Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xenical   
Auth. number : EU/1/98/071
Active substance : 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: Xenical is 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.Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
30/07/1998 Centralised - Authorisation EMEA/H/C/154 (1998)2372 of 29/07/1998
20/01/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/3
05/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/4
18/05/1999 Centralised - Notification EMEA/H/C/154/N/1 (1999)1295 of 11/05/1999
18/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/8
18/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/6
18/05/1999 Centralised - Variation EMEA/H/C/154/II/2 (1999)1294 of 11/05/1999
25/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/5
25/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/9
25/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/7
15/12/1999 Centralised - Variation EMEA/H/C/154/II/10 (1999)4279 of 08/12/1999
17/05/2000 Centralised - Variation EMEA/H/C/154/II/11 (2000)1219 of 11/05/2000
18/12/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/14
08/05/2001 Centralised - Variation EMEA/H/C/154/II/12, 13 (2001)916 of 03/05/2001
04/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/17
04/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/16
08/08/2001 Centralised - Notification EMEA/H/C/154/N/20 (2001)2084 of 06/08/2001
04/10/2001 Centralised - Variation EMEA/H/C/154/I/15 (2001)2766 of 03/10/2001
01/11/2001 Centralised - Variation EMEA/H/C/154/II/18 (2001)2988 of 31/10/2001
23/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/21
23/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/22
23/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/I/23
24/06/2002 Centralised - Variation EMEA/H/C/154/II/19 (2002)2417 of 20/06/2002
06/03/2003 Centralised - Variation EMEA/H/C/154/II/24 (2003)750 of 04/03/2003
02/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/II/25
27/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/II/26
10/10/2003 Centralised - Variation EMEA/H/C/154/II/28 (2003)3730 of 08/10/2003
10/10/2003 Centralised - Renewal EMEA/H/C/154/R/27 (2003)3728 of 08/10/2003
13/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IB/30
04/03/2004 Centralised - Variation EMEA/H/C/154/II/29 (2004)744 of 02/03/2004
18/06/2004 Centralised - Notification EMEA/H/C/154/N/32
Updated with Decision(2004)3530 of 15/09/2004
10/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/35
10/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/33
17/09/2004 Centralised - Variation EMEA/H/C/154/II/31 (2004)3530 of 15/09/2004
14/06/2005 Centralised - Variation EMEA/H/C/154/II/34 (2005)1810 of 10/06/2005
25/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/37
03/02/2006 Centralised - Variation EMEA/H/C/154/IA/38
Updated with Decision(2006)2225 of 31/05/2006
20/03/2006 Centralised - Variation EMEA/H/C/154/IA/40
Updated with Decision(2006)2225 of 31/05/2006
01/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/41
02/06/2006 Centralised - Variation EMEA/H/C/154/II/39 (2006)2225 of 31/05/2006
26/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/42
19/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/44
10/05/2007 Centralised - Notification EMEA/H/C/154/N/43
Updated with Decision(2008)3016 of 17/06/2008
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/II/45
06/11/2007 Centralised - Variation EMEA/H/C/154/IA/47
Updated with Decision(2008)3016 of 17/06/2008
20/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/49
19/06/2008 Centralised - Renewal EMEA/H/C/154/R/50 (2008)3016 of 17/06/2008
09/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/52
27/03/2009 Centralised - Variation EMEA/H/C/154/II/53 (2009)2314 of 25/03/2009
09/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/154/IA/54
02/05/2011 Centralised - Variation EMEA/H/C/154/IA/55/G
Updated with Decision(2011)9181 of 05/12/2011
07/12/2011 Centralised - Variation (2011)9181 of 05/12/2011
24/04/2012 Referral EMEA/H/C/154/A-20/57 (2012)2815 of 20/04/2012
26/09/2012 Referral EMEA/H/C/154/A-20/59 (2012)6847 of 24/09/2012
25/06/2013 PSUSA - Modification EMEA/H/C/154/PSU/17 (2013)4023 of 21/06/2013
21/08/2013 Centralised - Variation EMEA/H/C/154/IA/63
Updated with Decision(2014) 6178 of 26/08/2014
15/04/2014 Centralised - Variation EMEA/H/C/154/IB/65
Updated with Decision(2014) 6178 of 26/08/2014
12/06/2014 Centralised - Variation EMEA/H/C/154/IB/66
Updated with Decision(2014) 6178 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014) 6178 of 26/08/2014