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Luprolex - Philippines FDA Drug Approval Details
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
7228cde0f04cef9e
Company
Takeda Pharmaceutical Company Limited (Hikari Plant)
Type
Standard
Approval Details
Approval Id
7228cde0f04cef9e
Drug Approval Philippines Name
Luprolex
Product Name
Luprolex
Registration Number
DR-XY48478
Brand Name
Luprolex
Generic Name
Leuprorelin Acetate
Dosage Form
Powder For Prolong-Release Suspension for Injection (IM/SC)
Dosage Strength
3.75mg/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
7228cde0f04cef9e
Type
Standard
Back to Philippines FDA Approvals