Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium
Amversio 1 g oral powder.
| Pharmaceutical Form |
|---|
|
Oral powder. White crystalline free flowing powder. |
1 g of powder contains 1 g of betaine anhydrous.
| Active Ingredient | Description | |
|---|---|---|
| Betaine |
Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e. CBS deficiency; MTHFR deficiency and cbl defect. The extent of this effect was dependent on the absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia. Betaine anhydrous acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria. |
| List of Excipients |
|---|
|
None. |
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.
SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium
EU/1/22/1640/001
| Drug | Countries | |
|---|---|---|
| AMVERSIO | Estonia, Croatia, Lithuania |
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