Epclusa 400 mg/100 mg and 200 mg/50 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 28 July 2021

File name

Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE & XI SmPC (July 2021)_1627492447.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 28 July 2021

File name

Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE & XI PIL (July 2021)_1627492328.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 12 April 2021

File name

Epclusa - IE&XI PIL (March 2021)_1618252154.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 12 April 2021

File name

Epclusa - IE&XI SmPC (March 2021)_1618252103.pdf

Reasons for updating

  • 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)

Updated on 03 September 2020

File name

Epclusa _SmPC_August 2020_1599130741.pdf

Reasons for updating

  • Addition of joint SPC covering all presentations
  • 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 4.8 - 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 10 - Date of revision of the text

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

Updated on 03 September 2020

File name

Epclusa_PIL_August 2020_1599130483.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 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 27 March 2020

File name

Epclusa SmPC - March 2020_1585317536.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 27 March 2020

File name

Epclusa PIL - March 2020_1585317395.pdf

Reasons for updating

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

Updated on 04 March 2020

File name

Epclusa_SmPC_Jan2020_1583338167.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

Epclusa_PIL_Jan2020_1583337844.pdf

Reasons for updating

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

Updated on 29 October 2019

File name

Epclusa SmPC October 2019_1572368093.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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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 29 October 2019

File name

Epclusa PIL October 2019_1572367948.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 03 October 2019

File name

Epclusa PIL - September 2019_1570109986.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 03 October 2019

File name

Epclusa SmPC - September 2019_1570109907.pdf

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 29 August 2019

File name

Epclusa PIL - August 2019_1567013447.pdf

Reasons for updating

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

Updated on 28 August 2019

File name

Epclusa SmPC - August 2019_1567013407.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 01 May 2019

File name

Epclusa_SmPC_Apr2019_1556722452.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Error in previous uploaded of Epclusa SmPC Arp2019

Updated on 01 May 2019

File name

Epclusa_SmPC_Apr2019_1556722164.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 12 March 2019

File name

Epclusa_PIL-Dec2018_1552323746.pdf

Reasons for updating

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

Updated on 11 March 2019

File name

Epclusa_SmPC_Dec2018_1552323815.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
  • 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

Epclusa PIL -November 2018_1545216948.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

Epclusa SmPC - November 2018_1545217072.pdf

Reasons for updating

  • New individual SPC (was previously included in combined SPC)
  • 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

Epclusa SmPC - June 2018_1533109272.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

Epclusa PIL - May 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 11 June 2018

File name

Epclusa-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 09 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 09 March 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 extension from 24 months to 36 months

Updated on 16 October 2017

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Update of section 5.3 of the SmPC in order to add non-clinical safety findings based on a 6-month carcinogenicity study conducted with velpatasvir in transgenic mice (Study TX-281-2043).

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 5.3 of the SmPC in order to add non-clinical safety findings based on a 6-month carcinogenicity study conducted with velpatasvir in transgenic mice (Study TX-281-2043).

Updated on 14 June 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

  • Update section 4.4 to align the Product Information with the review initiated under Article 20 of Regulation (EC) No 726/2004 and follows cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C.
  • Update to section 5.1 with recently assigned ATC code
  • Minor administrative change to the local representative details of the Marketing Authorisation Holder for Estonia, Lithuania and Latvia within the PL.

Updated on 09 June 2017

File name

PIL_16794_294.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 June 2017

Reasons for updating

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

Updated on 07 April 2017

Reasons for updating

  • 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

Submission of the final CSR for the ASTRAL-5 study:

 

GS-US-342-1202 - A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 weeks in Subjects with Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

 

Updates to section 5.1 of the EU Summary of Product Characteristics (SmPC) as well as minor administrative changes to certain sections of the EU SmPC and Patient Information Leaflet (PIL) have been included.

 

Study GS-US-342-1202 was detailed in the EU RMP as Category 3 additional pharmacovigilance activity in the Pharmacovigilance Plan. The data provided with this submission fulfils the post-authorisation measure (PAM) and the RMP has been updated to reflect this.

Updated on 05 April 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect

Updated on 09 December 2016

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)

Free text change information supplied by the pharmaceutical company

·        Update to Section 4.5 Special warnings and precautions to update and include a subsection Patients treated with vitamin K antagonists  ‘ As liver function may change during treatment with Epclusa, a close monitoring of International Normalised Ratio (INR) values is recommended’.

·        Table 3 includes an additional section ‘AntiCoagulants’ and the information that has been included in this section is ‘Close monitoring of INR is recommended with all vitamin K antagonists.  This is due to liver function changes during treatment with Epclusa’.

Updated on 08 December 2016

Reasons for updating

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

Updated on 09 August 2016

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 12 July 2016

Reasons for updating

  • New PIL for new product