Nirmatrelvir (also known as PF-07321332) is an orally bioavailable 3C-like protease (3CLPRO) inhibitor. The United States (US) Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the emergency use of the combination therapy which included nirmatrelvir and ritonavir for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older, weighing. at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Nirmatrelvir and ritonavir was approved for use in Canada in January 2022 for the treatment of adult patients with mild-to-moderate COVID-19.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Nirmatrelvir, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.