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FDA BLA · BLA761388

PIASKY

crovalimab

Sponsor: GENENTECH INC

APPLICATION
BLA761388
TYPE
BLA
ORIGINAL APPROVAL
2024-06-20
LATEST ACTION
2025-05-14
ROUTE
SUBCUTANEOUS, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PIASKYPrescription
CROVALIMAB-AKKZ 340MG/2ML(170MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2025-05-14REMS · Supplement 1LetterAP
2024-06-20Type 1 - New Molecular Entity · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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