Basic Information
ZEPZELCA POWDER FOR SOLUTION FOR INFUSION 4MG/VIAL
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Regulatory Information
SIN16327P
September 21, 2021
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
June 4, 2025
Company Information
SPECIALISED THERAPEUTICS ASIA PTE LTD
SPECIALISED THERAPEUTICS ASIA PTE LTD
Active Ingredients
Strength: 4.0 mg/vial
Detailed Information
Contraindications
**4.3 CONTRAINDICATIONS** ZEPZELCA is contraindicated in patients with history of significant drug allergy to the active substance or any of the excipients.
Indication Information
**4.1 THERAPEUTIC INDICATIONS** ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing therapy. This indication is approved under provisional approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials \[ _see 5.1 Clinical Trials_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].