The marketing authorisation for Zerene has been withdrawn at the request of the marketing-authorisation holder.
Zerene : EPAR - Summary for the public (PDF/260.8 KB)
First published: 26/03/2009
Last updated: 16/10/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Sleep Initiation and Maintenance Disorders
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
Pipers väg 2A
SE-Solna 170 09
23/08/2012 Zerene - EMEA/H/C/000228 - IA/0023
- 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
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Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.