The Medicines Agency announces the suspension of marketing authorizations for the drugs Zolmitriptan and Efavirenz. Atorvastatin Mylan is also subject to a batch recall.
France recalls all batches of drugs Zolmitriptan® and Efavirenz® marketed by the Mylan-Viatris laboratory, announces theMedicines Agency on January 5, 2023. The marketing authorizations (MA) for these medicines indicated, respectively in the case of migraine in adults from the age of 18 and in the treatment of HIV, are suspended by the ANSM. L’Atorvastatin Mylan 10 mg film-coated tablets indicated to reduce blood cholesterol and triglyceride levels is also the subject of a batch recall but its Marketing Authorization has not been suspended. At the origin of these decisions, the performance of bioequivalence studies by the Indian company Synchron Research Services. Of the “malfunctions in the management of the data system of Synchron Research Services calling into question the reliability of the results of all of its bioequivalence tests” have been highlighted. The aim of these studies is to make sure of “becoming of the active ingredient between the generic medicine and the originator medicine“ explains the health agency. On November 28, 2022, the European Commission has imposed on the Member States of the European Union to suspend the marketing authorizations of medicinal products whose bioequivalence studies have been carried out by the company Synchron Research Services. The suspension of marketing authorizations will be lifted when bioequivalence with a European Union reference medicinal product is established on the basis of new bioequivalence data. In total, approximately 100 generic drugs are affected in Europe. The marketing authorization for Atorvastatin Mylan 10mg tablets is not suspended because “the results of the new bioequivalence studies carried out as part of a modification of the marketing authorization dossier were deemed satisfactory”.“No reports of safety or loss of efficacy have been reported for the recalled drugs” reassures the ANSM before specifying that these reminders should not have an impact on the care of patients “to the extent that several comparable drugs can be used as an alternative”.
What if you are taking Zolmitriptan or Efavirenz or Atorvastatin Mylan 10mg?
“There is no identified risk if you are using, or have used, Zolmitriptan Mylan, Efavirenz Mylan or Atorvastatin Mylan” indicates the ANSM. If you are currently taking any of these medicines, you can finish your box. In case of renewal of your treatment, the pharmacist will give you a box of another generic (marketed by another laboratory).
Source: Suspension of marketing authorizations for two medicinal products following a decision by the European Commission. ANSM. January 5, 2023.