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CYSTADANE Oral powder (2017)

Active ingredients: Betaine

Product Name and Form

Cystadane 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.

For the full list of excipients, see section 6.1.

Chemical substance
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

HDPE bottles with a child resistant closure.

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

Marketing authorization holder
Authorization dates

Orphan Europe SARL, Immeuble “Le Wilson”, 70, Avenue du General de Gaulle, F-92 800 Puteaux, France

Date of first authorisation: 15 February 2007
Date of latest renewal: 21 November 2016

Marketing authorization number:

EU/1/06/379/001