Summary of Product Characteristics
last updated on the eMC:
06/12/2011
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 06/12/2011 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 27/09/2010 and displayed until 06/12/2011
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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-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| additional Almus product name to Section 1 and to add BCM as a trading style to Section 7. |
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Updated on 08/02/2008 and displayed until 27/09/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 02/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 6.3 Shelf life
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Updated on 19/08/2005 and displayed until 08/02/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Updated on 11/11/2002 and displayed until 19/08/2005
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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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