Nirsevimab Pregnancy Warnings
There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help healthcare providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
This vaccine is not indicated for use in females of reproductive potential
US FDA pregnancy category: Not assigned
Risk summary: This vaccine is not approved for use in persons over 24 months of age.
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