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

biomarin pharmaceutical inc. - vosoritide (unii: 7se5582q2p) (vosoritide - unii:7se5582q2p) - voxzogo is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. this indication is approved under accelerated approval based on an improvement in annualized growth velocity [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none risk summary there are no available data on vosoritide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of embryo-fetal toxicity or congenital malformations when pregnant rats and rabbits were administered vosoritide subcutaneously at doses equivalent to 14-times and 200-times, respectively, the exposure at the maximum recommended human dose (mrhd) (see data). the estimated background risk of major birth defects for the indicated population is higher than the general population. the est

European Union - English - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - drugs for treatment of bone diseases - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 1.2 mg - injection, powder for - excipient ingredients: citric acid monohydrate; mannitol; methionine; polysorbate 80; sodium citrate dihydrate; trehalose dihydrate - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 0.56 mg - injection, powder for - excipient ingredients: mannitol; sodium citrate dihydrate; citric acid monohydrate; polysorbate 80; trehalose dihydrate; methionine - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

biomarin pharmaceutical australia pty ltd - vosoritide, quantity: 0.4 mg - injection, powder for - excipient ingredients: citric acid monohydrate; mannitol; polysorbate 80; methionine; trehalose dihydrate; sodium citrate dihydrate - voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

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

scios llc - nesiritide (unii: p7wi8ul647) (nesiritide - unii:p7wi8ul647) - nesiritide 1.5 mg in 5 ml - natrecor (nesiritide) is indicated for the treatment of patients with acutely decompensated heart failure who have dyspnea at rest or with minimal activity. in this population, the use of natrecor reduced pulmonary capillary wedge pressure and improved short term (3 hours) symptoms of dyspnea. natrecor is contraindicated in patients with: - persistent systolic blood pressure <100 mm hg prior to therapy because of an increased risk of symptomatic hypotension [see warnings and precautions (5.1)] - known hypersensitivity to any of its components [see warnings and precautions (5.3)] - cardiogenic shock risk summary there are no data to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes with natrecor use in pregnant women. in animal reproduction studies, intravenous administration of natrecor to pregnant rabbits, during the period of organogenesis at 100 times the maximum recommended human dose (mrhd) did not result in any toxicities to the rabbits or their develo

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

plymouth healthcare products llc - potassium bromide (unii: osd78555zm) (bromide ion - unii:952902ix06), nickel sulfate (unii: 4flt4t3wun) (nickel cation - unii:ois2cxw7am), zinc bromide (unii: oo7zbu9703) (zinc cation - unii:13s1s8sf37) - potassium bromide 1 [hp_x] - psorizide ® ultra is indicated for the treatment of moderate to severe eczema, atopic dermatitis, seborrhea and seborrheic dermatitis. it has been found to work well with variety of combination therapies. psoriasis also responds, but generally has a more favorable response to psorizide ® forte (ndc 61480-255-05.) although there are no known contraindications, patients who are allergic to any psorizide ® ultra ingredient should consult a physician prior to taking the medication. (refer to section on hypersensitivity)

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

plymouth healthcare products llc - nickel sulfate (unii: 4flt4t3wun) (nickel cation - unii:ois2cxw7am), potassium bromide (unii: osd78555zm) (bromide ion - unii:952902ix06), fumaric acid (unii: 88xhz13131) (fumaric acid - unii:88xhz13131) - nickel sulfate 1 [hp_x] - psorizide ® forte is indicated for the treatment of contact dermatitis due to nickel (metal/jewelry allergy,) dyshidrotic hand/foot eczema, and mild to severe psoriasis. it has been found to work well with a variety of combination therapies. eczema, seborrhea and a variety of chronic pruritic inflammatory dermatoses generally respond well also. although there are no known contraindications, patients who are allergic to any psorizide ® forte ingredient should consult a physician prior to taking the medication. (refer to section on hypersensitivity)

Canada - English - Health Canada

janssen inc - nesiritide - powder for solution - 1.5mg - nesiritide 1.5mg - miscellaneous vasodilatating agents

Kenya - English - Pharmacy and Poisons Board

zawadi healthcare ltd p.o.box 14629 - 00800, maua close,westlands, - voritoxetine - tablet - 10 mg - vortioxetine