Luprodex
Brand Name: Luprodex
Generic Name: Leuprorelin Acetate
Active
Registration Number
DR-XY48476
Dosage Form
Lyophilized Powder For Injection (IM/SC)
Issuance Date
November 18, 2022
Expiry Date
November 18, 2027
Product Information
Philippine FDA product specifications and classification details
Product Specifications
Dosage Strength11.25 mg
PackagingEach box contains the following in PVC tray:
1. 5 mL USP Type I glass vial with bromobutyl rubber stopper, and white aluminum flip-off seal x 1's 2. 2 mL USP type I ampoule (diluent) x 1's
3. 3 mL syringe x 1's
4. 22G needle x 2's
5. alcohol swabs x 2's
Classification
C
Classification
Prescription Drug (RX)
A
Application
Initial
Philippine FDA Classification
Active Ingredients (1)
Complete list of active ingredients in this pharmaceutical product.
Leuprorelin AcetateActive
Monograph: Leuprolide