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Aspen
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: + 44 1748 828 391
Medical Information Direct Line: 0800 0087 392
Medical Information e-mail: aspenglobal@professionalinformation.co.uk

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: 09/05/2011
SPC Imuran Injection

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 09/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The PL number was incorrect changed from PL 35468/011 to PL 35468/0008
Updated on 18/04/2011 and displayed until 09/05/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to date of revision of text
Updated on 05/03/2010 and displayed until 18/04/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   27-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7. Marketing Authorisation Holder
Updated on 29/05/2009 and displayed until 05/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Varicella Zoster Virus Infection (see also section 4.8 Undesirable Effects)
Infection with varicella zoster virus (VZV; chickenpox and herpes zoster) may become severe during the administration of immunosuppressants. Caution should be exercised especially with respect to the following:

Before starting the administration of immunosuppressants, the prescriber should check to see if the patient has a history of VZV. Serologic testing may be useful in determining previous exposure. Patients who have no history of exposure should avoid contact with individuals with chickenpox or herpes zoster. If the patient is exposed to VZV, special care must be taken to avoid patients developing chickenpox or herpes zoster, and passive immunisation with varicella-zoster immunoglobulin (VZIG) may be considered.

If the patient is infected with VZV, appropriate measures should be taken, which may include antiviral therapy and supportive care.

 

Section 4.8 - Patients receiving Imuran alone, or in combination with other immunosupressants, particularly corticosteroids, have shown increased susceptibility to viral, fungal and bacterial infections

 

, including severe or atypical infection with varicella, herpes zoster and other infectious agents (see also section 4.4 Special Warnings and Precautions for Use).

 

Section 10 - 27/5/2009
Updated on 06/06/2007 and displayed until 29/05/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8: Addition of the very rare immune system disorders, Stevens-Johnson Syndrome and toxic epidermal necrolysis
Section 10: Updated to: 01/06/2007
Updated on 14/02/2006 and displayed until 06/06/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 30/01/2006 and displayed until 14/02/2006
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 27/06/2003 and displayed until 30/01/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/04/2003 and displayed until 27/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 18/02/2003 and displayed until 22/04/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 12/02/2003 and displayed until 18/02/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 20/12/2002 and displayed until 12/02/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 19/12/2002 and displayed until 20/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 16/12/2002 and displayed until 19/12/2002
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 02/09/2002 and displayed until 16/12/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Updated on 02/08/2001 and displayed until 02/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 03/07/2000 and displayed until 02/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 03/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  azathioprine