Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lumigan   
Auth. number : EU/1/02/205
INN : Bimatoprost
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01E - Antiglaucoma preparations and miotics
Chemical subgroup: S01EE - Prostaglandin analogues
Chemical substance: S01EE03 - Bimatoprost
(See WHO ATC Index)
Indication: Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).
Marketing Authorisation Holder: Allergan Pharmaceuticals Ireland
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
12/03/2002 Centralised - Authorisation EMEA/H/C/391 (2002)1033 of 08/03/2002
27/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/3
27/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/2
27/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/4
11/07/2002 Centralised - Variation EMEA/H/C/391/I/1 (2002)2680 of 09/07/2002
07/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/5
29/10/2002 Centralised - Variation EMEA/H/C/391/I/6 (2002)4291 of 23/10/2002
08/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/7
17/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/9
22/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/I/10
22/01/2004 Centralised - Variation EMEA/H/C/391/II/8 (2004)139 of 20/01/2004
24/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IA/15
06/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IA/14
19/07/2004 Centralised - Notification EMEA/H/C/391/N/13
Updated with Decision(2006)1816 of 27/04/2006
14/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IB/16
02/05/2006 Centralised - Variation EMEA/H/C/391/II/17 (2006)1816 of 27/04/2006
01/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IB/18
11/08/2006 Centralised - Notification EMEA/H/C/391/N/19
Updated with Decision(2007)611 of 20/02/2007
26/02/2007 Centralised - Renewal EMEA/H/C/391/R/20 (2007)611 of 20/02/2007
28/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IA/21
29/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IB/22
16/08/2007 Centralised - Notification EMEA/H/C/391/N/23
Updated with Decision(2009)6828 of 02/09/2009
07/03/2008 Centralised - Notification EMEA/H/C/391/N/25
Updated with Decision(2009)6828 of 02/09/2009
28/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/II/24
10/03/2009 Centralised - Notification EMEA/H/C/391/N/27
Updated with Decision(2009)6828 of 02/09/2009
07/09/2009 Centralised - Variation EMEA/H/C/391/II/28 (2009)6828 of 02/09/2009
11/01/2010 Centralised - Variation EMEA/H/C/391/X/26 (2010)47 of 07/01/2010
09/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/II/29
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/II/30
26/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/IA/32
06/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/391/II/31
21/01/2011 Centralised - Notification EMEA/H/C/391/N/33
Updated with Decision(2012)5339 of 23/07/2012
19/07/2011 Centralised - Notification EMEA/H/C/391/N/34
Updated with Decision(2012)5339 of 23/07/2012
25/07/2012 Centralised - Variation EMEA/H/C/391/II/35 (2012)5339 of 23/07/2012
23/11/2012 Centralised - Variation EMEA/H/C/391/II/36/G (2012)8600 of 19/11/2012
15/02/2013 Centralised - Notification EMEA/H/C/391/N/39
Updated with Decision(2013)9828 of 20/12/2013
27/02/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/391/T/40 (2013)1184 of 25/02/2013
21/03/2013 Centralised - Variation EMEA/H/C/391/IB/41
Updated with Decision(2013)9828 of 20/12/2013
29/03/2013 Corrigendum (2013)1902 of 26/03/2013
01/07/2013 Centralised - Notification EMEA/H/C/391/N/43
Updated with Decision(2013)9828 of 20/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/391/II/42
Updated with Decision(2013)9828 of 20/12/2013
02/01/2014 Centralised - Modification EMEA/H/C/391/PSUV/46 (2013)9828 of 20/12/2013
01/08/2014 Centralised - Notification EMEA/H/C/391/N/47