Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Azopt   
Auth. number : EU/1/00/129
INN : Brinzolamide
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01E - Antiglaucoma preparations and miotics
Chemical subgroup: S01EC - Carbonic anhydrase inhibitors
Chemical substance: S01EC04 - Brinzolamide
(See WHO ATC Index)
Indication: AZOPT is indicated to decrease elevated intraocular pressure in:- ocular hypertension- open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also section 5.1).
Marketing Authorisation Holder: Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, 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
10/03/2000 Centralised - Authorisation EMEA/H/C/267 (2000)576 of 09/03/2000
17/11/2000 Centralised - Variation EMEA/H/C/267/I/1 (2000)3239 of 16/11/2000
15/02/2002 Centralised - Variation EMEA/H/C/267/I/2, 3
18/03/2002 Centralised - Variation EMEA/H/C/267/I/4
23/05/2002 Centralised - Variation EMEA/H/C/267/I/5
28/06/2002 Centralised - Variation EMEA/H/C/267/I/6
14/11/2002 Centralised - Variation EMEA/H/C/267/N/7 (2002)4502 of 12/11/2002
13/05/2004 Centralised - Variation EMEA/H/C/267/N/8
Updated with Decision(2005)1712 of 02/06/2005
06/06/2005 Centralised - Renewal EMEA/H/C/267/R/11 (2005)1712 of 02/06/2005
06/06/2006 Centralised - Variation EMEA/H/C/267/IB/12
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/19
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/18
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/14
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/13
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/16
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/17
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/15
31/07/2006 Centralised - Variation EMEA/H/C/267/IA/20
16/08/2006 Centralised - Variation EMEA/H/C/267/IA/23
16/08/2006 Centralised - Variation EMEA/H/C/267/IA/22
16/08/2006 Centralised - Variation EMEA/H/C/267/IA/21
22/02/2007 Centralised - Variation EMEA/H/C/267/II/24 (2007)607 of 20/02/2007
12/04/2007 Centralised - Variation EMEA/H/C/267/IA/28
12/04/2007 Centralised - Variation EMEA/H/C/267/IA/27
15/06/2007 Centralised - Variation EMEA/H/C/267/II/25 (2007)2598 of 13/06/2007
22/06/2007 Centralised - Variation EMEA/H/C/267/II/26
23/10/2007 Centralised - Variation EMEA/H/C/267/II/31
04/12/2007 Centralised - Variation EMEA/H/C/267/II/29 (2007)6093 of 30/11/2007
04/06/2008 Centralised - Variation EMEA/H/C/267/IA/32
24/06/2008 Centralised - Variation EMEA/H/C/267/II/30 (2008)3152 of 20/06/2008
21/01/2009 Centralised - Variation EMEA/H/C/267/N/33
Updated with Decision(2010)706 of 29/01/2010
26/01/2009 Centralised - Variation EMEA/H/C/267/II/34
01/06/2009 Centralised - Variation EMEA/H/C/267/IA/38
01/06/2009 Centralised - Variation EMEA/H/C/267/IA/37
16/06/2009 Centralised - Variation EMEA/H/C/267/II/36
16/06/2009 Centralised - Variation EMEA/H/C/267/II/35
02/02/2010 Centralised - Renewal EMEA/H/C/267/R/39 (2010)706 of 29/01/2010
21/05/2010 Centralised - Variation EMEA/H/C/267/IB/42
15/09/2010 Centralised - Variation EMEA/H/C/267/IB/43/G
02/12/2010 Centralised - Variation EMEA/H/C/267/N/44
Updated with Decision(2011)6596 of 16/09/2011
18/01/2011 Centralised - Variation EMEA/H/C/267/IG/39
Updated with Decision(2011)6596 of 16/09/2011
04/02/2011 Centralised - Variation EMEA/H/C/267/WS/75
18/04/2011 Centralised - Variation EMEA/H/C/267/IB/45
20/09/2011 Centralised - Variation (2011)6596 of 16/09/2011
06/03/2012 Centralised - Variation EMEA/H/C/267/IG/149/G
Updated with Decision(2012)4211 of 15/06/2012
20/06/2012 Centralised - Variation (2012)4211 of 15/06/2012
19/03/2013 Centralised - Variation EMEA/H/C/267/IG/274
Updated with Decision(2014)1617 of 05/03/2014
01/07/2013 Centralised - Variation EMEA/H/C/267/N/56
Updated with Decision(2014)1617 of 05/03/2014
10/03/2014 Centralised - Variation (2014)1617 of 05/03/2014
25/04/2014 Centralised - Variation EMEA/H/C/267/II/59