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

janssen-cilag pty ltd - topiramate, quantity: 15 mg - capsule, hard - excipient ingredients: cellulose acetate; povidone; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol; maize starch; sucrose - epilepsy topamax is indicated in adults and children, 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome; migraine topamax is indicated for the prophylaxis of migraine headache in adults. the usefulness of topamax in the acute treatment of migraine headache has not been studied.

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

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 156 mg (equivalent: paliperidone, qty 100 mg) - injection - excipient ingredients: dibasic sodium phosphate; water for injections; macrogol 4000; monobasic sodium phosphate monohydrate; polysorbate 20; citric acid monohydrate; sodium hydroxide - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 117 mg (equivalent: paliperidone, qty 75 mg) - injection - excipient ingredients: sodium hydroxide; polysorbate 20; macrogol 4000; water for injections; dibasic sodium phosphate; monobasic sodium phosphate monohydrate; citric acid monohydrate - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 39 mg (equivalent: paliperidone, qty 25 mg) - injection - excipient ingredients: dibasic sodium phosphate; sodium hydroxide; monobasic sodium phosphate monohydrate; citric acid monohydrate; polysorbate 20; water for injections; macrogol 4000 - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 234 mg (equivalent: paliperidone, qty 150 mg) - injection - excipient ingredients: monobasic sodium phosphate monohydrate; citric acid monohydrate; water for injections; polysorbate 20; macrogol 4000; dibasic sodium phosphate; sodium hydroxide - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 78 mg (equivalent: paliperidone, qty 50 mg) - injection - excipient ingredients: macrogol 4000; polysorbate 20; water for injections; citric acid monohydrate; dibasic sodium phosphate; sodium hydroxide; monobasic sodium phosphate monohydrate - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - darunavir -

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 4 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; macrogol 3350; iron oxide yellow; lactose; titanium dioxide; macrogol 400; iron oxide red; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; water for injections; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).