Summary of Product Characteristics
last updated on the eMC:
08/07/2009
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 08/07/2009 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 10 date of revision of the text
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| Date of revision of text on the SPC: 09-Jun-2009 |
| 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 lactose warning.
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Updated on 21/09/2007 and displayed until 08/07/2009
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Reasons for adding or updating:
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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to separate SPC covering remaining 160mg strength due to discontinuation of the 40mg tablets
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Updated on 14/09/2005 and displayed until 21/09/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/09/2002 and displayed until 14/09/2005
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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 9 - Date of Renewal of Authorisation
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Updated on 16/09/2002 and displayed until 23/09/2002
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 20/08/2001 and displayed until 16/09/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 20/08/2001
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Reasons for adding or updating:
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