Summary of Product Characteristics
last updated on the eMC:
30/01/2009
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 30/01/2009 and displayed until Current
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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: 19-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| MAH has changed from Aventis to Winthrop Pharmaceuticals
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Updated on 24/09/2008 and displayed until 30/01/2009
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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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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 12-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Completely updated version of SmPC including an update to section 4.4 of SPC following a CHM safety update on early psychiatric side-effects, with consequential change to section 4.8.
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Updated on 13/09/2005 and displayed until 24/09/2008
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/05/2002 and displayed until 13/09/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 21/05/2002 and displayed until 24/05/2002
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Reasons for adding or updating:
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