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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 02/09/2011
SPC Arelix Tablets 6mg

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 02/09/2011 and displayed until Current
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Improved presentation
Updated on 19/08/2011 and displayed until 02/09/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Addition of statement re breakability of tablet.
Updated on 16/09/2010 and displayed until 19/08/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 4.3 - Contraindications
  • 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
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Changes made to above sections to bring SPC in line with the core SPC.
Updated on 20/05/2010 and displayed until 16/09/2010
Reasons for adding or updating:
  • Change to improve clarity and readability
Date of revision of text on the SPC:   01-Oct-2006
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Administrative changes.
Updated on 24/07/2008 and displayed until 20/05/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 10 Date of Revision
Updated on 18/12/2006 and displayed until 24/07/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section
7 - Change MAH to sanofi-aventis Ireland Ltd.
10 - Date of Revision
Updated on 13/04/2006 and displayed until 18/12/2006
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation
Updated on 04/04/2006 and displayed until 13/04/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 14/11/2005 and displayed until 04/04/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/02/2004 and displayed until 14/11/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 18/09/2003 and displayed until 23/02/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 05/06/2003 and displayed until 18/09/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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