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

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; iron oxide black; macrogol 3350 - 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; iron oxide yellow; purified talc; polyvinyl alcohol; iron oxide black; macrogol 3350 - 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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil present as imazalil sulphate; pyrimethanil - suspension concentrate - imazalil present as imazalil sulphate imidazole active 200.0 g/l; pyrimethanil pyrimidine active 200.0 g/l - fungicide - citrus | grapefruit | lemon | lime | mandarin | orange - blue and green moulds

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil present as the sulfate - water soluble granules - imazalil present as the sulfate imidazole active 750.0 g/kg - fungicide - citrus - post-harvest dip | potato tuber - blue mould on citrus - p. italicum | fusarium dry rot | gangrene - phoma exigua | green mould | silver scurf

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).

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen-cilag international nv, belgium - ad26 cov2s - suspension for injection - 1000000000 vector genomes/ml

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.