Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Hipra Human Health, S.L.U., Avda. la Selva, 135, 17170 Amer (Girona), SPAIN
BIMERVAX emulsion for injection.
COVID-19 Vaccine (recombinant, adjuvanted).
| Pharmaceutical Form |
|---|
|
Emulsion for injection (injection). White homogeneous emulsion. |
This is a multidose vial which contains 10 doses of 0.5 mL.
One dose (0.5 mL) contains 40 micrograms of SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer* (B.1.351 and B.1.1.7 strains) adjuvanted with SQBA.
* Produced by recombinant DNA technology using a plasmid expression vector in a CHO cell line.
SQBA adjuvant containing per 0.5 mL dose: squalene (9.75 mg), polysorbate 80 (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injections.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| SARS-CoV-2 spike glycoprotein (B.1 strains) |
|
| List of Excipients |
|---|
|
Disodium phosphate dodecahydrate For adjuvant, see section 2. |
5 mL of emulsion in a multidose vial (type I glass) closed with a type I elastomeric stopper and an aluminium seal fitted with a plastic flip-off cap.
Each vial contains: 10 doses of 0.5 mL.
Pack size: 10 multidose vials.
Hipra Human Health, S.L.U., Avda. la Selva, 135, 17170 Amer (Girona), SPAIN
EU/1/22/1709/001
| Drug | Countries | |
|---|---|---|
| BIMERVAX | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania |
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