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 15/05/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Allergan Pharmaceuticals International Limited
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
25/11/2012
Contact address
Clonshaugh Business Technology Park
Dublin 17
D17 E400
Ireland

Product information

17/04/2018 Constella - EMEA/H/C/002490 - IB/0037/G

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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