Engerix B is indicated in neonates, infants, children and adolescents up to and including 15 years of age for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes in non immune subjects. The 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. The 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. The categories within the population to be immunised are determined on the basis of official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with Engerix B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
VBI Vaccines announced positive top-line results from the randomized, double-blind, pivotal Phase III study, PROTECT, designed to evaluate the efficacy...
Dynavax Technologies reported preliminary top-line results from HBV-23, a Phase III trial of the safety and immunogenicity of its investigational...
PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations.
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients (see section 4.2). Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Dynavax Technologies Corporation announced that the FDA has accepted for review the Biologics License Application (BLA) for Hepilisav-B, the company's...
Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Cervarix should be in accordance with official recommendations.
Dynavax Technologies said that the FDA will now need until mid-December to assess whether to approve Heplisav B vaccine after...
VBI Vaccines Inc. announced that the FDA has approved PreHevbrio [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older.