
Pharmacovigilance Plan Review Addendum, April 24, 2012 - MenHibrix

 

 

Date:                April 24, 2012

 

FDA STN:        125363/0

 

Sponsor:            GlaxoSmithKline

 

Product:           Haemophilus influenzae type b, Neisseria meningitides serogroups C and Y-tetanus toxoid (TT) conjugate (MENHIBRIX®)

 

From:               Manette Niu, MD (HFM-222)

                        Medical Officer, Vaccine Safety Branch (VSB)

 

Through:           Michael Nguyen, MD (HFM-222)

                        Acting Branch Chief, VSB

 

                        David Martin, MD, MPH (HFM-220)

                        Director, Division of Epidemiology

 

Subject:            Addendum to the May 7, 2010 Pharmacovigilance Plan Review by Patricia Rohan

 

 

Background: The sponsor is seeking the approval for licensure of its Haemophilus influenzae type b, Neisseria meningitides serogroups C and Y-tetanus toxoid (TT) conjugate (MENHIBRIX®). This vaccine is proposed to be indicated for active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Haemophilus influenzae type b, and Neisseria meningitides serogroups C and Y. 

 

No data has been added to the original Pharmacovigilance plan that was reviewed by Dr. Patricia Rohan, OBE in her May 7, 2010 memo. We have not received any additional information identifying new safety signals from other sources for this product. I agree with Dr. Rohan’s Pharmacovigilance Plan review. 