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

a a h pharmaceuticals ltd - zinc oxide - cutaneous cream - 320mg/1gram

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

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

pharma-z ltd - zinc sulfate - oral capsule - 220mg

Australia - English - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - zinc chloride, quantity: 5.3 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid - indications as at 01 jan 1991 : zinc chloride injection is intended for use as an additive to compatible intravenous fluids or total parenteral nutrition solutions. it is indicated for the prevention and treatment of zinc deficiency, which may be characterised by growth deterioration, skin lesions, alopecia, impaired reproductive development and function, and delayed or inhibited wound healing. indications as at 01 jan 1991 : zinc chloride injection is intended for use as an additive to compatible intravenous fluids or total parenteral nutrition solutions. it is indicated for the prevention and treatment of zinc deficiency, which may be characterised by growth deterioration, skin lesions, alopecia, impaired reproductive development and function, and delayed or inhibited wound healing.

Singapore - English - HSA (Health Sciences Authority)

aguettant asia pacific pte. ltd. - zinc gluconate eqv elemental zinc - infusion, solution concentrate - zinc gluconate eqv elemental zinc 1mg/ml

Australia - English - Department of Health (Therapeutic Goods Administration)

care pharmaceuticals pty ltd - zinc oxide -

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

j m loveridge ltd - zinc oxide - cutaneous ointment - 150mg/1gram

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

alliance healthcare (distribution) ltd - zinc oxide - cutaneous ointment - 150mg/1gram

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - zinc chloride, quantity: 5.3 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - zinc chloride injection is intended for use as an additive to compatible intravenous fluids or total parenteral nutrition solutions. it is indicated for the prevention and treatment of zinc deficiency, which may be characterised by growth deterioration, skin lesions, alopecia, impaired reproductive development and function, and delayed or inhibited wound healing.

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

novartis pharmaceuticals corporation - inclisiran sodium (unii: upc6btx7py) (inclisiran - unii:uow2c71pg5) - leqvio® is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce low-density lipoprotein cholesterol (ldl-c). none. risk summary discontinue leqvio when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. inclisiran increases ldl-c uptake and lowers ldl-c levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, leqvio may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. there are no available data on the use of leqvio in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed in rats and rabbits with subcutaneous administration of inclisiran during organogenesis at doses up to 5 to 10 times the maximum recommended human dose (mrhd) based on body surface area (bsa) comparison (see data ). no adverse developmental outcomes were observed in offspring of rats administered inclisiran from organogenesis through lactation at 5 times the mrhd based on bsa comparison (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. data animal data in embryo-fetal development studies conducted in sprague-dawley rats and new zealand white rabbits, inclisiran was administered by subcutaneous injection at dose levels of 50, 100, and 150 mg/kg once daily during organogenesis (rats: gestation days 6 to 17; rabbits: gestation days 7 to 19). there was no evidence of embryo-fetal toxicity or teratogenicity at doses up to 5 and 10 times, respectively, the mrhd based on bsa comparison/dose. inclisiran crosses the placenta and was detected in rat fetal plasma at concentrations that were 65 to 154 times lower than maternal levels. in a pre- and postnatal development study conducted in sprague-dawley rats, inclisiran was administered once daily by subcutaneous injection at levels of 50, 100, and 150 mg/kg from gestation day 6 through lactation day 20. inclisiran was well-tolerated in maternal rats, with no evidence of maternal toxicity and no effects on maternal performance. there were no effects on the development of the f1 generation, including survival, growth, physical and reflexological development, behavior, and reproductive performance at doses up to 5 times the mrhd, based on bsa comparison/dose. risk summary there is no information on the presence of inclisiran in human milk, the effects on the breastfed infant, or the effects on milk production. inclisiran was present in the milk of lactating rats in all dose groups. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data ). oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered unlikely that low levels of inclisiran present in milk will adversely impact an infant’s development during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for leqvio and any potential adverse effects on the breastfed infant from leqvio or from the underlying maternal condition. data in lactating rats, inclisiran was detected in milk at mean maternal plasma:milk ratios that ranged between 0.361 and 1.79. however, there is no evidence of systemic absorption in the suckling rat neonates. the safety and effectiveness of leqvio have not been established in pediatric patients. of the 1,833 patients treated with leqvio in clinical studies, 981 (54%) patients were 65 years of age and older, while 239 (13%) patients were 75 years of age and older. no overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. no dose adjustments are necessary for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . leqvio has not been studied in patients with end stage renal disease [see clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate hepatic impairment. leqvio has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .