Circadin
melatonin
Table of contents
Overview
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).
Authorisation details
Product details | |
---|---|
Name |
Circadin
|
Agency product number |
EMEA/H/C/000695
|
Active substance |
melatonin
|
International non-proprietary name (INN) or common name |
melatonin
|
Therapeutic area (MeSH) |
Sleep Initiation and Maintenance Disorders
|
Anatomical therapeutic chemical (ATC) code |
N05CH01
|
Publication details | |
---|---|
Marketing-authorisation holder |
RAD Neurim Pharmaceuticals EEC SARL
|
Revision |
34
|
Date of issue of marketing authorisation valid throughout the European Union |
29/06/2007
|
Contact address |
4 rue de Marivaux |
Product information
16/05/2023 Circadin - EMEA/H/C/000695 - IAIN/0070
This medicine’s product information is available in all official EU languages.
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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).
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
Psycholeptics
Therapeutic indication
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.