Updated on 26/11/2010 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: 25-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 - Update to include Angiodema
Frequency classifications updated from > to ≥
Section 10 - Update to date
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Updated on 02/08/2010 and displayed until 26/11/2010
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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 revision of the text
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| Date of revision of text on the SPC: 29-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - MAH transfer to ViiV – address updates
Section 10 - Date updated
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Updated on 25/11/2009 and displayed until 02/08/2010
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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 4.6 - Pregnancy and Lactation
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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: 28-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Addition of "Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine."
Section 4.5 - - Removal of information regarding zalcitabine has been removed
- Removal information regarding coadministration with iv ganciclovir or foscarnet removed
Section 4.6 -Pregnancy information updated and information regarding mitochondrial dysfunction added
Section 5.1 - zalcitabine removed
Section 10 - Date updated
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Updated on 25/09/2008 and displayed until 25/11/2009
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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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: 05-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Tablets may be crushed
Section 5.2 - Paragraph on crushed tablets
Section 10 - Date of approval
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Updated on 26/11/2007 and displayed until 25/09/2008
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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 4.2 - Posology and method of administration
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Change to section 5.2 - Pharmacokinetic 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: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 3: Inclusion of scored tablet description
Secton 4.2: Dosing recommendations in children, by weight
Section 5.2: Pharmacokinetics in children updated
Section 10: Revision date 30/10/2007
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Updated on 21/09/2007 and displayed until 26/11/2007
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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update section 5.1 (Pharmacodynamics) of the SPC regarding M184V resistance and lamivudine, with the addition of the following wording:
"In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness). The clinical relevance of these findings is not established. Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field. In any case, initiation of susceptible NRTIs should always be preferred to maintenance of lamivudine therapy. Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTIs are available."
Section 10: Update to 31st August 2007
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Updated on 13/03/2007 and displayed until 21/09/2007
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic 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: 03/2007 |
| 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 13/02/2007 and displayed until 13/03/2007
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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 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: 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 11/08/2006 and displayed until 13/02/2007
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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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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 07/2006 |
| 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 14/01/2005 and displayed until 11/08/2006
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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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Updated on 05/08/2004 and displayed until 14/01/2005
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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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Updated on 15/03/2004 and displayed until 05/08/2004
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 15/08/2003 and displayed until 15/03/2004
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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 4.8 - Undesirable Effects
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Updated on 20/12/2002 and displayed until 15/08/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 20/12/2002 and displayed until 20/12/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/12/2002 and displayed until 20/12/2002
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 08/11/2002 and displayed until 19/12/2002
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Updated on 23/10/2002 and displayed until 08/11/2002
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Improved Electronic Presentation
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Updated on 08/01/2002 and displayed until 23/10/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/12/2001 and displayed until 08/01/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/12/2001 and displayed until 20/12/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/11/2001 and displayed until 18/12/2001
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 30/11/2001 and displayed until 30/11/2001
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 02/08/2001 and displayed until 30/11/2001
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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 - Interactions with other Medicaments and other forms of Interaction
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Updated on 06/03/2001 and displayed until 02/08/2001
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Updated on 21/09/2000 and displayed until 06/03/2001
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Updated on 18/08/2000 and displayed until 21/09/2000
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Updated on 27/01/2000 and displayed until 18/08/2000
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Updated on 06/09/1999 and displayed until 27/01/2000
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