Intuniv

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guanfacine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 04/10/2022

Authorisation details

Product details
Name
Intuniv
Agency product number
EMEA/H/C/003759
Active substance
guanfacine hydrochloride
International non-proprietary name (INN) or common name
guanfacine
Therapeutic area (MeSH)
Attention Deficit Disorder with Hyperactivity
Anatomical therapeutic chemical (ATC) code
C02AC02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Takeda Pharmaceuticals International AG Ireland Branch
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
17/09/2015
Contact address

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

Product information

03/10/2022 Intuniv - EMEA/H/C/003759 - IB/0031

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antihypertensives

  • Antiadrenergic agents, centrally acting

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.

Assessment history

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