Summary of Product Characteristics
last updated on the eMC:
04/05/2011
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 04/05/2011 and displayed until Current
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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: 01-Jun-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Correction of marketed name
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Updated on 16/08/2010 and displayed until 04/05/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change the pharmaceutical form in Section 3 from Oral Solution to Syrup. |
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Updated on 22/07/2009 and displayed until 16/08/2010
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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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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Sep-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - New name added to SPC
Section 7 - BCM added as a trading style
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Updated on 20/09/2007 and displayed until 22/07/2009
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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: 07/2004 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 - added additonal marketed product name
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Updated on 23/12/2004 and displayed until 20/09/2007
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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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