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QUASYM LP (methylphenidate), psychostimulant
PSYCHIATRY - New medicinal product
Opinions on drugs -
Posted on
Jan 03 2017
Reason for request
Renewal of inclusion
No improvement in actual clinical benefit demonstrated in attention deficit hyperactivity disorder in children aged 6 years and over when remedial measures alone fail.
- QUASYM LP has Marketing Authorisation in attention deficit hyperactivity disorder (ADHD) in children aged six years and over when remedial measures alone prove insufficient.
- A summary of the clinical trial results, of poor methodological quality, showed that methylphenidate improves ADHD symptoms.
- Its short and long-term adverse effects, particularly those related to its amphetamine-like structure, remain concerning. It causes sleep disorders, reduced appetite, reduced BMI and abnormally elevated pulse.
- The use of the lowest possible effective doses as well as regular reassessment of the treatment is recommended.
Clinical Benefit
| Substantial |
- |
Therapeutic use
- |
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