Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Arcturus Therapeutics Europe B.V., Claude Debussylaan 10, 1082 MD Amsterdam, The Netherlands
Kostaive powder for dispersion for injection.
COVID-19 sa-mRNA Vaccine.
| Pharmaceutical Form |
|---|
|
Powder for dispersion for injection. White to off-white lyophilised cake or powder. |
This is a multidose vial and must be reconstituted before use.
One vial contains 16 doses of 0.5 mL after reconstitution with 10 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection; see sections 4.2 and 6.6.
One dose (0.5 mL) contains 5 micrograms of zapomeran, a COVID-19 self-amplifying messenger RNA (sa-mRNA) (encapsulated in lipid nanoparticles).
Zapomeran is a single-stranded, 5'-capped sa-mRNA replicon, produced using a cell-free in vitro transcription from the corresponding DNA templates encoding a replicase and the spike glycoprotein of the ancestral strain of SARS-CoV-2 with D614G mutation.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Zapomeran |
Zapomeran is composed of a self-amplifying mRNA encoding the spike protein of SARS-CoV-2, encapsulated in lipid nanoparticles. The self-amplifying mRNA is designed to produce extra copies of mRNA within the host cells after intramuscular injection, to achieve enhanced expression of the spike protein antigen. |
| List of Excipients |
|---|
|
Di(pentadecan-8-yl) |
Powder contained in a vial (type I glass) with a stopper (bromobutyl rubber) and a plastic flip-off cap with seal (aluminum crimp).
Each multidose vial contains 16 doses of 0.5 mL; see section 6.6.
Pack size: 20 multidose vials.
Arcturus Therapeutics Europe B.V., Claude Debussylaan 10, 1082 MD Amsterdam, The Netherlands
EU/1/24/1873/001
| Drug | Countries | |
|---|---|---|
| KOSTAIVE | Lithuania |
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