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Saphnelo - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Saphnelo
Approved
STANDARD
Saphnelo
AstraZeneca Nijmegen B.V.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
389b7346f6ed1a13
Company
AstraZeneca Nijmegen B.V.
Type
Standard
Approval Details
Approval Id
389b7346f6ed1a13
Drug Approval Philippines Name
Saphnelo
Product Name
Saphnelo
Registration Number
BR-1466
Brand Name
Saphnelo
Generic Name
Anifrolumab
Dosage Form
Concentrate for Solution for Infusion (IV)
Dosage Strength
300 mg/2 mL (150 mg/ml)
Manufacturer
AstraZeneca Nijmegen B.V.
Importer
AstraZeneca Pharmaceuticals (Phils.), Inc.
Company Detail Path
/organization/astrazeneca-nijmegen-b-v
Issuance Date
14 February 2024
Expiry Date
14 February 2029
Pharmacologic Category
Monoclonal Antibody.
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
389b7346f6ed1a13
Type
Standard
Back to Philippines FDA Approvals