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AREXVY Powder and Suspension for Suspension for Injection 120mcg/0.5mL - HSA Drug Approval Details

Approvals/HSA/AREXVY Powder and Suspension for Suspension for Injection 120mcg/0.5mL

Approved

THERAPEUTIC

AREXVY Powder and Suspension for Suspension for Injection 120mcg/0.5mL

GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA (adjuvant)GlaxoSmithKline Vaccines S.r.l. (adjuvant)🇸🇬 Health Sciences Authority

Approval Date: May 10, 2024
Approval ID: 74ebf799d68fe38f
Company: GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA (adjuvant)GlaxoSmithKline Vaccines S.r.l. (adjuvant)
Type: Therapeutic

Approval Details

Approval Id: 74ebf799d68fe38f
Drug Name: AREXVY Powder and Suspension for Suspension for Injection 120mcg/0.5mL
Product Name: AREXVY Powder and Suspension for Suspension for Injection 120mcg/0.5mL
Approval Number: SIN17008P
Approval Date: 2024-05-10
Registrant: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
Route Of Administration: INTRAMUSCULAR
Atc Code: J07BX05
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD
Company Detail Path: /organization/cac9b4e7bceb9ea7/glaxosmithkline-pte-ltd

Active Ingredients

RSVPreF3 antigen

120mcg/0.5mL

RSVPreF3 antigen

120mcg/0.5mL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 10, 2024

Approval ID

74ebf799d68fe38f

Type

Therapeutic

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