Genvoya 150mg/150mg/200mg/10mg film coated tablets

Product Information *

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 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

$0·Section 4.3 toclarify the mechanism of interaction (CYP3A) for drugs contraindicated withthese products, and to inform that the list of contraindicated drugs is notall-inclusive.$0

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

 Section 4.5 (Interaction with other medicinal products and other forms of interaction) of the Summary of Product Characteristics (SmPC) has been updated based on data from an in vitro study (AD-120-2045)

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 Section 4.8 and 5.1 of the SmPC withlong‑term clinical efficacy and safety data in HIV-infected, virologicallysuppressed adults with estimated glomerular filtration rate (eGFR) measured bythe Cockcroft-Gault formula (eGFRCG) 30 to 69 mL/min in Study GS-US-292-0112through 144 weeks of treatment; a category 4 study in the Risk Management Plan$0$0$0$0-  administrative update to the Genvoya SmPCSection 2 to correct the lactose content$0

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

Section 4.5 of the SmPC has been updated

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

$0$0Updateof section 5.2 in order to provide the final results from StudyGS-US-320-1615$0$0$0·Section 4.4 was alsoupdated with regards to a warning pertaining to the co-administration ofemtricitabine/tenofovir alafenamide fumarate and other products containingtenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatmentof Hepatitis B virus infection.$0$0$0Sections4.4 and 4.5 were also updated to remove the term “fumarate”.$0$0

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

$0$0Updateto sections 4.8 and 5.1 per 144-Week clinical study reports for studiesGS-US-292-0104 and GS-US-292-0111.$0$0Updateto sections 4.5 with the PRAC adopted wording on interaction betweencobicistat (COBI)-containing products and corticosteroids.$0$0Administrativeupdates to section 4.4 and 5.1.$0$0

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

$0Submission of final clinical study report (CSR) for Study GS-US-311-1790"A Phase 1, Randomized, Open Label, Drug Interaction Study Evaluating theEffect of Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Tablet orGS-9883 on the Pharmacokinetics of a Representative Hormonal ContraceptiveMedication, Norgestimate/Ethinyl Estradiol".$0$0Section 4.5 of the Summary of Product Characteristics (SmPC)have been updated to reflect these data.$0

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

$0$0Submission of Week 96 data from Study GS-US-292-0112 “A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment”. Section 4.8 and 5.1 of the SmPC have been updated to reflect these data. $0$0Opportunity has been taken to update Section 4.4. of the Summary of Product Characteristics (SmPC) with the MITOC class-labelling text approved in procedure EMEA/H/C/xxxx/WS/0792. The Product Information (PI) has been updated to QRDv10 for Genvoya and Descovy. Minor linguistics amendments (MLAs) were submitted for Genvoya and Odefsey.$0$0

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

$0·Update to Section5.1 - addition of 96 Week efficacy and safety switch data from StudyGS-US-292-0109.$0

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

$0·Update to Section4.5 (Interaction with other medicinal products and other forms of interaction)updated the field in Table 1 headed Anti-hepatitis C virus medicinal productsto include a footnote for Tenofovir alafenamide which states 5Thisstudy was conducted using Genvoya.$0$0·Update to Section4.5 (Interaction with other medicinal products and other forms of interaction)updated the field in Table 1 headed ANTIDEPRESSANTS to include all componentsof Genvoya - Elvitegravir (150 mg once daily)/ Cobicistat (150 mg oncedaily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg oncedaily) 5$0$0·Update to Section4.8(Undesirable effects) and 4.8(Undesirable effects) sub-heading Paediatric Population to include 48 Weekadolescent data.$0

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

None provided

Updated on 26 November 2015

Reasons for updating

  • New PIL for new product