Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Azarga   
Auth. number : EU/1/08/482
INN : brinzolamide / timolol
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01E - Antiglaucoma preparations and miotics
Chemical subgroup: S01ED - Beta blocking agents
Chemical substance: S01ED51 - Timolol, combinations
(See WHO ATC Index)
Indication: Decrease of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
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
27/11/2008 Centralised - Authorisation EMEA/H/C/960 (2008)7609 of 25/11/2008
23/12/2009 Centralised - Variation EMEA/H/C/960/II/1 (2009)10701 of 21/12/2009
11/02/2010 Centralised - Variation EMEA/H/C/960/II/3
11/02/2010 Centralised - Variation EMEA/H/C/960/II/2
02/06/2010 Centralised - Variation EMEA/H/C/960/IB/4
14/09/2010 Centralised - Variation EMEA/H/C/960/IG/19
07/12/2010 Centralised - Variation EMEA/H/C/960/IA/6/G
Updated with Decision(2011)978 of 11/02/2011
09/12/2010 Centralised - Variation EMEA/H/C/960/N/5
Updated with Decision(2011)978 of 11/02/2011
31/01/2011 Centralised - Variation EMEA/H/C/960/II/WS/75
01/02/2011 Centralised - Variation EMEA/H/C/960/IB/7
15/02/2011 Centralised - Variation (2011)978 of 11/02/2011
17/02/2012 Centralised - Variation EMEA/H/C/960/IB/15/G
Updated with Decision(2012)6710 of 20/09/2012
20/04/2012 Centralised - Variation EMEA/H/C/960/N/19
Updated with Decision(2012)6710 of 20/09/2012
24/09/2012 Centralised - Variation (2012)6710 of 20/09/2012
19/03/2013 Centralised - Variation EMEA/H/C/960/IG/274
Updated with Decision(2013)5619 of 26/08/2013
27/06/2013 Centralised - Variation EMEA/H/C/960/II/21
Updated with Decision(2013)5619 of 26/08/2013
29/08/2013 Centralised - Renewal EMEA/H/C/960/R/23 (2013)5619 of 26/08/2013
20/03/2014 Centralised - Variation EMEA/H/C/960/II/28