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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: 03/06/2011
SPC BuTrans transdermal patches

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 03/06/2011 and displayed until Current
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
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 7

Marketing Authorisation Holder has been changed to
Mundipharma Pharmaceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland

Section 8

Marketing Authorisation number has been changed to PA 1688/2/1



                                                                          
Updated on 27/03/2009 and displayed until 03/06/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
4.1  Deleted: Treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid angalgesics.
 
BuTrans 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 - has been reprhrase and re-formatted.
 
Preganancy see section 4.6 - has been deleted.
 
4.8  Undesirable effects has been rewritten and reformatted.
 
 
 
Updated on 14/11/2006 and displayed until 27/03/2009
Reasons for adding or updating:
  • 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
Section 6.5 updated pack sizes MRP procedure. No effect on section in ireland.
 
Section 10 updated only in Ireland..
Updated on 22/12/2005 and displayed until 14/11/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 12/10/2005 and displayed until 22/12/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Buprenorphine