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)

cold faid - chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - good sense nasal decongestant pe purpose: nasal decongestant chlorphen -12 purpose: antihistamine good sense naproxen sodium purpose: pain reliever/fever reducer indications & usage section good sense nasal decongestant pe indications & usage: temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies chlorphen-12 indications & usage: temporarily relieves the following symptoms due to hayfever, or other respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat good sense naproxen sodium indications & usage: temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

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

cold faid - chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - good sense nasal decongestant pe purpose: nasal decongestant good sense 4-hour allergy relief purpose: antihistamine good sense naproxen sodium purpose: pain reliever/fever reducer indications & usage section good sense nasal decongestant pe indications & usage: temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies good sense 4-hour allergy relief indications & usage: temporarily relieves the following symptoms due to hayfever, or other respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat good sense naproxen sodium indications & usage: temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

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

cold faid - chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - good sense nasal decongestant pe purpose: nasal decongestant good sense 4-hour allergy relief purpose: antihistamine good sense naproxen sodium purpose: pain reliever/fever reducer indications & usage section good sense nasal decongestant pe indications & usage: temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies good sense 4-hour allergy relief indications & usage: temporarily relieves the following symptoms due to hayfever, or other respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat good sense naproxen sodium indications & usage: temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

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.

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

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.

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

old nick williams company inc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - indications & usage hand sanitizer to help reduce the bacteria that potentially can cause disease. for use when soap and water are not available. purpose antiseptic do not use *in children less than 2 months of age *on open skin wounds stop use and ask doctor if irritation or rash occurs. thes may be signs of serious condition. use(s) hand sanitizer to help reduce the bacteria that potentially can cause disease. for use when soap and water are not available.

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

old nick williams company inc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

Philippines - English - FDA (Food And Drug Administration)

isopropyl alcohol - topical solution classification: household remedy (hr) - 70% v/v dosage