Summary of Product Characteristics
last updated on the eMC:
17/11/2010
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 17/11/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 02-Sep-2010 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To add a pack size of 10 tablets and to update the registered details of the drum container, including the container materials (HDPE), technical dimensions and specifications.
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Updated on 06/05/2010 and displayed until 17/11/2010
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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: P, 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 15/05/2008 and displayed until 06/05/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 18-Apr-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update of section 4.8 re Hypersensitivity warnings following MHRA letter of 27/09/07
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Updated on 12/02/2008 and displayed until 15/05/2008
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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 4.9 - Overdose
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6.2 - Incompatibilities
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the SMPC to bring in line with other Wyeth Products containing the same active ingredients
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Updated on 06/12/2007 and displayed until 12/02/2008
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Increase of shelf life from 24th months to 36 months.
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Updated on 22/10/2007 and displayed until 06/12/2007
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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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One line got missed out of the description of the pharmaceutical form ie:
White, capsule shaped tablet with a break bar on one side, with the letter "A" and "E" debossed on the other.
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Updated on 24/07/2006 and displayed until 22/10/2007
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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/P |
| 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 active substances (Aspirin/Paracetamol/Caffeine)
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Updated on 22/03/2006 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 17/12/2004 and displayed until 22/03/2006
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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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