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METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX (Teva Pharma Australia Pty Ltd)

Product name
METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX
Date registered
Evaluation commenced
Decision date
Approval time
112 (175 working days)
Active ingredients
methylphenidate hydrochloride
Registration type
New generic medicine
Indication

METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX (modified release tablet) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be commenced by a specialist.

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.

Need for comprehensive treatment programme

METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

Long term use

The effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. Therefore the physician who elects to use METHYLPHENIDATE SANDOZ XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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