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EMERGENCY USE AUTHORIZATION

PAXLOVID™ has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV- 2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death; and

The emergency use of PAXLOVID™ is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID- 19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization revoked sooner.

PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)

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