Tivicay film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    ViiV Healthcare UK Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 26 July 2023

File name

ieukni-spc-tivicayfct-issue33draft1-clean.pdf

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 July 2023

File name

ieukni-spc-tivicayfct-issue33draft1-clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 October 2022

File name

ieukni-spc-tivicayfct-issue32draft1-clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 September 2022

File name

ieukni-spc-tivicayfct-issue31draft1-clean.pdf

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 September 2022

File name

ieukni-pl-tivicayfct-issue28draft1-clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 February 2022

File name

ieukni-spc-combined-tivicayfct-issue29draft1-clean-nh.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 February 2022

File name

ieukni-pl-combined-tivicayfct-issue26draft1-clean-emc.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 02 December 2021

File name

ieukni-spc-combined-tivicayfct-issue28draft1.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 December 2021

File name

ieukni-pl-combined-tivicayfct-issue25draft1.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 07 October 2021

File name

ieukni-pl-tivicayfct-issue24draft1.pdf

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 07 October 2021

File name

ieukni-spc-tivicayfct-issue27draft1.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 - update to ATC code and information relating to the week 144 data from Gemini studies

 

Updated on 27 January 2021

File name

ie-spc-tivicayfct-issue26draft1.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

update to section 2 and section 4.4 regarding the excipient statement for sodium

update to section 4.1, in relation to the indication for children 6 years and older and weighing at least 15 kg in the eu

update to section 4.2, 4.8, 5.1, 5.2 in relation to the line extension to add the indication for children aged 4 weeks and weighing at least 3kg and introduce a new tablet formulation (5mg dispersible tablets)

update to section 4.8 to include elevated bilirubin levels

update to section 6.6 to introduce a revised statement in line with the qrd template

updates to provide clarity in section 4.3, 6.1

Updated on 27 January 2021

File name

ie-pl-tivicayfct-issue23draft1.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

update to section 2 and 6 regarding the excipient statement for sodium

update to section 2 in relation to the indication for children 6 years and older and weighing at least 15 kg in the eu

update to section 2, 3, 4 in relation to the line extension to add the indication for children aged 4 weeks and weighing at least 3kg and introduce a new tablet formulation (5mg dispersible tablets)

update to section 4 to include elevated bilirubin levels

other minor updates to provide clarity throughout the PIL

Updated on 27 January 2021

File name

ie-spc-tivicayfct-issue26draft1.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

update to section 2 and section 4.4 regarding the excipient statement for sodium

update to section 4.1, in relation to the indication for children 6 years and older and weighing at least 15 kg in the eu

update to section 4.2, 4.8, 5.1, 5.2 in relation to the line extension to add the indication for children aged 4 weeks and weighing at least 3kg and introduce a new tablet formulation (5mg dispersible tablets)

update to section 4.8 to include elevated bilirubin levels

update to section 6.6 to introduce a revised statement in line with the qrd template

updates to provide clarity in section 4.3, 6.1

Updated on 25 November 2020

File name

ie-pl-tivicaytabs-issue21draft1.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

- update relating to the Breast-feeding information

Updated on 25 November 2020

File name

ie-spc-tivicaytabs-issue24draft1.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 - update relating to the Breast-feeding sub-section of section 4.6 of the SmPC

Updated on 20 October 2020

File name

ie-spc-tivicaytabs-issue23draft1.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 - update to add long-term efficacy and safety data, following the week 96 results from clinical studies. 

Updated on 27 August 2020

File name

ie-spc-tivicaytabs-issue22draft1.pdf

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

An update to section 4 to add a possible side effect in relation to weight, blood lipid and blood glucose effects

Updated on 27 August 2020

File name

ie-pl-tivicaytabs-issue20draft1.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

An update to section 4 to add a possible side effect in relation to weight, blood lipid and blood glucose effects

 

Updated on 30 July 2020

File name

ie-pl-tivicaytabs-issue19draft1.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

section 2: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 6: update to the approval date

Updated on 30 July 2020

File name

ie-spc-tivicaytabs-issue21draft1.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 4.6: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 10: update to the approval date

Updated on 02 June 2020

File name

ie-spc-tivicaytabs-issue20draft1.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change of the address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.

Updated on 02 June 2020

File name

ie-pl-tivicaytabs-issue18draft1.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change of the address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.

Updated on 21 April 2020

File name

ie-pl-tivicaytabs-issue17draft1.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 - addition of a contraindication in relation to co-administration with medicinal products with narrow therapeutic windows, that are substrates of OCT-2, including fampridine.

Section 2 - other edits to the interaction section including the removal of drug-drug interactions for products no longer authorised in the EU (boceprevir, dofetilide, nelfinavir).

Section 4 - Irish reporting details for the HPRA have been updated to reflect the update to Appendix V of the QRD template

Section 6 - date of text

Updated on 21 April 2020

File name

ie-spc-tivicaytabs-issue19draft1.pdf

Reasons for 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.3 - addition of a contraindication in relation to co-administration with medicinal products with narrow therapeutic windows, that are substrates of OCT-2, including fampridine.

Section 4.5 - other edits to the interaction section including the removal of drug-drug interactions for products no longer authorised in the EU (boceprevir, dofetilide, nelfinavir).

Section 4.8 - Irish reporting details for the HPRA have been updated to reflect the update to Appendix V of the QRD template

Section 10 - date of text

Updated on 01 April 2019

File name

ie-pl-tivicaytabs-issue16draft1.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 01 April 2019

File name

ie-spc-tivicaytabs-issue18draft1.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

removal of the black triangle

Updated on 07 December 2018

File name

ie-pl-tivicaytabs-issue15draft1 for Meds.ie.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 07 December 2018

File name

ie-spc-tivicaytabs-issue17draft1 for Meds.ie.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.6 Pregnancy with information on neural tube defect (NTD) risk a

Updated on 21 November 2018

File name

ie-pl-tivicaytabs-issue14draft1 - Meds ie.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 21 November 2018

File name

ie-spc-tivicaytabs-issue16draft1 - Meds ie.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4:
Addition of GEMINI data including Warning & Precaution regarding resistance to lamivudine and dolutegravir

Section 4.8:
update to improve clarity of message concerning frequency of suicide ideation and suicide attempt

Sections 5.1:
Addition of GEMINI data including Warning & Precaution regarding resistance to lamivudine and dolutegravir

Updated on 26 October 2018

File name

ie-spc-tivicaytabs-issue15draft1-MED.IE.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Warnings:
- Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

Section 4.8 Undesirable events:
- Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4).

- Removal of the UK reporting information.

Updated on 01 October 2018

File name

ukie-pi-tivicaytabs-issue13draft1 for meds compendia.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 01 October 2018

File name

ukie-spc-tivicaytabs-issue14draft1 for meds.ie.pdf

Reasons for 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 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

- Minor amendments to the SPC sections section 4.2, 4.4, 4.8 and 5.1.
- Section 2 - Changes were made to the PI to bring it in line with the current QRD template, SmPC guideline and other relevant guideline(s), including recent update to excipient guideline which resulted in very minor changes proposed relating to sodium content.
- Section 4.5 - to delete the information in the SmPC related to telaprevir (i.e. section 4.5) due to its withdrawal from EU market
- Section 6.4 - addition of a statement 'do not swallow the desiccant.'

Updated on 20 July 2018

File name

ukie-pl-tivicaytabs-medicinescompendia.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 July 2018

File name

ie-spc-tivicaytabs-medsie.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of section 4.8 of the SPC to add the new ADR ‘acute hepatic failure’ with a frequency 'rare' based on post-marketing and clinical trial data.
 

Updated on 05 June 2018

File name

ukie-pl-tivicaytabs-issue11draft1-medsie.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 01 June 2018

File name

ukie-spc-tivicaytabsformedsie.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 of SPC updated: MAH transfer.

Updated on 09 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 March 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of section 4.8 of the SPC to add the new ADR ‘anxiety’ with a frequency of ‘common’ based on post-marketing and clinical trial data.

Updated on 06 March 2018

File name

PIL_15937_418.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 March 2018

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 July 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Section 6.3 (Shelf Life) of combined SmPC:

To extend the shelf-life of the Tivicay 10 mg tablets as packaged for sale from 3 to 5 years.
To extend the shelf-life of the Tivicay 25 mg tablets as packaged for sale from 3 to 4 years.
To extend the shelf-life of the Tivicay 50 mg tablets as packaged for sale from 2 to 5 years.

Updated on 08 March 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Extension of Indication to include paediatric patients from 6 years of age infected with HIV for Tivicay 50mg film-coated tablets; as a consequence, sections 4.1, 4.2, 4.5, 4.7, 4.8, 5.1, 5.2, and 5.3 of the SmPC are updated based on the analysis of the pivotal study ING112578 and the non-clinical investigations performed for the paediatric development program.

Updated on 07 March 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 31 January 2017

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Added the ADRs arthralgia and myalgia with a frequency of uncommon.
Section 5.1 - Minor typographical correction.

Updated on 27 January 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 September 2016

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 01 December 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 01 October 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of section 5.1 of the SmPC in order to include additional, long-term efficacy and safety data from week 144 of the Phase III study ING114467 (SINGLE) and week 96 of the Phase IIIb study ING114915 (FLAMINGO).

Updated on 17 August 2015

Reasons for 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of section 5.1 of the SmPC with week-48 results (end of study) from Phase III Study.

Update of sections 4.4 and 4.5 of the SmPC to reflect:

- Data from a drug:drug interaction study 200901 with dolutegravir (DTG) and carbamazepine (REC 2);

- Metformin drug:drug interaction data from study 201167;

- Daclatasvir drug:drug interaction data from study 201102;

- PK modelling of DTG when co-administered with etravirine (ETV) without a ritonavir (RTV)-boosted protease inhibitor (PI);

- PK modelling of DTG when co-administered with the metabolic inducers phenytoin, phenobarbital, oxcarbazepine, and St. John’s Wort (hyperforin).

Updated on 14 August 2015

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 06 May 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of section 4.8 of the SmPC to add the term depression with a frequency “common” and the term suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness) with a frequency “uncommon”.

Updated on 01 May 2015

Reasons for updating

  • Correction of spelling/typing errors
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 03 October 2014

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Description of change to SPC:

·         to update section 4.5 of the SmPC in order to revise information concerning the interaction between dolutegravir and boceprevir based on a drug-drug interaction study

·         to update section 5.2 of the SmPC to include in vitro information on which enzymes dolutegravir is not a substrate of.

Updated on 31 July 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5 – Update to “Effect of dolutegravir on the pharmacokinetics of other agents”

Section 5.2 – Inclusion of wording around effect of dolutegravir on medicinal products that are substrates of major enzymes or transporters

Updated on 07 July 2014

Reasons for 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

·         4.4 - Admin update

·         4.5 – reference to organic anion transporters added, concentration at end of dosing interval added, Tivicay reference throughout changed to active “dolutegravir”, deletion of protease inhibitor statements

·         4.6 – update to the statements about the data available for use of product in pregnant women

·         4.8 – update to include longer term treatment data, reference to active rather than brand name, update to IE reporting details

·         5.1- admin updates, update to data on VIKING-3 study, inclusion of 48 week data from FLAMINGO study

·         9 – Update to include licence authorisation date

Updated on 04 July 2014

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 09 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 03 February 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 29 January 2014

Reasons for updating

  • New PIL for new product