General MedicationsINJECTIONStandard
KEPIVANCE
PALIFERMIN
Standard Dose
60MCG/KG/DAY
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KEPIVANCE is listed in Drugs@FDA under application 125103 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PALIFERMIN Form and strength INJECTABLE; INJECTION - 60MCG/KG/DAY Sponsor BIOVITRUM AB Submission history Latest submission status date: 2023-07-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview KEPIVANCE is listed in Drugs@FDA under application 125103 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient PALIFERMIN Form and strength INJECTABLE; INJECTION - 60MCG/KG/DAY Sponsor BIOVITRUM AB Submission history Latest submission status date: 2023-07-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.