General MedicationsINJECTIONStandard
PALYNZIQ
PEGVALIASE-PQPZ
Standard Dose
20MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview PALYNZIQ is listed in Drugs@FDA under application 761079 (BLA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGVALIASE-PQPZ Form and strength INJECTABLE;INJECTION - 20MG/ML Sponsor BIOMARIN PHARM Submission history Latest submission status date: 2026-02-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview PALYNZIQ is listed in Drugs@FDA under application 761079 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGVALIASE-PQPZ Form and strength INJECTABLE;INJECTION - 20MG/ML Sponsor BIOMARIN PHARM Submission history Latest submission status date: 2026-02-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.