Summary of Product Characteristics
last updated on the eMC:
31/03/2011
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 31/03/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 6.1 - List of Excipients
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 17-Sep-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 6.1 (List of excipients) the excipient 'anise oil' has been corrected to 'star anise oil EP'.
In Section 9 (Date of first authorisation/Renewal of the authorisation) the Renewal approval date has been included (06/08/2002).
In Section 10 (Date of Revision of the text) the date has been corrected to the 17/09/2010.
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Updated on 22/09/2010 and displayed until 31/03/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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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-Sep-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes in SPC sections:
6.3. Shelf life
Two years.
6.4. Special precautions for storage
Do not store above 25 °C.
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Updated on 26/07/2010 and displayed until 22/09/2010
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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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| 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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