STN: BL 125546
Proper Name: Meningococcal Group B Vaccine
Trade Name: BEXSERO
Manufacture: GlaxoSmithKline Biologicals SA
Indication:

• For active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years.

Product Information

• Package Insert - BEXSERO

Supporting Documents

• August 19, 2024 Approval Letter - BEXSERO
• April 26, 2023 Approval Letter - BEXSERO
• January 6, 2022 Approval Letter - BEXSERO
• October 24, 2019 Approval Letter - BEXSERO
• May 31, 2018 Approval Letter - BEXSERO
• October 12, 2017 Approval Letter - BEXSERO
  To update the package insert to include additional adverse events of extensive limb swelling and injection nodule in Section 6.3 Postmarketing Experience.
• Clinical Review, January 23, 2015 - BEXSERO
• Statistical Review - BEXSERO
• Approval History, Letters, Reviews, and Related Documents - BEXSERO
• Supporting Documents older than three years - BEXSERO