Stelara Evropská unie - angličtina - EMA (European Medicines Agency)

stelara

janssen-cilag international nv - ustekinumab - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - immunosuppressants - crohn’s diseasestelara is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnfα antagonist or have medical contraindications to such therapies.ulcerative colitisstelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen ultraviolet a.paediatric plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.psoriatic arthritisstelara, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (dmard) therapy has been inadequate.

Zavesca Evropská unie - angličtina - EMA (European Medicines Agency)

zavesca

janssen cilag international nv - miglustat - gaucher disease; niemann-pick diseases - other alimentary tract and metabolism products, - zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 gaucher disease. zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with niemann-pick type-c disease.

Tremfya Evropská unie - angličtina - EMA (European Medicines Agency)

tremfya

janssen-cilag international nv - guselkumab - psoriasis - immunosuppressants - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (dmard) therapy (see section 5.1).,

Spravato Evropská unie - angličtina - EMA (European Medicines Agency)

spravato

janssen-cilag international nv - esketamine hydrochloride - depressive disorder - other antidepressants - spravato, in combination with a ssri or snri, is indicated for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Rekambys Evropská unie - angličtina - EMA (European Medicines Agency)

rekambys

janssen-cilag international nv - rilpivirine - hiv infections - antivirals for systemic use - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Invokana Evropská unie - angličtina - EMA (European Medicines Agency)

invokana

janssen-cilag international nv - canagliflozin - diabetes mellitus, type 2 - drugs used in diabetes - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Vokanamet Evropská unie - angličtina - EMA (European Medicines Agency)

vokanamet

janssen-cilag international nv - canagliflozin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated doses of metformin alonein patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control.in patients already being treated with the combination of canagliflozin and metformin as separate tabletsfor study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Evra transdermal patches Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

evra transdermal patches

janssen-cilag ltd - norelgestromin; ethinylestradiol - transdermal patch - 203microgram/24hour ; 33.9microgram/24hour