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

amicus therapeutics us, llc - migalastat hydrochloride (unii: cly7m0xd20) (migalastat - unii:c4xny919fw) - galafold is indicated for the treatment of adults with a confirmed diagnosis of fabry disease and an amenable galactosidase alpha gene (gla ) variant based on in vitro assay data [see dosage and administration (2.1) and clinical pharmacology (12.1)] . this indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (kic gl-3) substrate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary there were three pregnant women with fabry disease exposed to galafold in clinical trials. as such, the available data are not sufficient to assess drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed (see data) . the background risk for major birth defects and miscarriage for the indicated population is unk

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

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

axichem pty ltd - hexazinone - soluble concentrate - hexazinone triazine-triazinones active 250.0 g/l - herbicide - agricultural/farm buildings | commercial/industrial premises | loamy sands & sandy soils | native woodland heath & second rotati - african boxthorn | annual ryegrass | artichoke thistle | asthma plant | barnyard grass or water grass | bitter bark or quinine tree | blackberry | blackberry nightshade | blakely's red gum or gum | bracken | brigalow | broadleaf peppermint | broadleaf teatree | brown stringybark | budda or false sandalwood | cat's ear or flatweed | chicory | clover | common sida | coolibah | couch grass | creeping buttercup | creswick apple box or scent bark | dandelion - hypochaeris glabra | dawson gum | dock | dogwood,common cassinia or dollybush | eucalyptus | fleabane | great, ripgut or kingston brome | green amaranth | grey box | gum topped or grey box | hickory, whitewood or currawong | hop goodenia | kangaroo grass | kikuyu grass | limebush | longleaf box | lovegrass | medic | messmate stringybark | monterey cypress | moreton bay ash | mountain grey or monkey gum | narrowleaf peppermint | nutgrass | parkinsonia | parthenium weed | paspalum | paterson's curse | pointed or red mallee | poplar box | prickly acacia | red i

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

adama australia pty limited - hexazinone - soluble concentrate - hexazinone triazine-triazinones active 250.0 g/l - herbicide - commercial/industrial land | pasture | pine plantation - pre-planting | pinus radiata plantation - post planting | rights of wa - acacia genus | african boxthorn | annual clovers | annual or wimmera ryegrass | artichoke thistle | asthma plant | barnyard or water grass | bitter bark or quinine tree | blackberry - rubus spp. | blackberry nightshade | blakely's red gum or gum | bracken | broadleaf peppermint | broadleaf teatree | brome grass | brown stringybark | budda or false sandalwood | capeweed | cat's ear or flatweed | cat's ears or flatweeds | chickweed | chicory | common sida | coolibah | couch grass | creeping buttercup | creswick apple box or scent bark | dandelion - hypochaeris glabra | dandelion - taraxacum officinale | dawson gum | dock | dogwood,common cassinia or dollybush | eucalyptus species - see label | fleabane | great, ripgut or kingston brome | green amaranth | grey box | gum topped or grey box | hickory, whitewood or currawong | hop goodenia | kangaroo grass | kangaroo grass - suppression | kikuyu grass | limebush | longleaf box | lovegrass | medic | messmate stringybark | monterey cypress | moreton bay ash | mountai

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - agalsidase beta - fabry disease - other alimentary tract and metabolism products, - fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (α-galactosidase-a deficiency).

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

crop smart pty ltd - hexazinone - soluble concentrate - hexazinone triazine-triazinones active 250.0 g/l - herbicide

European Union - English - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - fabry disease - other alimentary tract and metabolism products, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

European Union - English - EMA (European Medicines Agency)

amicus therapeutics europe limited - migalastat hydrochloride - fabry disease - migalastat - galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of fabry disease (α-galactosidase a deficiency) and who have an amenable mutation.

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - agalsidase alfa - fabry disease - other alimentary tract and metabolism products, - replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of fabry disease (α-galactosidase-a deficiency).

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

sanofi-aventis australia pty ltd - agalsidase beta, quantity: 5.5 mg - injection, powder for - excipient ingredients: nitrogen; monobasic sodium phosphate monohydrate; mannitol; dibasic sodium phosphate heptahydrate - fabrazyme is indicated for the long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (alpha-galactosidase deficiency).