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EMA Product

Intuniv

Product approved by European Medicines Agency (EU)

Basic Information

Intuniv

Regulatory Information

EMEA/H/C/003759

Authorised

September 17, 2015

13

June 10, 2024

Company Information

Ireland

Branch Block 2 Miesian Plaza 50 -58 Baggot Street Lower Dublin 2 D02 HW68

Takeda Pharmaceuticals International AG

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Intuniv. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Intuniv. For practical information about using Intuniv, patients should read the package leaflet or contact their doctor or pharmacist.

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