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Details for: BEXSERO

Company: GLAXOSMITHKLINE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02417030BEXSERORECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; OUTER MEMBRANE VESICLES (NEISSERIA MENINGITIDIS GROUP B NZ98/254 STRAIN)50 MCG / 0.5 ML; 50 MCG / 0.5 ML; 50 MCG / 0.5 ML; 25 MCG / 0.5 MLSUSPENSIONINTRAMUSCULAR
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary
Summary Safety Review - SOLIRIS (eculizumab) and BEXSERO (Multicomponent Meningococcal B Vaccine [recombinant, adsorbed]) - Assessing the Potential Risk of Hemolysis and Low Hemoglobin in Patients Treated with Soliris and Vaccinated with Bexsero

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