Summary of Product Characteristics
last updated on the eMC:
17/11/2010
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 17/11/2010 and displayed until Current
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Reasons for adding or updating:
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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: 08-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Type IB variation to include pseudomembranous colitis to section 4.8 (Undesirable effects) of the SPC, as requested by the MHRA following a review of literature and PSURs.
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Updated on 18/09/2007 and displayed until 17/11/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Marketing Authorisation Holder): Change to MA Holder's details
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Updated on 08/08/2006 and displayed until 18/09/2007
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Reasons for adding or updating:
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| Date of revision of text on the SPC: 04/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1 Methicillin now reads meticiilin
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Updated on 22/11/2005 and displayed until 08/08/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/09/2004 and displayed until 22/11/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 03/04/2003 and displayed until 22/09/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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