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Helem-100 - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Helem-100
Approved
STANDARD
Helem-100
Celon Laboratories Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
20efcab040500c2a
Company
Celon Laboratories Limited
Type
Standard
Approval Details
Approval Id
20efcab040500c2a
Drug Approval Philippines Name
Helem-100
Product Name
Helem-100
Registration Number
DRP-7738-02
Brand Name
Helem-100
Generic Name
Epirubicin hydrochloride
Dosage Form
Lyophilized Powder for Solution for IV Infusion
Dosage Strength
100 mg
Manufacturer
Celon Laboratories Limited
Importer
I.E. Medica, Inc.
Distributor
Kaufmann Pharma Inc.
Issuance Date
27 September 2024
Expiry Date
19 March 2028
Pharmacologic Category
Cytotoxic Antibiotic (Anthracycline)
Classification
Prescription Drug (Rx)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
20efcab040500c2a
Type
Standard
Back to Philippines FDA Approvals