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

interpharma pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

abbvie pty ltd - risankizumab, quantity: 600 mg - injection, intravenous infusion - excipient ingredients: sodium acetate trihydrate; glacial acetic acid; trehalose dihydrate; polysorbate 20; water for injections - crohn?s disease,skyrizi is indicated for the treatment of moderate to severe crohn?s disease in adult patients, who have an inadequate response, a lost response, an intolerance or a contra-indication to either conventional or biologic therapy.

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

alexion pharmaceuticals australasia pty ltd - ravulizumab, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections - ultomiris is indicated:,? for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh),? for the treatment of patients with atypical haemolytic uraemic syndrome (ahus),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.,? for the treatment of adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin 4 (aqp4) antibody-positive.,ultomiris is not intended for the acute treatment of a nmosd relapse.

Singapore - English - HSA (Health Sciences Authority)

apex pharma marketing pte. ltd. - furosemide - injection, solution - furosemide 20mg/2ml

Philippines - English - FDA (Food And Drug Administration)

int'l apex pharma'l inc - amoxicillin , clavulanic acid - tablet, film coated - 500mg + 125mg

Philippines - English - FDA (Food And Drug Administration)

int'l apex pharma'l inc - amoxicillin , clavulanic acid - suspension, oral - 400mg + 57mg / 5ml

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

rebel distributors corp - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.500 mg - mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson's disease. the effectiveness of mirapex tablets was demonstrated in randomized, controlled trials in patients with early parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see clinical studies ). mirapex tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). key diagnostic criteria for rls are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. difficulty falling asleep may frequently be associated with symptoms of rls. mir

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

takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - trintellix is indicated for the treatment of major depressive disorder (mdd) in adults. - hypersensitivity to vortioxetine or any component of the formulation. hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with trintellix [see adverse reactions (6.2)] . - the use of maois intended to treat psychiatric disorders with trintellix or within 21 days of stopping treatment with trintellix is contraindicated because of an increased risk of serotonin syndrome. the use of trintellix within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.4), warnings and precautions (5.2)] . starting trintellix in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monit

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

cardinal health 107, llc - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - trintellix is indicated for the treatment of major depressive disorder (mdd) in adults. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. risk summary there are limited human data on trintellix use during pregnancy to inform any drug-associated risks. however, there are clinical considerations regarding neonates exposed to ssris and snris, including trintellix, during the third trimester of pregnancy [see clinical considerations] . vortioxetine administered to pregnant rats and rabbits during the period of organogenesis at doses ≥15 times and 10 times the maximum recommended human dose (mrhd), respectively, resulted in decreased fetal body weight and del

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

remedyrepack inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - trintellix is indicated for the treatment of major depressive disorder (mdd) in adults. - hypersensitivity to vortioxetine or any component of the formulation. hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with trintellix [see adverse reactions (6.2)] . - the use of maois intended to treat psychiatric disorders with trintellix or within 21 days of stopping treatment with trintellix is contraindicated because of an increased risk of serotonin syndrome. the use of trintellix within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.4), warnings and precautions (5.2)] . starting trintellix in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk o