MedPath

Koselugo

Brand Name: Koselugo

Generic Name: Selumetinib sulfate

Active
Registration Number

DR-XY49395

Dosage Form

Capsule

Issuance Date

May 14, 2025

Expiry Date

May 14, 2030

Product Information

Philippine FDA product specifications and classification details

Product Specifications

Dosage Strength10 mg
Packaging75 mL HDPE Plastic Bottle with Blue Child-Resistant e with PP Closure (Box of 60's)

Classification

C
Classification
Prescription Drug (RX)
P
Pharmacologic
Antineoplastic Agent (Protein Kinase Inhibitor)
A
Application
Monitored Release
Philippine FDA Classification

Active Ingredients (1)

Complete list of active ingredients in this pharmaceutical product.

Selumetinib sulfateActive
Monograph: Selumetinib

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

Product

Company

Legal

© 2025 MedPath, Inc. All rights reserved.