Constella

RSS

linaclotide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 23/06/2022

Authorisation details

Product details
Name
Constella
Agency product number
EMEA/H/C/002490
Active substance
linaclotide
International non-proprietary name (INN) or common name
linaclotide
Therapeutic area (MeSH)
Irritable Bowel Syndrome
Anatomical therapeutic chemical (ATC) code
A06AX04
Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH & Co. KG
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
26/11/2012
Contact address

Knollstrasse
67061 Ludwigshafen
GERMANY

Product information

07/06/2022 Constella - EMEA/H/C/002490 - T/0057

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for constipation

Therapeutic indication

Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.

Assessment history

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