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Medical device warning no. 7/2020
Counterfeit HARVONI (Ledipasvir / sofosbuvir) identified in WHO regions in America and Europe
Warning Summary
This WHO medical device warning applies to one batch of confirmed counterfeit HARVONI (Ledipasvir / sofosbuvir) identified in Brazil and Turkey.
Counterfeit Harvons were identified in Brazil in May 2020 and in Turkey in November 2020. The WHO has received recent information suggesting that these products are still in circulation. The available information indicates that these counterfeit drugs were delivered at the patient level.
Who Global surveillance and monitoring system the database contains previous records of other counterfeit Harvonia series. Consistent reporting is key to determining the scope and scale of such counterfeit products.
HARVONI is an antiviral drug indicated for the treatment of chronic hepatitis C. Please see the WHO fact sheet here for further information on hepatitis C.
The counterfeit products identified in this warning are identified as counterfeit on the grounds that they intentionally / fraudulently misrepresent their identity, composition or source:
- The real manufacturer HARVONI – Gilead Sciences – has confirmed that it has not produced the product listed in this WHO medical device warning no. 7/2020;
- And the variable data (batch number and expiration dates) of these products do not correspond to the original production records.
Table 1: Products listed in WHO Medical Product Alert no. 7/202
Advice to regulators and the public
The WHO is calling for greater vigilance within the supply chains of countries and regions that could be affected by these counterfeit products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.
All medical devices must be obtained from authorized / licensed and reliable suppliers. The authenticity and physical condition of the product should be carefully checked. If in doubt, seek advice from a healthcare professional.
If you own the above counterfeit products, do not use them.
If you have used these counterfeit products or have suffered a side effect / event if you have used them, it is advisable to seek medical help immediately from a qualified healthcare professional and to report the incident to the national regulatory authorities / National Pharmacovigilance Center.
National regulatory / health authorities are advised to notify the WHO immediately if these counterfeit products are detected in their country. If you have any information regarding the production, distribution or supply of these products, please contact [email protected]
Table 2: Photographs of products that are subject to the WHO warning on medical devices no. 7/2020
WHO World Surveillance and Monitoring System
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