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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: 15/03/2010
SPC Brolene 0.1%w/v Eye Drops Solution

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 15/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update Section 4.8 - eye pain irritation
Updated on 07/01/2009 and displayed until 15/03/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 6.3 of SPC Shelf Life
Updated on 14/10/2008 and displayed until 07/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/09/2007 and displayed until 14/10/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 2
Propamidine Isethionate changed to Propamidine Isetionate
Updated on 13/12/2006 and displayed until 17/09/2007
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:   10/2006
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 13/02/2004 and displayed until 13/12/2006
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 28/01/2004 and displayed until 13/02/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Updated on 07/11/2003 and displayed until 28/01/2004
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 03/06/2003 and displayed until 07/11/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Propamidine Isethionate