Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Relistor   
Auth. number : EU/1/08/463
INN : methylnaltrexone bromide
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A06 - Laxatives
Pharmacological subgroup: A06A - Laxatives
Chemical subgroup: A06AH - Peripheral opioid receptor antagonists
Chemical substance: A06AH01 - Methylnaltrexone bromide
(See WHO ATC Index)
Indication: Relistor is indicated for the treatment of opioid-induced constipation in advanced illness adult patients, aged 18 years and older, who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Marketing Authorisation Holder: TMC Pharma Services Ltd
Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, 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
04/07/2008 Centralised - Authorisation EMEA/H/C/870 (2008)3438 of 02/07/2008
05/02/2009 Centralised - Notification EMEA/H/C/870/N/1
Updated with Decision(2009)5535 of 03/07/2009
07/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/870/IB/4
07/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/870/II/2
02/06/2009 Centralised - Variation EMEA/H/C/870/IA/5
Updated with Decision(2009)5535 of 03/07/2009
07/07/2009 Centralised - Variation EMEA/H/C/870/II/3 (2009)5535 of 03/07/2009
24/12/2009 Centralised - Variation EMEA/H/C/870/II/7 (2009)10747 of 22/12/2009
05/05/2010 Centralised - Variation EMEA/H/C/870/IB/14
Updated with Decision(2010)4791 of 05/07/2010
05/05/2010 Centralised - Variation EMEA/H/C/870/IB/15
Updated with Decision(2010)4791 of 05/07/2010
07/05/2010 Centralised - Variation EMEA/H/C/870/IA/11
Updated with Decision(2010)4791 of 05/07/2010
07/05/2010 Centralised - Variation EMEA/H/C/870/IA/12
Updated with Decision(2010)4791 of 05/07/2010
07/05/2010 Centralised - Variation EMEA/H/C/870/IA/13
Updated with Decision(2010)4791 of 05/07/2010
07/05/2010 Centralised - Variation EMEA/H/C/870/IA/9
Updated with Decision(2010)4791 of 05/07/2010
07/05/2010 Centralised - Variation EMEA/H/C/870/IA/10
Updated with Decision(2010)4791 of 05/07/2010
08/07/2010 Centralised - Variation EMEA/H/C/870/II/8 (2010)4791 of 05/07/2010
06/09/2010 Centralised - Variation EMEA/H/C/870/II/16 (2010)6135 of 01/09/2010
08/09/2010 Centralised - Variation EMEA/H/C/870/X/6 (2010)6235 of 06/09/2010
04/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/870/IA/17
21/06/2011 Centralised - Variation EMEA/H/C/870/WS/117 (2011)4456 of 17/06/2011
07/07/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/870/T/19 (2011)4992 of 05/07/2011
01/08/2011 Centralised - Variation EMEA/H/C/870/II/18 (2011)5593 of 27/07/2011
14/12/2012 Centralised - Variation EMEA/H/C/870/IAin/23
Updated with Decision(2013)3234 of 27/05/2013
21/01/2013 Centralised - Notification EMEA/H/C/870/N/24
Updated with Decision(2013)3234 of 27/05/2013
29/05/2013 Centralised - Renewal EMEA/H/C/870/R/22 (2013)3234 of 27/05/2013
19/09/2013 Centralised - Variation EMEA/H/C/870/II/28
Updated with Decision(2014)6510 of 11/09/2014
23/06/2014 Centralised - Variation EMEA/H/C/870/IAin/31/G
Updated with Decision(2014)6510 of 11/09/2014
22/08/2014 Centralised - Variation EMEA/H/C/870/IB/35
Updated with Decision(2014)6510 of 11/09/2014
15/09/2014 Centralised - Yearly update (2014)6510 of 11/09/2014