Summary of Product Characteristics
last updated on the eMC:
12/08/2009
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 12/08/2009 and displayed until Current
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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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| Date of revision of text on the SPC: 31-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - interstitial nephritis and acute renal failure added under new heading 'renal and urinary disorders'
Section 10 - Date of approval added
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Updated on 26/11/2008 and displayed until 12/08/2009
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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: 13-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 - details added to include pack size of 1 and not all sizes may be marketed
Section 10 - added the date of approval
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Updated on 08/08/2008 and displayed until 26/11/2008
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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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| Date of revision of text on the SPC: 17-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 - Whole section has been updated
Section 10 - Added the date of approval
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Updated on 01/06/2007 and displayed until 08/08/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5: Updated to include possible interactions with oral contraceptives
Section 4.8: Punctuation correction, and changed into MedDRA
Section 10: Updated to 31/05/2007
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Updated on 24/11/2006 and displayed until 01/06/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 24/11/2006 and displayed until 24/11/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 22/11/2006 and displayed until 24/11/2006
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 06/2005 |
| 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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