Veklury 100 mg powder for concentrate for solution for infusion *
Pharmacy Only: Prescription

  • 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

Updated on 24 November 2022

File name

637f721becd2e.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

636177ac74300.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

63617687ea226.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 27 September 2022

File name

6332eaac5922f.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

6332e993e0d5c.pdf

Reasons for updating

  • Change to improve clarity and readability

Updated on 22 September 2022

File name

632c3d7a28cc0.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

632c3d29e461c.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

62fa3b7b1326f.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

62fa3a292b35b.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Product/presentation re-marketed

Updated on 27 July 2022

File name

62e15d9ad407e.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

62e15d67d6980.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)_1650876980.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)_1648732719.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)_1641311396.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)_1641311247.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)_1637081010.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)_1630699474.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)_1630699448.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 05 July 2021

File name

Veklury - SmPC (June 2021)_1625504370.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)_1625504296.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_1614183367.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_1614183291.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_1614181568.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_1614181520.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_1608813522.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_1608813383.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_1593795992.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_1593795968.pdf

Reasons for updating

  • New PIL for new product