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Risperidone is approved by the FDA. It treats irritability in children with Autism and is for ages 5 to 16. It helps with aggression, self-injury, tantrums and mood swings.
The European Medicines Agency (EMA) has not approved Risperidone specifically for Autism Spectrum Disorder (ASD). However, it is approved in the EU for behavior issues in children and teens including conduct disorders and intellectual disability. It is used when aggression and irritability are present. This is similar to the FDA's approval for autism-related use.
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