Summary of Product Characteristics
last updated on the eMC:
22/12/2011
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 22/12/2011 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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| 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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| Updated section 4.8 of the SmPC with 'Hypersensitivity reactions'
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Updated on 27/07/2011 and displayed until 22/12/2011
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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 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 01-Dec-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| changes are to Section 1 product names have been changed and to Section 3 to amend the Pharmaceutical form.
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Updated on 29/06/2010 and displayed until 27/07/2011
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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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| Date of revision of text on the SPC: 01-Jan-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2 - Changed liquid sugar demineralised to liquid sugar |
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Updated on 15/02/2008 and displayed until 29/06/2010
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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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| 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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| Change to section 1 Trade Names
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Updated on 16/07/2004 and displayed until 15/02/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 29/01/2004 and displayed until 16/07/2004
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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 12/11/2003 and displayed until 29/01/2004
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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 04/03/2002 and displayed until 12/11/2003
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Reasons for adding or updating:
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