Disclosure of information about the safety of the Kagocel® antiviral drug

Disclosure of information about the safety of the Kagocel® antiviral drug

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Recently, social networks and a number of media outlets have been ever more frequently spreading knowingly false and absurd speculations about the composition, non-core properties and non-existent side effects, as well as adverse effects associated with the Kagocel® antiviral drug.

In this regard OOO Nearmedic Plus as the holder of the registration certificate for Kagocel®, deems it necessary to make an official statement about the safety of the drug.

OOO Nearmedic Plus, as the holder of the registration certificate for the Kagocel® antiviral drug, operates in strict compliance with the current legislation of the Russian Federation and the EEU, which regulates constant supervision and monitoring of the safety of drug circulation.

For this purpose, the company has established and operates a Pharmacovigilance Service that deals with monitoring the pharmacological safety of medical products, in particular Kagocel®: thorough monitoring of information about adverse effects and any other data related to safety is carried out on a regular basis to prevent any negative reactions associated with the use of the company's products.

According to the requirements of the current legislation, OOO Nearmedic Plus, along with direct reporting of the received information about serious adverse events to the database of the Roszdravnadzor automated information system (AIS), also prepares Periodic drug safety reports on Kagocel® submitted on a regular basis to Roszdravnadzor, who, in parallel, keep their own records of messages from subjects of drug circulation (patients).

The high level of safety of Kagocel® has been demonstrated during the entire period of circulation of this antiviral drug on the market (16 years) at all levels of supervision and monitoring of the safety of drug circulation (implemented by state authorities and the company's own pharmacovigilance service):

• The total number of adverse events detected during the period of circulation of the Kagocel® antiviral drug on the market is 181, which amounts to 0.0000905% of the total number of packages sold during the entire period of circulation of Kagocel® on the market and is negligible.

• All adverse events detected during the period of the antiviral drug Kagocel® circulation on the market are in their nature allergic reactions, the possibility of which is mentioned in the package leaflet of Kagocel®. Most of them, according to the WHO classification, are classified as "rare" (with a rate of 1/10,000 to 1/1000 prescriptions).

• Detected among the identified adverse effects were no adverse effects associated with reproductive dysfunction or any of the adverse effects mentioned by unscrupulous competitors in mass media sources.

From April 29 to May 31, 2019, Roszdravnadzor conducted a scheduled field inspection of the Nearmedic Plus company to monitor compliance with the mandatory requirements established in the Russian Federation drug circulation legislation, which audit resulted in no violations detected in the procedure for monitoring the safety of medicines.

For the entire period (16 years) of Kagocel® in the market, Roszdravnadzor never withdrew or suspended the registration certificate for the drug and neither did it find reasons for restricting the distribution of the drug, suspending clinical trials, or for emergency restrictions, including introduction of changes in the Basic Prescribing Information (BPI).

Available summary data obtained for the Kagocel® period of circulation on the market (16 years) by state regulatory authorities and by the OOO Nearmedic Plus (the holder of the registration certificate for the drug) own Pharmacovigilance Service, as well as the results of observational studies clearly demonstrate a high safety profile of the antiviral drug Kagocel®.

OOO Nearmedic Plus also states that it intends to take legal action against media sources and persons engaged in the dissemination of defamatory and false information.

THE FULL TEXT OF THE REPORT CAN BE FOUND HERE:

https://www.kagocel.ru/MONITORING_THE_SAFETY_OF_KAGOCEL.pdf





06.02.2020 11:22:00



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