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

astrazeneca pty ltd - palivizumab, quantity: 100 mg - injection, solution - excipient ingredients: histidine; glycine; water for injections - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd). (see clinical trials).

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

astrazeneca pty ltd - palivizumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; glycine; water for injections - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd). (see clinical trials).

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - palivizumab 100mg (;+overage = 122mg/vial) - injection with diluent - 100 mg - active: palivizumab 100mg (;+overage = 122mg/vial) excipient: glycine histidine mannitol nitrogen transferrin water for injection - synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age < 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd).

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - palivizumab 50mg (;+ overage = 73mg/vial) - injection with diluent - 50 mg - active: palivizumab 50mg (;+ overage = 73mg/vial) excipient: glycine histidine mannitol nitrogen water for injection - synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age < 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd).

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - palivizumab 100mg;   - solution for injection - 100 mg/ml - active: palivizumab 100mg   excipient: glycine histidine water for injection - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd).

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - palivizumab 50mg;   - solution for injection - 100 mg/ml - active: palivizumab 50mg   excipient: glycine histidine water for injection - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd).

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

swedish orphan biovitrum ab (publ) - palivizumab (unii: dq448mw7ks) (palivizumab - unii:dq448mw7ks) - synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in pediatric patients: - with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of rsv season, - with bronchopulmonary dysplasia (bpd) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of rsv season, - with hemodynamically significant congenital heart disease (chd) and who are 24 months of age or younger at the beginning of rsv season [see clinical studies (14) ]. limitations of use: the safety and efficacy of synagis have not been established for treatment of rsv disease [see warnings and precautions (5.4)] . synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to synagis [see warnings and precautions (5.1) ]. risk summary synagis is not indicated for use in females of reproductive po

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - palivizumab - respiratory syncytial virus infections - immune sera and immunoglobulins, - synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (rsv) in children at high risk for rsv disease:children born at 35 weeks of gestation or less and less than six months of age at the onset of the rsv season;children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months;children less than two years of age and with haemodynamically significant congenital heart disease.

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

abbvie pty ltd - palivizumab -

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

medimmune, llc - palivizumab (unii: dq448mw7ks) (palivizumab - unii:dq448mw7ks) - palivizumab 100 mg in 1 ml - 1 indications and usage synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in pediatric patients: limitations of use: the safety and efficacy of synagis have not been established for treatment of rsv disease [see warnings and precautions (5.4)] . synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to synagis [see warnings and precautions (5.1)] . risk summary synagis is not indicated for use in females of reproductive potential. risk summary synagis is not indicated for use in females of reproductive potential. the safety and effectiveness of synagis in children older than 24 months of age at the start of dosing have not been established [see clinical studies (14) ] .