apremilast - Meklēšanas rezultāti

celgene corporation - apremilast (unii: up7qbp99pn) (apremilast - unii:up7qbp99pn) - apremilast 10.0 mg - otezla is indicated for the treatment of adult patients with active psoriatic arthritis. otezla is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. otezla is indicated for the treatment of adult patients with oral ulcers associated with behçet's disease. otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see adverse reactions (6.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to otezla during pregnancy. information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/. risk summary available pharmacovigilance data with otezla use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but these data are extremely limited. bas

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

otezla

amgen new zealand limited - apremilast 10mg; ; apremilast 20mg; apremilast 30mg - film coated tablet - active: apremilast 10mg excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 85f94245 purified water active: apremilast 20mg excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry brown 85f165037 purified water active: apremilast 30mg excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry beige 85f17424 purified water - for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phytotherapy or systemic therapy.