AMVERSIO Oral powder Ref.[50130] Active ingredients: Betaine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium

Product name and form

Amversio 1 g oral powder.

Pharmaceutical Form

Oral powder.

White crystalline free flowing powder.

Qualitative and quantitative composition

1 g of powder contains 1 g of betaine anhydrous.

Active Ingredient Description
Betaine

Betaine is a methyl derivative of glycine first isolated from the juice of sugar beets. Betaine participates in the methionine cycle, which produces vital biomolecules including proteins, hormones, phospholipids, polyamines, and nutrients. Betaine is used as a dietary supplement and has a beneficial effect on the human health. The drug acts as a methyl group donor in the remethylation of homocysteine to methionine.

List of Excipients

None.

Pack sizes and marketing

White opaque HDPE bottle with a child resistant polypropylene cap with an induction seal liner.

Each pack contains 1 bottle with 180 g of powder and three measuring spoons.

The green measuring spoon dispenses 100 mg.

The blue measuring spoon dispenses 150 mg.

The purple measuring spoon dispenses 1 g.

Marketing authorization holder

SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium

Marketing authorization dates and numbers

EU/1/22/1640/001

Drugs

Drug Countries
AMVERSIO Estonia, Croatia, Lithuania

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