Harvoni 90 mg/400 mg and 45 mg/200 mg film-coated tablets *

  • Company:

    Gilead Sciences Ltd
  • Status:

    Updated
  • 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 09 September 2021

File name

Harvoni 90 mg-400 mg and 45 mg-200 mg film-coated tablets IE & XI PIL (August 2021)_1631213833.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 09 September 2021

File name

Harvoni 90 mg-400 mg and 45 mg-200 mg film-coated tablets IE & XI SmPC (August 2021)_1631213728.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 28 July 2021

File name

Harvoni 90 mg-400 mg and 45 mg-200 mg film-coated tablets IE & XI SmPC (July 2021)_1627492965.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 28 July 2021

File name

Harvoni 90 mg-400 mg and 45 mg-200 mg film-coated tablets IE & XI PIL (July 2021)_1627492915.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 04 June 2021

File name

Harvoni 90 mg - 400 mg and 45 mg - 200 mg tablets IE & XI PIL (May 2021)_1622819576.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 10 July 2020

File name

Harvoni 90 mg-400 mg and 45 mg-200 mg film-coated tablets PIL (July 2020)_1594389591.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 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - marketing authorisation number

Updated on 10 July 2020

File name

Harvoni 90 mg-400 mg and 45 mg-200 mg film-coated tablets SmPC (July 2020)_1594388812.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 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 11 May 2020

File name

Harvoni PIL (February 2020)_1589206923.pdf

Reasons for updating

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

Updated on 11 May 2020

File name

Harvoni SmPC (February 2020)_1589206882.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 24 January 2020

File name

Harvoni SmPC - December 2019_1579879844.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Updated on 07 November 2019

File name

Harvoni SmPC - October 2019_1573148269.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 - how to report a side effect
  • 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 07 November 2019

File name

Harvoni PIL - October 2019_1573148227.pdf

Reasons for updating

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

Updated on 29 August 2019

File name

Harvoni PIL - August 2019_1567013241.pdf

Reasons for updating

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

Updated on 28 August 2019

File name

Harvoni SmPC - August 2019_1567013170.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 14 August 2019

File name

Harvoni_PIL_ August 2019_1565715789.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 13 August 2019

File name

Harvoni_SmPC_ August 2019_1565715873.pdf

Reasons for updating

  • 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 of Section 4.5 of the SmPC to add new information on the impact of direct-acting antiviral (DAA) therapy on drugs metabolized by the liver (e.g. immunosuppressive agents) and on the potential need for dose adjustment of those drugs when they are co-administered with DAA therapy.
.

Updated on 08 March 2019

File name

Harvoni PIL Dec 2018_1552060280.pdf

Reasons for updating

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

Updated on 08 March 2019

File name

Harvoni SmPC Feb 2019_1552060410.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 21 February 2019

File name

Harvoni SmPC_Feb2019_1550758546.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

Harvoni PIL-November 2018_1545222799.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

Harvoni SmPC-November 2018_1545222862.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 19 July 2018

File name

Harvoni SmPC - July 2018.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life

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

Updated on 04 July 2018

File name

HarvoniSmPCJuly2018.docx

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 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 July 2018

File name

Harvoni PIL - June 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 20 December 2017

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

  • Section 4.5 – updated information related to the Cytochrome P450 3A (CYP3A) mediated drug-drug interaction potential of ledipasvir

Updated on 20 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 01 August 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 4.5 - 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 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

$0• Extension of indication to add treatment of chronic hepatitis C in adolescents aged 12 to < 18 years. As a consequence, 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.$0$0$0$0$0• Section 6.3 - Extend the shelf-life to 48 months$0$0$0$0

Updated on 28 July 2017

File name

PIL_16169_211.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 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 - date of revision

Updated on 22 June 2017

Reasons for updating

  • 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

  • Update sections 4.8, in light of a post approval safety review on cases of angioedema.

Updated on 21 June 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 June 2017

Reasons for updating

  • 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

  • Update sections 4.8, 5.1 and 5.2 with clinical data available from studies GS-US-337-0123 and GS-US-337-0124 (SOLAR-1 and SOLAR-2), and in light of a post approval safety review on cases of angioedema.

Updated on 09 June 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 06 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 limited data on the use of Harvoni 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 20 December 2016

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

To extend the shelf-life of Harvoni film-coated tablets from 24 months to 36 months

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 Harvoni, 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 Harvoni’.

Updated on 08 December 2016

Reasons for updating

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

Updated on 24 October 2016

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 limited data on the use of Harvoni in patients with HCV/HBV co‑infection

Updated on 02 August 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Addition of legal category

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 4.8 ofthe SmPC to add the adverse reaction “rash” with a frequency “common”. ThePackage leaflet is updated accordingly.$0addition of annex IV $0

Updated on 01 August 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 26 April 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 4.3 (Contraindications) to include the use with potent P-gp inducers could decrease ledipasvir and sofosbuvir plasma concentration.

•             Update to Section 4.4 (Special warnings and precautions for use) to include use with moderate P-gp inducers in combination may decrease ledipasvir and sofosbuvir plasma concentrations.

•             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 ledipasvir and sofosbuvir plasma leading to reduced therapeutic effect of Harvoni.  Co-    administration with such medicinal products is not recommended with Harvoni

Updated on 18 April 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 07 January 2016

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 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 4.2: Update to the posology and method of administration section to include patient genotypes 5 or 6
• Section 4.4: Update to the special warnings and precautions for use to include efficacy statement in genotypes 5 and 6 HCV infected patients
• Section 5.1: Update to the pharmacodynamic properties to include clinical study updates in genotypes 2,3,4,5 and 6
• Section 10: Change to the date of revision to December 2015

Updated on 25 November 2015

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

• Section 5.3: Inclusion of data from the 26 week carcinogenicity study conducted with ledipasvir.

Updated on 09 November 2015

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
  • 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 4.2: Inclusion of a 12 week +RBV treatment option based on the data from the SIRIUS study
• Section 4.8: Include safety profile information for ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in patients
• Section 5.1: Update to pharmacodynamic properties to include information related to the SOLAR-1 & SIRIUS studies
• Section 10: Change to the date of revision to October 2015

Updated on 06 November 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 03 November 2015

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
  • 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

• Sections 4.2, 4.8 and 5.1: Include a 12 week +RBV treatment option for decompensated and/or pre-/ post-transplant patients based on the data from Study GS-US-337-0123 (SOLAR-1). This variation affects the posology table in section 4.2 for liver transplant patients and patients suffering from decompensated cirrhosis
• Section 5.1: Include additional clinical data from Study GS-US-337-0115 (ION-4) in HIV/HCV co-infected patients
• Section 5.1: Include clinical data on the treatment of HCV-infected subjects who have previously failed on a sofosbuvir-based regimen
• Section 10: Change to the date of revision to September 2015

Updated on 09 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

Sections 4.4 & 4.8:

- Updated to include safety signals of cardiac arrhythmias
- Cases of severe bradycardia and heart block have been observed with Harvoni 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 Harvoni

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 13 March 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 23 January 2015

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

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 19 November 2014

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie