Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ganfort   
Auth. number : EU/1/06/340
INN : bimatoprost / 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: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues
Marketing Authorisation Holder: Allergan Pharmaceuticals Ireland, (514125)
Castlebar Road, Westport, County Mayo, Ireland

  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
23/05/2006 Centralised - Authorisation EMEA/H/C/668 (2006)2125 of 19/05/2006
28/06/2007 Centralised - Variation EMEA/H/C/668/IA/1
22/08/2007 Centralised - Variation EMEA/H/C/668/N/2
Updated with Decision(2009)1577 of 02/03/2009
20/02/2008 Centralised - Variation EMEA/H/C/668/N/3
Updated with Decision(2009)1577 of 02/03/2009
31/10/2008 Centralised - Variation EMEA/H/C/668/IA/4
05/03/2009 Centralised - Variation EMEA/H/C/668/II/5 (2009)1577 of 02/03/2009
29/09/2009 Centralised - Variation EMEA/H/C/668/II/6
13/01/2010 Centralised - Variation EMEA/H/C/668/N/7
Updated with Decision(2011)4641 of 23/06/2011
27/07/2010 Centralised - Variation EMEA/H/C/668/N/9
Updated with Decision(2011)4641 of 23/06/2011
06/12/2010 Centralised - Variation EMEA/H/C/668/IA/10
06/01/2011 Centralised - Variation EMEA/H/C/668/II/8
28/07/2011 Centralised - Renewal EMEA/H/C/668/R/11 (2011)4641 of 23/06/2011
20/12/2011 Centralised - Variation EMEA/H/C/668/IB/13
Updated with Decision(2012)4853 of 06/07/2012
10/07/2012 Centralised - Variation (2012)4853 of 06/07/2012
26/10/2012 Centralised - Variation EMEA/H/C/668/II/14, 15 (2012)7642 of 24/10/2012
15/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/668/T/18 (2013)1640 of 13/03/2013
31/05/2013 Centralised - Variation EMEA/H/C/668/II/17/G, EMEA/H/C/668/II/19
Updated with Decision(2013)6698 of 04/10/2013
08/10/2013 Centralised - Maintain EMEA/H/C/668/PSUV/20 (PSU-10) (2013)6698 of 04/10/2013