Stati Uniti - inglese - NLM (National Library of Medicine)

janssen products, lp - bedaquiline fumarate (unii: p04qx2c1a5) (bedaquiline - unii:78846i289y) - bedaquiline 100 mg - sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (mdr-tb). reserve sirturo for use when an effective treatment regimen cannot otherwise be provided. this indication is approved under accelerated approval based on time to sputum culture conversion [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitations of use: - do not use sirturo for the treatment of: latent infection due to mycobacterium tuberculosis drug-sensitive tuberculosis extra-pulmonary tuberculosis infections caused by non-tuberculous mycobacteria - latent infection due to mycobacterium tuberculosis - drug-sensitive tuberculosis - extra-pulmonary tuberculosis - infections caused by non-tuberculous myco

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - telaprevir - tablet - 375mg

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

janssen-cilag - telaprevir - film-coated tablet - 375 mg

Nuova Zelanda - inglese - 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.

Nuova Zelanda - inglese - 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.

Nuova Zelanda - inglese - 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.

Nuova Zelanda - inglese - 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.

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 3mg (drug layer 1 = 0.9 mg, drug layer 2 = 2.1 mg) - modified release tablet - 3 mg - active: paliperidone 3mg (drug layer 1 = 0.9 mg, drug layer 2 = 2.1 mg) excipient: butylated hydroxytoluene carnauba wax cellulose acetate glycerol hyetellose hypromellose iron oxide red iron oxide yellow lactose macrogol 3350 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 6mg (drug layer 1 = 1.8 mg, drug layer 2 = 4.2 mg.) - modified release tablet - 6 mg - active: paliperidone 6mg (drug layer 1 = 1.8 mg, drug layer 2 = 4.2 mg.) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide red iron oxide yellow macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone palmitate 156mg equivalent to 100 mg paliperidone base;   - suspension for injection - 100 mg - active: paliperidone palmitate 156mg equivalent to 100 mg paliperidone base   excipient: citric acid monohydrate dibasic sodium phosphate macrogol 4000 monobasic sodium phosphate monohydrate polysorbate 20 sodium hydroxide water for injection - invega sustenna® is indicated for the acute and maintenance treatment of schizophrenia in adults.