Nimedine
Brand Name: Nimedine
Generic Name: Imipenem (as monohydrate) + Cilastatin (as sodium)
Active
Registration Number
DRP-16072
Dosage Form
Powder for Injection (IV)
Issuance Date
November 1, 2024
Expiry Date
August 15, 2026
Product Information
Philippine FDA product specifications and classification details
Product Specifications
Dosage Strength500 mg/500 mg
Packaging20 mL-capacity type III glass vial with bromobutyl rubber
Iglass vial with bromobutyl rubber stopper and aluminum cap with plastic flip-off seal (Box aluminum of 1's)
Classification
C
Classification
Prescription (Rx) Drug
P
Pharmacologic
Antibacterial (Carbapenem)
A
Application
Initial
Philippine FDA Classification
Active Ingredients (2)
Complete list of active ingredients in this pharmaceutical product.
Imipenem (as monohydrate)Active
Monograph: imipenem (as monohydrate)
Cilastatin (as sodium)Active
Monograph: cilastatin (as sodium)