NovoSeven RT
Brand Name: NovoSeven RT
Generic Name: Eptacog alfa activated
Active
Registration Number
BR-1282
Dosage Form
Powder And Solvent For Solution For Injection
Issuance Date
August 1, 2023
Expiry Date
July 25, 2028
Product Information
Philippine FDA product specifications and classification details
Product Specifications
Dosage Strength1 mg/vial (50KIU/vial)
PackagingVial: Type I glass vial closed with chlorobutyl rubber stopper, covered with an aluminium cap. The closed vial is equipped with a polypropylene tamper-evident snap-off cap. Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger. The syringe cap consists of bromobutyl rubber and polypropylene tamper evident seal. Plunger rod: made of polypropylene.
Classification
C
Classification
Prescription Drug (RX)
P
Pharmacologic
Blood Coagulation Factor
A
Application
Renewal
Philippine FDA Classification
Active Ingredients (1)
Complete list of active ingredients in this pharmaceutical product.
Eptacog alfa activatedActive
Monograph: eptacog alfa activated