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RISPERDAL - RISPERDALORO

Name: Avis sur RISPERDAL - RISPERDALORO
Item: RISPERDAL - RISPERDALORO
Author: Haute Autorité de Santé

Opinions on drugs - Posted on May 30 2014

Reason for request

Renewal of inclusion

Clinical Benefit

Substantial

The actual benefit of RISPERDAL and RISPERDALORO remains substantial in the "treatment of schizophrenia".

The actual benefit of RISPERDALCONSTA L.P. remains substantial for the "maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics".

The actual benefit of RISPERDAL and RISPERDALORO remains substantial for the "treatment of moderate to severe manic episodes associated with bipolar disorders".

The actual benefit of RISPERDAL and RISPERDALORO remains substantial for "the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment."

Insufficient

In the extension of indication in the treatment of persistent aggression in Alzheimer's disease
Given the importance of non-drug therapy, the fact that the use of antipsychotics in people with Alzheimer's or a related disease is not recommended, the adverse effects of risperidone and its low efficacy in case of aggressive behaviour and the difficulty in implementing short-term treatment, the Committee considers that the actual benefit of the proprietary medicinal products RISPERDAL and RISPERDALORO is sufficient in "the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non pharmacological approaches and when there is a risk of harm to self or others".