Summary of Product Characteristics
last updated on the eMC:
19/10/2011
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 19/10/2011 and displayed until Current
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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: 03-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.5
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Clear Type I or Type III glass vials fitted with a chlorobutyl rubber bung and an aluminium seal. Supplied in packs of four vials.
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10.
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Updated with new date of revision of text
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Updated on 18/02/2009 and displayed until 19/10/2011
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 17-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - Amendments to renal effects section (now reads renal and urinary effects)
Section 10 - Date changed to date of approval
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Updated on 29/07/2008 and displayed until 18/02/2009
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 21-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Amendments to children's dosage
Section 10 - Date changed to date of approval
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Updated on 13/07/2007 and displayed until 29/07/2008
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 - update to this section with regard to interactions with oral contraceptives and methotrexate
Section 10 - update date to 10 July 2007
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Updated on 16/02/2007 and displayed until 13/07/2007
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01/2007 |
| 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 06/12/2004 and displayed until 16/02/2007
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 05/08/2003 and displayed until 06/12/2004
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 23/07/2003 and displayed until 05/08/2003
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.8 - Undesirable Effects
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Updated on 10/03/2003 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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Updated on 27/09/2002 and displayed until 10/03/2003
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 05/08/2001 and displayed until 27/09/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 01/09/2000 and displayed until 05/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 01/09/2000
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Reasons for adding or updating:
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