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Gerard Laboratories
Unit 36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13,
Telephone: +353 1 832 2250
Fax: +353 1 466 1912
Medical Information Direct Line: +353 1800 272 272
Medical Information e-mail: sales@gerard-laboratories.ie
Summary of Product Characteristics last updated on medicines.ie: 16/08/2010
SPC Amisulpride Mylan 200mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 16/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   09-Jul-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Update the SmPC to include PhVWP recommendation on risk of venous thromboembolism (SPC sections 4.4 and 4.8) and increased mortality in elderly people with dementia
Updated on 01/03/2010 and displayed until 16/08/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Amisulpride