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

teva pharma australia pty ltd - levodopa, quantity: 75 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose; hyprolose; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; titanium dioxide; glycerol; iron oxide yellow; polysorbate 80; iron oxide red - lecteva (levodopa/carbidopa/entacapone) is indicated for the management of patients with parkinson?s disease who are experiencing motor fluctuations.

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

ventura corporation ltd - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - avobenzone 0.0003 g in 1 g

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

blue earth diagnostics - fluciclovine f-18 (unii: 38r1q0l1ze) (fluciclovine f-18 - unii:38r1q0l1ze) - fluciclovine f-18 221 mci in 1 ml - axumin is indicated for positron emission tomography (pet) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (psa) levels following prior treatment. none risk summary axumin is not indicated for use in females and there is no information on the risk of adverse development outcomes in pregnant women or animals with the use of fluciclovine f 18. risk summary axumin is not indicated for use in females and there is no information of the presence of fluciclovine f 18 in human milk. safety and effectiveness have not been established in pediatric patients. of the total number of patients in clinical studies of axumin, the average age was 66 years with a range of 21 to 90 years. no overall differences in safety or effectiveness were observed between older subjects and younger subjects.

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

global isotopes, llc d/b/a zevacor molecular - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 20 mci in 1 ml - fludeoxyglucose f18 injection, usp is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormality found by other testing modalities, or in patients with an existing diagnosis of cancer.  for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.  for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none. ( 4) pregnancy category c animal reproduction studies have not been conducted with fludeoxyglucose f18 injection. it is also not known whether fludeoxyglucose f18 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  consider alternative diagnostic te

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

sandoz pty ltd - levodopa, quantity: 75 mg; entacapone, quantity: 200 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; maize starch; mannitol; povidone; glycerol; hypromellose; polysorbate 80; iron oxide red; sucrose; titanium dioxide - stalevo is indicated for the management of patients with parkinson's disease who are experiencing motor fluctuations.

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

medis pharma pty ltd - levodopa, quantity: 75 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: sodium sulfate; hyprolose; carmellose sodium; microcrystalline cellulose; magnesium stearate; trehalose dihydrate; powdered cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin - levodopa/carbidopa/entacapone is indicated for the management of patients with parkinson?s disease who are experiencing motor fluctuations.

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

stada pharmaceuticals australia pty ltd - levodopa, quantity: 75 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: trehalose dihydrate; microcrystalline cellulose; carmellose sodium; hyprolose; sodium sulfate; magnesium stearate; powdered cellulose; titanium dioxide; iron oxide yellow; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin - levodopa/carbidopa/entacapone is indicated for the management of patients with parkinson?s disease who are experiencing motor fluctuations.

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

sunovion pharmaceuticals europe ltd - lurasidone hydrochloride - tablet - 18.5mg

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

accord-uk ltd - carbidopa; levodopa; entacapone - oral tablet - 18.75mg ; 75mg ; 200mg

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim vetmedica gmbh - ivermectin - oral paste - 18.7 milligram(s)/gram - ivermectin