Vosevi 400 mg/100 mg/100 mg & 200 mg/50 mg/50 mg 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 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
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Type IB variation to extend the shelf-life for Vosevi tablets, from 36 months to 48 months. In addition:
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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