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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 21/10/2010
SPC Transtec 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 21/10/2010 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
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
Change to formatting
Updated on 26/03/2009 and displayed until 21/10/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.1 Deleted:  Treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesia.
 
TRANSTEC is not suitable for the treatment of acute pain has been moved from section 4.2.
 
4.3 - opioid dependent patients and for narcotic withdrawal treatment (this has been rewritten)
 
4.8  This section has been reformatted and re-written.
 
6.1  Has be reformatted and spelling errors corrected.
 
Updated on 22/06/2007 and displayed until 26/03/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 conversion table removed
 
Section 5.1 section updated in line wiht current literature
Updated on 05/06/2006 and displayed until 22/06/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Updated on 04/07/2003 and displayed until 05/06/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 04/07/2003 and displayed until 04/07/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors

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Active Ingredients

 
  Buprenorphine