Maviret 100 mg-40 mg film-coated tablets
- Name:
Maviret 100 mg-40 mg film-coated tablets
- Company:
AbbVie Limited
- 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: 29/04/19
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AbbVie Limited
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 February 2020 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 23 September 2019 SmPC
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)
Updated on 29 July 2019 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 29 April 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 April 2019 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 20 March 2019 PIL
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 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 20 March 2019 SmPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2019 PIL
Reasons for updating
- Change to other sources of information section
Updated on 3 December 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 3 December 2018 SmPC
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)
Updated on 18 July 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 June 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Description of change
SmPC was updated to reflect approval of Type IB variation to transfer EU MA from UK to Germany due to Brexit for Maviret 100 mg/40 mg film-coated tablets.
The following is summary of the changes:
7. Marketing Authorisation Holder
Updated to AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
10. Date of Revision of Text
Updated to 06/2018.
Updated on 20 June 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 18 May 2018 SmPC
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Description of change
SmPC was updated to reflect approval of Type II variation to include dosing and administration for patients who are liver or kidney transplant recipient based on additional data gathered during the transplant study (M13-596) for Maviret 100 mg/40 mg Film-coated Tablets.
The following is summary of the changes:
4.2 Posology and method of administration
Update to to include dosing and administration for patients who are liver or kidney transplant recipient.
4.4 Special warnings and precautions for use
Removed section on liver transplant patients.
4.5 Interaction with other medicinal products and other forms of interaction
Updated wording on HCV-infected transplant recipients under Table 3: Interactions between Maviret and other medicinal products.
4.8 Undesirable effects
Added section on Adverse Reactions in Subjects with Liver or Kidney Transplant.
5.1 Pharmacodynamic properties
Updated Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection with Liver or Kidney Transplant Recipients Study MAGELLAN-2.
Added Section on Clinical Study in Liver or Kidney Transplant Recipients.
10. Date of Revision of Text
Updated to 04/2018.
Updated on 4 May 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 1 March 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Addition of information on alternative format leaflets
Updated on 1 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 1 March 2018 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 4.5 Interaction with other medicinal products and other forms of interaction
Ø Table 3: Interactions between Maviret and other medicinal products, Proton Pump Inhibitors:
“Co-administration of Maviret with omeprazole 40 mg once daily may lead to reduced therapeutic effect and is not recommended” has been amended to “No dose adjustment is required.”
Section 5.1 Pharmacodynamic properties
Ø ATC code has been added:
J05AP57 glecaprevir and pibrentasvir
Ø Minor editorial updates made to Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection
Section 10. DATE OF REVISION OF THE TEXT
Ø Updated to 02/2018
Updated on 1 March 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2017 SmPC
Reasons for updating
- 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 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
- 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
Updated on 9 August 2017 SmPC
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 2 August 2017 PIL
Reasons for updating
- New PIL for new product