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43 result(s) found, displaying 21 to 30
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Australian public assessment report (AusPar)Spikevax (Elasomeran/davesomeran), a vaccine, has transitioned from provisional to full registration. Spikevax is for the prevention of coronavirus disease 2019 caused by SARS-CoV-2.
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Australian public assessment report (AusPar)New AusPAR for Spikevax (elasomeran) for the prevention of COVID-19 caused by SARS-CoV-2.
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Designation or determinationPriority review
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Australian public assessment report (AusPar)AusPAR for SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) as booster dose for active immunisation to prevent COVID-19
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Prescription medicine decision summaryapproved to prevent coronavirus disease 2019 (COVID-19)
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Prescription medicine registrationActive ingredients: elasomeran, davesomeran.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for SPIKEVAX (elasomeran) COVID-19 VACCINE 0.2 mg/mL suspension for injection vial.
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Australian public assessment report (AusPar)AusPAR for SPIKEVAX COVID-19 VACCINE (elasomeran) as booster in 12 to 17 years of age for prevention of COVID-19
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Designation or determinationProvisional determination
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Prescription medicine decision summarySpikevax Bivalent Original/Omicron (elasomeran and imelasomeran) was approved for the prevention of COVID-19.