CYSTADANE Oral powder Ref.[6303] Active ingredients: Betaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Orphan Europe SARL, Immeuble Le Wilson, 70, Avenue du General de Gaulle, F-92 800 Puteaux, France

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.

Active Ingredient
Description
Betaine
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

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

Marketing authorization dates and numbers

EU/1/06/379/001

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

Drugs

Drug
Countries
CYSTADANE
Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States
 
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