Setam
Brand Name: Setam
Generic Name: Levetiracetam
Active
Registration Number
DR-XY48015
Dosage Form
Solution for Injection (I.V. Infusion)
Issuance Date
May 16, 2022
Expiry Date
May 16, 2027
Product Information
Philippine FDA product specifications and classification details
Product Specifications
Dosage Strength100 mg/mL (500 mg/5 mL)
Packaging5 mL (net content) USP Type I clear and colorless glass
vial with gray elastic rubber stopper and aluminum seal with plastic flip-off cap (box of 5 vials and 10 vials)
Classification
C
Classification
Prescription Drug (RX)
A
Application
Initial
Philippine FDA Classification
Active Ingredients (1)
Complete list of active ingredients in this pharmaceutical product.
LevetiracetamActive
Monograph: Levetiracetam