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Aspen
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: +44 1748 828 798
Medical Information Direct Line: 0080000404142 - Freephone
Medical Information e-mail: aspenglobal@professionalinformation.co.uk
Summary of Product Characteristics last updated on medicines.ie: 05/05/2011
SPC Imuran Tablets 50mg

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 05/05/2011 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-Jan-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Product ownership changed from GSK to Aspen
Updated on 22/03/2010 and displayed until 05/05/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Nov-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Change to section 7 - Marketing Authrisation Holder
From GlaxoSmithKline to Aspen Europe

 
Updated on 26/08/2008 and displayed until 22/03/2010
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 03/04/2007 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update to section 4.8 to add Steven Johnson Syndrome and toxic epidermal necrolysis
Updated on 30/01/2007 and displayed until 03/04/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8

Immune System Disorders

Uncommon: hypersensitivity reactions

Very rare: Stevens-Johnson syndrome and toxic epidermal necrolysis
Updated on 25/05/2005 and displayed until 30/01/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 28/01/2005 and displayed until 25/05/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 07/01/2004 and displayed until 28/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 13/08/2003 and displayed until 07/01/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/07/2003 and displayed until 13/08/2003
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 30/06/2003 and displayed until 25/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Azathioprine