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Authorization revocation for some omeprazole generics

  The marketing authorization for some generics of omeprazole has been revoked, due to studies on bioequivalence "not conducted in accordance with current regulations and without respecting the principles and guidelines of the Standards of good clinical practice (GCP)". The Italian Medicines Agency (AIFA) specifies that there are no risks to public health and points out that it ordered the provision in the Official Gazette of 17 December 2009, but only for some formal problems encountered in the studies carried out by the Gabriele d'Annunzio University Foundation of Chieti in April last year.
The revocation concerns medicines, generics but also copies, produced by Angenerico, Errekappa Euroterapici, Rkg, Blue Fish Pharma, Sofar, Fidia, Ranbaxy Italia, Pharmacare, Savio National Biochemical Institute, Ipd (Industrial Pharmaceutical Development) and Polifarma. Due to the deviations from the law, "AIFA – reads the Official Gazette – considers the results of the clinical trials of bioequivalence" conducted on these medicines unreliable. From the date of the provision, the drugs in question cannot be kept on the market. "AIFA's drug monitoring activities - the Agency informs us - are constant to guarantee the safety of citizens. In this case, the revocation of the AIC does not concern aspects that affect public health".

Pharmacist33 – 23 February 2010 – Year 6, Number 32

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