Epclusa 400 mg/100 mg and 200 mg/50 mg film-coated tablets
- Name:
Epclusa 400 mg/100 mg and 200 mg/50 mg film-coated tablets
- Company:
Gilead Sciences Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/09/20
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Gilead Sciences Ltd
Company Products
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 3 September 2020
Reasons for updating
- Addition of joint SmPC 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
Updated on 3 September 2020 PIL
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
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
Updated on 27 March 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 4 March 2020
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Updated on 4 March 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 October 2019
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
Updated on 29 October 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 3 October 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 3 October 2019
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Updated on 29 August 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 28 August 2019
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
Updated on 1 May 2019
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Error in previous uploaded of Epclusa SmPC Arp2019
Updated on 1 May 2019
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Updated on 12 March 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 March 2019
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
Updated on 19 December 2018 PIL
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
Reasons for updating
- New individual SmPC (was previously included in combined SmPC)
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Updated on 1 August 2018
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Updated on 14 June 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 11 June 2018
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 9 March 2018
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 March 2018 SPC
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 SPC
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 SPC
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 9 June 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 9 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 7 April 2017 SPC
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 5 April 2017 PIL
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 9 December 2016 SPC
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 8 December 2016 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 9 August 2016 SPC
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 12 July 2016 PIL
Reasons for updating
- New PIL for new product