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

nufarm australia limited - amisulbrom; copper (cu) present as tribasic copper sulphate - suspension concentrate - amisulbrom active 32.0 g/l; copper (cu) present as tribasic copper sulphate mineral-copper active 180.0 g/l - fungicide

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

amicus sdn. bhd. - omega-3 fish oil; tocopherol acetate, d-alpha -

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)

amicus therapeutics europe limited - cipaglucosidase alfa - glycogen storage disease type ii - other alimentary tract and metabolism products, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

European Union - English - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - glycogen storage disease type ii - other alimentary tract and metabolism products - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

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

amicus therapeutics pty ltd - migalastat hydrochloride, quantity: 150 mg - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; indigo carmine; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; gelatin; sodium lauryl sulfate - galafold is indicated for long-term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of fabry disease (alpha-galactosidase a deficiency) and who have an amenable mutation (see the table in section 5.1 pharmacodynamic properties, mechanism of action).

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

Singapore - English - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - general hospital - for extended platelet storage with plasma/red blood cell collection. for use with the amicus™ separator.

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

baxter healthcare pty ltd -

Israel - English - Ministry of Health

truemed ltd, israel - migalastat as hydrochloride - hard capsule - migalastat as hydrochloride 123 mg - 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.