Rizmoic
naldemedine
Table of contents
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.
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List item
Rizmoic : EPAR - Medicine overview (PDF/73.92 KB)
First published: 01/03/2019
Last updated: 06/03/2019
EMA/21684/2019 -
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List item
Rizmoic : EPAR - Risk-management-plan summary (PDF/167.75 KB)
First published: 01/03/2019
Authorisation details
Product details | |
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Name |
Rizmoic
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Agency product number |
EMEA/H/C/004256
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Active substance |
Naldemedine tosilate
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International non-proprietary name (INN) or common name |
naldemedine
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Therapeutic area (MeSH) |
Constipation
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Anatomical therapeutic chemical (ATC) code |
A06AH05
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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 | |
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Marketing-authorisation holder |
Shionogi B.V.
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
18/02/2019
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Contact address |
Herengracht 464 |
Product information
08/03/2023 Rizmoic - EMEA/H/C/004256 - IAIN/0021/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Drugs for constipation
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Peripheral opioid receptor antagonists
Therapeutic indication
Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.