Vemlidy 25 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 June 2023
File name
Vemlidy IE & NI SmPC (May 2023).pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2023
File name
Vemlidy IE & NI PIL (May 2023).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
Updated on 26 August 2022
File name
Vemlidy IE & NI SmPC (August 2022).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2022
File name
Vemlidy IE & NI PIL (August 2022).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 24 December 2021
File name
Vemlidy IE & XI SmPC (December 2021).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Several changes throughout the SmPC text.
Main changes:
Vemlidy 5-year License Renewal - Vemlidy EU SmPC, Annex II, Labelling and Package Leaflet were amended as per comments received during the procedure (please see details in table below). In addition, Vemlidy is removed from the additional monitoring list as a new active substance following five years of authorisation (removal of black triangle).
Updated on 24 December 2021
File name
Vemlidy IE & XI PIL (December 2021).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Several changes throughout the PIL text.
Main changes:
Vemlidy 5-year License Renewal - Vemlidy EU SmPC, Annex II, Labelling and Package Leaflet were amended as per comments received during the procedure (please see details in table below). In addition, Vemlidy is removed from the additional monitoring list as a new active substance following five years of authorisation (removal of black triangle).
Updated on 23 November 2021
File name
Vemlidy IE & XI SmPC (September 2021).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
GS-US-320 4035 - Week96 -Final CSR - Type II Variation
Type II variation to update sections 4.4, 4.8, 5.1 and 5.2 of the SmPC based on final analysis data at Week 96 from study GS-US-320-4035. This was a Phase 2, open-label study evaluating the efficacy and safety of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B subjects with renal and/or hepatic impairment who switch from tenofovir disoproxil fumarate and/or other oral antiviral agents to TAF 25 mg once daily.
MLA table was submitted as part of this procedure.
MLA and Formatting changes were also included during the Linguistic Review.
Updated on 23 November 2021
File name
Vemlidy IE & XI PIL (April 2021).pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
GS-US-320 4035 - Week96 -Final CSR - Type II Variation
Type II variation to update sections 4.4, 4.8, 5.1 and 5.2 of the SmPC based on final analysis data at Week 96 from study GS-US-320-4035. This was a Phase 2, open-label study evaluating the efficacy and safety of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B subjects with renal and/or hepatic impairment who switch from tenofovir disoproxil fumarate and/or other oral antiviral agents to TAF 25 mg once daily.
MLA table was submitted as part of this procedure.
MLA and Formatting changes were also included during the Linguistic Review.
Updated on 08 September 2021
File name
Vemlidy IE & XI SmPC (July 2021).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2021
File name
Vemlidy XI & IE PIL (April 2021).pdf
Reasons for updating
- Change to other sources of information section
Updated on 18 November 2020
File name
Vemlidy SmPC (September 2020).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 September 2020
File name
Vemlidy PIL (August 2020).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 04 September 2020
File name
Vemlidy SmPC (August 2020).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2020
File name
Vemlidy PIL (May 2020).pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
Updated on 05 June 2020
File name
Vemlidy SmPC (May 2020).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2020
File name
Vemlidy PIL - December 2019.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 24 January 2020
File name
Vemlidy SmPC - December 2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 July 2019
File name
Vemlidy PIL May 2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 July 2019
File name
Vemlidy SmPC May 2019.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)
Free text change information supplied by the pharmaceutical company
Update to section 4.8 of SmPC to include angioedema and urticaria
File name
Vemlidy PIL Jul 2019.pdf
Updated on 08 July 2019
File name
Vemlidy SmPC Jul 2019.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 to section 4.8. of the SmPC, specifically tabulated list of adverse reactions to include angioedema and urticarial as additional adverse reactions, following a safety review conducted by Gilead, concluding the causal association of the two adverse reactions with TAF-containing products.
Updated on 24 June 2019
File name
Vemlidy SmPC - May 2018.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 June 2018
File name
Vemlidy PIL - May 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 11 June 2018
File name
Vemlidy-SmPC-May-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 02 May 2018
File name
VemlidySmPC_March2018.docx
Reasons for updating
- 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 30 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 January 2018
Reasons for updating
- 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
SPC
- Section 6.3 – Shelf life extended to 4 years (previously this was 2 years)
Updated on 20 December 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Type II variation to update Sections 4.8 and 5.1 of the Vemlidy EU Summary of Product Characteristics (SmPC) based on interim CSRs data at Week 96 from Phase III studies GS-US-320-0108 and GS-US-320-0110 (both category 3 additional pharmacovigilance activities in the Vemlidy Risk Management Plan). In addition, safety analysis based on pooled data from Week 96 through Week 120, was also provided.
Updated on 14 December 2017
File name
PIL_17050_628.pdf
Reasons for updating
- New PIL for new product
Updated on 14 December 2017
Reasons for updating
- Change to section 3 - how to take/use
Updated on 18 January 2017
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
Updated on 16 January 2017
Reasons for updating
- New PIL for new product