This medicine is authorised for use in the European Union.


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 30/11/2017

Authorisation details

Product details
Agency product number
Active substance
guanfacine hydrochloride
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Attention Deficit Disorder with Hyperactivity
Anatomical therapeutic chemical (ATC) code
Additional 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
Shire Pharmaceuticals Ireland Ltd
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Block 2-3, Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 Y754 

Product information

16/10/2017 Intuniv - EMEA/H/C/003759 - IAIN/0011


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • antiadrenergic agents
  • centrally acting
  • Imidazoline receptor agonists

Therapeutic indication

Treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 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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