STN: BL 125546
Proper Name: Meningococcal Group B Vaccine
Trade Name: BEXSERO
Manufacture: Novartis Vaccines and Diagnostics, Inc
- Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
- 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.
- January 23, 2015 Approval Letter - BEXSERO
- January 23, 2015 Summary Basis for Regulatory Action - BEXSERO
- Clinical Review, January 23, 2015 - BEXSERO
- Statistical Review - BEXSERO
- Approval History, Letters, Reviews, and Related Documents - BEXSERO