Nigērija - angļu - NAFDAC (National Agency for Food and Drugs Administration and Control)

diclofenac sodium 25mg/ml

Malta - angļu - Medicines Authority

egis pharmaceuticals plc kereszturi ut 30-38 1106 budapest, hungary - vildagliptin - tablet - vildagliptin 50 mg - drugs used in diabetes

Malta - angļu - Medicines Authority

egis pharmaceuticals plc kereszturi ut 30-38 1106 budapest, hungary - vildagliptin, metformin hydrochloride - film-coated tablet - metformin hydrochloride 850 mg vildagliptin 50 mg - drugs used in diabetes

Malta - angļu - Medicines Authority

egis pharmaceuticals plc kereszturi ut 30-38 1106 budapest, hungary - vildagliptin, metformin hydrochloride - film-coated tablet - vildagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes

Eiropas Savienība - angļu - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - other nervous system drugs - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

kowa pharmaceuticals america, inc. - pitavastatin calcium (unii: iyd54xeg3w) (pitavastatin - unii:m5681q5f9p) - pitavastatin 1.045 mg - livalo is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c) in: - adults with primary hyperlipidemia. - adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (hefh). livalo is contraindicated in the following conditions: - concomitant use of cyclosporine [see drug interactions (7)]. - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3)]. - hypersensitivity to pitavastatin or any excipents in livalo. hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with livalo [see adverse reactions (6)] . risk summary discontinue livalo when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. livalo decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, livalo 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. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with statin use in pregnant women are insufficient to determine if there is a drug associated risk of miscarriage (see data) . in animal reproduction studies, no embryo-fetal toxicity or congenital malformations were observed in pregnant rats and rabbits orally administered pitavastatin during the period of organogenesis at doses which were 22 and 4 times, respectively, the human exposure at the maximum recommended human dosage (mrhd) of 4 mg, based on auc [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 human data a medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. animal data embryo-fetal developmental studies were conducted in pregnant rats administered 3, 10, 30 mg/kg/day pitavastatin by oral gavage during organogenesis (gestation days 7-17). no adverse effects were observed at 3 mg/kg/day, systemic exposures 22 times human systemic exposure at 4 mg/day based on auc. embryo-fetal developmental studies were conducted in pregnant rabbits administered 0.1, 0.3, 1 mg/kg/day pitavastatin by oral gavage during the period of fetal organogenesis (gestation days 6-18). maternal toxicity consisting of reduced body weight and abortion was observed at all doses tested (4 times human systemic exposure at 4 mg/day based on auc). in perinatal/postnatal studies in pregnant rats given oral gavage doses of pitavastatin at 0.1, 0.3, 1, 3, 10, 30 mg/kg/day from organogenesis through weaning (gestation day 17 to lactation day 21), maternal toxicity consisting of mortality at ≥0.3 mg/kg/day and impaired lactation at all doses contributed to the decreased survival of neonates in all dose groups (0.1 mg/kg/day represents approximately 1 time human systemic exposure at 4 mg/day dose based on auc). reproductive toxicity studies have shown that pitavastatin crosses the placenta in rats and is found in fetal tissues at ≤36% of maternal plasma concentrations following a single dose of 1 mg/kg/day during gestation (at the end of organogenesis). risk summary there is no available information about the prescence of pitavastatin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, it has been shown that another drug in this class passes into human milk. statins, including livalo, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based upon the mechanism of action, advise patients that breastfeeding is not recommended during treatment with livalo. [see use in specific populations (8.1), clinical pharmacology (12.1)] the safety and effectiveness of livalo as an adjunctive therapy to diet to reduce elevated ldl-c in pediatric patients aged 8 years and older with hefh have been established. use of livalo for this indication is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with hefh [see clinical studies (14.2)] and a 52-week open-label trial in 85 pediatric patients with hefh. the safety and effectiveness of livalo have not been established in pediatric patients younger than 8 years of age with hefh or in pediatric patients with other types of hyperlipidemia (other than hefh). in controlled clinical studies, 1,209 (43%) patients were 65 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients. advanced age (≥65 years) is a risk factor for livalo-associated myopathy and rhabdomyolysis. dose selection for a geriatric patient should be cautious, reognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving livalo for the increased risk of myopathy [see warnings and precautions (5.1)]. renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. due to the risk of myopathy, a dosage modification of livalo is recommended for patients with moderate and severe renal impairment (estimated glomerular filtration rate 30 – 59 ml/min/1.73 m2 and 15 – 29 ml/min/1.73 m2 , respectively), as well as end-stage renal disease receiving hemodialysis. [see dosage and administration (2.3), warnings and precautions (5.1), clinical pharmacology (12.3)] . livalo is contraindicated in patients with active liver failure or decompensated cirrhosis [see contraindications (4), warnings and precautions (5.3)] .

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - pitavastatin calcium (as hydrate) -

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - pitavastatin calcium (as hydrate) -

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

advantage medical products consulting pty ltd - pitavastatin calcium, quantity: 4.18 mg (equivalent: pitavastatin, qty 4 mg) - tablet, film coated - excipient ingredients: aluminium magnesium silicate; lactose monohydrate; hypromellose; triethyl citrate; magnesium stearate; hyprolose; titanium dioxide; colloidal anhydrous silica - livalo is indicated as an adjunct to diet for the treatment of adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, when response to diet and other non-pharmacological measures is inadequate. prior to initiating therapy with livalo, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

advantage medical products consulting pty ltd - pitavastatin calcium, quantity: 2.09 mg (equivalent: pitavastatin, qty 2 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; triethyl citrate; aluminium magnesium silicate; magnesium stearate; lactose monohydrate; hypromellose; titanium dioxide; hyprolose - livalo is indicated as an adjunct to diet for the treatment of adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, when response to diet and other non-pharmacological measures is inadequate. prior to initiating therapy with livalo, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.