Zerene

Withdrawn

This medicine's authorisation has been withdrawn

zaleplon

Overview

On 21 April 2009, the European Commission issued a marketing authorisation valid throughout the European Union (EU) for the medicinal product Zerene (zaleplon), indicated for the treatment of patients with insomnia who have difficulty falling asleep, only when the disorder is severe, disabling or subjecting the individual to extreme distress. The Marketing Authorisation Holder (MAH) responsible for Zerene was Meda AB. 

The European Commission was notified by a letter dated 24 April 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Zerene, as of the Commission Decision date on the withdrawal, for commercial reasons. Therapeutic alternatives are available throughout the European Union. Zerene was a duplicate application to Sonata, which is marketed in several EU countries. The MAH will maintain the Marketing Authorisations for Sonata. Patients taking Zerene are advised to consult their physician. 

On 23 August 2012 the European Commission issued a decision to withdraw the marketing authorisation for Zerene. Pursuant to this decision the European Public Assessment Report for Zerene is updated to reflect that the marketing authorisation is no longer valid.

Zerene : EPAR - Summary for the public

Product information

Zerene : EPAR - Product Information

Zerene : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zerene
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000228
• Marketing authorisation holder:
  Meda AB

  Pipers väg 2A; SE-Solna 170 09; Sweden

• Marketing authorisation issued:
  12/03/1999
• Withdrawal of marketing authorisation:
  23/08/2012
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Zerene : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Zerene : EPAR - Procedural steps taken before authorisation

Zerene : EPAR - Scientific Discussion