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

janssen products, lp - ad26.cov2.s (unii: jt2ns6183b) (ad26.cov2.s - unii:jt2ns6183b) - janssen covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 18 years of age and older for whom other fda-authorized or approved covid-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the janssen covid-19 vaccine because they would otherwise not receive a covid-19 vaccine. do not administer the janssen covid-19 vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the janssen covid-19 vaccine [see description (13)] . do not administer the janssen covid-19 vaccine to individuals with a history of thrombosis with thrombocytopenia following the janssen covid-19 vaccine or any other adenovirus-vectored covid-19 vaccine (e.g., astrazeneca's covid-19 vac

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.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - fentanyl hydrochloride - pain, postoperative - analgesics - management of acute moderate to severe post-operative pain for use in a hospital setting only

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.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - doripenem - pneumonia, ventilator-associated; pneumonia, bacterial; urinary tract infections; bacterial infections; cross infection - antibacterials for systemic use, - doribax is indicated for the treatment of the following infections in adults:nosocomial pneumonia (including ventilator-associated pneumonia);complicated intra-abdominal infections;complicated urinary tract infections.consideration should be given to official guidance on the appropriate use of antibacterial agents.

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

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - janssen abiraterone is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

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

janssen-cilag pty ltd - abiraterone acetate, quantity: 250 mg - tablet - excipient ingredients: colloidal anhydrous silica; povidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium - janssen abiraterone is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

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

janssen-cilag pty ltd - apalutamide, quantity: 60 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; hypromellose acetate succinate; croscarmellose sodium; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - janssen apalutamide (apalutamide) is indicated for the treatment of patients with: ? metastatic castration-sensitive prostate cancer (mcspc) or ? non-metastatic, castration-resistant prostate cancer (nmcrpc).

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.