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

sm pharmaceuticals sdn. bhd. - live attenuated bovine-human rotavirus reassortant [g1, g2, g3, g4 and g9] -

Panama - engelska - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

glaxosmithkline biologicals, s.a. - rotavirus humano, vivo atenuado, cepa rix4414 - rotavirus humano, vivo atenuado, cepa rix4414....no menos de 10x6 ccid50

Europeiska unionen - engelska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - human rotavirus, live attenuated - immunization; rotavirus infections - vaccines - rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection.the use of rotarix should be based on official recommendation.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - rotavirus -

Tanzania - engelska - Tanzania Medicinces & Medical Devices Authority

bharat biotech international limited, india - rotavirus vaccine - freeze dried lyophilised vaccine - 5 ml/10 dose. 0.5 ml (5 drops) contains nlt 105.0 ffu of rotavirus 116e bulk, neomycin sulfate 15 µg, kanamycin acid sulphate 15 µg

Kanada - engelska - Health Canada

merck canada inc - human-bovine rotavirus reassortant type g1; human-bovine rotavirus reassortant type g2; human-bovine rotavirus reassortant type g3; human-bovine rotavirus reassortant type g4; human-bovine rotavirus reassortant type p1(8) - solution - 2210000unit; 2840000unit; 2220000unit; 2040000unit; 2290000unit - human-bovine rotavirus reassortant type g1 2210000unit; human-bovine rotavirus reassortant type g2 2840000unit; human-bovine rotavirus reassortant type g3 2220000unit; human-bovine rotavirus reassortant type g4 2040000unit; human-bovine rotavirus reassortant type p1(8) 2290000unit - vaccines

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - live attenuated human rotavirus 1e+006 ccid50 ((rix 4414 strain)) - oral suspension - 1e+006 ccid50 - active: live attenuated human rotavirus 1e+006 ccid50 ((rix 4414 strain)) excipient: di-sodium adipate dulbecco's modified eagle medium sucrose water for injection - rotarix is indicated for the prevention of rotavirus gastroenteritis

USA - engelska - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - human rotavirus a type g1p(8) strain rix4414 live antigen (unii: kz3l01d2pc) (human rotavirus a type g1p(8) strain rix4414 live antigen - unii:kz3l01d2pc) - human rotavirus a type g1p(8) strain rix4414 live antigen 1000000 [ccid_50] in 1 ml - rotarix is indicated for the prevention of rotavirus gastroenteritis caused by g1 and non-g1 types (g3, g4, and g9) when administered as a 2-dose series [see clinical studies (14.3)] . rotarix is approved for use in infants 6 weeks and up to 24 weeks of age. a demonstrated history of hypersensitivity to any component of the vaccine. infants who develop symptoms suggestive of hypersensitivity after receiving a dose of rotarix should not receive further doses of rotarix. infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as meckel’s diverticulum) that would predispose the infant for intussusception should not receive rotarix. infants with a history of intussusception should not receive rotarix [see warnings and precautions (5.5)] . in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see adverse reactions (6.2)] . infants with severe combined immunodeficiency disease (scid) should not receive rotarix. postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having scid [see adverse reactions (6.2)] . safety and effectiveness of rotarix in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated. the effectiveness of rotarix in pre-term infants has not been established. safety data are available in pre-term infants (rotarix = 134, placebo = 120) with a reported gestational age ≤36 weeks. these pre-term infants were followed for saes up to 30 to 90 days after dose 2. saes were observed in 5.2% of recipients of rotarix as compared with 5.0% of placebo recipients. no deaths or cases of intussusception were reported in this population.

Irland - engelska - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - equine rotavirus h2 strain - emulsion for injection - unknown - equine rotavirus vaccine - equine - food - immunological - inactivated vaccine

Irland - engelska - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - equine rotavirus h2 strain - emulsion for injection - equine rotavirus - equine - food - immunological - inactivated vaccine