Summary of Product Characteristics
last updated on the eMC:
26/08/2009
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 26/08/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 9 (Renewal of the Authorisation) the date has changed to "13 July 2009"
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Updated on 22/07/2009 and displayed until 26/08/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.8 (Undesirable effects) the following text has been added: Although the bath emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment. These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature.
In section 10 (Date of revision of the text) the date has changed to July 2009
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Updated on 11/09/2007 and displayed until 22/07/2009
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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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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 - Special warnings and precautions for use - Additional text added 'Keep out of the reach and sight of children'
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Updated on 03/08/2004 and displayed until 11/09/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 17/02/2003 and displayed until 03/08/2004
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 17/09/2002 and displayed until 17/02/2003
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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 19/07/2001 and displayed until 17/09/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 13/03/2001 and displayed until 19/07/2001
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Updated on 29/06/2000 and displayed until 13/03/2001
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