Biktarvy 50 mg/200 mg/25 mg and 30 mg/120 mg/ 15mg film-coated tablets
*Company:
Gilead Sciences 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 11 May 2023
File name
Biktarvy IE & XI SmPC (April 2023).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Q-Shelf-life extension for Biktarvy blisters to 36 months (with consequential updates to Section 6.3 of SmPC)
Updated on 11 May 2023
File name
Biktarvy IE & XI SmPC (April 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2023
File name
Biktarvy IE & XI SmPC (April 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2023
File name
Biktarvy IE & XI SmPC (January 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 January 2023
File name
Biktarvy 30-120-15 IE & XI PIL (January 2023).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - overdose, missed or forgotten doses
- Removal of Black Inverted Triangle
Updated on 23 January 2023
File name
Biktarvy 50-200-25 IE & XI PIL (January 2023).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product looks like and pack contents
- Removal of Black Inverted Triangle
Updated on 23 January 2023
File name
Biktarvy IE & XI SmPC (January 2023).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 January 2023
File name
Biktarvy 30-120-15 IE & XI PIL (January 2023).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - overdose, missed or forgotten doses
- Removal of Black Inverted Triangle
Updated on 23 January 2023
File name
Biktarvy 50-200-25 IE & XI PIL (January 2023).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product looks like and pack contents
- Removal of Black Inverted Triangle
Updated on 24 November 2022
File name
Biktarvy 30-120-15 IE & XI PIL November 2022.pdf
Reasons for updating
- New PIL for new product
Updated on 24 November 2022
File name
Biktarvy 30-120-15 and Biktarvy 50-200-25 IE & XI SmPC November 2022.pdf
Reasons for updating
- 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 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2022
File name
Biktarvy 50-200-25 IE & XI PIL November 2022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 July 2022
File name
Biktarvy IE&XI SmPC (June 2022).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2021
File name
Biktarvy SmPC XI&IE ( May 2021).pdf
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 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update the nephrotoxicity information (Section 4.4 of the Summary of Product Characteristics [SmPC] and Section 2 of the Patient Information Leaflet [PIL])
Administrative updates to the SmPC sections 4.5 and 4.9 for Biktarvy
Updated on 01 June 2021
File name
Biktarvy PIL XI&IE ( May 2021).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 30 April 2021
File name
Biktarvy - SmPC - April 2021 .pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 blister packaging for Biktarvy tablets, 30 and 90 film-coated tablet packs.
Sections of the SmPC updated: 6.3, 6.4, 6.5, 8 and 10
Annex III A: Outer carton for 30- tablet pack
Outer carton for 90- tablet pack
Intermediate carton for 90- tablet pack
7- tablet blister
2- tablet blister
Sections of the PIL updated: 3, 4, 5 and 6
Updated on 30 April 2021
File name
Biktarvy PIL - April 2021.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation number
Free text change information supplied by the pharmaceutical company
To add blister packaging for Biktarvy tablets, 30 and 90 film-coated tablet packs.
Sections of the SmPC updated: 6.3, 6.4, 6.5, 8 and 10
Annex III A: Outer carton for 30- tablet pack
Outer carton for 90- tablet pack
Intermediate carton for 90- tablet pack
7- tablet blister
2- tablet blister
Sections of the PIL updated: 3, 4, 5 and 6
Updated on 18 December 2020
File name
Biktarvy SmPC - December 2020.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II variation application, to update the Biktarvy product information with the adverse drug reaction Stevens-Johnson Syndrome (SJS). This variation is a result of the CCDS v6.0 Category 2. The product information has been updated as follows: SmPC section 4.8
Updated on 18 December 2020
File name
Biktarvy PIL - December 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Type II variation application, to update the Biktarvy product information with the adverse drug reaction Stevens-Johnson Syndrome (SJS). This variation is a result of the CCDS v6.0 Category 2. The product information has been updated as follows:PIL section 4
Updated on 25 November 2020
File name
Biktarvy SmPC - November 2020.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 November 2020
File name
Biktarvy PIL - November 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 25 November 2020
File name
Biktarvy PIL - November 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 04 November 2020
File name
Biktarvy SmPC - October 2020.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 4.8 - Undesirable effects
- 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
Updated on 04 November 2020
File name
Biktarvy PIL - October 2020.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 21 August 2020
File name
Biktarvy SmPC - July 2020.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 10 June 2020
File name
Biktarvy SmPC (May 2020).pdf
Reasons for updating
- 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)
Updated on 10 June 2020
File name
Biktarvy PIL (May 2020).pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 31 March 2020
File name
Biktarvy - SmPC - February 2020.pdf
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 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)
Updated on 31 March 2020
File name
Biktarvy - PIL - February 2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 16 December 2019
File name
Biktarvy SmPC Dec 2019.pdf
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)
Updated on 15 July 2019
File name
Biktarvy PIL Jun 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Updated on 15 July 2019
File name
Biktarvy SmPC Jun 2019.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
section 2 of the Patient Information Leaflet (PIL) in order to remove the recommendation for caution when methadone is co-administered with Biktarvy
File name
Biktarvy PIL - May 2019.pdf
Updated on 09 July 2019
File name
Biktarvy SPC - May 2019.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 to section 4.8 of SmPC to include urticaria and angioedema
Updated on 08 July 2019
File name
Biktarvy PIL - Jul 2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 July 2019
File name
Biktarvy SPC - Jul 2019.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 to section 4.8. of the SmPC, specifically tabulated list of adverse reactions to include angioedema and urticarial as additional adverse reactions, following a safety review conducted by Gilead, concluding the causal association of the two adverse reactions with TAF-containing products.
Updated on 27 May 2019
File name
Biktarvy PIL - Apr 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 25 May 2019
File name
Biktarvy SmPC - Apr 2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Variation submitted to update sections 4.8 and 5.1 of the SmPC with efficacy and safety information based on pooled 96-week data from two randomized, double-blind, active controlled studies GS-US-380-1489 and GS-US-380-1490 in HIV-1 infected, antiretroviral treatment-naïve adults receiving Biktarvy compared with each of the comparator treatment groups (i.e. pooled Biktarvy (BVY) vs abacavir /dolutegravir /lamivudine and pooled BVY vs dolutegravir + emtricitabine/tenofovir alafenamide).
The opportunity was also taken to include an administrative update to the PIL to align the warnings and precautions wording related to potential kidney problems with the warnings and precautions wording in the Odefsey PIL.
Updated on 31 October 2018
File name
Biktarvy SmPC - Oct 2018.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 August 2018
File name
Biktarvy PIL - Aug 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 31 August 2018
File name
Biktarvy SmPC - Aug 2018.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 July 2018
File name
Biktarvy_SmPC_Jun2018.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 July 2018
File name
Biktarvy PIL - Jun2018.pdf
Reasons for updating
- New PIL for new product