Vemlidy 25 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)
  • Active Ingredient(s):

    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 08 September 2021

File name

Vemlidy IE & XI SmPC (July 2021)_1631127933.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)_1619536666.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 18 November 2020

File name

Vemlidy SmPC (September 2020)_1605714229.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)_1599223476.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)_1599223404.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)_1591366072.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)_1591365705.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_1579892410.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_1579892332.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_1562683629.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_1562683730.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_1562588211.pdf

Updated on 08 July 2019

File name

Vemlidy SmPC Jul 2019_1562588061.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_1561390782.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

None provided

Updated on 16 January 2017

Reasons for updating

  • New PIL for new product