Updated on 14/05/2012 and displayed until Current
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7. Marketing Authorisation Holder changed from Aspen Europe GmbH, Industriestrasse 32-36, D23843, Bad Oldesloe, Germany to
Aspen Pharma Trading Limited
12/13 Exchange Place,
I.F.S.C,
Dublin 1, Ireland
8. Marketing Authorisation Number changed from PL 35468/0010 to PL 39699/0005
10. Date of (Partial) Revision of Text changed from November 2009 to Jan 2012
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Updated on 18/04/2011 and displayed until 14/05/2012
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| 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
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| Date of first renewal
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Updated on 08/03/2010 and displayed until 18/04/2011
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Change to section 7 - Marketing Authorisation Holder
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| 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
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| Change to section 7. Marketing Authorisation Holder
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Updated on 29/05/2009 and displayed until 08/03/2010
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| 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
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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
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Updated on 11/02/2009 and displayed until 29/05/2009
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jun-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 - date of revision reflect the date of last MHRA approval
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Updated on 22/09/2008 and displayed until 11/02/2009
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 12-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 8 - correction of PL number from 0003/0226 to PL 00003/0226.
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Updated on 06/06/2007 and displayed until 22/09/2008
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| 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
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Section 4.8: Addition of the very rare immune system disorders, Stevens-Johnson Syndrome and toxic epidermal necrolysis
Section 10: Now 01/04/2007
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Updated on 14/02/2006 and displayed until 06/06/2007
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Correction of spelling/typing errors
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Updated on 30/01/2006 and displayed until 14/02/2006
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 05/08/2003 and displayed until 30/01/2006
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Change to section 2 - qualitative and quantitative composition
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 25/04/2003 and displayed until 05/08/2003
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Change to section 7 - Marketing Authorisation Holder
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Updated on 12/02/2003 and displayed until 25/04/2003
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Change to section 4.8 - Undesirable Effects
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Updated on 16/12/2002 and displayed until 12/02/2003
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 17/09/2002 and displayed until 16/12/2002
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Improved Electronic Presentation
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Updated on 11/09/2002 and displayed until 17/09/2002
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 30/08/2002 and displayed until 11/09/2002
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Updated on 02/08/2001 and displayed until 30/08/2002
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Transferred from eMC version 1
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Updated on 03/07/2000 and displayed until 02/08/2001
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