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HSA Approval

ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML

SIN17026P

ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML

ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML

June 19, 2024

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

ASTRAZENECA SINGAPORE PTE LTD

Therapeutic

Prescription Only

Formulation Information

INFUSION, SOLUTION CONCENTRATE

INTRAVENOUS

Medical Information

L04AA43

Manufacturer Information

ASTRAZENECA SINGAPORE PTE LTD

Catalent Indiana, LLC

Alexion Pharma International Operations Limited (AAMF)

Active Ingredients

Ravulizumab

100 mg/mL

Ravulizumab

Documents

Package Inserts

Ultomiris Approved PI.pdf

Approved: June 19, 2024

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ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML - HSA Approval | MedPath