Genvoya 150mg/150mg/200mg/10mg film coated tablets *
Company:
Gilead Sciences LtdStatus:
UpdatedLegal 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
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 October 2021
File name
Genvoya IE & XI SmPC (September 2021)_1634805899.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II workshare variation to update the product information (PI) of Genvoya, Stribild and Tybost to include data on drug-drug interactions (DDI) between cobicistat-containing products and cutaneously-administered corticosteroids.
Gilead has also taken the opportunity to make the following changes:
- Some minor linguistic amendments for Stribild, Tybost and Genvoya
- addition of E-numbers of excipients for Genvoya, Stribild and Tybost
Updated on 21 October 2021
File name
Genvoya IE & XI PIL (September 2021)_1634805844.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Type II workshare variation to update the product information (PI) of Genvoya, Stribild and Tybost to include data on drug-drug interactions (DDI) between cobicistat-containing products and cutaneously-administered corticosteroids.
Gilead has also taken the opportunity to make the following changes:
- Some minor linguistic amendments for Stribild, Tybost and Genvoya
- addition of E-numbers of excipients for Genvoya, Stribild and Tybost
Updated on 24 August 2021
File name
Genvoya XI & IE SmPC (July 2021)_1629809384.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
Type II variation category C.I.4 to update the Genvoya Summary of Product Characteristics (SmPC) sections 4.8 and 5.1 to include long term safety and efficacy data from week 48 Cohort 2 Part B of study GS-US-292-0106 (CCDS v15 No change Category)
Updated on 01 June 2021
File name
Genvoya SmPC XI&IE (May 2021)_1622543587.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II grouped variation to include data on drug-drug interactions between Genvoya and polyvalent cations and thienopyridines (CCDS v13). As a result, the following changes to summary of product characteristics (SmPC) and the patient information leaflet (PIL) have been made:
- Update of section 4.5 of the EU SmPC and Sections 2 and 3 of the PIL to include data on drug-drug interactions between Genvoya and thienopyridines (CCDS v13 Category 2) and between Genvoya and polyvalent cations (CCDS v13 Category 3)
In addition, Gilead taken the opportunity to make the following administrative changes to the Product Information Annexes:
- Correction of the amount of lactose declared in Section 2 of the SmPC. Whilst Genvoya does contain 61 mg lactose monohydrate per tablet (see Module 3.2.P.1 Description and Composition of the Drug Product), this equates to 58 mg lactose per tablet not 61 mg as stated in the previously approved SmPC.
- Administrative update in Section 4.5 of the SmPC regarding the concentration of buprenorphine.
- Update has been made in Section 4.5 of the SmPC in line with the clinical study report for Study GS-US-216-0125 previously submitted (eCTD 0000)
- Update has been made in Section 4.5 of the SmPC to replace “NC” to “N/A” for consistency within the rest of the table.
- Minor updates have been made in Section 6 of the PIL to the list of local representatives for the marketing authorisation holder.
Updated on 01 June 2021
File name
Genvoya PIL XI&IE (May 2021)_1622543425.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 19 April 2021
File name
Genvoya IE & XI SmPC (March 2021)_1618823707.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 September 2020
File name
Genvoya SmPC - September 2020_1600956419.pdf
Reasons for 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 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 - how to report a side effect
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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)
Updated on 24 September 2020
File name
Genvoya PIL - September 2020_1600956311.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 08 August 2019
File name
Genvoya PIL July 2019_1565162736.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 August 2019
File name
Genvoya SmPC July 2019_1565162835.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 suicidal ideation
Updated on 10 July 2019
File name
Genvoya PIL Jun 2019_1562689819.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 July 2019
File name
Genvoya SmPC Jun 2019_1562689880.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 26 June 2019
File name
Genvoya SmPC June 19_1561541453.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 June 2019
File name
Genvoya PIL June 19_1561451523.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
Updated on 25 June 2019
File name
Genvoya SmPC June 19_1561451663.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
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, 4.8, 5.1 and 5.2 of the SmPC with data in patients on chronic haemodialysis from the Study GS-US-292-1825; this is a Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Haemodialysis.
The Patient information leaflet (PIL) for all three products was updated accordingly.
In addition, changes to the lactose wording for Genvoya and Odefsey were introduced and an administrative correction to the Genvoya Patient information leaflet (PIL) in order to add “lurasidone” to the second list of contra-indicated drugs appearing in the PIL was also introduced.
Updated on 06 June 2019
File name
Genvoya SmPC – May 2019_1559780511.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
B.II.f.1.a.1 To reduce the shelf-life of the finished product as packaged for sale, from 36 months to 24 months
Updated on 16 April 2019
File name
Genvoya PIL – Mar 2019_1555371981.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 15 April 2019
File name
Genvoya SmPC – Mar 2019_1555372187.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 4.6 - Pregnancy and lactation
- 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
Update to Sections 4.2, 4.4, 4.6 and 5.2 of the Summary of Product Characteristics (SmPC) to recommend to not initiate these products during pregnancy, and to switch to an alternative regimen for women who become pregnant during therapy with these products based on the data from the IMPAACT study P1026s. This study is an ongoing prospective study assessing the pharmacokinetics of antiretroviral treatment in pregnant women; this study has showed that treatment with cobicistat and elvitegravir-containing regimens resulted in lower elvitegravir and cobicistat exposures during the second and third trimesters of pregnancy compared to postpartum.
With this procedure, Gilead has been requested to issue a Dear Healthcare Professional Communication (DHPC) to inform about the increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection due to lower exposure of elvitegravir and cobicistat during the second and third trimesters of pregnancy. The DHPC was disseminated as per the agreed communication plan.
Updated on 15 November 2018
File name
Genvoya SmPC – Nov 2018_1542277233.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 September 2018
File name
Genvoya SmPC–Sep 2018_1537459172.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 19 September 2018
File name
Genvoya SmPC – Sep 2018_1537365324.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 08 August 2018
File name
Genvoya PIL – Jul 2018_1533723967.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
Updated on 08 August 2018
File name
Genvoya SmPC – Jul 2018_1533724266.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 June 2018
File name
Genvoya-SmPC–JUN-2018.docx
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 21 June 2018
File name
Genvoya PIL – JUN 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 02 May 2018
File name
GenvoyaSmPC_Mar2018.docx
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2018
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 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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 December 2017
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
SPC
· Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated based on the analysis of the paediatric study GS-US-292-0106 (Cohort 2).
Updated on 19 December 2017
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 3 - how to take/use
Updated on 19 December 2017
File name
PIL_16524_432.pdf
Reasons for updating
- New PIL for new product
Updated on 26 October 2017
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
Updated on 06 September 2017
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 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Updates to sections 4.4, 4.8 and 5.1 to provide 48 weeks data from Study GS-US-292-1249
- Updates to section 4.5: deletion of telaprevir DDI due to the withdrawal of telaprevir from the EU
- Updates to section 4.5 (in line with the CCDS): clarification that co-administration with other breast cancer resistance protein (BCRP) inhibitors (as well as P-glycoprotein [P-gp] inhibitors) is not expected to further increase TAF exposures . SmPC section 4.4 for DVY was also updated.
- Updates to section 4.5 (in line with the CCDS): correction of the spelling of “norelgestromin”.
- Updates to sections 4.4 and 4.5 (in line with the CCDS): added warning against the co-administration with TAF
- Updates to sections 4.6, 5.1, 5.3 and throughout as needed: correction of abbreviations and/or formatting as needed in line with the CCDS and/or EU QRD template.
Updated on 22 August 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - manufacturer
Updated on 04 July 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Updated on 02 June 2017
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
Updated on 07 April 2017
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
Updated on 05 April 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 08 March 2017
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 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
Updated on 03 March 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 24 January 2017
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
Updated on 20 October 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 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
Updated on 19 October 2016
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 21 September 2016
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 19 September 2016
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 29 June 2016
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 5.1 - 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
Updated on 28 June 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 04 April 2016
Reasons for updating
- 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 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 sections 4.2, 4.8 and 5.1 of the SmPC with additional efficacy and safety interim data from studies GS-US-292-0104 and GS-US-292-0111 through 96 weeks of treatment.
Updated on 07 March 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
Sections 4.4 & 4.8:
- Update to delete previous lipodystrophy class labelling text and, to add new class labelling regarding weight and metabolic parameters (blood lipids and glucose).
Section 10:
- Change to the date of revision to February 2016.
Updated on 03 March 2016
Reasons for updating
- Change to side-effects
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 27 November 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 26 November 2015
Reasons for updating
- New PIL for new product