The French Medicines Agency has suspended the marketing of this “miracle” spray, due to the need for data demonstrating its performance and safety.
Lthe 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.
But despite its allegations, the ANSM affirms Monday that it has “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 regulations. European ”.
“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.
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.
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.