Summary of Product Characteristics
last updated on the eMC:
07/05/2010
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 07/05/2010 and displayed until Current
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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 revision of the text
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| Date of revision of text on the SPC: 27-Apr-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in Marketing Authorisation Holder name and address.
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Updated on 21/01/2008 and displayed until 07/05/2010
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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 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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01/2008 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To udpate sections 2; 4.2; 4.4; 4.5; 4.6; 4.8; 4.9 of the SmPC to bring in line with other wyeth products containing the same active ingredients.
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Updated on 24/07/2006 and displayed until 21/01/2008
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 4.9 overdose amended to reflect changes to symptoms and management of the active ingredient paracetamol.
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Updated on 17/03/2006 and displayed until 24/07/2006
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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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Change to section 10 (date of (partial) revision of the text
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Updated on 26/08/2005 and displayed until 17/03/2006
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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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Change to section 10 (date of (partial) revision of the text
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Updated on 12/01/2005 and displayed until 26/08/2005
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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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