European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - hiv infections - antivirals for systemic use - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabine - leukemia, myeloid - antineoplastic agents - treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (aml), according to the world health organization (who) classification, who are not candidates for standard induction chemotherapy.

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen-cilag ltd - topiramate - capsule, hard - 50 milligram(s) - other antiepileptics; topiramate

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

janssen biotech, inc. - siltuximab (unii: t4h8fma7im) (siltuximab - unii:t4h8fma7im) - siltuximab 100 mg - sylvant is indicated for the treatment of patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative. limitations of use sylvant was not studied in patients with mcd who are hiv positive or hhv-8 positive because sylvant did not bind to virally produced il-6 in a nonclinical study. severe hypersensitivity reaction to siltuximab or any of the excipients in sylvant [see warnings and precautions (5.3)] . hypersensitivity reactions, including anaphylactic reaction, hypersensitivity, and drug hypersensitivity have been reported in patients treated with siltuximab. pregnancy category c risk-summary there are no adequate or well-controlled studies in pregnant women. in animal reproduction studies, administration of a human antibody to il-6 to pregnant cynomolgus monkeys caused decreases in globulin levels in pregnant animals and in the offspring. siltuximab crossed the placenta in monkeys. infants born to pregnant women treated wi

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

janssen pharmaceutica n.v. - imazalil present as the sulfate - soluble powder - imazalil present as the sulfate imidazole active 1000.0 g/kg - fungicide

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

janssen pharmaceutica n.v. - propiconazole - emulsifiable concentrate - propiconazole triazole active 250.0 g/l - fungicide - mushroom bed | mushroom growing tray - control adhesion of mushroom mycelium | allow easy tip out of compost | tray

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 18mg (drug layer 1, drug layer 2 & drug coat) - modified release tablet - 18 mg - active: methylphenidate hydrochloride 18mg (drug layer 1, drug layer 2 & drug coat) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hypromellose ferric oxide, green (push layer) iron oxide yellow opacode black ns-78-17715 opadry clear ys-1-19025-a opadry yellow ys-30-12788a phosphoric acid poloxamer 188 polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 27mg - modified release tablet - 27 mg - active: methylphenidate hydrochloride 27mg excipient: butylated hydroxytoluene cellulose acetate hypromellose caranuba wax iron oxide black iron oxide red iron oxide yellow opacode black ns-78-17715 opadry clear ys-1-19025-a opadry grey y-30-17528 phosphoric acid poloxamer polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 36mg (drug layer 1, drug layer 2 & drug coat) - modified release tablet - 36 mg - active: methylphenidate hydrochloride 36mg (drug layer 1, drug layer 2 & drug coat) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hypromellose ferric oxide, green (push layer) iron oxide yellow opacode black ns-78-17715 opadry clear ys-1-19025-a opadry white y-30-18037 phosphoric acid poloxamer 188 polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 54mg (drug layer 1, drug layer 2 & drug coat);   - modified release tablet - 54 mg - active: methylphenidate hydrochloride 54mg (drug layer 1, drug layer 2 & drug coat)   excipient: butylated hydroxytoluene carnauba wax cellulose acetate hypromellose ferric oxide, green (push layer) iron oxide red opacode black ns-78-17715 opadry clear ys-1-19025-a opadry red y-30-15567-a phosphoric acid poloxamer 188 polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). 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.