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Approvals/Philippines FDA/Luprolex

Approved

STANDARD

Luprolex

Takeda Pharmaceutical Company Limited (Hikari Plant)🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 0bdb337c8014c9a2
Company: Takeda Pharmaceutical Company Limited (Hikari Plant)
Type: Standard

Approval Details

Approval Id: 0bdb337c8014c9a2
Drug Approval Philippines Name: Luprolex
Product Name: Luprolex
Registration Number: DR-XY48479
Brand Name: Luprolex
Generic Name: Leuprorelin Acetate
Dosage Form: Powder For Prolong-Release Suspension for Injection (IM/SC)
Dosage Strength: 1.88mg/mL
Manufacturer: Takeda Pharmaceutical Company Limited (Hikari Plant)
Importer: Hizon Laboratories Inc.
Distributor: Hizon Laboratories Inc.
Issuance Date: 24 November 2022
Expiry Date: 24 November 2027
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

0bdb337c8014c9a2

Type

Standard

Back to Philippines FDA Approvals

Luprolex - Philippines FDA Drug Approval Details