Summary of Product Characteristics
last updated on the eMC:
28/02/2012
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 28/02/2012 and displayed until Current
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 01-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Name of MAH holder and PL number.
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Updated on 11/11/2009 and displayed until 28/02/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8: There has been an amendment to the clinical data.
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Updated on 17/04/2008 and displayed until 11/11/2009
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 01-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.4 – Addition of warning of potential psychiatric side-effects occurring with systemic steroids.
4.8 – Addition of psychiatric side-effects that have been reported with corticosteroids.
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Updated on 11/09/2007 and displayed until 17/04/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7.1 – Change to the MAH address
10 – change in the date of revision
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Updated on 24/08/2001 and displayed until 11/09/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/07/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/05/2001 and displayed until 20/07/2001
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Reasons for adding or updating:
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Updated on 12/09/2000 and displayed until 18/05/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 12/09/2000
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