Summary of Product Characteristics
last updated on the eMC:
22/10/2009
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 22/10/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 05-Oct-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to sections
4.1 of the SPC to include the indications of colds and influenza and to harmonise the other indications throughout the range.
4.8 of the SPC to add ‘anaphylactic reactions’ as a possible side-effect
Other updates to several sections of the SPC in line with current QRD template/regulatory guidelines and rephrasing of the storage conditions to some licences to align with the wording used across the current Calpol 6+ product range.
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Updated on 08/07/2009 and displayed until 22/10/2009
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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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