Summary of Product Characteristics
last updated on the eMC:
25/01/2012
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 25/01/2012 and displayed until Current
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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 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 23-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 warning of syncope
10 revision date
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Updated on 10/11/2009 and displayed until 25/01/2012
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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: 03-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 6.3 - Shelf life increase from 2 to 3 years
section 10 - New revision date: 3/11/09
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Updated on 02/09/2008 and displayed until 10/11/2009
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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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Change to section 4.3 - Contraindications
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 07-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes throughout the SmPC to bring it in line with the new EU guidelinees on SMPCs. Significant change to Section 4.8 to include the frequencies of the undesirable effects.
Section 4.3 - Administration guidance if suffering from acute febrile illness (previously in section 4.4)
Section 4.8 - Addition of frequencies of the undesirable effects
Section 6.4 - Updated statements on storage
Section 10 - Approval date
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Updated on 22/08/2006 and displayed until 02/09/2008
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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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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 08/2003 |
| 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 02/08/2005 and displayed until 22/08/2006
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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 22/10/2004 and displayed until 02/08/2005
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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 19/12/2002 and displayed until 22/10/2004
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Correction of spelling/typing errors
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Updated on 08/11/2002 and displayed until 19/12/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 25/10/2002 and displayed until 08/11/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 30/09/2002 and displayed until 25/10/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 26/09/2002 and displayed until 30/09/2002
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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 14/03/2002 and displayed until 26/09/2002
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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 13/08/2001 and displayed until 14/03/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 13/08/2001
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Reasons for adding or updating:
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