Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp and dohme limited - rubellavirus mumps vaccine (live attenuated) -

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein - hemorrhagic fever, ebola - vaccines - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus.the use of ervebo should be in accordance with official recommendations.

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

merck sharp & dohme llc - zaire ebolavirus (strain kikwit-95) envelope glycoprotein (unii: xh5v2sq5fi) (zaire ebolavirus (strain kikwit-95) envelope glycoprotein - unii:xh5v2sq5fi) - ervebo® is indicated for the prevention of disease caused by zaire ebolavirus in individuals 12 months of age and older. - the duration of protection conferred by ervebo is unknown. - ervebo does not protect against other species of ebolavirus or marburgvirus . - effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (ig), and/or blood or plasma transfusions is unknown. do not administer ervebo to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. there are no adequate and well-controlled studies of ervebo in pregnant women, and human data available from clinical trials with ervebo are ins

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - hemorrhagic fever, ebola - vaccines - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - hemorrhagic fever, ebola - vaccines - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.,

Canada - English - Health Canada

merck canada inc - ebola zaÏre vaccine (rvsv [delta] g-zebov-gp, live) - solution - 72000000pfu - ebola zaÏre vaccine (rvsv [delta] g-zebov-gp, live) 72000000pfu

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

ridgeback biotherapeutics, lp - ansuvimab (unii: tg8iq19ng2) (ansuvimab - unii:tg8iq19ng2) - ebanga is indicated for the treatment of infection caused by zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is rt-pcr positive for zaire ebolavirus infection [see dosage and administration (2.2) and clinical studies (14)] . limitations of use: the efficacy of ebanga has not been established for other species of the ebolavirus and marburgvirus genera. zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating zaire ebolavirus strains when deciding whether to use ebanga. none . risk summary zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (

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

regeneron pharmaceuticals, inc. - atoltivimab (unii: fjz07q63vy) (atoltivimab - unii:fjz07q63vy), maftivimab (unii: kop95331m4) (maftivimab - unii:kop95331m4), odesivimab (unii: uy9lq8p6hw) (odesivimab - unii:uy9lq8p6hw) - inmazeb is indicated for the treatment of infection caused by zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is rt-pcr positive for zaire ebolavirus infection [see dosage and administration (2.2), and clinical studies (14)] . limitations of use the efficacy of inmazeb has not been established for other species of the ebolavirus and marburgvirus genera. zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating zaire ebolavirus strains when deciding whether to use inmazeb. none. risk summary zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see clinical considerations). available data from the palm trial and an expanded access program in which pregnant women with zaire ebolavirus infection we

Uganda - English - National Drug Authority

janssen-cilag international nv - one dose (0.5 ml) contains:modified vaccinia ankara bavarian nordic virus* encoding the: zaire ebolavirus (ebov) mayinga variant glycoprotein (gp), sudan ebolavirus gulu variant gp, taÏ forest ebolavirus nucleoprotein, marburg marburgvirus musoke variant - parenteral ordinary vials - not less than 0.7 x 108 infectious units (inf.u), /dose (0.5 ml)

Uganda - English - National Drug Authority

janssen-cilag international nv - adenovirus type 26 encoding the zaire ebolavirus (ebov) mayinga variant glycoprotein (gp), - parenteral ordinary vials - not less than 8.75 log 10 infectious units (inf.u),/dose (0.5 ml)