The indications included in the marketing authorization application (MAA) are immunoprophylaxis of hepatitis B and prevention of hepatitis B virus recurrence after liver transplantation in patients who are positive for hepatitis B surface antigen. The submission has been accepted for review.
The MAA was submitted using the centralized procedure, under which, the company submits a single application to the European Medicines Agency. If marketing authorization is subsequently granted by the European Commission, it is valid in the 30 European Economic Area countries (all 27 EU members and three European Free Trade Association members – Iceland, Liechtenstein and Norway) and immediately confers licensure and permission to market the product.
John Langstaff, Cangene’s president and CEO, said: “This is another positive milestone for Cangene. HepaGam B is already approved in the US and Canada, where it is the only product of its type licensed for the liver transplantation indication; approval in Europe would establish its place as a global product.”