Zerene

RSS

zaleplon

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zerene has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 15/10/2012

Authorisation details

Product details
Name
Zerene
Agency product number
EMEA/H/C/000228
Active substance
zaleplon
International non-proprietary name (INN) or common name
zaleplon
Therapeutic area (MeSH)
Sleep Initiation and Maintenance Disorders
Anatomical therapeutic chemical (ATC) code
N05CF03
Publication details
Marketing-authorisation holder
Meda AB
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
12/03/1999
Contact address
Pipers väg 2A
SE-Solna 170 09
Sweden

Product information

23/08/2012 Zerene - EMEA/H/C/000228 - IA/0023

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

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.

Assessment history

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