Eiropas Savienība - angļu - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv infections - antivirals for systemic use - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista.prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection.prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated.for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista.prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection.prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve.art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Saūda Arābija - angļu - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen-cilag international nv, belgium - ad26 cov2s - suspension for injection - 1000000000 vector genomes/ml

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 12mg (drug layer 1 = 3.6 mg, drug layer 2 = 8.4 mg.) - modified release tablet - 12 mg - active: paliperidone 12mg (drug layer 1 = 3.6 mg, drug layer 2 = 8.4 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 prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 9mg (drug layer 1: 2.7 mg, drug layer 2: 6.3 mg) - modified release tablet - 9 mg - active: paliperidone 9mg (drug layer 1: 2.7 mg, drug layer 2: 6.3 mg) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide black iron oxide red macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 0.5mg;  ;   - film coated tablet - 0.5 mg - active: risperidone 0.5mg     excipient: colloidal silicon dioxide hypromellose e-15 hypromellose e-5 iron oxide red lactose monohydrate magnesium stearate maize starch microcrystalline cellulose propylene glycol purified talc sodium laurilsulfate titanium dioxide - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 1mg;  ;   - film coated tablet - 1 mg - active: risperidone 1mg     excipient: colloidal silicon dioxide hypromellose e-15 hypromellose e-5 lactose monohydrate magnesium stearate maize starch microcrystalline cellulose propylene glycol purified water sodium laurilsulfate - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 2mg;  ;   - film coated tablet - 2 mg - active: risperidone 2mg     excipient: colloidal silicon dioxide hypromellose   lactose monohydrate magnesium stearate maize starch microcrystalline cellulose propylene glycol purified talc sodium laurilsulfate sunset yellow fcf titanium dioxide - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 3mg;  ;   - film coated tablet - 3 mg - active: risperidone 3mg     excipient: colloidal silicon dioxide hypromellose   lactose monohydrate magnesium stearate maize starch microcrystalline cellulose propylene glycol purified talc quinoline yellow sodium laurilsulfate titanium dioxide - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 4mg;  ;   - film coated tablet - 4 mg - active: risperidone 4mg     excipient: colloidal silicon dioxide hypromellose   indigo carmine lactose monohydrate magnesium stearate maize starch microcrystalline cellulose propylene glycol purified talc quinoline yellow sodium laurilsulfate titanium dioxide - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - risperidone 1 mg/ml (r064766);  ;   - oral solution - 1 mg/ml - active: risperidone 1 mg/ml (r064766)     excipient: benzoic acid purified water sodium hydroxide as 1n solution, to ph 3.0 tartaric acid - risperdal is indicated for the treatment of schizophrenia and other psychotic disorders. these include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.