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).

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).

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

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).

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

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

Canada - English - Health Canada

amicus therapeutics canada inc. - migalastat (migalastat hydrochloride) - capsule - 123mg - migalastat (migalastat hydrochloride) 123mg - other miscellaneous therapeutic agents

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.

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 -