Biktarvy 50 mg/200 mg/25 mg film-coated tablets
- Name:
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
- Company:
Gilead Sciences Ltd
- Active Ingredients:
Emtricitabine, Tenofovir alafenamide fumarate, Bictegravir sodium
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/06/20
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Gilead Sciences Ltd
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 21 August 2020 SmPC
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 SmPC
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 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 16 December 2019 SmPC
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 PIL
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 SmPC
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
Updated on 9 July 2019
Updated on 9 July 2019 SmPC
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 8 July 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 8 July 2019 SmPC
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 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 25 May 2019 SmPC
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 SmPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 31 August 2018 SmPC
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 3 July 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 July 2018 PIL
Reasons for updating
- New PIL for new product