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

janssen pharmaceuticals, inc - paliperidone palmitate (unii: r8p8usm8fr) (paliperidone - unii:838f01t721) - paliperidone palmitate 273 mg in 0.875 ml - invega trinza® (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with invega sustenna® (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see dosage and administration (2.2) and clinical studies (14)] . invega trinza® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega trinza® formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including invega trinza® , during pregnancy. healthcare providers are encouraged to

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

janssen pharmaceuticals, inc. - paliperidone palmitate (unii: r8p8usm8fr) (paliperidone - unii:838f01t721) - paliperidone palmitate 39 mg in 0.25 ml - invega sustenna® (paliperidone palmitate) is indicated for the treatment of: - schizophrenia in adults [see clinical studies (14.1)]. - schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see clinical studies (14.2)]. invega sustenna® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega sustenna® formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including invega sustenna® , during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for

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

tolmar inc. - paliperidone palmitate (unii: r8p8usm8fr) (paliperidone - unii:838f01t721) -

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - paliperidone palmitate 156 mg/ml - eq. paliperidone 100 mg/ml (pre-filled syringe 150 mg); paliperidone palmitate 156 mg/ml - eq. paliperidone 100 mg/ml (pre-filled syringe 100 mg) - prolonged-release suspension for injection - 150 mg + 100 mg - paliperidone palmitate 156 mg/ml; paliperidone palmitate 156 mg/ml - paliperidone

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 312 mg/ml (equivalent: paliperidone, qty 200 mg/ml) - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 312 mg/ml (equivalent: paliperidone, qty 200 mg/ml) - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 312 mg/ml (equivalent: paliperidone, qty 200 mg/ml) - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 312 mg/ml (equivalent: paliperidone, qty 200 mg/ml) - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

Ireland - English - HPRA (Health Products Regulatory Authority)

norton waterford - paliperidone; paliperidone - prolonged-release suspension for injection - 150 mg + 100 milligram(s) - paliperidone

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - paliperidone palmitate - schizophrenia - psycholeptics - byannli (previously paliperidone janssen-cilag international) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).