The nasal spray will not be marketed -
NICOLAS TUCAT / AFP
The planned marketing of the “COV-Defense” nasal spray, also known as “Biokami” nasal spray, is suspended by a health policy decision from the Medicines Agency (ANSM), for lack of having received data demonstrating its performance and safety. .
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 announced the marketing of this spray on March 1 in pharmacies and mid-March in drugstores and online pharmacy.
No clinical guarantee
But despite its allegations, the ANSM said on Monday that it had "not received any 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 the European regulations ”.
"In the absence of such guarantees and pending further information, the marketing, distribution, advertising and use of the spray are suspended until they are brought into compliance with the regulations", adds the health products policeman.
Pharma & Beauty-Centrepharma is also required to recall the batches of these sprayers which have already been distributed and to inform all natural or legal persons who may have them.
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, aiming to control compliance with the regulations applicable to them, particularly in terms of performance and safety of use. for patients, recalls the health agency.
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