Sovaldi 400 mg and 200 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 19 January 2024
File name
Sovaldi 400 mg and 200 mg film-coated tablets IE & XI PIL (August 2022).pdf
Reasons for updating
- XPIL Created
Updated on 02 September 2022
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Sovaldi 400 mg and 200 mg film-coated tablets IE & XI PIL (August 2022).pdf
Reasons for updating
- Change to name of manufacturer
Updated on 13 June 2022
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Sovaldi 400 mg and 200 mg film-coated tablets IE & XI SmPC (May 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 13 June 2022
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Sovaldi 400 mg and 200 mg film-coated tablets IE & XI PIL (May 2022).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 28 July 2021
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Sovaldi 400 mg and 200 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
Sovaldi 400 mg and 200 mg film-coated tablets IE & XI PIL (July 2021).pdf
Reasons for updating
- Change to other sources of information section
Updated on 08 July 2021
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Sovaldi 400 mg and 200 mg tablets SmPC (June 2021).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
To extend the shelf-life of the Sovaldi oral granules (150 and 200 mg) as packaged for sale from 2 to 3 years (EU/1/13/894/004-005).
Additional sodium excipient wording has also been added for all Sovaldi presentations (EU/1/13/894/001-005) in Section 4.4 of the SmPC and Section 2 of the package leaflet in accordance with the Annex to the European Commission guideline on “Excipients in the labelling and package leaflet of medicinal products for human use” (SANTE-2017-11668) – Revision 1.
Updated on 08 July 2021
File name
Sovaldi 400 mg and 200 mg tablets PIL (June 2021).pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 04 June 2021
File name
Sovaldi 400 mg and 200 mg tablets IE & XI PIL (May 2021).pdf
Reasons for updating
- Change to other sources of information section
Updated on 02 July 2020
File name
Sovaldi 400 mg and 200 mg tablets SmPC (June 2020).pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 July 2020
File name
Sovaldi 400 mg and 200 mg tablets PIL (June 2020).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 11 May 2020
File name
Sovaldi PIL (February 2020).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 11 May 2020
File name
Sovaldi SmPC (February 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 30 October 2019
File name
Sovaldi PIL (October 2019).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Updated on 30 October 2019
File name
Sovaldi 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 September 2019
File name
Sovaldi PIL - September 2019.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2019
File name
Sovaldi 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
Sovaldi PIL - August 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 28 August 2019
File name
Sovaldi SmPC - August 2019.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 02 April 2019
File name
Sovaldi SmPC Mar2019.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 19 December 2018
File name
Sovaldi 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
Sovaldi SmPC- November 2018.pdf
Reasons for updating
- 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 04 October 2018
File name
Sovaldi UK (Ireland and Malta) PIL_Sept 2018.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 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 04 October 2018
File name
Sovaldi UK (Ireland and Malta) SPC_Sept 2018.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 9 - Date of first authorisation/renewal of the authorisation
- 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 31 August 2018
File name
Sovaldi UK (Ireland and Malta) PIL - August 2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 31 August 2018
File name
Sovaldi UK (Ireland and Malta) SmPC - August 2018.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
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Following the submission of PSUR 8 (Reporting Period 06-Jun-17 to 05-Dec-17), the PRAC adopted a recommendation to update of sections 4.4 and 4.5 of the SmPC to modify an existing warning regarding cardiac arrhythmias with co-administration of sofosbuvir-containing regimens and amiodarone.
Update of section 4.8 of the SmPC to add the adverse reaction Steven-Johnson Syndrome (SJS) with a frequency unknown.
Updated on 25 July 2018
File name
Sovaldi PIL - July 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 25 July 2018
File name
Sovaldi SmPC - July 2018.pdf
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 28 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2017
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 4.8 - 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
SPC
· Extension of indication to add treatment of chronic hepatitis C in adolescents aged 12 to < 18 years.
· Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC were updated in order to add information on posology, warnings, safety, efficacy and pharmacokinetics.
Updated on 27 September 2017
File name
PIL_15935_108.pdf
Reasons for updating
- New PIL for new product
Updated on 27 September 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 6 - manufacturer
Updated on 18 July 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Section 6.3 - Extend the shelf-life for Sovaldi tablets from 36 months to 60 months.
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 6.3 - Extend the shelf-life for Sovaldi tablets from 36 months to 60 months.
Updated on 03 March 2017
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)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
HCV/HBV (hepatitis B virus) co‑infection
There are no data on the use of Sovaldi in patients with HCV/HBV co‑infection.Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Updated on 01 March 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 19 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 Sovaldi, 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 Sovaldi’.
Updated on 08 December 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 04 October 2016
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
- 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
Updated on 03 October 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 08 February 2016
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 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 4.4 (Special warnings and precautions for use) to include Co-administration of moderate P-gp inducers is not recommended with Sovaldi.
• Update to Section 4.5 (Interaction with other medicinal products and other forms of interaction) to include medicinal products that are moderate P-gp inducers in the intestine may significantly decrease sofosbuvir plasma concentration along with Co administration with such medicinal products is not recommended with Sovaldi.
• Update to Section 10 (Date of revision) to state January 2016.
Updated on 05 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to date of revision
Updated on 28 January 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
· Update to Section 4.2 Posology and method of administration to include administration of Sovaldi in liver transplant patients
· Update to Section 4.8 Undesirable effects to include the safety profile of sofosbuvir and ribavirin in liver transplant recipients
· Update to 5.1 section 5.1 Pharmacodynamic properties to include Liver transplant recipients in Study 0126.
Updated on 27 August 2015
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
• Change to the date of revision in section 10 to August 2015
Updated on 03 July 2015
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
- 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
- Updated to include safety signals of cardiac arrhythmias
- Cases of severe bradycardia and heart block have been observed with Sovaldi (in combination with Daklinza) and concomitant amiodarone with or without other drugs that lower heart rate
Section 4.5
- Amiodarone interaction listed with recommendation of close monitoring when amiodarone is co- administered with Sovaldi + Daklinza
Section 10:
- Change to the date of revision to June 2015
Updated on 30 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to MA holder contact details
Updated on 16 March 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
• Section 10: Change to the date of revision to January 2015
Updated on 12 March 2015
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 29 January 2015
Reasons for updating
- Change to date of revision
Updated on 03 January 2015
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
• Section 10: Change to the date of revision to November 2014
Updated on 18 August 2014
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
· Section 5.2: addition of data from pre-clinical study
Updated on 31 July 2014
Reasons for updating
- Change to date of revision
Updated on 25 February 2014
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 24 January 2014
Reasons for updating
- New PIL for new product