Tuzulby

Opinion

EMA has issued an opinion on this medicine

methylphenidate hydrochloride

Overview

On 12 December 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a paediatric use marketing authorisation (PUMA) for the medicinal product Tuzulby, intended for the treatment of children with attention-deficit hyperactivity disorder (ADHD).

The applicant for this medicinal product is Neuraxpharm Pharmaceuticals S.L.

Tuzulby will be available as 20 mg, 30 mg and 40 mg modified-release chewable tablets. The active substance of Tuzulby is methylphenidate hydrochloride, a psychostimulant agent used for ADHD (ATC code: N06BA04). Methylphenidate is thought to work by inhibiting dopamine reuptake in the brain without triggering dopamine release.

Tuzulby is a hybrid medicine¹ of Ritalin, which has been authorised in the EU since 15 January 1997. Tuzulby contains the same active substance as Ritalin, but is available in a different formulation and strength, and is given once daily. Studies have demonstrated the satisfactory quality of Tuzulby.

The benefits of Tuzulby are expected to be comparable to that of the reference medicine Ritalin; it improves the attention and behaviour of people with ADHD throughout the day. The most common side effects with Truzulby are decreased appetite, insomnia, nervousness, headache, nausea and dry mouth.

The full indication is:

Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children aged 6 years of age and over 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.

Treatment with Tuzulby must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹ Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

CHMP summary of positive opinion for Tuzulby

AdoptedReference Number: EMA/CHMP/574129/2024

Product details

• Name of medicine:
  Tuzulby
• Active substance:
  methylphenidate hydrochloride
• International non-proprietary name (INN) or common name:
  methylphenidate hydrochloride
• Therapeutic area (MeSH):
  Attention Deficit Disorder with Hyperactivity
• Anatomical therapeutic chemical (ATC) code:
  N06BA04
• EMA product number:
  EMEA/H/C/005975
• Marketing authorisation applicant:
  Neuraxpharm Pharmaceuticals S.L.
• Opinion adopted:
  12/12/2024
• Opinion status:
  Positive