In France, the Medicines Agency (ANSM) has given the order to suspend the marketing of the nasal spray for lack of results validating its effectiveness.
The planned marketing in France of the “COV-Defense” nasal spray, also known as “Biokami” nasal spray, is suspended by decision of the Medicines Agency (ANSM), for lack of having received data demonstrating its performance and safety.
According to recent communications from the manufacturer, the French 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.
Lack of guarantees
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 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 likely to have them. This health police decision was signed on February 19 by the Director General of ANSM, Dr Christelle Ratignier-Carbonneil.
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