Summary of Product Characteristics
last updated on the eMC:
30/03/2009
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 30/03/2009 and displayed until Current
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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: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4
To add statement regarding ‘myocardial ischaemia’
Section 4.8
To add side effect regarding ‘myocardial ischaemia’
Section 10
Date revised to February 2009.
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Updated on 27/08/2003 and displayed until 30/03/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 06/12/2002 and displayed until 27/08/2003
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 18/07/2002 and displayed until 06/12/2002
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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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