Irland - engelska - HPRA (Health Products Regulatory Authority)

chiesi farmaceutici s.p.a. - beclometasone dipropionate anhydrous; formoterol fumarate dihydrate - pressurised inhalation, solution - 200/6 µg/µg - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone

Irland - engelska - HPRA (Health Products Regulatory Authority)

chiesi farmaceutici s.p.a. - beclometasone dipropionate anhydrous; formoterol fumarate dihydrate - inhalation powder - 200/6 mcg/acutuation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone

Australien - engelska - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - formoterol fumarate dihydrate, quantity: 6 microgram; beclometasone dipropionate, quantity: 200 microgram; glycopyrronium bromide, quantity: 12.5 microgram (equivalent: glycopyrronium, qty microgram) - inhalation, pressurised - excipient ingredients: ethanol absolute; norflurane; dilute hydrochloric acid - asthma trimbow 200/6/10 maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Europeiska unionen - engelska - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - fabry disease - other alimentary tract and metabolism products, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Irland - engelska - HPRA (Health Products Regulatory Authority)

chiesi limited - tobramycin - nebuliser solution - 300/4 milligram(s)/millilitre - other aminoglycosides; tobramycin

Storbritannien - engelska - myHealthbox

chiesi gmbh - dipropionate anhydrous, formoterol fumarate dihydrate. - inhalation powder. - 200 micrograms/6 micrograms for metered dose - rugs for obstructive airway diseases; adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics. - fostair nexthaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. fostair nexthaler is indicated in adults. note: there are no relevant clinical data on the use of fostair nexthaler for the treatment of acute asthma attacks.

USA - engelska - NLM (National Library of Medicine)

chiesi usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes. ferriprox tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias. - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%,

USA - engelska - NLM (National Library of Medicine)

chiesi usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox oral solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortalit

USA - engelska - NLM (National Library of Medicine)

chiesi usa, inc. - pegunigalsidase alfa (unii: 8m7v7q6537) (pegunigalsidase alfa - unii:8m7v7q6537) - elfabrio is indicated for the treatment of adults with confirmed fabry disease. none. risk summary there are no available data on elfabrio use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; however, as an enzyme replacement, elfabrio is not expected to cause adverse outcomes. animal reproduction studies have been conducted with pegunigalsidase alfa-iwxj in pregnant rats and rabbits. no adverse effects on embryofetal development were observed in pregnant rats intravenously administered pegunigalsidase alfa-iwxj twice per week at exposures up to 3.6 times that of the maximum recommended human dose (mrhd) (based on area under the concentration-time curve (auc)). maternal toxicity was observed in pregnant rabbits intravenously administered pegunigalsidase alfa-iwxj twice per week at doses that were ≥ 3.2 times the mrhd (based on human equivalent dose) [ see data ] . the estimated background risk of major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there is a pregnancy safety study for elfabrio. if a patient becomes pregnant while receiving elfabrio, healthcare providers should report elfabrio exposure by calling 1-888-661-9260 or visiting https://chiesirarediseases.com/contact-us/medical-information-form. data animal data in an embryofetal development study in the rat, pegunigalsidase alfa-iwxj was administered during the period of organogenesis on gestation day 6, 9, 12, and 15. no maternal or fetal adverse effects were noted at exposures that were up to 3.6-fold greater than the recommended dose of 1 mg/kg every two weeks. in an embryofetal development study in the rabbit, administration of pegunigalsidase alfa-iwxj during the period of organogenesis on gestation day 6, 9, 12, 15, and 18, resulted in maternal toxicity, including maternal mortality, decreased body weight, and decreased feed consumption. these effects were observed at exposures that were ≥ 3.2-fold greater than the recommended dose of 1 mg/kg every two weeks. adverse embryofetal effects included abortion, increased late resorptions, number of does with resorptions, and increased post-implantation loss at exposures that were 6.5 fold greater than the recommended dose of 1 mg/kg every two weeks. decreased fetal body weight was observed at exposures that were ≥ 3.2 times greater than the recommended dose of 1 mg/kg every two weeks. there was no increase in fetal external, skeletal, or visceral malformations. risk summary there are no data on the presence of pegunigalsidase alfa-iwxj in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for elfabrio and any potential adverse effects on the breastfed infant from pegunigalsidase alfa-iwxj or from the underlying maternal condition. the safety and effectiveness of elfabrio have not been established in pediatric patients. clinical trials of elfabrio did not include patients 65 years of age and older to determine if they respond differently from younger adult patients. patients that received prior ert are more likely to have pre-existing anti-drug antibodies (ada) to pegunigalsidase alfa-iwxj which could be due to the ada cross-reactivity to pegunigalsidase alfa-iwxj by prior ert. when switching from other ert to elfabrio: - pre-existing ada may reduce the plasma pegunigalsidase alfa-iwxj concentrations, which may reduce elfabrio efficacy [see clinical pharmacology ( 12.2 , 12.6 ) ]. - the risk of elfabrio-related hypersensitivity and infusion-associated reactions may be increased in certain patients with pre-existing ada from prior ert [ see warnings and precautions ( 5.1 , 5.2 ) and adverse reactions ( 6.1 )] . consider monitoring clinical or pharmacodynamic responses (e.g., plasma lyso-gb3 levels) when switching from agalsidase beta to elfabrio, in patients with pre-existing ada. 

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

chiesi ltd - formoterol fumarate dihydrate - pressurised inhalation - 12microgram/1dose