Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Constella   
Auth. number : EU/1/12/801
Active substance : linaclotide
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A06 - Laxatives
Pharmacological subgroup: A06A - Laxatives
Chemical subgroup: A06AX - Other laxatives
Chemical substance: A06AX04 - linaclotide
(See WHO ATC Index)
Indication: Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Marketing Authorisation Holder: Allergan Pharmaceuticals International Ltd.
Clonshaugh Business and Technology Park Coolock Dublin D17 E400, 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
28/11/2012 Centralised - Authorisation EMEA/H/C/2490 (2012)8832 of 26/11/2012
01/03/2013 Centralised - Variation EMEA/H/C/2490/N/1
Updated with Decision(2014)1251 of 20/02/2014
02/08/2013 Centralised - Variation EMEA/H/C/2490/IAin/5
Updated with Decision(2014)1251 of 20/02/2014
22/10/2013 Centralised - Notification EMEA/H/C/2490/N/6
Updated with Decision(2014)1251 of 20/02/2014
22/11/2013 Centralised - Variation EMEA/H/C/2490/IA/7
Updated with Decision(2014)1251 of 20/02/2014
24/02/2014 PSUSA - Maintain EMEA/H/C/2490/PSUV/9 (2014)1251 of 20/02/2014
14/03/2014 Centralised - Variation EMEA/H/C/2490/IB/11
Updated with Decision(2015)1915 of 16/03/2015
23/05/2014 Centralised - Variation EMEA/H/C/2490/IAin/15
Updated with Decision(2015)1915 of 16/03/2015
18/03/2015 Centralised - Yearly update (2015)1915 of 16/03/2015
25/06/2015 Centralised - Variation EMEA/H/C/2490/II/21
Updated with Decision(2016)1206 of 22/02/2016
24/02/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2490/T/24 (2016)1206 of 22/02/2016
22/04/2016 Centralised - Variation EMEA/H/C/2490/IAin/25/G