Maviret 100 mg-40 mg film-coated tablets
*Company:
AbbVie LimitedStatus:
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 13 July 2022
File name
SPC_Maviret 100mg-40mg Tablets_Shelf Life Extension_12July2022.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
Section 6.3
Shelf life extended from 3 years to 5 years
Updated on 27 May 2022
File name
PL_Maviret 100mg-40mg Tablets_PASS recurrence removal_19May2022.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 May 2022
File name
PL_Maviret 100mg-40mg Tablets_PASS recurrence removal_19May2022.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 25 May 2022
File name
SPC_Maviret 100mg-40mg Tablets_PASS recurrence removal_19May2022.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of inverted black triangle and additional monitoring statement
Updated on 28 March 2022
File name
PL_Maviret 100mg-40mg Tablets_Renewal_22Mar2022.pdf
Reasons for updating
- 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 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 28 March 2022
File name
SPC_Maviret 100mg-40mg Tablets_Renewal_22Mar2022.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Section 2.0
Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
Amended to:
Each film-coated tablet contains 7.48 mg lactose (as monohydrate).
Section 4.4
The following statement added:
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Section 4.8
“elevation in total bilirubin” added as a Common adverse reaction to Table 4.
Section 9.0
Date of latest renewal: 22 March 2022
Section 10.0
Date of Revision of the Text: 03/2022
Minor editorial updates have been made throughout the document
Updated on 23 June 2021
File name
Maviret 100mg-40mg Film-coated Tablets_SmPC_Paediatric Line Extension_June 2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 23 June 2021
File name
Maviret 100mg-40mg Film-coated Tablets_PL_Paediatric Line Extension_June 2021.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 25 March 2021
File name
Maviret_IE_SmPC_M13-576_March 2021.pdf
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 15 January 2021
File name
Maviret_IE_SmPC_B16-439 (TARGET Study)_January 2021.pdf
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 15 January 2021
File name
Maviret_IE_SmPC_B16-439 (TARGET Study)_January 2021.pdf
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 01 May 2020
File name
Maviret_IE_SmPC_Final Study Report M16-133_April 2020.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 01 May 2020
File name
Maviret_IE_PL_Final Study Report M16-133_April 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 March 2020
File name
Maviret_IE_SmPC_EXPEDITION-8 GT3_March 2020.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 03 February 2020
File name
Maviret_IE_SmPC_Medication Errors Wording_January 2020.pdf
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
File name
Maviret_IE_SmPC_Endurance 5+6 Data_September 2019.pdf
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
File name
Maviret_IE_SmPC_China Registry Data + EXPEDITION-8_July 2019.pdf
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
File name
Maviret_IE_PL_Adolescent Indication + Pruritus ADR_April 2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 April 2019
File name
Maviret_IE_SmPC_Adolescent Indication + Pruritus ADR+M16-127+Shelf Life_April 2019.pdf
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
File name
Maviret_IE_PL_Adolescent Indication + Pruritus ADR_March 2019.pdf
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
File name
Maviret_IE_SmPC_Adolescent Indication + Pruritus ADR_March 2019.pdf
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
File name
Maviret_IE_PL_Dysglycaemia_November 2018.pdf
Reasons for updating
- Change to other sources of information section
Updated on 03 December 2018
File name
Maviret_IE_PL_Dysglycaemia_November 2018.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 03 December 2018
File name
Maviret_IE_SmPC_Dysglycaemia_November 2018.pdf
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
File name
Maviret_IE_SmPC_MAH Transfer (Brexit)_June_2018.pdf
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
File name
Maviret_IE_SmPC_MAH Transfer (Brexit)_June_2018.docx
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
File name
Maviret_IE_PL_MAH Transfer (Brexit)_June 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 18 May 2018
File name
Maviret_IE_SmPC_Kidney_Liver_Transplant_April_2018_NOT_MARKETED.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 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 04 May 2018
File name
Maviret_IE_PIL_Kidney Liver Transplant_April 2018_NOT MARKETED.pdf
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 01 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 01 March 2018
File name
PIL_17241_276.pdf
Reasons for updating
- New PIL for new product
Updated on 01 March 2018
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 01 March 2018
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 20 December 2017
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 09 August 2017
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 02 August 2017
Reasons for updating
- New PIL for new product