General MedicationsINJECTIONStandard
LEMTRADA
ALEMTUZUMAB
Standard Dose
12MG/1.2ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LEMTRADA is listed in Drugs@FDA under application 103948 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ALEMTUZUMAB Form and strength INJECTABLE;INJECTION - 12MG/1.2ML (10MG/ML) Sponsor GENZYME Submission history Latest submission status date: 2024-05-20 00:00:00.
Structured Monograph
Clinical summary
Approval overview LEMTRADA is listed in Drugs@FDA under application 103948 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALEMTUZUMAB Form and strength INJECTABLE;INJECTION - 12MG/1.2ML (10MG/ML) Sponsor GENZYME Submission history Latest submission status date: 2024-05-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.