Zerene
Withdrawn
This medicine's authorisation has been withdrawn
zaleplon
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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decision the European Public Assessment Report for Zerene is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IA/0023
23/08/2012
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).
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
PsycholepticsTherapeutic 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.
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