Summary of Product Characteristics
last updated on the eMC:
04/02/2010
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 04/02/2010 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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| Date of revision of text on the SPC: 01-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3 change shelf life from 60 months to 36 months.
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Updated on 04/09/2007 and displayed until 04/02/2010
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.8 – addition of statement regarding depression of reticulo-endothelial system
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Updated on 15/08/2007 and displayed until 04/09/2007
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7. Marketing Authorisation Holder
Pharmacia Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
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Updated on 08/02/2006 and displayed until 15/08/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 25/09/2002 and displayed until 08/02/2006
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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