European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate - prostatic neoplasms - endocrine therapy - zytiga is indicated with prednisone or prednisolone for:the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years or older.genotypic testing should guide the use of rezolsta.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - bedaquiline fumarate - tuberculosis, multidrug-resistant - antimycobacterials - sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (mdr tb) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - other antihypertensives - treatment of pulmonary arterial hypertension (pah) to improve exercise capacity and symptoms in patients with world health organization (who) functional class iii. efficacy has been shown in:primary (idiopathic and familial) pah;pah secondary to scleroderma without significant interstitial pulmonary disease;pah associated with congenital systemic-to-pulmonary shunts and eisenmenger’s physiology.some improvements have also been shown in patients with pah who functional class ii.stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - antihypertensives, - treatment of pulmonary arterial hypertension (pah) to improve exercise capacity and symptoms in patients with who functional class iii.efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. , some improvements have also been shown in patients with pah who functional class ii. tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - macitentan - hypertension, pulmonary - antihypertensives, - opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease.

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

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).,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - prostatic neoplasms - endocrine therapy - erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt).