European Union - English - EMA (European Medicines Agency)

amryt ag - betulae cortex - wounds and injuries; wound healing - preparations for treatment of wounds and ulcers - treatment of partial thickness wounds in adults. see sections 4.4 and 5.1 in product information with respect to type of wounds studied.,

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

amryt pharmaceuticals dac - metreleptin (unii: tl60c27rlh) (metreleptin - unii:tl60c27rlh) - metreleptin 11.3 mg in 2.2 ml - myalept (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. limitations of use - the safety and effectiveness of myalept for the treatment of complications of partial lipodystrophy have not been established. - the safety and effectiveness of myalept for the treatment of liver disease, including nonalcoholic steatohepatitis (nash), have not been established. - myalept is not indicated for use in patients with hiv-related lipodystrophy. - myalept is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy. myalept is contraindicated in patients with general obesity not associated with congenital leptin deficiency. myalept has not been shown to be effective in treating general obesity, and the development of anti-metreleptin antibodi

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

amryt pharmaceuticals dac - lomitapide mesylate (unii: x4s83cp54e) (lomitapide - unii:82kub0583f) - lomitapide 5 mg - juxtapid is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including ldl apheresis where available, to reduce low-density lipoprotein cholesterol (ldl-c), total cholesterol (tc), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (hofh). limitations of use - the safety and effectiveness of juxtapid have not been established in patients with hypercholesterolemia who do not have hofh, including those with heterozygous familial hypercholesterolemia (hefh). - the effect of juxtapid on cardiovascular morbidity and mortality has not been determined. juxtapid is contraindicated in the following conditions: - pregnancy [see warnings and precautions (5.3) and use in specific populations (8.1)] . - concomitant administration of juxtapid with moderate or strong cyp3a4 inhibitors, as this can increase juxtapid exposure [see warnings and precautions (5.6), drug interactions (7.1), and clinical pharmac

European Union - English - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparations for treatment of wounds and ulcers - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amryt pharma - lomitapide - capsule - 5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amryt pharma - lomitapide - capsule - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amryt pharma - lomitapide - capsule - 20mg

European Union - English - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - lipodystrophy, familial partial - other alimentary tract and metabolism products, - myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (ld) patients:with confirmed congenital generalised ld (berardinelli-seip syndrome) or acquired generalised ld (lawrence syndrome) in adults and children 2 years of age and abovewith confirmed familial partial ld or acquired partial ld (barraquer-simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.

European Union - English - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hypercholesterolemia - lipid modifying agents - lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (ldl) apheresis in adult patients with homozygous familial hypercholesterolaemia (hofh). genetic confirmation of hofh should be obtained whenever possible. other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.,

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

amryt pharmaceuticals designated activity company - octreotide (unii: rwm8ccw8gp) (octreotide - unii:rwm8ccw8gp) - mycapssa is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. hypersensitivity to octreotide or any of the components of mycapssa. anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see adverse reactions (‎6.3)]. risk summary available data from case reports with octreotide acetate use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with mycapssa. no adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively, the clinical dose based on octreotide injection body surface area. transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post