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Orion Pharma (UK) Limited
Oaklea Court, 22 Park Street, Newbury, Berkshire, RG14 1EA
Telephone: +44 (0)1635 520 300
Fax: +44 (0)1635 580 180
Medical Information e-mail: medicalinformation@orionpharma.com
Out of Hours Telephone: +44 (0)1635 520 300

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/02/2012
SPC Kentera oxybutynin transdermal patch

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 09/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The date of revision of the text has been change.  No other updates to SmPC text.
Updated on 28/09/2011 and displayed until 09/02/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Date of revision of the text has been updated
Updated on 18/10/2010 and displayed until 28/09/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The shelf life has increased from 2 to 3 years
Updated on 20/07/2010 and displayed until 18/10/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated date of approval following change to contact details in package leaflet
Updated on 10/08/2009 and displayed until 20/07/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
There are no substantive changes.  The changes are to make clear certain statements in the SPC and to use wording more acceptable to the authorities, such as replacing the word drug with medicinal product.  There is a fuller description of the transdermal patch and it is made clear that there is no experience with children.  The specificity that was in the previous SPC about the incidence of ADRs has been removed and the incidence is now expressed in the wide categories used in other SPCs (common, uncommon, etc.)
Updated on 11/11/2008 and displayed until 10/08/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  oxybutynin