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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: 31/08/2009
SPC Anthisan Cream

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 31/08/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Change storage conditions to Store below 30*C.
Updated on 11/08/2009 and displayed until 31/08/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 2 - Addition of 'For a full list of excipients'.
Section 5.1 - Addition of ATC code
Updated on 11/12/2008 and displayed until 11/08/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/12/2008 and displayed until 11/12/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update to section 4.1, 4.3, 4.6, 4.7, 4.8, 4.9 of SPC.
Updated on 28/07/2008 and displayed until 09/12/2008
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 7 and Section 10.
Updated on 13/05/2008 and displayed until 28/07/2008
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 13/11/2006 and displayed until 13/05/2008
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:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update Section 10 - Change in date of revision
Updated on 19/03/2004 and displayed until 13/11/2006
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 18/07/2003 and displayed until 19/03/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Updated on 20/06/2003 and displayed until 18/07/2003
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 13/06/2003 and displayed until 20/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Mepyramine Maleate