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

southern cross pharma pty ltd - prasugrel, quantity: 5 mg - tablet, film coated - excipient ingredients: sucrose stearate; microcrystalline cellulose; lactose monohydrate; crospovidone; croscarmellose sodium; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow - prasugrel, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (ua), non st-segment elevation myocardial infarction (nstemi) or st-segment elevation myocardial infarction (stemi)) who are to undergo percutaneous coronary intervention (pci).

New Zealand - English - Medsafe (Medicines Safety Authority)

eli lilly and company (nz) limited - prasugrel hydrochloride 10.98mg - film coated tablet - 10 mg - active: prasugrel hydrochloride 10.98mg excipient: croscarmellose sodium glycerol hypromellose iron oxide red iron oxide yellow lactose magnesium stearate mannitol microcrystalline cellulose purified talc titanium dioxide - effient, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (ua), non st-segment elevation myocardial infarction (nstemi) or st-segment elevation myocardial infarction (stemi)) who are to undergo percutaneous coronary intervention (pci).

New Zealand - English - Medsafe (Medicines Safety Authority)

eli lilly and company (nz) limited - prasugrel hydrochloride 5.49mg - film coated tablet - 5 mg - active: prasugrel hydrochloride 5.49mg excipient: croscarmellose sodium glycerol hypromellose iron oxide yellow lactose magnesium stearate mannitol microcrystalline cellulose purified talc titanium dioxide - effient, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (ua), non st-segment elevation myocardial infarction (nstemi) or st-segment elevation myocardial infarction (stemi)) who are to undergo percutaneous coronary intervention (pci).

European Union - English - EMA (European Medicines Agency)

substipharm - prasugrel - acute coronary syndrome; angina, unstable; myocardial infarction - antithrombotic agents - efient, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-st-segment-elevation myocardial infarction [ua / nstemi] or st-segment-elevation myocardial infarction [stemi]) undergoing primary or delayed percutaneous coronary intervention (pci).

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

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections; dilute hydrochloric acid - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

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

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: dilute hydrochloric acid; water for injections - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

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

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 20 mg/ml - injection, solution - excipient ingredients: dilute hydrochloric acid; water for injections - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

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

juno pharmaceuticals pty ltd - morphine hydrochloride trihydrate, quantity: 20 mg/ml - injection, solution - excipient ingredients: water for injections; dilute hydrochloric acid - - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. - symptomatic relief of severe and intractable pains in terminal cancer patients. - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

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

glaxosmithkline llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - zyban is indicated as an aid to smoking cessation treatment. pregnancy category c. risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (mrhd) and greater and decreased fetal weights were seen at doses three times the mrhd and greater. zyban should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical considerations pregnant smokers should be encouraged to attempt cessation using educational and behavioral i

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

lake erie medical dba quality care products llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets, usp (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14.1)]. bupropion hydrochloride extended-release tablets, usp (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets (xl) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlle