Epclusa 400 mg/100 mg and 200 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 21 August 2023
File name
Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE&XI PIL (August 2023).pdf
Reasons for updating
- Change to further information section
Updated on 06 June 2022
File name
Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE-XI PIL (June 2022).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 06 June 2022
File name
Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE-XI SmPC (June 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 21 January 2022
File name
Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE-XI PIL (January 2022).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 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Extension of indication for the treatment of chronic hepatitis C virus (HCV) infection to include paediatric use in in patients aged 3 years and older
Updated on 21 January 2022
File name
Epclusa 400 mg-100 mg and 200 mg-50 mg film-coated tablets IE-XI SmPC (January 2022).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extension of indication for the treatment of chronic hepatitis C virus (HCV) infection to include paediatric use in in patients aged 3 years and older.
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).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).pdf
Reasons for updating
- Change to other sources of information section
Updated on 12 April 2021
File name
Epclusa - IE&XI PIL (March 2021).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 12 April 2021
File name
Epclusa - IE&XI SmPC (March 2021).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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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
Updated on 12 July 2016
Reasons for updating
- New PIL for new product