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Proper Name
Hepatitis A Vaccine, Inactivated
For active immunization against disease caused by hepatitis A virus (HAV) for persons 12 months of age and older.

HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. 

Key Regulatory Milestones

07/24/2011 - PDUFA goal date

12/19/2018 - FDA approval date

Advisory Committee

There were no product-specific concerns that would have benefited from an advisory committee discussion.

Advanced Facts