European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - paliperidone palmitate - schizophrenia - psycholeptics - byannli (previously paliperidone janssen-cilag international) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - vaccines - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older.the use of this vaccine should be in accordance with official recommendations.

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

janssen-cilag pty ltd - ad26.cov2.s, quantity: 50000000000 vp - injection, suspension - excipient ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections - covid-19 vaccine janssen has provisional approval for the indication:,covid-19 vaccine janssen is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older.,the use of this vaccine should be in accordance with official recommendations. the decision has been made on the basis of short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - paliperidone palmitate - schizophrenia - psycholeptics - trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - becaplermin - wound healing; skin ulcer - preparations for treatment of wounds and ulcers - regranex is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) - suspension for injection - active: ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) excipient: citric acid monohydrate ethanol hydrochloric acid hydroxypropyl-beta-cyclodextrin polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - covid-19 vaccine janssen has provisional consent for the indication below: active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations.

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 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 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.