Veklury 100 mg powder for concentrate for solution for infusion
*Company:
Gilead Sciences LtdStatus:
No Recent UpdateLegal 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
Updated on 21 November 2024
File name
Veklury_SmPC_XI_IE Oct 2024.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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 4.9 overdose updated
Section 5.1 updated regarding the QT study.
We have also taken this opportunity to correct the admin errors in sections 4.8 and 5.2 of the SmPC.
Updated on 24 October 2024
File name
Veklury_SmPC_XI_IE_Sep 2024.pdf
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 - how to report a side effect
- 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 02 July 2024
File name
Veklury SmPC_IE_XI_May_2024.pdf
Reasons for updating
- 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 08 December 2023
File name
Veklury SmPC XI-IE (Nov 23).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 October 2023
File name
Veklury SmPC XI-IE (October 2023).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 4.5 - 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 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 October 2023
File name
Veklury PIL XI-IE (October 2023).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 20 July 2023
File name
Veklury SmPC XI-IE (June 2023).pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 20 July 2023
File name
Veklury PIL XI-IE (June 2023).pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 06 July 2023
File name
Veklury SmPC XI-IE (June 2023).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 06 July 2023
File name
Veklury PIL XI-IE (June 2023).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
Updated on 26 June 2023
File name
Veklury SmPC IX-IE (May 2023).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 17 May 2023
File name
Veklury IE XI SPC (April 2023).pdf
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
Update Section 5.1
Updated on 17 May 2023
File name
Veklury IE XI SPC (April 2023).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2023
File name
Veklury SmPC IE-XI (February 2023).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 January 2023
File name
Veklury SmPC IE-XI (January 2023).pdf
Reasons for updating
- 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
Section 5.1 of the SmPC was updated to add resistance data from Study GS-US-540-9012.
Updated on 24 November 2022
File name
Veklury IE-XI SmPC (November 2022).pdf
Reasons for updating
- 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
Section 5.1 of the SmPC was updated to provide in vitro data on the antiviral activity of remdesivir against the Omicron subvariants BA.2.12.1, BA.4 and BA.5 based on PC-540-2039
Updated on 01 November 2022
File name
Veklury IE-XI SmPC (October 2022).pdf
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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2022
File name
Veklury IE-XI PIL (October 2022).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 27 September 2022
File name
Veklury SmPC IE-XI (September 2022).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - 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
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2022
File name
Veklury IE-XI PIL (September 2022).pdf
Reasons for updating
- Change to improve clarity and readability
Updated on 22 September 2022
File name
Veklury SmPC IE-XI (Sept 2022) .pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - 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
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 September 2022
File name
Veklury IE-XI PIL (Sept 2022) .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 - contraindications
- 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 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
Updated on 15 August 2022
File name
Veklury SmPC XI&IE (Aug 2022).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 August 2022
File name
Veklury IE-XI PIL (Aug 2022) .pdf
Reasons for updating
- Change to section 6 - date of revision
- Product/presentation re-marketed
Updated on 27 July 2022
File name
Veklury SmPC XI&IE (July 2022).pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2022
File name
Veklury Leaflet XI&IE (July 2022).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 25 April 2022
File name
Veklury SmPC XI&IE (April 2022).pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 March 2022
File name
Veklury SmPC IE-XI (March 2022).pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2022
File name
Veklury Leaflet IE-XI (December 2021).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 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
Updated on 04 January 2022
File name
Veklury SmPC IE-XI (December 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 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2021
File name
Veklury IE-XI SmPC (October 2021).pdf
Reasons for updating
- 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
A PAM July submission to fulfil 3 components (listed below) of Specific Obligation (SOB) 012:
- Characterization of clinical isolates and/or recombinant viruses with P323L, A92V, and A547V substitutions
- Chloroquine/hydroxychloroquine antagonism
- Activity of Remdesivir in additional cell lines
Recommendations 16 and 17 are also fulfilled:
- REC 16: Analysis of antiviral activity using additional cells and clinical isolates; analysis of influence of other antiviral agents on Remdesivir activity; provision of missing data.
- REC 17: Analysis of antiviral activity of Remdesivir to clinical isolates of circulating viral strains from different geographical regions, i.e. clinical isolates with substitutions P323L, A97V and A574V.
As a result, section 5.1 of the SmPC has been updated.
Updated on 03 September 2021
File name
Veklury IE-XI SmPC (August 2021).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)
Updated on 03 September 2021
File name
Veklury IE-XI PIL (August 2021).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 05 July 2021
File name
Veklury - SmPC (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 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
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 05 July 2021
File name
Veklury - PIL (June 2021).pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 24 February 2021
File name
Veklury 100mg Powder - PIL - December 2020.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 24 February 2021
File name
Veklury 100mg Powder - SmPC - December 2020.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 24 February 2021
File name
Veklury 100mg Powder - SmPC - February 2021.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 24 February 2021
File name
Veklury 100mg Powder - PIL - February 2021.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change of licence holder
- Change to date of revision
Updated on 24 December 2020
File name
Veklury 100mg Powder - SmPC - December 2020.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
A type II variation was submitted in order to fulfill the Specific Obligation (SOB#13) within Annex II of the product information. “In order to confirm the efficacy and safety of remdesivir in patients on IMV/ECMO, the MAH should submit the published final D28 mortality data by ordinal scale categories of Study CO-US-540-5776 (NIAID-ACTT1). In addition, the MAH should discuss potential imbalance in the use of corticosteroids and effect modification in Study CO-US-540-5776.”
Additionally, during the procedure the MAH was requested to restrict the indication to those on low- or high-flow oxygen or other non-invasive ventilation at start of treatment and to exclude patients on IMV/ECMO. This change has been made in section 4.1 of the SmPC with consequential updates to the PIL.
Finally during the procedure the MAH was requested to include mortality data from the final NIAID-ACTT1 study. This data has been included in section 5.1 of the SmPC.
Minor corrections were also made throughout the SmPC
Updated on 24 December 2020
File name
Veklury 100mg Powder - PIL - December 2020.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
A type II variation was submitted in order to fulfill the Specific Obligation (SOB#13) within Annex II of the product information. “In order to confirm the efficacy and safety of remdesivir in patients on IMV/ECMO, the MAH should submit the published final D28 mortality data by ordinal scale categories of Study CO-US-540-5776 (NIAID-ACTT1). In addition, the MAH should discuss potential imbalance in the use of corticosteroids and effect modification in Study CO-US-540-5776.”
Additionally, during the procedure the MAH was requested to restrict the indication to those on low- or high-flow oxygen or other non-invasive ventilation at start of treatment and to exclude patients on IMV/ECMO. This change has been made in section 4.1 of the SmPC with consequential updates to the PIL.
Finally during the procedure the MAH was requested to include mortality data from the final NIAID-ACTT1 study. This data has been included in section 5.1 of the SmPC.
Minor corrections were also made throughout the PIL.
Updated on 03 July 2020
File name
Veklury 100mg Powder - SmPC - July 2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 July 2020
File name
Veklury 100mg Powder - PIL - July 2020.pdf
Reasons for updating
- New PIL for new product