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ViiV Healthcare UK Ltd
Stockley Park West, Uxbridge, Middlesex,, UB11 1BT, UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 26/11/2010
SPC Epivir 300mg Tablets

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 26/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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
Section 4.6 -

Updated to read;

Epivir can be used during pregnancy if clinically needed

From

Zeffix can be used during pregnancy if clinically needed

Section 4.8 -

Update to include Angiodema

Frequency classifications updated from > to ≥

Section 10 -
Update to date
Updated on 02/08/2010 and displayed until 26/11/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
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


Section 7 - MAH transfer to ViiV – address updates
Section 10 - Date updated
Updated on 21/01/2010 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
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
Section 4.6- Correction of typo;

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative toxicity. Epivir can be used during pregnancy if clinically needed'.
Updated on 26/11/2009 and displayed until 21/01/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
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
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
Updated on 25/09/2008 and displayed until 26/11/2009
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration
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
Section 4.2 - Tablets may be crushed

Section 5.2 - Paragraph on crushed tablets

Section 10 - Date of approval
Updated on 21/09/2007 and displayed until 25/09/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
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

updatesection 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
Updated on 13/03/2007 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
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

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 13/02/2007 and displayed until 13/03/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 11/08/2006 and displayed until 13/02/2007
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
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

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 14/01/2005 and displayed until 11/08/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 05/08/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 18/03/2004 and displayed until 05/08/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 15/03/2004 and displayed until 18/03/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/09/2003 and displayed until 15/03/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 15/08/2003 and displayed until 03/09/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 20/12/2002 and displayed until 15/08/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 08/11/2002 and displayed until 20/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 22/10/2002 and displayed until 08/11/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 08/01/2002 and displayed until 22/10/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  lamivudine