variation EMEA/H/C/595/IA/6
18/08/2006 Centralised - Variation EMEA/H/C/595/IA/9
Updated with Decision(2006)4342 of 26/09/2006
28/09/2006 Centralised - Variation (2006)4342 of 26/09/2006
26/10/2006 Centralised - Variation EMEA/H/C/595/II/7, 8 (2006)5177 of 24/10/2006
13/11/2006 Centralised - Variation EMEA/H/C/595/IB/11
Updated with Decision(2007)3703 of 25/07/2007
13/11/2006 Centralised - Variation EMEA/H/C/595/IB/12
11/05/2007 Centralised - Variation EMEA/H/C/595/N/15
Updated with Decision(2007)3703 of 25/07/2007
21/05/2007 Centralised - Variation EMEA/H/C/595/IA/13
30/07/2007 Centralised - Variation (2007)3703 of 25/07/2007
05/10/2007 Centralised - Variation EMEA/H/C/595/II/14, 10 (2007)4618 of 03/10/2007
05/10/2007 Centralised - Variation EMEA/H/C/595/II/14, 10 (2007)4619 of 03/10/2007
16/04/2008 Centralised - Variation EMEA/H/C/595/IB/18
17/09/2008 Centralised - Variation EMEA/H/C/595/IA/19
29/09/2008 Centralised - Variation EMEA/H/C/595/II/16 (2008)5591 of 26/09/2008
30/09/2008 Centralised - Variation EMEA/H/C/595/II/16 (2008)5592 of 26/09/2008
23/03/2009 Centralised - Variation EMEA/H/C/595/II/20
24/06/2009 Centralised - Variation EMEA/H/C/595/II/17 (2009)5127 of 22/06/2009
24/06/2009 Centralised - Variation EMEA/H/C/595/II/17 (2009)5128 of 22/06/2009
29/09/2009 Centralised - Variation EMEA/H/C/595/II/21
01/04/2010 Centralised - Renewal EMEA/H/C/595/R/22 (2010)2263 of 30/03/2010
03/05/2010 Centralised - Variation EMEA/H/C/595/II/23 (2010)2947 of 29/04/2010
18/05/2010 Centralised - Variation EMEA/H/C/595/II/24 (2010)3233 of 12/05/2010
17/08/2010 Centralised - Variation EMEA/H/C/595/IB/25/G
13/01/2011 Centralised - Variation EMEA/H/C/595/IG/32/G
Updated with Decision(2011)2699 of 12/04/2011
09/02/2011 Centralised - Variation EMEA/H/C/595/IG/41/G
13/04/2011 Centralised - Variation EMEA/H/C/595/II/27/G
14/04/2011 Centralised - Variation (2011)2699 of 12/04/2011
04/07/2011 Referral EMEA/H/C/595/A-20/26 (2011)4813 of 29/06/2011
09/02/2012 Centralised - Variation EMEA/H/C/595/II/28 (2012)821 of 06/02/2012
13/03/2012 Centralised - Variation EMEA/H/C/595/II/28 (2012)1736 of 09/03/2012
25/04/2012 Centralised - Variation EMEA/H/C/595/II/34 (2012)2840 of 20/04/2012
25/07/2013 Centralised - Variation EMEA/H/C/595/II/41
Updated with Decision(2014)5052 of 11/07/2014