Canada - English - Health Canada

apotex inc - ticagrelor - tablet - 90mg - ticagrelor 90mg - platelet aggregation inhibitors

Canada - English - Health Canada

angita pharma inc. - ticagrelor - tablet - 90mg - ticagrelor 90mg

Canada - English - Health Canada

taro pharmaceuticals inc - ticagrelor - tablet - 90mg - ticagrelor 90mg - platelet aggregation inhibitors

Canada - English - Health Canada

teva canada limited - ticagrelor - tablet - 90mg - ticagrelor 90mg - platelet aggregation inhibitors

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

arrotex pharmaceuticals pty ltd - ticagrelor, quantity: 90 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; hypromellose; mannitol; magnesium stearate; hyprolose; iron oxide yellow; purified talc; macrogol 400; titanium dioxide - apo-ticagrelor, in combination with aspirin, is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult patients with acute coronary syndromes (unstable angina [ua], non st elevation myocardial infarction [nstemi] or st elevation myocardial infarction [stemi]) including patients managed medically, and those who are managed with percutaneous coronary intervention (pci) or coronary artery by-pass grafting (cabg).

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - ticagrelor 90mg - film coated tablet - 90 mg - active: ticagrelor 90mg excipient: calcium hydrogen phosphate dihydrate maize starch mannitol opadry yellow 88a220017 purified talc purified water sodium stearyl fumarate starch - co-administered with acetylsalicylic acid (aspirin), this product is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) " in patients with acute coronary syndromes (unstable angina [ua], non st elevation myocardial infarction [nstemi] or st elevation myocardial infarction [stemi]); including patients managed medically, and those who are managed with percutaneous coronary intervention (pci) or coronary artery by-pass grafting (cabg). " in patients with a history of myocardial infarction (mi occurred at least one year ago) and a high risk of developing an atherothrombotic event.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - ticagrelor - film coated tablets - ticagrelor 90 mg - ticagrelor - ticagrelor - brilinta, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with - acute coronary syndromes (acs) or- a history of myocardial infarction (mi) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1).limitations of use: 90 mg twice daily during the first year after an acs event followed by 60 mg twice daily for additional 2 years.

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

cardinal health 107, llc - ticagrelor (unii: glh0314rvc) (ticagrelor - unii:glh0314rvc) - ticagrelor 90 mg - brilinta is indicated to reduce the risk of cardiovascular (cv) death, myocardial infarction (mi), and stroke in patients with acute coronary syndrome (acs) or a history of mi. for at least the first 12 months following acs, it is superior to clopidogrel. brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of acs [see clinical studies (14.1)] . brilinta is indicated to reduce the risk of a first mi or stroke in patients with coronary artery disease (cad) at high risk for such events [see clinical studies (14.2)] . while use is not limited to this setting, the efficacy of brilinta was established in a population with type 2 diabetes mellitus (t2dm). brilinta is indicated to reduce the risk of stroke in patients with acute ischemic stroke (nih stroke scale score ≤5) or high-risk transient ischemic attack (tia) [see clinical studies (14.3)] . brilinta is contraindicated in patients with a history of intracranial hemorrhage (ich) because of a high risk of recurrent ich in this population [see clinical studies (14.1), (14.2)]. brilinta is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see warnings and precautions (5.1) and adverse reactions (6.1)] . brilinta is contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product. risk summary available data from case reports with brilinta use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (mrhd) based on body surface area. when ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the mrhd (see data). the estimated background risk of major birth defects and miscarriage for 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. data animal data in reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. 20 mg/kg/day is approximately the same as the mrhd of 90 mg twice daily for a 60 kg human on a mg/m2 basis. adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the mrhd on a mg/m2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae. at the mid-dose of 100 mg/kg/day (5.5 times the mrhd on a mg/m2 basis), delayed development of liver and skeleton was seen. when pregnant rabbits received ticagrelor during organogenesis at doses from 21 to 63 mg/kg/day, fetuses exposed to the highest maternal dose of 63 mg/kg/day (6.8 times the mrhd on a mg/m2 basis) had delayed gall bladder development and incomplete ossification of the hyoid, pubis and sternebrae occurred. in a prenatal/postnatal study, pregnant rats received ticagrelor at doses of 10 to 180 mg/kg/day during late gestation and lactation. pup death and effects on pup growth were observed at 180 mg/kg/day (approximately 10 times the mrhd on a mg/m2 basis). relatively minor effects such as delays in pinna unfolding and eye opening occurred at doses of 10 and 60 mg/kg (approximately one-half and 3.2 times the mrhd on a mg/m2 basis). risk summary there are no data on the presence of ticagrelor or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. ticagrelor and its metabolites were present in rat milk at higher concentrations than in maternal plasma. when a drug is present in animal milk, it is likely that the drug will be present in human milk. breastfeeding is not recommended during treatment with brilinta. the safety and effectiveness of brilinta have not been established in pediatric patients. effectiveness was not demonstrated in an adequate and well-controlled study conducted in 101 brilinta-treated pediatric patients, aged 2 to <18 for reducing the rate of vaso-occlusive crises in sickle cell disease. about half of the patients in plato, pegasus, themis, and thales were ≥65 years of age and at least 15% were ≥75 years of age. no overall differences in safety or effectiveness were observed between elderly and younger patients. ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. avoid use of brilinta in patients with severe hepatic impairment. there is limited experience with brilinta in patients with moderate hepatic impairment; consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor. no dosage adjustment is needed in patients with mild hepatic impairment [see warnings and precautions (5.5) and clinical pharmacology (12.3)] . no dosage adjustment is needed in patients with renal impairment [see clinical pharmacology (12.3)] . patients with end-stage renal disease on dialysis clinical efficacy and safety studies with brilinta did not enroll patients with end-stage renal disease (esrd) on dialysis. in patients with esrd maintained on intermittent hemodialysis, no clinically significant difference in concentrations of ticagrelor and its metabolite and platelet inhibition are expected compared to those observed in patients with normal renal function [see clinical pharmacology (12.3)] . it is not known whether these concentrations will lead to similar efficacy and safety in patients with esrd on dialysis as were seen in plato, pegasus, themis and thales.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - ticagrelor 90 mg - film-coated tablet - 90 mg - ticagrelor 90 mg - ticagrelor

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - ticagrelor 90 mg - film-coated tablet - 90 mg - ticagrelor 90 mg - ticagrelor