Risperidone ODT Mylan

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Risperidone 4 mg
Available from:
Viatris Limited
INN (International Name):
Risperidone 4 mg
Dosage:
4 mg
Pharmaceutical form:
Orodispersible tablet
Composition:
Active: Risperidone 4 mg Excipient: Aspartame Colloidal silicon dioxide Crospovidone Guar gum Iron oxide red Magnesium stearate Mannitol Microcrystalline cellulose Polacrilin
Prescription type:
Prescription
Manufactured by:
Mylan Laboratories Limited
Therapeutic indications:
Indicated for the treatment of schizophrenia and other psychotic disorders. These include first episode pyschoses, 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. Risperidone also alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. Risperidone also appears effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial response to treatment with this agent.
Product summary:
Package - Contents - Shelf Life: Blister pack, OPA/Al/PVC-Al in cardboard carton - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, OPA/Al/PVC-Al in cardboard carton - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, OPA/Al/PVC-Al in cardboard carton - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, OPA/Al/PVC-Al in cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, OPA/Al/PVC-Al in cardboard carton - 84 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-9417/1d
Authorization date:
2013-12-03

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