European Union - English - EMA (European Medicines Agency)

bavarian nordic a/s - modified vaccinia ankara - bavarian nordic (mva-bn) virus - smallpox vaccine; monkeypox virus - other viral vaccines, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).the use of this vaccine should be in accordance with official recommendations.

Canada - English - Health Canada

bavarian nordic as - modified vaccinia virus (ankara-bavarian nordic) - suspension - 50000000ccid50 - modified vaccinia virus (ankara-bavarian nordic) 50000000ccid50 - vaccines

United States - English - NLM (National Library of Medicine)

bavarian nordic a/s - vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen (unii: tu8j357395) (vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen - unii:tu8j357395) - jynneos is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available human data on jynneos administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. the effect of jynneos on embryo-fetal and post-natal development was evaluated in four developmental toxicity studies conducted in female rats and rabbits. in two studies, rats were administered a single human dose of jynneos (0.5 ml) once prior to mating and on one or two occasions during gestation. in the third study, rats were administered a single human dose of jynneos (0.5 ml) on two occasions during gestation. in the fourth study, rabbits were ad

Canada - English - Health Canada

sanofi pasteur limited - smallpox vaccine dried - powder for solution - 100m - smallpox vaccine dried 100m - vaccines

Canada - English - Health Canada

connaught laboratories ltd. - smallpox vaccine liquid (calf) - suspension - 100m - smallpox vaccine liquid (calf) 100m - vaccines

United States - English - NLM (National Library of Medicine)

emergent product development gaithersburg inc. - vaccinia virus strain new york city board of health live antigen (unii: 4sv59689sk) (vaccinia virus strain new york city board of health live antigen - unii:4sv59689sk) - acam2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. there are very few absolute contraindications to this vaccine for those who are at high risk for smallpox. the risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection. see warnings and precautions (5) for persons who are at higher risk of experiencing serious vaccination complications. severe immune deficiency severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive acam2000. these individuals may include individuals who are undergoing bone marrow transplantation or individuals with primary or acquired immunodeficiency who require isolation. acam2000 has not been studied in pregnant women. live vaccini

Australia - English - Department of Health (Therapeutic Goods Administration)

emergent sales and marketing australia pty ltd - vaccinia virus, quantity: 100000000 pfu/ml - injection, powder for - excipient ingredients: sodium chloride; albumin; neomycin sulfate; mannitol; hepes; polymyxin b sulfate - acam2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection in an officially declared outbreak.

European Union - English - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirals for systemic use - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4.4 and 5.1).tecovirimat siga should be used in accordance with official recommendations.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

live) vv lister/cep suspension 0.25ml vials (secretary of state for health - vaccinia virus live (lister strain) - liquid

United States - English - NLM (National Library of Medicine)

chimerix, inc. - brincidofovir (unii: 6794o900ax) (brincidofovir - unii:6794o900ax) - tembexa® is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. tembexa is not indicated for the treatment of diseases other than human smallpox disease [see warnings and precautions (5.1, 5.2)] . the effectiveness of tembexa for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical [see clinical studies (14)] . tembexa efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. none. based on findings from animal reproduction studies, tembexa may cause fetal harm when administered to pregnant individuals. use an alternative therapy to treat smallpox during pregnancy, if feasible. there are no available data on the use of brincidofovir in pregnant individuals to evaluate for a drug-associated risk of major birth defects, m