Summary of Product Characteristics
last updated on the eMC:
04/02/2010
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 04/02/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 29-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 - Removal of 'phenoxyethanol'
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Updated on 06/11/2008 and displayed until 04/02/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 29-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Black triangle removed
Section 10 - Updated to date of MHRA advisory
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Updated on 30/10/2006 and displayed until 06/11/2008
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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 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 5 - Pharmacological Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
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 30/10/2006
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 15/09/2004 and displayed until 14/06/2005
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 17/06/2004 and displayed until 15/09/2004
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Reasons for adding or updating:
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