Unopened bottle: 3 years
After the first opening: 3 months.
Not applicable.
None.
At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats. Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine anhydrous. A standard battery of genotoxicity test reveals no specific hazard for humans.
14 February 2017
Orphan Europe SARL
Immeuble “Le Wilsonâ€
70, Avenue du General de Gaulle
F-92 800 Puteaux
France
Do not store above 25°C.
Keep the bottle tightly closed in order to protect from moisture.
HDPE bottles with a child resistant closure.
Each pack contains 1 bottle with 180 g of powder and three measuring spoons.
EU/1/06/379/001
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 15 February 2007
Date of latest renewal: 21 November 2016
