Summary of Product Characteristics
last updated on the eMC:
20/08/2009
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 20/08/2009 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 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 30-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Reason for change: To update sections 4.1 (Therapeutic indications), 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) and 4.8 (Undesirable effects) of the SPC in response to the MHRA’s letter of 18 February 2009, relating to recent advice from the UK Commission on Human Medicines (CHM) regarding appropriate use of OTC Cough and Cold products in children.
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Updated on 20/04/2009 and displayed until 20/08/2009
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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 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SPC changes resulting from MHRA review of paediatric cough & colds medicines:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908
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Updated on 03/04/2008 and displayed until 20/04/2009
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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: 03/2008 |
| 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 15/09/2006 and displayed until 03/04/2008
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 08/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 Change to date of revision of text
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Updated on 21/04/2005 and displayed until 15/09/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 29/09/2004 and displayed until 21/04/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 16/01/2004 and displayed until 29/09/2004
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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 16/09/2002 and displayed until 16/01/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2001 and displayed until 16/09/2002
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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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