Summary of Product Characteristics
last updated on the eMC:
25/03/2010
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 25/03/2010 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 4.2 - Posology and method of administration
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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: 08-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - 2% added to name
Section 4.2- Details regarding children under 1 year of age added
Section 4.4- Whole section updated
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Updated on 21/05/2009 and displayed until 25/03/2010
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 28-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 - Wording change to whole section
Section 5.1 - Additional Wording on ATC classification
Section 10 - New date
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Updated on 13/12/2007 and displayed until 21/05/2009
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5: To change this to:
"Squeezable aluminium tubes with a screw cap containing 15 g of white cream." (i.e. to remove reference to 1 g or 30 g tube sizes)
Section 10: To change from "2 May 2006" to "30 November 2007"
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Updated on 16/06/2006 and displayed until 13/12/2007
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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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| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 14/06/2005 and displayed until 16/06/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 10/03/2003 and displayed until 14/06/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 19/12/2002 and displayed until 10/03/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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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 05/08/2001 and displayed until 19/12/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 03/05/2000 and displayed until 05/08/2001
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Reasons for adding or updating:
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