Sonata

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Withdrawn

This medicine's authorisation has been withdrawn

zaleplon
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Sonata has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information: PSUSA/00003140/201407
03/07/2015
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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
Sonata
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

Sonata 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/000227
Marketing authorisation holder
Meda AB

Pipers väg 2A
170 09 Solna
Sweden

Marketing authorisation issued
12/03/1999
Revision
19

Assessment history

This page was last updated on

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