Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Resolor   
Auth. number : EU/1/09/581
INN : prucalopride
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A06 - Laxatives
Pharmacological subgroup: A06A - Laxatives
Chemical subgroup: A06AX - Other laxatives
Chemical substance: A06AX05 - Prucalopride
(See WHO ATC Index)
Indication: Symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
Marketing Authorisation Holder: Shire Pharmaceuticals Ireland Limited
5 River Walk, Citywest Business Campus, Dublin 24, 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
19/10/2009 Centralised - Authorisation EMEA/H/C/1012 (2009)8083 of 15/10/2009
08/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1012/IB/1
15/07/2010 Centralised - Variation EMEA/H/C/1012/IA/4
Updated with Decision(2011)73 of 06/01/2011
03/08/2010 Centralised - Variation EMEA/H/C/1012/IB/2/G
Updated with Decision(2011)73 of 06/01/2011
14/09/2010 Centralised - Variation EMEA/H/C/1012/IA/5
Updated with Decision(2011)73 of 06/01/2011
06/10/2010 Centralised - Variation EMEA/H/C/1012/IB/6
Updated with Decision(2011)73 of 06/01/2011
06/10/2010 Centralised - Variation EMEA/H/C/1012/IB/7/G
Updated with Decision(2011)73 of 06/01/2011
11/01/2011 Centralised - Variation (2011)73 of 06/01/2011
19/01/2011 Centralised - Variation EMEA/H/C/1012/IA/9
Updated with Decision(2011)6591 of 16/09/2011
21/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1012/IB/10
21/09/2011 Centralised - Variation (2011)6591 of 16/09/2011
21/09/2011 Centralised - Variation EMEA/H/C/1012/IB/8
Updated with Decision(2011)6591 of 16/09/2011
21/09/2011 Centralised - Notification EMEA/H/C/1012/N/11
Updated with Decision(2011)6591 of 16/09/2011
01/02/2012 Centralised - Variation EMEA/H/C/1012/IB/15
Updated with Decision(2012)583 of 30/01/2012
01/02/2012 Centralised - Variation EMEA/H/C/1012/II/16 (2012)583 of 30/01/2012
27/02/2012 Centralised - Variation EMEA/H/C/1012/II/14 (2012)1338 of 23/02/2012
21/03/2012 Centralised - Variation EMEA/H/C/1012/II/13 (2012)1907 of 19/03/2012
13/12/2012 Centralised - Variation EMEA/H/C/1012/II/22
Updated with Decision(2013)6341 of 25/09/2013
27/02/2013 Centralised - Variation EMEA/H/C/1012/IA/23
Updated with Decision(2013)6341 of 25/09/2013
05/06/2013 Centralised - Variation EMEA/H/C/1012/IAin/24
Updated with Decision(2013)6341 of 25/09/2013
22/08/2013 Centralised - Notification EMEA/H/C/1012/N/26
Updated with Decision(2013)6341 of 25/09/2013
27/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1012/T/25 (2013)6341 of 25/09/2013
11/06/2014 Centralised - Renewal EMEA/H/C/1012/R/32 (2014)3947 of 06/06/2014
26/06/2014 Centralised - Variation EMEA/H/C/1012/II/27
24/07/2014 Centralised - Variation EMEA/H/C/1012/II/31