European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - vaccines - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older.the use of this vaccine should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vaccines - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age. the use of this vaccine should be in accordance with official recommendations.

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

janssen-cilag pty ltd - ad26.cov2.s, quantity: 50000000000 vp - injection, suspension - excipient ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections - covid-19 vaccine janssen has provisional approval for the indication:,covid-19 vaccine janssen is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older.,the use of this vaccine should be in accordance with official recommendations. the decision has been made on the basis of short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Kenya - English - Pharmacy and Poisons Board

covid-19 vaccine (ad26.cov2-s [recombinant]) - suspension for injection - one dose (0.5 ml) contains: adenovirus type 26… - other viral vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) - suspension for injection - active: ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) excipient: citric acid monohydrate ethanol hydrochloric acid hydroxypropyl-beta-cyclodextrin polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - covid-19 vaccine janssen has provisional consent for the indication below: active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations.

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

janssen products, lp - ad26.cov2.s (unii: jt2ns6183b) (ad26.cov2.s - unii:jt2ns6183b) - janssen covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 18 years of age and older for whom other fda-authorized or approved covid-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the janssen covid-19 vaccine because they would otherwise not receive a covid-19 vaccine. do not administer the janssen covid-19 vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the janssen covid-19 vaccine [see description (13)] . do not administer the janssen covid-19 vaccine to individuals with a history of thrombosis with thrombocytopenia following the janssen covid-19 vaccine or any other adenovirus-vectored covid-19 vaccine (e.g., astrazeneca's covid-19 vac

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - vaccines - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older.the use of this vaccine should be in accordance with official recommendations.

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

novavax, inc. - sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 (unii: uk9ak2in1p) (sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 - unii:uk9ak2in1p) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of novavax covid-19 vaccine, adjuvanted (2023-2024 formula) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. novavax covid-19 vaccine, adjuvanted is not licensed for any use. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: - determined that there is a public health emergency, or a significant potential for a public health emergency related to covid-19.4 - declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the covid-19 pandemic.5 an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - rad26.cov2-s -

European Union - English - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vaccines - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.spikevax bivalent original/omicron ba.1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19.spikevax bivalent original/omicron ba.4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax xbb.1.5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older.the use of this vaccine should be in accordance with official recommendations.