Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: alli   
Auth. number : EU/1/07/401
INN : Orlistat
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A08 - Antiobesity preparations, excluding diet products
Pharmacological subgroup: A08A - Antiobesity preparations, excluding diet products
Chemical subgroup: A08AB - Peripherally acting antiobesity products
Chemical substance: A08AB01 - Orlistat
(See WHO ATC Index)
Indication: indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, 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
25/07/2007 Centralised - Authorisation EMEA/H/C/854 (2007)3628 of 23/07/2007
12/09/2008 Centralised - Variation EMEA/H/C/854/IB/2
Updated with Decision(2009)426 of 20/01/2009
22/01/2009 Centralised - Variation EMEA/H/C/854/X/1 (2009)426 of 20/01/2009
31/03/2009 Centralised - Variation EMEA/H/C/854/IA/3
Updated with Decision(2009)8009 of 14/10/2009
31/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IA/5
31/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IA/4
06/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IA/6
06/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IA/8
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/II/7
16/10/2009 Centralised - Variation (2009)8009 of 14/10/2009
26/11/2009 Centralised - Variation EMEA/H/C/854/II/9 (2009)9461 of 24/11/2009
24/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IA/12
24/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IA/13
31/03/2010 Centralised - Variation EMEA/H/C/854/IB/15
Updated with Decision(2010)5844 of 18/08/2010
30/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/II/11
26/05/2010 Centralised - Variation EMEA/H/C/854/IA/18
Updated with Decision(2010)5844 of 18/08/2010
26/05/2010 Centralised - Variation EMEA/H/C/854/IA/20
Updated with Decision(2010)5844 of 18/08/2010
26/05/2010 Centralised - Variation EMEA/H/C/854/IA/19
Updated with Decision(2010)5844 of 18/08/2010
04/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IB/22
04/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/854/IB/21
20/08/2010 Centralised - Notification EMEA/H/C/854/N/23
Updated with Decision(2010)8638 of 29/11/2010
24/08/2010 Centralised - Variation (2010)5844 of 18/08/2010
03/12/2010 Centralised - Variation EMEA/H/C/854/X/10 (2010)8638 of 29/11/2010
01/03/2011 Centralised - Variation EMEA/H/C/854/IB/24
Updated with Decision(2011)5691 of 01/08/2011
24/06/2011 Centralised - Notification EMEA/H/C/854/N/27
Updated with Decision(2011)5691 of 01/08/2011
03/08/2011 Centralised - Variation EMEA/H/C/854/II/25 (2011)5691 of 01/08/2011
16/11/2011 Centralised - Variation EMEA/H/C/854/IA/35/G
Updated with Decision(2012)584 of 30/01/2012
01/02/2012 Centralised - Variation (2012)584 of 30/01/2012
17/04/2012 Referral EMEA/H/C/854/A-20/29 (2012)2544 of 13/04/2012
25/06/2012 Centralised - Renewal EMEA/H/C/854/R/37 (2012)4349 of 21/06/2012
26/09/2012 Referral EMEA/H/C/854/A-20/36 (2012)6850 of 24/09/2012
18/04/2013 Centralised - Variation EMEA/H/C/854/IA/279
Updated with Decision(2014)2920 of 28/04/2014
05/07/2013 Centralised - Notification EMEA/H/C/854/N/41
Updated with Decision(2014)2920 of 28/04/2014
23/01/2014 Centralised - Variation EMEA/H/C/854/II/42
Updated with Decision(2014)2920 of 28/04/2014
30/04/2014 Centralised - Yearly update (2014)2920 of 28/04/2014
16/06/2014 Centralised - Variation EMEA/H/C/854/IB/45