Circadin

RSS

melatonin

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

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).

This EPAR was last updated on 03/09/2018

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 Ltd
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
29/06/2007
Contact address
Reading
Berks RG1 1LX
United Kingdom

Product information

26/07/2018 Circadin - EMEA/H/C/000695 - IAIN/0055

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

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.

Assessment history

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