Summary of Product Characteristics
last updated on the eMC:
06/11/2009
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 06/11/2009 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: 29-Oct-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Reason:
Urgent safety variation at the request of the MHRA (statins class labelling) to add new warnings and side effects to sections 4.4 & 4.8 of the SPC
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Updated on 04/11/2009 and displayed until 06/11/2009
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Reasons for adding or updating:
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Company name change or merger
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| Date of revision of text on the SPC: 26-Oct-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The change to the SPC is a change of ownership from McNeil Ltd to McNeil Products Ltd.
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Updated on 09/05/2008 and displayed until 04/11/2009
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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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| Date of revision of text on the SPC: 25-Apr-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the SPC for Zocor Heart-Pro 10 mg tablets, the over-the-counter version of simvastatin to include recommendations regarding the risk of myopathy when fusidic acid and simvastatin are administered concomitantly, and the addition of hepatic failure as an undesirable affect.
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Updated on 03/09/2007 and displayed until 09/05/2008
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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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