Intuniv
guanfacine
Table of contents
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.
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List item
Intuniv : EPAR - Summary for the public (PDF/77.71 KB)
First published: 06/10/2015
Last updated: 06/10/2015
EMA/597493/2015 -
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List item
Intuniv : EPAR - Risk-management-plan summary (PDF/63.16 KB)
First published: 06/10/2015
Last updated: 06/10/2015
Authorisation details
Product details | |
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Name |
Intuniv
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Agency product number |
EMEA/H/C/003759
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Active substance |
guanfacine hydrochloride
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International non-proprietary name (INN) or common name |
guanfacine
|
Therapeutic area (MeSH) |
Attention Deficit Disorder with Hyperactivity
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Anatomical therapeutic chemical (ATC) code |
C02AC02
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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 | |
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Marketing-authorisation holder |
Takeda Pharmaceuticals International AG Ireland Branch
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Revision |
12
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Date of issue of marketing authorisation valid throughout the European Union |
17/09/2015
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Contact address |
Block 2 Miesian Plaza |
Product information
03/02/2023 Intuniv - EMEA/H/C/003759 - IAIN/0032/G
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Antihypertensives
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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.