Summary of Product Characteristics
last updated on the eMC:
03/01/2012
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 03/01/2012 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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 6.3 (shelf life) the shelf life has changed from 60 months to 36 months
- In Section 10 the date of revision of the text has changed to March 2011
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Updated on 11/06/2008 and displayed until 03/01/2012
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Nov-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 7 the Marketing Authorisation Holder name has changed to Archimedes Pharma Limited, 250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, UK
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Updated on 06/03/2007 and displayed until 11/06/2008
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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: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to in-use shelf life.
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Updated on 13/02/2006 and displayed until 06/03/2007
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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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Updated on 05/05/2004 and displayed until 13/02/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 21/08/2001 and displayed until 05/05/2004
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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 7 - Marketing Authorisation Holder
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Updated on 06/09/1999 and displayed until 21/08/2001
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Reasons for adding or updating:
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