Summary of Product Characteristics
last updated on the eMC:
16/12/2009
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 16/12/2009 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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| Date of revision of text on the SPC: 02-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 4.4 - Removal of thiomersal statement
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Updated on 19/03/2009 and displayed until 16/12/2009
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 02-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - For a full list of excipients, see section 6.1
Section 4.2 - Minor formatting changes
Section 4.4 - Updated header "Special warnings and
special precautions for use"
Section 4.8 - New ADRs added
Section 5.1 - Minor formatting changes
Section 5.3 - Change "preclinical" to "non-clinical" and added cross section reference.
Section 6.6 - Updated header to "Special precautions for disposal and other handling"
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Updated on 03/11/2008 and displayed until 19/03/2009
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 02-Feb-2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of Black Triangle
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Updated on 29/09/2005 and displayed until 03/11/2008
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 29/09/2005 and displayed until 29/09/2005
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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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