Summary of Product Characteristics
last updated on the eMC:
04/04/2012
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 04/04/2012 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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Change to section 4.6 - Pregnancy and Lactation
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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: 26-Mar-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| · Nature of change:
o To introduce a syringe with a 2.5 and 5 ml measure, to add a new 2-piece child resistant cap and to remove a redundant 3-piece child resistant cap, as requested by the MHRA. Consequentially, sections 4.2, 4.4, 4.6 and 6.5 of the SPC have been updated and the labelling and leaflet have been updated to reflect this change.
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Updated on 21/06/2011 and displayed until 04/04/2012
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06-Jun-2011 |
| Legal Category: GSL |
| 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 07/07/2010 and displayed until 21/06/2011
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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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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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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: 17-Jun-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2: Addition of a list of selected excipients (sugars, preservatives and colouring).
Section 3: Addition of the word “Oral” before suspension, and inclusion of the text “A pink strawberry flavoured suspension”.
Section 4.4: Addition of warnings relating to the sugars, preservatives and colouring.
Section 10: Change to date of revision of text.
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Updated on 27/08/2009 and displayed until 07/07/2010
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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 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 4.1 - Therapeutic indications
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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| Date of revision of text on the SPC: 05-Aug-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Nature of changes
4.1 - to include the conditions which can be relieved by taking the finished product, bringing it in line with other paracetamol products for children
4.8 to update this section to include anaphylactic reactions as an adverse effect of paracetamol which occurs very rarely.
4.4, 4.7,6.1, 6.4, 6.6, 9. In addition update to several sections of the SPC bringing it in line with the QRD template.
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Updated on 16/03/2009 and displayed until 27/08/2009
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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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| Date of revision of text on the SPC: 25-Feb-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| licence renewal
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Updated on 25/04/2008 and displayed until 16/03/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 04/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MA as a result of integration
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Updated on 09/08/2007 and displayed until 25/04/2008
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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: 10/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10: Change to the date of the revision of the text
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Updated on 26/09/2006 and displayed until 09/08/2007
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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: 12/2005 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The original SPC has been split into two seperate ones.
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