Summary of Product Characteristics
last updated on the eMC:
15/12/2011
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 15/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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: 01-Nov-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC update, inclusion of hypersensitivity reactions
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Updated on 06/06/2011 and displayed until 15/12/2011
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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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| Date of revision of text on the SPC: 01-May-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1. Removal of redundant marketed names.
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Updated on 15/08/2005 and displayed until 06/06/2011
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 14/11/2003 and displayed until 15/08/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/11/2003 and displayed until 14/11/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 11/11/2003 and displayed until 12/11/2003
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 7 - Marketing Authorisation Holder
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Updated on 11/11/2002 and displayed until 11/11/2003
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 29/11/2001 and displayed until 11/11/2002
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Reasons for adding or updating:
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