Summary of Product Characteristics
last updated on the eMC:
19/01/2010
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 19/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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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: 22-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3: deletion of text relating to precise appearance of cream
Section 6.1 :addition of sulphuric acid to list of excipients
Section 6.3: shelf life changed from 60 months to 30 months
Section 10 changed from July 2006 to December 2009
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Updated on 28/09/2007 and displayed until 19/01/2010
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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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: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 3: addition of cream description
section6.1 removal of sulphuric acid from excipients list
section6.3 shelf life changed from 30 to 60 months
section 6.4 : instructions changed from "protect from heat" to "Do not store above 25 degrees C
section 10 revision date changed to 24 July 2006
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Updated on 30/09/2003 and displayed until 28/09/2007
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Reasons for adding or updating:
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