Swissmedic would like to inform you of the following:
Summary
- The nitrosamine impurity N-nitroso-betahistine, shown to be highly mutagenic, has been found in batches of medicines/products containing betahistine
- A safety level has been established internationally to ensure a sufficient quality of batches released for the Swiss market based on the authorised maximum daily dose.
- When prescribing betahistine products, the indications authorised by Swissmedic, corresponding dosages and expiry dates must be strictly adhered to.
For further information, please refer to the information letter.