Summary of Product Characteristics
last updated on the eMC:
31/07/2009
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 31/07/2009 and displayed until Current
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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Product Acquisition
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| Date of revision of text on the SPC: 31-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The Marketing Authorisation for these products has transferred from BMS to Merck Sharp & Dohme Limited. Marketing of these products by MSD Ltd will commence from 1 Aug 2009.
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Updated on 05/11/2008 and displayed until 31/07/2009
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 and 4.8: To add a class warning regarding rare reports of intestinal angioedema in patients treated with ACE inhibitors.
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Updated on 08/07/2005 and displayed until 05/11/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 09/04/2002 and displayed until 08/07/2005
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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