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Recordati Ireland Limited
Raheens East, Ringaskiddy, Co. Cork, Ireland
Telephone: +353 21 437 9413
Fax: +353 21 437 9280
Medical Information Direct Line: 1800 303 351
Medical Information e-mail: medinfo@recordati.co.uk
Summary of Product Characteristics last updated on medicines.ie: 06/02/2012
SPC Kentera oxybutynin transdermal patch

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 06/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change of distributor details
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
The SPC was revised together with the PIL after submission of the art. 61(3) to the EU commission for the change of company name of the local representative in Austria and Germany as listed on the current PIL. There were no specific changes to the SPC text.
Updated on 14/10/2010 and displayed until 06/02/2012
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   30-Sep-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
The shelf life was two years and is now three years.
Updated on 14/08/2009 and displayed until 14/10/2010
Reasons for adding or updating:
  • Change to section 4 - Clinical particulars
  • Change to section 10 - Date of revision of the text
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   30-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
The main changes are to make the SPC clearer.  There are no real substantive changes; mostly changes to wording.  The undesirable effects changes are to remove comparisons with placebo and to categorise the ADRs in the accepted broad categories, rather than give specific values.
Updated on 07/11/2008 and displayed until 14/08/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Oxybutynin