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Veklury 100 mg concentrate for solution for infusion

  • Name:

    Veklury 100 mg concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Remdesivir

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/02/21

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Summary of Product Characteristics last updated on medicines.ie: 24/2/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Gilead Sciences Ltd

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Medicine Name Tybost 150mg film coated tablets Active Ingredients Cobicistat
Medicine Name Veklury 100 mg concentrate for solution for infusion Active Ingredients Remdesivir
Medicine Name Veklury 100 mg powder for concentrate for solution for infusion Active Ingredients Remdesivir
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1 - 0 of 27 items.Total: Infinity pages

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 24 February 2021 SPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 February 2021 PIL

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 SPC

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 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 24 December 2020 SPC

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 PIL

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 3 July 2020 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 July 2020 PIL

Reasons for updating

  • New PIL for new product