Summary of Product Characteristics
last updated on the eMC:
27/04/2012
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 27/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 23-Apr-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update section 6.6 (Special precautions for disposal) of the SPC
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Updated on 14/12/2009 and displayed until 27/04/2012
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 03-Dec-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| change to section 1 of the SPC, additional product name
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Updated on 20/03/2009 and displayed until 14/12/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 10 date of revision of the text
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Change to Legal category
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| Date of revision of text on the SPC: 09-Mar-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to contraindications
“This product is contraindicated in children under the age of 12 years”
Change to Legal Category
Chamge of revision of text
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Updated on 28/02/2008 and displayed until 20/03/2009
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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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