Falsified Medical Product Alert N°7/2020
HARVONI (ledipasvir/sofosbuvir): falsified product alert
WHO issued this alert on one batch of falsified HARVONI, a hepatitis C medicine, identified in Brazil in May 2020 and in Türkiye in November 2020. The products were supplied at patient level and WHO had information suggesting they were still in circulation.1
- Issued
- 8 December 2020
- Issued by
- World Health Organization
- Name stated on packaging
- Packaging bears the HARVONI brand of Gilead Sciences with batch numbers and expiry dates that do not match genuine manufacturing records.
- Genuine manufacturer's statement
- WHO said Gilead Sciences confirmed it did not produce the product.
- Countries where detected
- Brazil, Türkiye
Batches named in the alert
One batch, listed in Table 1 of the alert
Advice as stated
Do not use the listed products. Obtain medicines only from authorised or licensed suppliers and check their authenticity and condition. Report adverse events or suspected falsification to the national regulatory authority or pharmacovigilance centre.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°7/2020: Falsified HARVONI (Ledipasvir/sofosbuvir) (8 December 2020)