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

janssen-cilag pty ltd - paliperidone, quantity: 6 mg - tablet, modified release - excipient ingredients: butylated hydroxytoluene; sodium chloride; povidone; stearic acid; polyethylene oxide; iron oxide red; hyetellose; macrogol 3350; macrogol 400; carnauba wax; isopropyl alcohol; propylene glycol; cellulose acetate; titanium dioxide; hypromellose; purified water; iron oxide black; iron oxide yellow - 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).

Australia - English - 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).

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - solution - excipient ingredients: water for injections; histidine; histidine hydrochloride monohydrate; sorbitol; polysorbate 80 - simponi iv,rheumatoid arthritis (ra),simponi iv, 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 iv has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi iv, 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.,ankylosing spondylitis (as),simponi iv is indicated for:,the treatment of active ankylosing spondylitis in adult patients

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

janssen-cilag pty ltd - daratumumab, quantity: 1800 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride monohydrate; sorbitol; methionine; polysorbate 20; water for injections - darzalex sc is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:-bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone.,? with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as: - monotherapy.,darzalex sc in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain al amyloidosis.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - rad26.cov2-s -

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

janssen pharmaceuticals, inc. - canagliflozin (unii: 0sac974z85) (canagliflozin anhydrous - unii:6s49dgr869) - canagliflozin anhydrous 100 mg - invokana (canagliflozin) is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (cvd). - to reduce the risk of end-stage kidney disease (eskd), doubling of serum creatinine, cardiovascular (cv) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. limitations of use invokana is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)] . invokana is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m 2 . invokana is likely to be ineffective in this setting based upon i

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

janssen pharmaceuticals, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] . hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with concerta. therefore, concerta is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.5)] . concerta is contraindicated during treatment with monoamine oxidase (mao) inhibitors, and also within a minimum of 14 days following discontinuation of a mao inhibitor (hypertensive crises may result) [see drug interactions (7.1)] . pregnancy category c methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m 2 basis

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

janssen pharmaceuticals inc. - esketamine hydrochloride (unii: l8p1h35p2z) (esketamine - unii:50lfg02txd) - spravato ® is indicated, in conjunction with an oral antidepressant, for the treatment of: - treatment-resistant depression (trd) in adults - depressive symptoms in adults with major depressive disorder (mdd) with acute suicidal ideation or behavior limitations of use: - the effectiveness of spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated [see clinical studies (14.2)] . use of spravato does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of spravato. - spravato is not approved as an anesthetic agent. the safety and effectiveness of spravato as an anesthetic agent have not been established. spravato is contraindicated in patients with: - aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation [see warnings and precautions (5.7)] - history of intracere

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

janssen biotech, inc. - teclistamab (unii: 54534mx6z9) (teclistamab - unii:54534mx6z9) - tecvayli is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on the mechanism of action, tecvayli may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of tecvayli in pregnant women to evaluate for a drug associated risk. no animal reproductive or developmental toxicity studies have been conducted with tecvayli. teclistamab-cqyv causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. human immunoglobulin g (igg) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. tecvayli is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with tecvayli should be considered. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tecvayli are unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with tecvayli and for 5 months after the last dose. tecvayli may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating tecvayli. contraception females advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of tecvayli. the safety and efficacy of tecvayli have not been established in pediatric patients. of the 165 patients with relapsed or refractory multiple myeloma treated with tecvayli in majestec-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. there is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.

Israel - English - Ministry of Health

j-c health care ltd - telaprevir 375 mg - film coated tablets - incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis c in adult patients with compensated liver disease (including cirrhosis):who are treatment na?ve; who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and responders.