Triumeq 50 mg/600 mg/300 mg film-coated tablets
*Company:
ViiV Healthcare UK LtdStatus:
No Recent UpdateLegal 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 23 November 2023
File name
ieukni-spc-triumeq-issue33draft1-clean-noheaders.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 November 2023
File name
ieukni-pl-triumeq-issue28draft1-clean-noheaders.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 28 February 2023
File name
ieukni-pl-triumeq-issue27draft1-no header.pdf
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 - excipient warnings
- Change to section 3 - use in children/adolescents
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to improve clarity and readability
Updated on 28 February 2023
File name
ieukni-spc-triumeq-issue32draft1-no header.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 4 - Clinical particulars
- Change to section 5 - Pharmacological properties
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 October 2022
File name
ieukni-spc-triumeq-issue31draft1-clean.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)
Updated on 22 September 2022
File name
ieukni-spc-triumeq-issue30draft1-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-triumeq-issue26draft1-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 September 2022
File name
ieukni-spc-triumeq-issue29draft2-clean_emc.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)
Updated on 06 September 2022
File name
ieukni-pl-triumeq-issue25draft2-workingcopy-clean_emc.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 07 July 2022
File name
ieukni-spc-triumeq-issue29draft1-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 07 July 2022
File name
ieukni-pl-triumeq-issue25draft1-workingcopy-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 24 February 2022
File name
ieukni-spc-triumeq-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)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPC to add “completed suicide” to the list of adverse drug reactions (ADRs) with frequency ”rare”. |
Updated on 24 February 2022
File name
ieukni-pl-triumeq-issue24draft1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 December 2021
File name
ieukni-spc-triumeq-issue27draft1.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 19 October 2021
File name
ieukni-spc-triumeq-issue26draft1.pdf
Reasons for updating
- 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 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
Section 4.2, 4.4 and section 5.1 - Update to lamivudine (3TC) dose with a creatinine clearance (CLcr) ≥30 milliliters (mL)/minute (min)
Updated on 19 July 2021
File name
ie-spc-Triumeq-issue25draft1-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the 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
-
Update of sections 4.2, 4.4 and 4.5 of the SmPC to include information on administration of an additional dose of 50mg dolutergravir when Triumeq is co-administered with strong enzyme inducing drugs, sections 4.4 and 4.5 to include information on co-administration of Triumeq and supplements or multivitamins containing calcium, iron or magnesium when taken with food and section 5.2 to include information on the eliminationhalf-life of lamivudine.
-
The Package Leaflet is updated accordingly.
Updated on 21 January 2021
File name
ie-pl-triumeq-issue20draft1.pdf
Reasons for updating
- 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
update to section 2 with new information about the drug-drug interactions between abacavir and riociguat.
update to section 4 to include elevated bilirubin levels
Updated on 21 January 2021
File name
ie-spc-triumeq-issue24draft1.pdf
Reasons for updating
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
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 4.5 and 5.2 of the SmPC with new information about the drug-drug interactions between abacavir and riociguat. update to section 6.6 to introduce a revised statement in line with the QRD template update to section 4.8 to include elevated bilirubin levels |
Updated on 04 January 2021
File name
ie-spc-triumeq-issue22draft1.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
The updates are in relation to data regarding the transfer of dolutegravir into breast milk and impact the information on Breast-feeding in section 4.6 of the SmPC.
Updated on 30 July 2020
File name
ie-pl-triumeq-issue18draft1.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-triumeq-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-triumeq-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-triumeq-issue17draft1.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 28 April 2020
File name
ie-spc-triumeq-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
SmPC 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.
SmPC 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).
SmPC section 4.8 - HPRA reporting of side effects details
SmPC section 10 - date of text
Updated on 28 April 2020
File name
ie-pl-triumeq-issue16draft1.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 - how to report a side effect
- 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 in section 4 of the PIL to reflect the update to Appendix V of the QRD template.
Section 6 - date of text
Updated on 08 July 2019
File name
ie-pl-triumeq-issue15draft1 - for medicines.ie.pdf
Reasons for updating
- 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 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Removal of Black Inverted Triangle
- Change to date of revision
Updated on 08 July 2019
File name
ie-spc-triumeq-issue18draft1 - for medicines.ie.pdf
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- 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 equilateral triangle
- section 4.3, contraindications – removal of the contraindication with dofetilide
- section 4.4, warnings and precautions – minor text updates to bring it in line with the current QRD template, SmPC guideline and other relevant guideline(s), including recent update to excipient guideline.
- section 4.5, interactions - removal of the interactions of telaprevir and dofetilide
- section 4.6, undesirable effects – minor additions and removals of text
- section 5.1, pharmacodynamic properties – minor formatting and grammatical updates
- section 5.2, pharmacokinetic properties – minor formatting and grammatical updates
- section 6.1, list of excipients, update to information updates to bring it in line with the SmPC guideline
Updated on 13 February 2019
File name
ie-pl-triumeq-issue14draft1 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 13 February 2019
File name
ie-spc-triumeq-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 13 February 2019
File name
ie-spc-triumeq-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)
Updated on 20 December 2018
File name
ie-pl-triumeq-issue13.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 December 2018
File name
ie-spc-triumeq-issue16draft1.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Brexit - MAH transfer to ViiV Healthcare BV - the MAH Name and Address has been updated in SmPC, labelling and PIL
Pursuant to Article 3 of Commission Regulation (EC) No 2141/96 of 7 November 1996, ViiV Healthcare UK Limited submitted to the Agency on 17/08/2018 an application for the Transfer of Marketing Authorisation from ViiV Healthcare UK Limited to ViiV Healthcare BV for the above mentioned medicinal product.
Updated on 21 September 2018
File name
ie-spc-triumeq-med.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 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
To add Autoimmune Hepatitis (AIH) to SmPC sections 4.4 and 4.8.
Updated on 24 July 2018
File name
ie-pl-triumeq.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 July 2018
File name
ie-spc-triumeq.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 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 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 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 21 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 21 March 2018
Reasons for updating
- 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 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
In addition, the MAH took the opportunity to implement minor corrections in section 5.1 of the SmPC and minor editorial changes in the SmPC (Section 4.6 and Section 5.1).
Updated on 08 March 2018
File name
PIL_16201_311.pdf
Reasons for updating
- New PIL for new product
Updated on 08 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
Updated on 08 March 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 February 2018
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 4.8 – 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: a minor amendment has been implemented throughout the SmPC in order to update the clinical terminology of Pneumocystis carinii pneumonia to Pneumocystis jiroveci pneumonia.
Section 4.5: add information regarding the interaction between lamivudine and sorbitol
Section 4.8: UK reporting details updated in line with EMA Appendix V
Updated on 31 January 2018
Reasons for updating
- 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
Updated on 31 January 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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: to add the ADR myalgia with a frequency of common, and to update the source of observed ADRs with the combination of dolutegravir + abacavir/lamivudine plus minor typographical update.
Section 5.1: To include data from ARIA and STRIIVING clinical studies.
Updated on 13 January 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 December 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 16 December 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 04 October 2016
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
Updated on 28 July 2016
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 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
Updated on 27 July 2016
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 09 February 2016
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
Updated on 08 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
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
- 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
Updated on 30 September 2015
Reasons for updating
- Change to further information section
- Change to date of revision
- Correction of spelling/typing errors
Updated on 30 June 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 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 to section 4.4 and 4.5 with drug interaction data.
Updated on 29 June 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 08 May 2015
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
Updated on 06 May 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 13 April 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 5.2 - 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:
Section 4.4 – correction of typographical errors;
Section 4.5 – update to data on interaction with midazolam; update to data on interaction with boceprevir; correction of typographical errors
Section 5.2 – update to data on interaction with midazolam; update to information on effect of DTG on substrates of hepatic uptake transporters
Updated on 09 April 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 07 January 2015
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
Updated on 05 January 2015
Reasons for updating
- New PIL for new product