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Gilead Sciences Ltd

Gilead Medical Information (UK & Eire), 280 High Holborn, London, WC1V 7EE, UK
Telephone: +44 (0)203 681 4500
E-mail: Product complaints: IEProductComplaints@gilead.com
Medical Information Direct Line: +353 214 825 999
Medical Information Direct Line: 08000 113 700 (UK)
Medical Information e-mail: ukmedinfo@gilead.com
Customer Care direct line: +44 (0)203 681 4681
Summary of Product Characteristics last updated on medicines.ie: 16/03/2017
SPC Tybost 150mg film coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 16/03/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   26-Jan-2017
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 13/05/2016 and displayed until 16/03/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2016
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 09/06/2015 and displayed until 13/05/2016
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2015
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 02/12/2014 and displayed until 09/06/2015
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2014
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 29/08/2014 and displayed until 02/12/2014
Reasons for adding or 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
Date of revision of text on the SPC:   01-Jul-2014
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 07/04/2014 and displayed until 29/08/2014
Reasons for adding or 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
Date of revision of text on the SPC:   20-Feb-2014
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 09/10/2013 and displayed until 07/04/2014
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Cobicistat