Summary of Product Characteristics
last updated on the eMC:
09/06/2011
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 09/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 06-Jun-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update sections 4.2 (Posology and administration) and 4.4 (Special warnings) to include paediatric posology requested by MHRA with regards to paracetamol containing products
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Updated on 07/12/2009 and displayed until 09/06/2011
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Reasons for adding or updating:
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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: 23-Nov-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.9 overdose section of SmPC
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Updated on 22/10/2009 and displayed until 07/12/2009
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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: P |
| 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 07/05/2009 and displayed until 22/10/2009
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| licence renewal – change in date of revision and renewal date
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Updated on 04/01/2008 and displayed until 07/05/2009
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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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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| 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
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Updated on 16/08/2007 and displayed until 04/01/2008
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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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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10: Change of date of the revision of the text
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Updated on 28/09/2004 and displayed until 16/08/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 18/02/2004 and displayed until 28/09/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 06/02/2004 and displayed until 18/02/2004
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 25/09/2002 and displayed until 06/02/2004
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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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