Tybost 150mg film coated tablets

  • Name:

    Tybost 150mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    Cobicistat

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/19

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Summary of Product Characteristics last updated on medicines.ie: 16/4/2019

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Gilead Sciences Ltd

Gilead Sciences Ltd

Company Products

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Medicine Name Cayston 75 mg powder and solvent for nebuliser solution Active Ingredients Aztreonam lysine
Medicine Name Descovy 200 mg/10 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Descovy 200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
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Medicine Name Eviplera 200 mg/25 mg/245 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir disoproxil fumarate
Medicine Name Genvoya 150mg/150mg/200mg/10mg film coated tablets Active Ingredients Cobicistat, Elvitegravir, Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Harvoni 90 mg/400 mg film-coated tablets Active Ingredients Ledipasvir, Sofosbuvir
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Medicine Name Odefsey 200 mg/25 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir alafenamide fumarate
Medicine Name Sovaldi 400 mg film coated tablets Active Ingredients Sofosbuvir
Medicine Name Stribild 150 mg/150 mg/200 mg/245 mg film coated tablets Active Ingredients Cobicistat, Elvitegravir, Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Truvada film-coated tablets Active Ingredients Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Tybost 150mg film coated tablets Active Ingredients Cobicistat
Medicine Name Vemlidy 25 mg film coated tablets Active Ingredients Tenofovir alafenamide fumarate
Medicine Name Viread 245 mg film-coated tablets Active Ingredients Tenofovir disoproxil fumarate
Medicine Name Vosevi 400 mg/100 mg/100 mg film coated tablets Active Ingredients Sofosbuvir, Velpatasvir, Voxilaprevir
Medicine Name YESCARTA (axicabtagene ciloleucel) Active Ingredients Axicabtagene Ciloleucel
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Medicine Name Zydelig (idelalisib) 150mg Active Ingredients Idelalisib
1 - 0 of 24 items.Total: Infinity pages

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 16 April 2019 PIL

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 SmPC

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 PIL

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 SmPC

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 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 14 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 5 June 2018 SmPC

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 5 June 2018 PIL

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 4 May 2018 PIL

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 8 March 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 8 March 2018 SmPC

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

$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$0·Reference toVitekta/elvitegravir (EVG) as single agent as this product has been withdrawnfrom the EU market.$0$0·Reference totelapravir has been removed as this product has also been withdrawn from the EUmarket.$0$0·Upon request from theCHMP, some references to ‘tenofovir disoproxil fumarate’ have been replaced by‘tenofovir disoproxil’ (specification of the salt removed) $0

Updated on 7 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 March 2018 PIL

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 SmPC

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

$0$0Updateto sections 4.5 with the PRAC adopted wording on interaction betweencobicistat (COBI)-containing products and corticosteroids.$0$0Streamliningthe text in SmPC section 4.4 to remove the reference toelvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate inconsideration of the approval of Genvoya(elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) and otherCOBI-containing products$0$0

Updated on 6 March 2017 PIL

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 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



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 5 May 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 9 June 2015 SmPC

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 4.5 – updated with data from the final study reports for the two drug-drug interaction studies GS-US-216-0136 and GS-US-216-0137
• 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 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 2 December 2014 SmPC

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

• Updates to sections 4.8 and 5.1 with 144 week safety and efficacy data from Study GS-US-216-0114
• Change to the date of revision in section 10 to October 2014 

Updated on 29 August 2014 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)

Free text change information supplied by the pharmaceutical company

• Updates to sections 4.2 and 4.8 of the SmPC with interim 48 weeks data from study GS-US-236-0118
• Change to the date of revision in section 10 to July 2014 

Updated on 26 August 2014 PIL

Reasons for updating

  • Change to date of revision

Updated on 7 April 2014 SmPC

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 4.5 - update based on a phase 1 study (GS-US-236-0135) evaluating the drug interaction potential between telaprevir (TVR) and cobicistat
- Section 6.1 - update the designation of the excipients
- Section 10 - change to date of revision

Updated on 28 March 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 9 October 2013 SmPC

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 7 October 2013 PIL

Reasons for updating

  • New PIL for new product