Ecuador: Cancellation of the Registry (marketing authorization) of medication ABCERTIN (imiglucerase)
The National Agency for Health Regulation, Control and Surveillance (Arcsa) informs the public that the Registry (marketing authorization) No. 22-MB3-0515 granted to the company ISU ABXIS CO. Has been definitively canceled. LTD., Through its legal representative MEDICAMENTA ECUATORIANA S.A., for the drug ABCERTIN (imiglucerase) 200 U CONCENTRATE POWDER FOR SOLUTION FOR PERFUSION.
The action responds to the fact that it has been verified that the medication has not been commercialized for a period of one year, which is why the company has the obligation to withdraw the stocks that are kept in the general market. Similarly, Arcsa requests not to commercialize, use or consume the drug ABCERTIN (imiglucerase) 200 U CONCENTRATE POWDER FOR SOLUTION FOR PERFUSION.
Additionally, citizens are invited to report on the sale or distribution of products without an Ecuadorian Health Registry or that come from dubious origin through the application “Arcsa Móvil”, or email email@example.com