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

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - live attenuated measles virus (schwarz strain); live attenuated mumps virus (rit 4385 strain); live attenuated rubella virus (wistar ra 27/3 strain); live attenuated varicella virus (oka strain) - powder and solvent for solution for injection in pre-filled syringe - unknown - measles vaccines; measles, combinations with mumps, rubella and varicella, live attenuated

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - live attenuated human rotavirus rix4414 strain - suspension - live attenuated human rotavirus rix4414 strain - rota virus, live attenuated - rota virus, live attenuated - rotarix is indicated for the active immunization of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection. in clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types g1p[8], g2p[4], g3p[8], g4p[8] and g9p[8]. the use of rotarix should be based on official recommendations.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - live attenuated measles virus (schwarz strain); live attenuated mumps virus (rit 4385 strain); live attenuated rubella virus (wistar ra 27/3 strain); live attenuated varicella virus (oka strain) - powder and solvent for solution for injection - unknown - measles vaccines; measles, combinations with mumps, rubella and varicella, live attenuated

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

sm pharmaceuticals sdn. bhd. - live attenuated measles virus -

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

sm pharmaceuticals sdn. bhd. - live attenuated measles virus -

Philippines - English - FDA (Food And Drug Administration)

broadchem philippines biopharma corporation - live attenuated canine distemper virus (cdv) , canine adenovirus type 1 (cav-1) , canine adenovirus type 2 (cav-2) , canine parvovirus (cpv) , canine parainfluenza virus (cpiv) , inactivated leptospira interrogans var. icterohaemorrhagiae , leptospira interrogans var. grippotyphosa , leptospira interrogans var. sejroe , rabies virus (rv) vaccine (vet.) - freeze-dried powder for injection (sc) - formulation: each ml (dose) contains: live attenuated canine distemper virus (cdv)...... >10^2.7-4.5 eid50 canine adenovirus type 1 (cav-1). .................. >10^3.5-7.5 tcid 50 canine adenovirus type 2 (cav-2)................... >10^3.5-7.5 tcid50 canine parvovirus (cpv)............. >10^2.1-3.6 hau canine parainfluenza virus (cpiv)..................... >10^3-6 ccid 50 inactivated leptospira interrogans var. icterohaemorrhagiae....... >32 vnab50 leptospira interrogans var. grippotyphosa.......>32 vnab50 leptospira interrogans var. sejroe............... >32 vnab 50 rabies virus (rv)................ >2 iu eid - egg infectious dose tcid-tissue culture infectious dose ccid-cell culture infectious dose hau - haemagglutination unit iu - international unit

Philippines - English - FDA (Food And Drug Administration)

broadchem philippines biopharma corporation; distributor: broadchem philippines biopharma corporation - live attenuated canine distemper virus (cdv) , canine parainfluenza virus (cpiv) , canine adenovirus (cav) , canine parvovirus (cpv) , inactivated leptospira interrogans icterohaemorrhagiae , leptospira interrogans canicola , leptospira vaccine (vet.) - solution for injection (im) - each ml (1 dose) contains: lyophilisate (live attenuated): canine distemper virus, strain cdv bio 11/a 103.1-5. tcid50 canine adenovirus type 2, strain cav-2 bio 13 103.6-5.3. tcid50 canine parvovirus type 2b, strain cpv-2b bio 12/b 104.3-6.6 tcid50 canine parainfluenza type 2 virus, strain cpiv-2 bio 15- 103.1:5.1 tcid50 tcid – tissue culture infectious dose suspension (inactivated): leptospira interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae, strain mslb 1089 gmt 1:51 alr leptospira interrogans serogroup canicola, serovar canicola, strain mslb 1090 gmt 1:51 alr leptospira kirschneri serogroup grippotyphosa, serovar grippotyphosa, strain mslb 1091 21:40 alr leptospira interrogans serogroup australis, serovar bratislava, strain mslb 1088 gmt 1:51 alr alr - antibody micro agglutination-lytic reaction gmt-geometric mean titre

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

boehringer ingelheim animal health australia pty. ltd. - canine adeno virus type 2; canine distemper virus; canine parainfluenza type 2; canine parvo virus - misc. vaccines or anti sera - canine adeno virus type 2 vaccine-viral active 0.0 p; canine distemper virus vaccine-viral active 0.0 p; canine parainfluenza type 2 vaccine-viral active 0.0 p; canine parvo virus vaccine-viral active 0.0 p - immunotherapy - dog - over 6 weeks old - canine adenovirus - type 2 | canine distemper | canine parainfluenza | canine parvovirus | parvovirus

European Union - English - EMA (European Medicines Agency)

medimmune llc - reassortant influenza virus (live attenuated) of the following strains:a/california/7/2009 (h1n1)pdm09 like strain, a/victoria/361/2011 (h3n2) like strain, b/massachusetts/2/2012 like strain - influenza, human; immunization - vaccines - prophylaxis of influenza in individuals 24 months to less than 18 years of age.the use of fluenz should be based on official recommendations.