The marketing of the anti-Covid nasal spray suspended
The planned marketing of the nasal spray “COV-Defense”, also called nasal spray “Biokami”, is suspended by decision of the health police of the Medicines Agency (ANSM), for lack of having received data demonstrating its performance and safety.
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According to recent communications from the manufacturer, the company Pharma & Beauty-Centrepharma, this virucidal spray, based on ionized water, “Ensures the inactivation of the Sars-CoV-2 virus by more than 99%”. The manufacturer had announced the marketing of this spray on March 1 in pharmacies and mid-March in drugstores and online pharmacy.
No guarantee, no marketing
But despite its allegations, the ANSM affirms this Monday, February 22, to have “Received no clinical validation data demonstrating the performance and safety of use of this spray, an essential condition for a medical device to be placed on the market according to European regulations”.
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“In the absence of such guarantees and while awaiting additional information, the marketing, distribution, advertising and use of the spray are suspended until they are brought into compliance with the regulations”, adds the policeman of health products.
Products already sold recalled
The company Pharma & Beauty-Centrepharma is also required to recall the batches of these sprayers that have already been distributed and to inform all natural or legal persons who may have them.
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This health policy decision was signed on February 19 by the Director General of the ANSM, Dr Christelle Ratignier-Carbonneil.
Medical devices are health products, which are monitored by the ANSM, aimed at monitoring compliance with the regulations applicable to them, in particular with regard to performance and safety of use. for patients, recalls the health agency.