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Cephalon Pharma (Ireland) Ltd

Cephalon Pharma  (Ireland) Ltd
Suite 43, Northwood Court, Northwood Business Campus, Santry, Dublin 9,
Telephone: +353 1 8621600
Fax: +353 1 8621601
Medical Information e-mail: UKMedInfo@cephalon.com
Summary of Product Characteristics last updated on medicines.ie: 11/03/2009
SPC Gabitril

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 11/03/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 of SmPC:  Implementation of safety warnings on higher risks of suicidal behaviour with anti-epileptic medicines

Updated on 08/10/2008 and displayed until 11/03/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/07/2008 and displayed until 08/10/2008
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7 Marketing Authorization Holder - change of address
Updated on 20/08/2007 and displayed until 29/07/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update in line with SPC guidance
Updated on 16/05/2005 and displayed until 20/08/2007
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 25/06/2003 and displayed until 16/05/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Tiagabine

Versions

 
11/03/2009 to Current
08/10/2008 to 11/03/2009
29/07/2008 to 08/10/2008
20/08/2007 to 29/07/2008
16/05/2005 to 20/08/2007
25/06/2003 to 16/05/2005
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  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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