Summary of Product Characteristics
last updated on the eMC:
09/08/2011
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 09/08/2011 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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| Date of revision of text on the SPC: 22-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updated according to CSP:
Section 4.4 additional warnings and testing for liver and kidney function and blood dycrasias.
Section 4.8 warnings grouped in SOC with frequencies assigned.
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Updated on 22/09/2005 and displayed until 09/08/2011
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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 (partial) revision of the text
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Joint SPC superseded by SPCs for individual presentations
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Updated on 20/01/2003 and displayed until 22/09/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 17/01/2003 and displayed until 20/01/2003
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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 24/09/2002 and displayed until 17/01/2003
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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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