말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sm pharmaceuticals sdn. bhd. - diphtheria toxoid; haemophilus influenza type b conjugate; hepatitis b, purified antigen; tetanus toxoid; bulk pertussis vaccine -

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - primidone - oral tablet - 50mg

이스라엘 - 영어 - Ministry of Health

gilead sciences israel ltd - axicabtagene ciloleucel - dispersion for infusion - axicabtagene ciloleucel - yescarta is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and primary mediastinal large b-cell lymphoma (pmbcl), after two or more lines of systemic therapy. limitation of use :yescarta is not indicated for the treatment of patients with primary or secondary central nervous system lymphoma.yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy

이스라엘 - 영어 - Ministry of Health

novartis israel ltd - tisagenlecleucel - dispersion for infusion - tisagenlecleucel - kymriah is indicated for the treatment of: - paediatric and young adult patients up to and including 25 years of age with cd19+ b-cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post-transplant or in second or later relapse. - adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy. limitation of use: kymriah is not indicated for treatment of patients with primary or secondary central nervous system lymphoma- adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy

뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) - suspension for injection - active: ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) excipient: citric acid monohydrate ethanol hydrochloric acid hydroxypropyl-beta-cyclodextrin polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - covid-19 vaccine janssen has provisional consent for the indication below: active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations.

말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - rad26.cov2-s -

미국 - 영어 - NLM (National Library of Medicine)

vbi vaccines (delaware) inc. - recombinant hepatitis b surface antigen (isoform s) (unii: 2u8266yw9l) (recombinant hepatitis b surface antigen (isoform s) - unii:2u8266yw9l), recombinant hepatitis b surface antigen (isoform m) (unii: snd8hl4kqg) (recombinant hepatitis b surface antigen (isoform m) - unii:snd8hl4kqg), recombinant hepatitis b surface antigen (isoform l) (unii: c6pfs5dx5y) (recombinant hepatitis b surface antigen (isoform l) - unii:c6pfs5dx5y) - prehevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. prehevbrio is approved for use in adults 18 years of age and older. do not administer prehevbrio to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b vaccine or to any component of prehevbrio [see description ( 11)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to prehevbrio during pregnancy. women who receive prehevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in clinically recognized pregnancies in the us general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%. there are no adequate and well-controlled studies of prehevbrio in pregnant women. available human data on prehevbrio administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of prehevbrio on four occasions; twice prior to mating, twice during gestation. the study revealed no evidence of harm to the fetus due to the vaccine [see animal data below]. data animal data a developmental toxicity study has been performed in female rats using a dose equivalent to the adult human dose. in the study, female rats received 0.5 ml (2 x 0.25 ml injections) of a vaccine formulation containing 10 mcg hbsag (s, pre-s1, pre-s2) adsorbed on to aluminum hydroxide by intramuscular injection 30 days and 15 days prior to mating and on gestation days 4 and 15. no adverse effects of pre-weaning development were observed. there was no evidence of fetal malformations or variations. risk summary it is not known whether prehevbrio is excreted in human milk. data are not available to assess the effects of prehevbrio on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for prehevbrio and any potential adverse effects on the breastfed child from prehevbrio or from the underlying maternal condition. for preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of prehevbrio have not been established in individuals less than 18 years of age. study 1 included 296 adults 65 through 86 years of age who received prehevbrio. among subjects who received prehevbrio, a seroprotective level of antibody to hbsag was achieved in 83.6% of those ≥ 65 years of age compared to 94.8% in adults 45 through 64 years of age and 99.2% in adults 18 through 44 years of age [see evaluation of immunogenicity ( 14.1)]. frequencies of local and systemic solicited adverse reactions were generally lower in elderly subjects ≥65 years of age than in younger subjects [see adverse reactions ( 6)]. safety and effectiveness of prehevbrio have not been established in adults on hemodialysis.

유럽 연합 - 영어 - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - amino acid metabolism, inborn errors - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.1).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ad26.cov2.s, quantity: 50000000000 vp - injection, suspension - excipient ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections - covid-19 vaccine janssen has provisional approval for the indication:,covid-19 vaccine janssen is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older.,the use of this vaccine should be in accordance with official recommendations. the decision has been made on the basis of short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

이스라엘 - 영어 - Ministry of Health

medison pharma ltd - setmelanotide - solution for injection - setmelanotide 10 mg / 1 ml - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet-biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.