Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Veklury 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white to yellow powder. |
Each vial contains 100 mg of remdesivir. After reconstitution, each vial contains 5 mg/mL of remdesivir solution.
Excipients with known effect:
Each vial contains 3 g betadex sulfobutyl ether sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Remdesivir |
Remdesivir is an adenosine nucleotide prodrug that is metabolized within host cells to form the pharmacologically active nucleoside triphosphate metabolite. Remdesivir triphosphate acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. As an additional mechanism, remdesivir triphosphate can also inhibit viral RNA synthesis following its incorporation into the template viral RNA as a result of read-through by the viral polymerase that may occur in the presence of higher nucleotide concentrations. |
| List of Excipients |
|---|
|
Betadex sulfobutyl ether sodium |
Type I clear glass vial, an elastomeric closure, and an aluminium overseal with a flip-off cap.
Pack size: 1 vial.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/20/1459/002
Date of first authorisation: 03 July 2020
Date of latest renewal: 12 April 2022
| Drug | Countries | |
|---|---|---|
| VEKLURY | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States, South Africa |
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