Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astrazeneca ab, sweden - palivizumab - solution for injection - 100 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

abbott laboratories - palivizumab - solution - 100 mg/ml

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

astrazeneca k.k - palivizumab(genetical recombination) - injection (vial)

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - injection - each 0,5 ml solution contains palivizumab 50,0 mg

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - nirsevimab - immune sera and immunoglobulins, - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in neonates and infants during their first rsv season.beyfortus should be used in accordance with official recommendations.

Canada - English - Health Canada

astrazeneca canada inc - nirsevimab - solution - 100mg - nirsevimab 100mg

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

sanofi pasteur inc. - nirsevimab (unii: vrn8s9cw5v) (nirsevimab - unii:vrn8s9cw5v) - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in: beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients [see warnings and precautions (5.1) and description (11)] . beyfortus is not indicated for use in females of reproductive potential. beyfortus is not indicated for use in females of reproductive potential. the safety and effectiveness of beyfortus have been established for the prevention of rsv lower respiratory tract disease in neonates and infants born during or entering their first rsv season and in children up to 24 months of age who remain vulnerable to severe rsv disease through their second rsv season. the safety and efficacy of beyfortus for this indication and populations are discussed throughout the labeling. use of beyfortus for this indication is supported by evidence from adequate and well-controlled studies in neonates and infants from birth up to 12 months of age with additional pharmacokinetic and safety data in children up to 24 months of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of beyfortus have not been established in children older than 24 months of age.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

abbvie (pty) ltd - injection - each 1,0 ml solution contains palivizumab 100,0 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - injection - see ingredients - each 1,0 ml solution contains palivizumab 100,0 mg