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Legal status

In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a pediatric use marketing authorization 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 is a hybrid medicine of Ritalin, which has been authorized in the EU since January 1997. Tuzulby contains the same active substance as Ritalin, but is available in a different formulation and strength, and is given once daily. Methylphenidate was authorized for medical use in the European Union in February 2025.