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MenHibrix FDA Approval History

FDA Approved: Yes (First approved June 14, 2012)
Brand name: MenHibrix
Generic name: Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Disease Prophylaxis

MenHibrix (Hib-MenCY-TT) is a combination vaccine for the active immunization of infants and young children 6 weeks through 18 months of age for the prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib).

Development timeline for MenHibrix

DateArticle
Jun 15, 2012Approval GSK Receives FDA Approval for MenHibrix
Dec  1, 2011Regulatory Update: Glaxosmithkline Submits Additional Information for Candidate Meningococcal and Hib Combination Vaccine
Sep 26, 2011Regulatory Update: GlaxoSmithKline Receives Complete Response Letter from FDA for MenHibrix meningococcal and Hib combination vaccine

See also

MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) Consumer information

Further information

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