Tuzulby (methylphenidate hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- methylphenidate hydrochloride
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Attention Deficit Disorder with Hyperactivity
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Fri 28 Feb 2025
- Application
- EMEA/H/C/005975
- ATC
- N06BA04
- Official record
- www.ema.europa.eu
Indication
Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.