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Ipsen Pharmaceuticals Ltd
7 Upper Leeson Street, Dublin 4,
Telephone: +353 1 6681377
Fax: +353 1 6602818
Summary of Product Characteristics last updated on medicines.ie: 09/03/2012
SPC Dysport

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 09/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Minor changes to format section 4.2, 4.8$0Minor change to wording: section 4.4, 4.6 (heading title)$0$0Major change to section 6.1$0
Updated on 22/09/2011 and displayed until 09/03/2012
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   24-Jan-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Changed to read Dysport 500 units powder for solution for injection
Updated on 16/07/2009 and displayed until 22/09/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
4.1 New indication - Persistent sever primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment

4.2 Axillary Hyperhidrosis - Posology and method of administration

4.4 Special Warnings and precautions for use - Primary Axillary Hyperhidrosis

4.8 Undesirable effects - Axillary Hyperhidrosis

10. Date of approval / revision of SPC
Updated on 21/02/2008 and displayed until 16/07/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/02/2008 and displayed until 21/02/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to Undesirable Effects, approved by IMB January 2008.
Updated on 13/09/2007 and displayed until 21/02/2008
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   03/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Shelf Life from 15 to 24 months
Updated on 23/08/2006 and displayed until 13/09/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2004
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Date of Partial Revision of Text
Correction of Spelling/Typing Errors
Updated on 19/05/2005 and displayed until 23/08/2006
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 16/08/2003 and displayed until 19/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 30/06/2003 and displayed until 16/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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