Ucedane

carglumic acid

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This is a summary of the European public assessment report (EPAR) for Ucedane. 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 Ucedane.

For practical information about using Ucedane, patients should read the package leaflet or contact their doctor or pharmacist.

What is Ucedane and what is it used for?

Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with N‑acetylglutamate synthase (NAGS) deficiency. Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia. If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.

Ucedane contains the active substance carglumic acid and is a ‘generic medicine’. This means that Ucedane contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Carbaglu.

How is Ucedane used?

Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water. The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with metabolic diseases such as NAGS deficiency.

Treatment may be started as early as the first day of life and the medicine is used for the patient’s whole life.

The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary. The dose should then be adjusted to maintain normal blood ammonia levels.

How does Ucedane work?

When ammonia builds up in the blood, it is toxic to the body, especially the brain. The active substance in Ucedane, carglumic acid, is very similar in structure to N‑acetylglutamate, which activates an enzyme that breaks down ammonia. Ucedane therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects.

How has Ucedane been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Carbaglu, and do not need to be repeated for Ucedane.

As for every medicine, the company provided studies on the quality of Ucedane. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Ucedane?

Because Ucedane is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Ucedane approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ucedane has been shown to have comparable quality and to be bioequivalent to Carbaglu. Therefore, the CHMP’s view was that, as for Carbaglu, the benefit outweighs the identified risk. The Committee recommended that Ucedane be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Ucedane?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ucedane have been included in the summary of product characteristics and the package leaflet.

Other information about Ucedane

The European Commission granted a marketing authorisation valid throughout the European Union for Ucedane on 23 June 2017.

For more information about treatment with Ucedane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ucedane : EPAR - Summary for the public BG = bălgarski 2017-06-30  
Ucedane : EPAR - Summary for the public ES = español 2017-06-30  
Ucedane : EPAR - Summary for the public CS = čeština 2017-06-30  
Ucedane : EPAR - Summary for the public DA = dansk 2017-06-30  
Ucedane : EPAR - Summary for the public DE = Deutsch 2017-06-30  
Ucedane : EPAR - Summary for the public ET = eesti keel 2017-06-30  
Ucedane : EPAR - Summary for the public EL = elliniká 2017-06-30  
Ucedane : EPAR - Summary for the public EN = English 2017-06-30  
Ucedane : EPAR - Summary for the public FR = français 2017-06-30  
Ucedane : EPAR - Summary for the public IT = italiano 2017-06-30  
Ucedane : EPAR - Summary for the public LV = latviešu valoda 2017-06-30  
Ucedane : EPAR - Summary for the public LT = lietuvių kalba 2017-06-30  
Ucedane : EPAR - Summary for the public HU = magyar 2017-06-30  
Ucedane : EPAR - Summary for the public MT = Malti 2017-06-30  
Ucedane : EPAR - Summary for the public NL = Nederlands 2017-06-30  
Ucedane : EPAR - Summary for the public PL = polski 2017-06-30  
Ucedane : EPAR - Summary for the public PT = português 2017-06-30  
Ucedane : EPAR - Summary for the public RO = română 2017-06-30  
Ucedane : EPAR - Summary for the public SK = slovenčina 2017-06-30  
Ucedane : EPAR - Summary for the public SL = slovenščina 2017-06-30  
Ucedane : EPAR - Summary for the public FI = suomi 2017-06-30  
Ucedane : EPAR - Summary for the public SV = svenska 2017-06-30  
Ucedane : EPAR - Summary for the public HR = Hrvatski 2017-06-30  

This EPAR was last updated on 28/09/2017 .

Authorisation details

Product details

Product details for Ucedane
NameUcedane
Agency product numberEMEA/H/C/004019
Active substance

carglumic acid

International non-proprietary name (INN) or common name

carglumic acid

Therapeutic area Amino Acid Metabolism, Inborn ErrorsHyperammonemia
Anatomical therapeutic chemical (ATC) code A16AA05
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Ucedane
Marketing-authorisation holder

Lucane Pharma

Revision1
Date of issue of marketing authorisation valid throughout the European Union23/06/2017

Contact address:

Lucane Pharma
172 rue de Charonne
Paris 75011 
France

Product information

Product information

19/07/2017  Ucedane -EMEA/H/C/004019 -IB/0001

Name Language First published Last updated
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  
Ucedane : EPAR - Product Information HR = Hrvatski 2017-06-30  

Contents

  • 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.


Name Language First published Last updated
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28
Ucedane : EPAR - All Authorised presentations HR = Hrvatski 2017-06-30 2017-09-28

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Treatment of hyperammonaemia due to N-acetylglutamate synthase primary deficiency

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ucedane : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-09-28  

Initial marketing-authorisation documents

Name Language First published Last updated
Ucedane : EPAR - Public assessment report HR = Hrvatski 2017-06-30  
CHMP summary of positive opinion for Ucedane HR = Hrvatski 2017-04-21  

Authorised

This medicine is approved for use in the European Union

More infomartion on Ucedane