European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidone palmitate - schizophrenia - psycholeptics - xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

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

janssen-cilag pty ltd - paliperidone palmitate -

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

janssen-cilag pty ltd - paliperidone palmitate -

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

janssen-cilag pty ltd - paliperidone palmitate -

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

janssen-cilag pty ltd - paliperidone palmitate -

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - paliperidone - prolonged-release tablet - 3 milligram(s) - paliperidone

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - paliperidone - prolonged-release tablet - 6 milligram(s) - paliperidone

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - paliperidone - prolonged-release tablet - 9 milligram(s) - paliperidone

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

remedyrepack inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)]. the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablet formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have bee

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

inventia healthcare limited - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)]. the efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)]. the efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults. paliperidoneis contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone is a metabolite of risperidone. pregnancy exposure reg