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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: monobasic potassium phosphate; magnesium chloride hexahydrate; sorbitan trioleate; squalene; sodium citrate dihydrate; citric acid monohydrate; calcium chloride dihydrate; potassium chloride; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80 - active immunisation against influenza in persons 65 years of age and older.

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

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19. (,refer to section 4.2 dose and method of administration and section 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

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

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19.,(refer to section 4.2 dose and method of administration and 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - varicella virus, vaccine live, oka, merck - powder and solvent for solution for injection - varicella virus vaccine live (oka/merck) 10 pfu/dose - vaccines

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - live fowl adenovirus - misc. vaccines or anti sera - live fowl adenovirus vaccine-viral active 0.0 ml - immunotherapy - poultry chicks - up to 28 days old | chicks of vaccinated hens - homologous types of fowl adenovirus infe | inclusion body hepatitus

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bioproperties pty. ltd. - marek's disease - misc. vaccines or anti sera - marek's disease vaccine-general active 0.0 p - immunotherapy - poultry | breeders | broiler | chickens | chicks | chooks | day old chicks | hatchlings | layers - vaccine | equine rotavirus

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - fowl pox vaccine - misc. vaccines or anti sera - fowl pox vaccine vaccine-viral active 0.0 p - immunotherapy - poultry | turkeys | breeder | breeders | broiler | broiler breeder | chickens | chicks | chooks | day old chicks | hatchlings | - fowl pox

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - influenza vaccine, split virion, inactivated - suspension for injection - influenza vaccine (split virion, inactivated) 15 µg - vaccines

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - vaccines - active immunisation against h5n1 subtype of influenza a virus.; this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,