Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

unomedical ltd -

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

unomedical ltd -

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

unomedical ltd -

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

unomedical ltd -

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

unomedical ltd -

Estados Unidos - inglês - NLM (National Library of Medicine)

readymeds - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 20 mg - fluoxetine capsules, usp are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years [see clinical studies (14.1)]. the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see dosage and administration (2.1)] . fluoxetine capsules, usp are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (ocd) [see clinical studies (14.2)]. the effectiveness of fluoxetine capsules, usp in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to use fluoxetine capsules, usp for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see dosage and administration (2.2)]. f

União Europeia - inglês - 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.

Austrália - inglês - 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).

Israel - inglês - 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.

Estados Unidos - inglês - NLM (National Library of Medicine)

strides pharma science limited - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation