Melatonin Neurim
melatonin
Table of contents
Overview
Melatonin Neurim is a medicine used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over. ‘Primary’ means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
Melatonin Neurim contains the active substance melatonin.
This medicine is the same as Circadin, which is already authorised in the EU. The company that makes Circadin has agreed that its scientific data can be used for Melatonin Neurim (‘informed consent’).
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Melatonin Neurim : EPAR - Medicine Overview (PDF/117.89 KB)
First published: 23/11/2022
Last updated: 25/11/2022
EMA/858804/2022 -
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Melatonin Neurim : EPAR - Risk management plan summary (PDF/55.35 KB)
First published: 23/11/2022
Authorisation details
Product details | |
---|---|
Name |
Melatonin Neurim
|
Agency product number |
EMEA/H/C/005603
|
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 |
1
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Date of issue of marketing authorisation valid throughout the European Union |
07/11/2022
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Contact address |
4 rue de Marivaux |
Product information
14/09/2023 Melatonin Neurim - EMEA/H/C/005603 - IAIN/0002
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
Psycholeptics
Therapeutic indication
Melatonin Neurim 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.