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Imatiplex - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Imatiplex
Approved
STANDARD
Imatiplex
Shilpa Medicare Limited - Unit 4 Pharmaceutical Formulation Sez
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
3662f692738e61c0
Company
Shilpa Medicare Limited - Unit 4 Pharmaceutical Formulation Sez
Type
Standard
Approval Details
Approval Id
3662f692738e61c0
Drug Approval Philippines Name
Imatiplex
Product Name
Imatiplex
Registration Number
DRP-12370
Brand Name
Imatiplex
Generic Name
Irinotecan hydrochloride (as trihydrate)
Dosage Form
Concentrate Solution for I.V. Infusion
Dosage Strength
20 mg/mL (100 mg/5 mL)
Manufacturer
Shilpa Medicare Limited - Unit 4 Pharmaceutical Formulation Sez
Importer
Ambica International Corporation
Distributor
Ambica International Corporation
Issuance Date
27 July 2022
Expiry Date
27 July 2027
Pharmacologic Category
Antineoplastic (Topoisomerase 1 (TOP 1) Inhibitor)
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
3662f692738e61c0
Type
Standard
Back to Philippines FDA Approvals