Tybost 150mg 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 22 February 2023
File name
Tybost IE XI SmPC (February 2023).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 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
- Updated to the expression of excipient sunset yellow from ‘sunset yellow FCF aluminium lake (E110)’ to ‘sunset yellow FCF (E110)’
- Removal of pregnancy related text in section 4.2 and its reference in section 4.4 & 4.6 of the SmPC.
Updated on 22 February 2023
File name
Tybost IE XI PIL (February 2023).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 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
- Updated to the expression of excipient sunset yellow from ‘sunset yellow FCF aluminium lake (E110)’ to ‘sunset yellow FCF (E110)’
- Updated Local Representatives listed in section 6 of the PIL for Estonia, Latvia, Lithuania and Romania.
- Updated pregnancy and breast-feeding wording.
Updated on 09 February 2023
File name
Tybost IE & XI SmPC (September 2021).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 October 2021
File name
Tybost IE & XI SmPC (September 2021).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
Tybost IE & XI PIL (September 2021).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 27 September 2021
File name
Tybost PIL IE-XI - September 2021.pdf
Reasons for updating
- Change to other sources of information section
Updated on 02 July 2020
File name
Tybost UK (Ireland and Malta) PIL - May 2020.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Type II variation to include data on drug-drug interactions between Tybost and thienopyridines (CCDS v12 Category 2)
Update of sections 4.4 and 4.5 of the SmPC in order to add information regarding drug-drug interactions between cobicistat -containing products and thienopyridines
The proposed addition is based on a cumulative safety review conducted by MAH and related to the Pharmacovigilance Risk Assessment Committee recommendation dated June 2019 with regards to the interaction of clopidogrel with boosted antiviral HIV therapy leading to insufficient inhibition of platelet aggregation. The section 2 of the Package Leaflet is updated accordingly.
In addition, the amount of sunset yellow FCF aluminium lake (E110) per tablet in section 2 of the SmPC was corrected and Sodium wording was introduced to both the SmPC (section 4.4) and PIL (section 2).
Finally, the PI is brought in line with the latest QRD template version 10.1
Updated on 02 July 2020
File name
Tybost UK (Ireland and Malta) SmPC - May 2020.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 variation to include data on drug-drug interactions between Tybost and thienopyridines (CCDS v12 Category 2)
Update of sections 4.4 and 4.5 of the SmPC in order to add information regarding drug-drug interactions between cobicistat -containing products and thienopyridines
The proposed addition is based on a cumulative safety review conducted by MAH and related to the Pharmacovigilance Risk Assessment Committee recommendation dated June 2019 with regards to the interaction of clopidogrel with boosted antiviral HIV therapy leading to insufficient inhibition of platelet aggregation. The section 2 of the Package Leaflet is updated accordingly.
In addition, the amount of sunset yellow FCF aluminium lake (E110) per tablet in section 2 of the SmPC was corrected and Sodium wording was introduced to both the SmPC (section 4.4) and PIL (section 2).
Finally, the PI is brought in line with the latest QRD template version 10.1
Updated on 03 June 2020
File name
Tybost - SmPC - May 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 4.6 - 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)
Updated on 03 June 2020
File name
Tybost - PIL - May 2020.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 23 March 2020
File name
Tybost - SmPC - March 2020.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 March 2020
File name
Tybost - PIL - March 2020.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 3 - use in children/adolescents
- Change to section 3 - how to take/use
Updated on 16 April 2019
File name
Tybost_PIL_Apr 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 16 April 2019
File name
Tybost_SmPC_Apr 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 4.6 - Pregnancy and lactation
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 of the SmPC for Tybost to recommend to not initiate darunavir/cobicistat (DRV/co) during pregnancy, and to switch to an alternative regimen (DRV/ritonavir may be considered as an alternative) for women who become pregnant during therapy with DRV/co in alignment with the SmPCs for Prezista and Rezolsta (Janssen products). The Janssen SmPCs were updated based on data from study TMC114HIV3015. This study has showed that treatment with DRV/co in pregnant women resulted in lower darunavir and cobicistat exposures during the second and third trimesters of pregnancy compared to postpartum.
Section 4.6 of the SmPC for Tybost was also updated in respect to atanazavir/cobisistat use during pregnancy to align with the SmPC for Evotaz (BMS product).
The Package Information Leaflet (PIL) for all three products was updated accordingly.
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 10 August 2018
File name
Tybost_PIL_Jul2018.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
- Change to section 2 - driving and using machines
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 10 August 2018
File name
Tybost_SmPC_Jul2018.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 4.7 - Effects on ability to drive and use machines
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 June 2018
File name
Tybost_SmPC_Jun2018.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 14 June 2018
File name
Tybost_PIL_Jun2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 05 June 2018
File name
Tybost_SmPC_May2018.docx
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Following submission of PSUR 6 (reporting period 27 Aug 2016 to 26 Aug 2017), the PRAC adopted a recommendation to update section 4.3 and section 4.5 of the SmPC a contraindication of co-administration with lurasidone. The Package leaflet was updated accordingly in Section 2
Updated on 05 June 2018
File name
Tybost PIL - May 2018.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
Updated on 04 May 2018
File name
Tybost PIL - January 2018.pdf
Reasons for updating
- 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 6 - marketing authorisation holder
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 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 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 07 March 2018
File name
PIL_15858_991.pdf
Reasons for updating
- New PIL for new product
Updated on 07 March 2018
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 16 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 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 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 13 May 2016
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
Type II worksharing variation to submit the final CSR for Study GS-US-236-0118 “A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients with Mild to Moderate Renal Impairment”, in fulfillment of a PAM.
Section 4.8 of the Tybost SmPC to include 96 week data from the study. Gilead took the opportunity to implement some minor administrative changes to the Tybost SmPC
Updated on 05 May 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 09 June 2015
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
• Section 6.3 – shelf life change from 2 years to 4 years
• Section 10 - change to the date of revision to May 2015
Updated on 13 March 2015
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 02 December 2014
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
• Change to the date of revision in section 10 to October 2014
Updated on 29 August 2014
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)
Free text change information supplied by the pharmaceutical company
• Change to the date of revision in section 10 to July 2014
Updated on 26 August 2014
Reasons for updating
- Change to date of revision
Updated on 07 April 2014
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
- 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 6.1 - update the designation of the excipients
- Section 10 - change to date of revision
Updated on 28 March 2014
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 09 October 2013
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 07 October 2013
Reasons for updating
- New PIL for new product