Vosevi 400 mg/100 mg/100 mg & 200 mg/50 mg/50 mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Gilead Sciences Ltd
  • Status:

    No Recent Update
  • Legal 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 05 September 2023

File name

Vosevi IE&XI PIL (August 2023).pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 14 June 2022

File name

Vosevi IE & XI SmPC (May 2022).pdf

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 14 June 2022

File name

Vosevi IE & XI PIL (May 2022).pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 12 May 2022

File name

Vosevi IE & XI PIL (April 2022).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
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - what the product contains

Updated on 12 May 2022

File name

Vosevi IE & XI SmPC (April 2022).pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Renewal of MA

Updated on 29 September 2021

File name

Vosevi IE & XI SmPC (September 2021).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 4.5 - 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
  • Change to section 4.9 - Overdose
  • 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)

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

Updated on 29 September 2021

File name

Vosevi IE & XI PIL (September 2021).pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 26 May 2020

File name

Vosevi SmPC May 2020.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.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.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.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.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.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.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.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.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.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.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 March 2019

File name

Vosevi SmPC Jan 2019.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.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 22 January 2019

File name

Vosevi SmPC- January 2019.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.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.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.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.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