Mexico.- Derived from information provided by the Surveillance and Monitoring System for Substandard and Counterfeit Medical Products of the World Health Organization (WHO), and health complaints, the Federal Commission for the Protection against Sanitary Risks (Cofepris), undertook verification actions with simultaneous operations in Nuevo Leon and Jalisco, and issues a health alert on counterfeits detected in several countries of the drug Soliris (eculizumab).
The medicine It belongs to the group of monoclonal antibodies and has health authorization in Mexico as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, both hematological disorders.
During the verification visits carried out in the two states, relevant products and documents were found, which are under technical analysis. 12 presumably counterfeit pieces were also identified, so they were immediately seized.
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Batches 1001381, 1012401, 1013715, 1001600 and 1001701 have been identified globally as counterfeit according to the company. Alexion Pharma International Operations Unlimited Company.
This alert is issued with the aim of preventing health risks, since there is a possibility that irregular batches identified in other countries may also be marketed in Mexican territory, so Cofepris research the products located.
For the above, Cofepris recommends verifying the batches of Soliris (eculizumab) in presentation of 300 milligrams (mg), and in case of finding any of the falsified batch numbers, suspend its application and file a health complaint at www.gob.mx/cofepris.
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The health authority reminds people and distributors of the importance of purchasing products only from suppliers authorized and validated by the company that owns the health registry, which must have a health license, notice of operation and documentation of the legal acquisition of the product.
This alert is issued solely and exclusively for dissemination purposes and is addressed to the general population, therefore, it does not represent a resolution that authorizes, extends, revokes sanitary authorizations or represents a definitive pronouncement that involves the imminent imposition of administrative sanctions or preventive or corrective security measures.
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