Summary of Product Characteristics
last updated on the eMC:
22/11/2010
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 22/11/2010 and displayed until Current
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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 revision of the text
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| Date of revision of text on the SPC: 27-Sep-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to sections 6.5 and 10 of the SPC
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Updated on 23/06/2010 and displayed until 22/11/2010
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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 4.8 - Undesirable Effects
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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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: 21-May-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to sections:
3 (Pharmaceutical form),
4.2 (Posology and method of administration)
4.4 (Special warnings and precautions for use)
4.5 (Interaction with other medicinal products and other forms of interaction),
4.8 (Undesirable effects),
6.3 (Shelf life),
6.4 (Special precautions for storage)
6.5 (Nature and content of container)
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Updated on 21/09/2009 and displayed until 23/06/2010
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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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-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to Sections 7. Marketing Authorisation Holder, 8. Marketing Authorisation Number and 10. Date of Revision of the Text
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Updated on 14/08/2009 and displayed until 21/09/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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