This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Circadin : EPAR - Summary for the public (PDF/59.75 KB)
First published: 11/07/2007
Last updated: 10/06/2010
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Sleep Initiation and Maintenance Disorders
|Anatomical therapeutic chemical (ATC) code||
RAD Neurim Pharmaceuticals EEC SARL
|Date of issue of marketing authorisation valid throughout the European Union||
4 rue de Marivaux
16/05/2023 Circadin - EMEA/H/C/000695 - IAIN/0070
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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).
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Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.