Vosevi 400 mg/100 mg/100 mg film coated tablets *

  • Company:

    Gilead Sciences Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 26 May 2020

File name

Vosevi SmPC May 2020_1590514430.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Type IB variation to extend the shelf-life for Vosevi tablets, from 36 months to 48 months.

In addition:

  • SmPC Section 2 Qualitative and Quantitative Composition has been updated with the correct amount for lactose. The lactose content language has also been aligned with the way it is presented in Sovaldi and Harvoni SmPCs

Updated on 06 May 2020

File name

Vosevi SmPC Feb 2020_1588781747.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)

Updated on 06 May 2020

File name

Vosevi PIL Feb 2020_1588781666.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 04 March 2020

File name

Vosevi_SmPC_Jan2020_1583338308.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 04 March 2020

File name

Vosevi_PIL_Jan2020_1583338239.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 November 2019

File name

Vosevi SmPC Nov 2019_1573472702.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 5.2 - Pharmacokinetic properties

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

Updated on 04 October 2019

File name

Vosevi SmPC Sept 2019_1570197452.pdf

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

Update of Section 4.5 of the SmPC to add new information on the impact of direct-acting antiviral (DAA) therapy on drugs metabolized by the liver (e.g. immunosuppressive agents) and on the potential need for dose adjustment of those drugs when they are co-administered with DAA therapy.

Updated on 04 October 2019

File name

Vosevi PIL Sept 2019_1570196765.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To add new information on the impact of direct-acting antiviral (DAA) therapy on drugs metabolized by the liver (e.g. immunosuppressive agents) and on the potential need for dose adjustment of those drugs when they are co-administered with DAA therapy

Updated on 29 August 2019

File name

Vosevi PIL - August 2019_1567013546.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 28 August 2019

File name

Vosevi SmPC - August 2019_1567013508.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)

Updated on 12 March 2019

File name

Vosevi PIL Dec 2018_1552323186.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 March 2019

File name

Vosevi SmPC Jan 2019_1552323271.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 22 January 2019

File name

Vosevi PIL -December 2018_1548175271.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 22 January 2019

File name

Vosevi SmPC- January 2019_1548175623.pdf

Reasons for updating

  • 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)

Updated on 19 December 2018

File name

Vosevi PIL- November 2018_1545225058.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 19 December 2018

File name

Vosevi SmPC- November 2018_1545225129.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 01 August 2018

File name

Vosevi PIL - June 2018_1533116282.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 01 August 2018

File name

Vosevi SmPC - June 2018_1533116205.pdf

Reasons for updating

  • 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)

Updated on 14 June 2018

File name

Vosevi-UK-SmPC-June-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 14 June 2018

File name

Vosevi UK (Ireland and Malta) PIL - June 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 03 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 02 August 2017

File name

PIL_17239_918.pdf

Reasons for updating

  • New PIL for new product