Summary of Product Characteristics
last updated on the eMC:
21/07/2010
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 21/07/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 01-Dec-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section updated from:
A white cream containing Urea Ph.Eur 10.0 % w/w and Lactic Acid Ph.Eur 5.0% w/w in a stabilising emulsified base.
to:
One gram of cream contains 100 mg of Urea and 50 mg of Lactic acid
Name changed from:
Calmurid Cream
to:
Calmurid 10%/5% w/w Cream
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Updated on 13/01/2010 and displayed until 21/07/2010
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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: 01-Dec-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The shelf life has been reduced from 30 months to 24 months
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Updated on 25/02/2008 and displayed until 13/01/2010
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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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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updated to include additional 30g pack size
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Updated on 06/09/2006 and displayed until 25/02/2008
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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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| Date of revision of text on the SPC: 02/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 – Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
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Updated on 19/02/2002 and displayed until 06/09/2006
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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 15/08/2001 and displayed until 19/02/2002
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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 06/09/1999 and displayed until 15/08/2001
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Reasons for adding or updating:
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