betaine anhydrous

This medicine is authorised for use in the European Union.


Amversio is a medicine used to treat homocystinuria, an inherited disease where the amino acid homocysteine cannot be broken down and therefore builds up in the body. This causes a wide range of symptoms, including impaired vision, weak bones and circulatory problems.

It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet.

Amversio is a ‘generic medicine’. This means that Amversio contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Cystadane. For more information on generic medicines, see the question-and-answer document here.

Amversio contains the active substance betaine anhydrous.

This EPAR was last updated on 28/07/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
betaine anhydrous
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
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.


This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Avenue Louise 480
1050 Brussels

Product information

05/05/2022 Amversio - EMEA/H/C/005637 -

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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

Other alimentary tract and metabolism products

Therapeutic indication

Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:
•         cystathionine beta-synthase (CBS),
•         5,10 methylene tetrahydrofolate reductase (MTHFR),
•         cobalamin cofactor metabolism (cbl).

Assessment history

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