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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