Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - paliperidone, quantity: 3 mg - tablet, modified release - excipient ingredients: polyethylene oxide; iron oxide yellow; iron oxide red; butylated hydroxytoluene; purified water; carnauba wax; sodium chloride; hypromellose; iron oxide black; lactose monohydrate; triacetin; stearic acid; povidone; macrogol 3350; titanium dioxide; hyetellose; isopropyl alcohol; cellulose acetate; propylene glycol - invega is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention. invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 27 mg - tablet, modified release - excipient ingredients: cellulose acetate; polyethylene oxide; butylated hydroxytoluene; stearic acid; succinic acid; iron oxide red; poloxamer; carnauba wax; hypromellose; sodium chloride; phosphoric acid; povidone; iron oxide yellow; iron oxide black; titanium dioxide; lactose monohydrate; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 250 mg - tablet - excipient ingredients: colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; povidone - zytiga 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.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind, controlled phase iii trials in treatment-naive adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment-naive adult patients (see clinical trials section).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - etravirine, quantity: 200 mg - tablet - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; hypromellose; magnesium stearate - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,this indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. both studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, n(t)rti, pi) treatment-experienced adults (see section 5.1 pharmacodynamic properties ? clinical trials).,treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - risperidone - orodispersible tablet - 4mg

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - risperidone - orodispersible tablet - 3mg

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - galantamine hydrobromide, quantity: 30.76 mg (equivalent: galantamine, qty 24 mg); galantamine, quantity: 24 mg (equivalent: galantamine hydrobromide, qty 30.76 mg) - capsule, modified release - excipient ingredients: ethylcellulose; hypromellose; diethyl phthalate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide; titanium dioxide; iron oxide yellow; sorbitan monolaurate; iron oxide red; gelatin; sodium lauryl sulfate; macrogol 400; maize starch; sucrose - indicated for the treatment of mild to moderately severe dementia of the alzheimer type.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - galantamine hydrobromide, quantity: 20.51 mg (equivalent: galantamine, qty 16 mg); galantamine, quantity: 16 mg (equivalent: galantamine hydrobromide, qty 20.51 mg) - capsule, modified release - excipient ingredients: diethyl phthalate; ethylcellulose; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; maize starch; sucrose; macrogol 400; titanium dioxide; sorbitan monolaurate; iron oxide red; gelatin; sodium lauryl sulfate; ethanol absolute; sulfuric acid - indicated for the treatment of mild to moderately severe dementia of the alzheimer type.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - galantamine hydrobromide, quantity: 10.25 mg (equivalent: galantamine, qty 8 mg); galantamine, quantity: 8 mg (equivalent: galantamine hydrobromide, qty 10.25 mg) - capsule, modified release - excipient ingredients: hypromellose; diethyl phthalate; ethylcellulose; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; maize starch; sucrose; macrogol 400; titanium dioxide; sorbitan monolaurate; gelatin; sodium lauryl sulfate; potassium hydroxide - indicated for the treatment of mild to moderately severe dementia of the alzheimer type.