Summary of Product Characteristics
last updated on the eMC:
28/04/2011
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 28/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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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: 12-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To make a minor change to section 4.8 (Undesirable effects) and to update section 4.6 (Pregnancy and lactation) to remove reference to section 5.3.
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Updated on 13/04/2011 and displayed until 28/04/2011
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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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: 22-Mar-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| update to SPC section 5.3 Preclinical safety data
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Updated on 21/03/2011 and displayed until 13/04/2011
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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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: 08-Mar-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.6 Pregnancy and lactation of the SmPC
Ketoconazole
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Updated on 26/08/2010 and displayed until 21/03/2011
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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: 20-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Nature of change: To update section 4.8 (Undesirable effects) of the SPC, to include hypersensitivity and angioedema
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Updated on 17/06/2010 and displayed until 26/08/2010
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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: 02-Jun-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change:
Update to section 4.8 (Undesirable effects) of the SPC .
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Updated on 30/03/2010 and displayed until 17/06/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Feb-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 6.5 where the sachets have now been removed
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Updated on 16/03/2010 and displayed until 30/03/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.9 - Overdose
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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: 25-Feb-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to section 4.4 and 4.9
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Updated on 26/01/2010 and displayed until 16/03/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 05-Jan-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change – to section 6.5 nature and contents of container – deletion of all reference to sachets
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Updated on 05/02/2009 and displayed until 26/01/2010
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: |
| 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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