Summary of Product Characteristics
last updated on the eMC:
04/03/2010
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 04/03/2010 and displayed until Current
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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 4.5 - 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Addition of text with regards to prolongation of prothrombin time
Section 4.5 - Deletion and addition of text with regards to prolongation of prothrombin time
Section 4.8 - Changes made under Blood and lymphatic system disorders
Section 10 - Date of approval added
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Updated on 17/10/2008 and displayed until 04/03/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - maximum 500mg twice daily and maximum 500mg added
Section 10 - date changed
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Updated on 04/08/2005 and displayed until 17/10/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 02/08/2005 and displayed until 04/08/2005
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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