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Brukinsa - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Brukinsa
Approved
STANDARD
Brukinsa
Catalent CTS, LLC
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
3b9a9c32104d0f44
Company
Catalent CTS, LLC
Type
Standard
Approval Details
Approval Id
3b9a9c32104d0f44
Drug Approval Philippines Name
Brukinsa
Product Name
Brukinsa
Registration Number
DR-XY48345
Brand Name
Brukinsa
Generic Name
Zanubrutinib
Dosage Form
Capsule
Dosage Strength
80 mg
Manufacturer
Catalent CTS, LLC
Importer
Zuellig Pharma Corporation
Distributor
Zuellig Pharma Corporation
Company Detail Path
/organization/catalent-cts-llc-allendale-new-jersey-united-states
Issuance Date
08 September 2022
Expiry Date
08 September 2027
Pharmacologic Category
Bruton's Tyrosine Kinase (BTK) Inhibitor
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
3b9a9c32104d0f44
Type
Standard
Back to Philippines FDA Approvals