This is a summary of the European public assessment report (EPAR) for Constella. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Constella.
Constella : EPAR - Summary for the public (PDF/57.79 KB)
First published: 30/11/2012
Last updated: 30/11/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Irritable Bowel Syndrome
|Anatomical therapeutic chemical (ATC) code||
Allergan Pharmaceuticals International Limited
|Date of issue of marketing authorisation valid throughout the European Union||
21/03/2019 Constella - EMEA/H/C/002490 - N/0040
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.