Descovy 200 mg/10 mg 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 28 February 2023
File name
Descovy SmPC 200 mg_10 mg film coated tablets XI&IE (February 2023).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)
Free text change information supplied by the pharmaceutical company
section 4
Updated on 28 February 2023
File name
Descovy PIL 200 mg_10 mg film coated tablets XI&IE (February 2023).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 23 November 2022
File name
Descovy SmPC 200 mg_10 mg film coated tablets XI&IE (November 2022).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)
Free text change information supplied by the pharmaceutical company
Update to section 4.4 and 4.6 to update wording related to the risk of HIV transmission and the removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding.
Updated on 23 November 2022
File name
Descovy PIL 200 mg_10 mg film coated tablets XI&IE (November 2022).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 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To update wording in section 2 related to the risk of HIV transmission - removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding. Also update the contact details of the local representative listed in the Package Leaflet for Estonia, Latvia, Lithuania and Romania.
Updated on 18 October 2022
File name
Descovy SmPC 200 mg_10 mg film coated tablets XI&IE (May 2021).pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 October 2022
File name
Descovy PIL 200 mg_10 mg film-coated tablets ( May 2021).pdf
Reasons for updating
- Change to further information section
Updated on 18 October 2022
File name
Genvoya 150-150-200-10 and Genvoya 90-90-120-6 IE & XI SmPC October 2022.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.8 - 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 8 - Marketing authorisation number(s)
- 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 18 October 2022
File name
Genvoya 150-150-200-10 and Genvoya 90-90-120-6 IE & XI PIL October 2022.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 01 June 2021
File name
Descovy SmPC 200 mg_10 mg film coated tablets XI&IE (May 2021).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)
Free text change information supplied by the pharmaceutical company
Updated the nephrotoxicity information (Section 4.4 of the Summary of Product Characteristics [SmPC])
Updated on 01 June 2021
File name
Descovy PIL 200 mg_10 mg film-coated tablets ( May 2021).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 18 February 2021
File name
Descovy 200 mg_10 mg SmPC (February 2021).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 18 February 2021
File name
Descovy 200 mg_10 mg PIL (February 2021).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 18 February 2021
File name
Descovy 200 mg_10 mg PIL (February 2021).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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 10 June 2020
File name
Descovy 200 mg_10 mg 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
Descovy 200 mg_10 mg 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 20 March 2020
File name
Descovy 200 mg10 mg SmPC Feb 2020.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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 March 2020
File name
Descovy 200 mg10 mg PIL Feb 2020.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 10 July 2019
File name
Descovy PIL 200mg_10mg Jun 2019.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
Descovy SmPC_200mg_10mg_ Jun 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 to include urticaria and angioedema
Updated on 25 June 2019
File name
Descovy PIL_200mg_10mg_Jun 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
Updated on 25 June 2019
File name
DescovySmPC_200mg_10mg_Jun 2019.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.
Some minor administrative amendments were also introduced throughout the product information for all three products as well as the implementation of some minor linguistic amendments (MLAs) to the translations of the respective product information annexes:
- Genvoya: DE, ES, FI, HR, HU, IS, IT, NO, SL and SV languages
- Descovy: DA, DE, ES, FR, HR, NL, NO, PT and SL languages
- Odefsey: CS, DE, LV, MT, NL, PL, SL and SV languages.
Updated on 19 September 2018
File name
DescovySmPC_200mg_10mg_Sep2018.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 06 June 2018
File name
DescovySmPC200mg_10mg_May2018.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 06 June 2018
File name
Descovy_PIL_200mg_10mg_May2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 02 May 2018
File name
DescovySmPC_200mg10mg_March2018.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 May 2018
File name
DescovySmPC_200mg10mg_March2018.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 28 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 February 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
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 20 September 2017
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 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 - how to report a side effect
- 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
File name
PIL_16702_5.pdf
Reasons for updating
- New PIL for new product
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 05 July 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Updated on 06 June 2017
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Variation to update the product information (PI) annexes of the TDF- and TAF-containing products with data from Studies GS-US-342-1167/1326, two drug-drug interaction studies between Epclusa (sofosbuvir/velpatasvir; SOF/VEL) and HIV antiretroviral regimens. Sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC) and Section 2 of the Patient Information Leaflet (PIL) have been updated for Viread (all strengths), Truvada, Stribild and Atripla. Section 4.5 of the SmPC has been updated for Eviplera, Genvoya, Descovy and Odefsey.
Note, an administrative edit has been done in Section 4.8 of the SmPC for Viread for all strengths, Stribild, Atripla and Eviplera (not required for Truvada). This administrative update was required to align with the table ‘Tabulated summary of AR associated with ‘XXX’ based on clinical study and post marketing experience’.
We took the opportunity of this application to submit minor linguistics amendments
Updated on 07 April 2017
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 4.5 - 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 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 07 March 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
Updated on 03 March 2017
Reasons for updating
- 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 26 October 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 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 20 October 2016
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 04 May 2016
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 29 April 2016
Reasons for updating
- New PIL for new product