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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: 10/06/2011
SPC Telzir 700 mg film-coated 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 10/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5 - Reference to Raltegravir interaction data
Section 10 - Date of revision
Updated on 17/05/2011 and displayed until 10/06/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - References to Alfuzosin and sildenafil added
Section 4.4 - Special Warnings : references to tadalafil and information about PDE5 inhibitors interaction data added
Section 10 - date of revision
Updated on 04/04/2011 and displayed until 17/05/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   30-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Updates to section 4.3 – addition of lovastatin and simvastatin

Updates to section 4.5 – deletion of lovastatin and simvastatin
Updated on 14/09/2010 and displayed until 04/04/2011
Reasons for adding or updating:
  • 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:   26-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Reformat of section
Section 10 - Date of revision
Updated on 02/08/2010 and displayed until 14/09/2010
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:   26-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 19/05/2010 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - To include reference to Etravirine

Section 10 - Update to date
Updated on 26/01/2010 and displayed until 19/05/2010
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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of wording re. hyperglycaemia and lipid elevations

Section 4.5 - re-format of section 4.5 and addition of atazanavir interaction wording

Section 4.8- table re-ordered for triglyceride/cholesterol

Clinical chemistry abnormalities section updated

Section 10- date updated
Updated on 09/06/2009 and displayed until 26/01/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   15-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 - Deletion of word "excipient"

 

Section 3 - Deletion of "s"

 

Section 4.2 - Deletion of the word Telzir & later on initial

 

Section 4.3 - Deletion of the end of first sentence

 

Section 4.4 - Deletion of "events" replaced with "reactions"

 

Section 4.8 - Re-ordering of two adverse reactions Angiodema & Stephen Johnson Syndrome and their frequencies. Plus deletion of events replaced with reactions
Updated on 02/04/2009 and displayed until 09/06/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   25-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 - Addition of dosing recommendations for adults with severe hepatic impairment.
No dose recommendations for children and adolescents with hepatic impairment.

Section 4.3 - Deletion of contraindication – patients with severe hepatic impairment

Section 4.4 - Liver Disease – Use with caution in severe hepatic impairment

Section 5.2 - Addition of paragraph – Subjects with severe hepatic impairment

Section 10 - Date of approval 25/03/2009

 
Updated on 17/03/2009 and displayed until 02/04/2009
Reasons for adding or updating:
  • 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:   26-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Addition of oral paraesthesia (common)

Section 10 - Changed to Date of approval 26/02/2009
Updated on 15/01/2009 and displayed until 17/03/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   22-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Paediatric dosing
Updated on 09/01/2009 and displayed until 15/01/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   22-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Paediatric dosing
Updated on 29/10/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - Combination of rifampicin with Telzir with concomitant low-dose ritonavir is contraindicated.

Section 4.5 - Rifampicin is a strong CYP34A inducer and has been shown to cause profound decreases in concentrations of other protease inhibitors.

Section 10 - Approval date
Updated on 23/09/2008 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   09-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Removal of black triangle
Updated on 13/08/2008 and displayed until 23/09/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.5 - concomitant administration of fosamprenavir and lopinavir/ritonavir is not recommended.

Ssection 10 - Approval date
Updated on 29/07/2008 and displayed until 13/08/2008
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   07-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Paroxetine added

Section 5.1 - Resistance update

Section 5.3 - Updated rat toxicity data

Section 10 - Updated to approval date
Updated on 19/03/2008 and displayed until 29/07/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Update to Section 4.5 (Interactions) of the SPC - Recommendation that phenytoin plasma concentrations should be monitored and phenytoin dose increased as appropriate.

Updated on 11/02/2008 and displayed until 19/03/2008
Reasons for adding or updating:
  • 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:   01/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8:  Addition of angiodema and Steven-Johnson syndrome
Section 10:  Revision date amended
Updated on 13/12/2007 and displayed until 11/02/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Type II variation to update Section 5.1 of SPC - Telzir

As a result of the last yearly resistance update provided to the CHMP, which included results from the NEAT and SOLO studies, Section 5.1 (Pharmacodynamics) of the SPC is amended to include updated information on PI-resistance associated mutations observed, cross-resistance and basic guidance on phenotypic resistance testing.
Updated on 05/11/2007 and displayed until 13/12/2007
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
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.4 Special Warnings and Precautions - Removal of methadone wording.

Section 4.5 Interaction with other medicinal products - Reference to FPV+ ritonavir and methadone DDI study included, to replace previous wording of "no data are available on the coadministration of fosamprenavir with ritonavir and methadone"
Updated on 03/10/2007 and displayed until 05/11/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  • Section 4.1 Therapeutic indications - now includes children from 6 - 11 years of age and adolescents
  • Section 4.2 - Posology and method of administration - dosing updated to include children
  • Section 4.8 - Undesirable effects - amending references to existing studies, so it is clear that these were performed in adults and not children
  • Section 5.1 - Pharmacodynamics - details from studies APV 20003 and APV 29005
  • Section 5.2 - Pharmacokinetics - PK data in children
  • Section 5.3 - Preclinical safety data - reference to studies in juvenile animals
    		•
    Updated on 03/09/2007 and displayed until 03/10/2007
    Reasons for adding or updating:
    • Change to section 4.2 - Posology and method of administration
    • Change to section 4.3 - Contraindications
    • 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 5.2 - Pharmacokinetic Properties
    • Change to section 10 date of revision of the text
    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
    Section 4.2 Dosing recommendations in hepatically impaired patients
    Section 4.3 Contraindication for oral midazolam
    Section 4.4 Update to liver disease advice -Telzir with ritonavir should be used with caution and at reduced doses in adults with mild or moderate hepatic impairment, Removal of midazolam interaction information
    Section 4.5 Information regarding benzodiazepines removed and details of midazolam warnings included
    Section 5.2 Pharmacokinetics data in hepatically impaired patients discussed
    Section 10  Update to date of revision of the text
    Updated on 12/03/2007 and displayed until 03/09/2007
    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:   02/2007
    Legal Category:   POM
    Black Triangle (CHM):   YES

    Free-text change information supplied by the pharmaceutical company

    For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
    Updated on 12/02/2007 and displayed until 12/03/2007
    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 5.3 - Preclinical Safety Data
    • 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:   01/2007
    Legal Category:   POM
    Black Triangle (CHM):   YES

    Free-text change information supplied by the pharmaceutical company

    For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
    Updated on 04/12/2006 and displayed until 12/02/2007
    Reasons for adding or updating:
    • Correction of spelling/typing errors
    Updated on 09/06/2006 and displayed until 04/12/2006
    Reasons for adding or updating:
    • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
    • Change to section 10 (date of (partial) revision of the text
    Date of revision of text on the SPC:   18/04/06
    Legal Category:   POM
    Black Triangle (CHM):   YES

    Free-text change information supplied by the pharmaceutical company

    For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
    Updated on 07/03/2006 and displayed until 09/06/2006
    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 4.5 - Interactions with other Medicaments and other forms of Interaction
    • Change to section 6. 6 - Instruction for Use/Handling
    Updated on 03/01/2006 and displayed until 07/03/2006
    Reasons for adding or updating:
    • 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 5.1 - Pharmacodynamic Properties
    Updated on 22/12/2005 and displayed until 03/01/2006
    Reasons for adding or updating:
    • 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 5.1 - Pharmacodynamic Properties
    • Pending awaiting re-submission
    Updated on 18/01/2005 and displayed until 22/12/2005
    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 12/08/2004 and displayed until 18/01/2005
    Reasons for adding or updating:
    • New SPC for new product

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