Maviret 50 mg/20 mg coated granules in sachet
*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 08 March 2023
File name
Maviret Granules SmPC_36 month SLE_March 2023.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
To extend the shelf-life of Maviret 50 mg/20 mg coated granules in sachet from 24 to 36 months.
Updated on 27 May 2022
File name
PL_Maviret 50mg-20mg Granules_PASS recurrence removal_19May2022.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 May 2022
File name
PL_Maviret 50mg-20mg Granules_PASS recurrence removal_19May2022.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 25 May 2022
File name
SPC_Maviret 50mg-20mg Granules_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
SPC_Maviret 50mg-20mg Granules_Renewal_22Mar2022.pdf
Reasons for updating
- 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 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
Updated on 28 March 2022
File name
PL_Maviret 50mg-20mg Granules_Renewal_22Mar2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- 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 16 August 2021
File name
Maviret 50mg-20mg Coated Granules_SmPC_28 Pack Size_August 2021_NOT MARKETED.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 August 2021
File name
Maviret 50mg-20mg Coated Granules_SmPC_28 Pack Size_August 2021_NOT MARKETED.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 August 2021
File name
Maviret 50mg-20mg Coated Granules_SmPC_28 Pack Size_August 2021_NOT MARKETED.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 August 2021
File name
Maviret 50mg-20mg Coated Granules_PL_28 Pack Size_August 2021_NOT MARKETED.pdf
Reasons for updating
- Deletion of a pack size
- Change to date of revision
Updated on 23 June 2021
File name
Maviret 50mg-20mg Coated Granules_SmPC_Paediatric Line Extension_June 2021.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 June 2021
File name
Maviret 50mg-20mg Coated Granules_PL_Paediatric Line Extension_June 2021.pdf
Reasons for updating
- New PIL for new product