Summary of Product Characteristics
last updated on the eMC:
01/02/2012
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 01/02/2012 and displayed until Current
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Reasons for adding or updating:
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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: 27-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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6.3
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Shelf life extension from 2 years to 3 years
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10.
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Updated with new date of revision of text
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Updated on 19/11/2008 and displayed until 01/02/2012
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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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: 17-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Amendment to add renal impairment and the warning for overgrowth of non-susceptible organisms
Section 4.5 - Information added regarding interaction with oral contraceptives
Section 4.8 - Very rare adverse event of cutaneous vasculitis has been added
Section 10 - Added the date of approval
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Updated on 16/05/2006 and displayed until 19/11/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/05/2006 and displayed until 16/05/2006
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 03/05/06 |
| 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 23/07/2003 and displayed until 12/05/2006
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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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Change to section 9 - Date of Renewal of Authorisation
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Updated on 11/02/2003 and displayed until 23/07/2003
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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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Change to section 8 - MA number
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Updated on 30/05/2002 and displayed until 11/02/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 20/08/2001 and displayed until 30/05/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 22/05/2002 and displayed until 20/08/2001
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Reasons for adding or updating:
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Updated on 18/10/2000 and displayed until 22/05/2002
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Reasons for adding or updating:
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Updated on 15/05/2000 and displayed until 18/10/2000
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 15/05/2000
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Reasons for adding or updating:
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