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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: 31/07/2009
SPC Orugesic Gel

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 31/07/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update Section 4.6 of SPC in relation to use in first and second trimester of pregnancy.
Updated on 02/04/2009 and displayed until 31/07/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 13/05/2008 and displayed until 02/04/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
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 date of revision.
Updated on 14/08/2006 and displayed until 13/11/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update to Section -
4.4 - addition of statement on closing of tube after use and also washing hands after application
6.6 - administrative
Updated on 09/03/2006 and displayed until 14/08/2006
Reasons for adding or updating:
  • 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
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 24/05/2005 and displayed until 09/03/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Updated on 18/05/2005 and displayed until 24/05/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text
Updated on 18/04/2005 and displayed until 18/05/2005
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Updated on 23/06/2003 and displayed until 18/04/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 17/06/2003 and displayed until 23/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ketoprofen