Rizmoic

RSS

naldemedine

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

Overview

Rizmoic is a medicine for treating constipation caused by opioid pain relief medicines in patients who have previously been treated with a laxative (a medicine that triggers bowel movements).

It contains the active substance naldemedine.

This EPAR was last updated on 29/08/2019

Authorisation details

Product details
Name
Rizmoic
Agency product number
EMEA/H/C/004256
Active substance
Naldemedine tosilate
International non-proprietary name (INN) or common name
naldemedine
Therapeutic area (MeSH)
Constipation
Additional monitoringAdditional 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
Shionogi B.V.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/02/2019
Contact address

Kingsfordweg 151
1043GR Amsterdam
The Netherlands

Product information

13/06/2019 Rizmoic - EMEA/H/C/004256 - IB/0001/G

Contents

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Pharmacotherapeutic group

DRUGS FOR CONSTIPATION

Therapeutic indication

Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.

Assessment history

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