Cystadane

RSS

betaine anhydrous

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

Overview

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

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

This EPAR was last updated on 24/05/2019

Authorisation details

Product details
Name
Cystadane
Agency product number
EMEA/H/C/000678
Active substance
Betaine anhydrous
International non-proprietary name (INN) or common name
betaine anhydrous
Therapeutic area (MeSH)
Homocystinuria
Anatomical therapeutic chemical (ATC) code
A16AA06
Publication details
Marketing-authorisation holder
Orphan Europe S.A.R.L.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
14/02/2007
Contact address
Immeuble "Le Wilson"
70, avenue du Général de Gaulle
FR-92800 Puteaux
France

Product information

05/03/2019 Cystadane - EMEA/H/C/000678 - N/0033

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Adjunctive treatment of homocystinuria, involving deficiencies or defects in:

  • cystathionine beta-synthase (CBS);
  • 5,10-methylene-tetrahydrofolate reductase (MTHFR);
  • cobalamin cofactor metabolism (cbl).

Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.

Assessment history

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