CHMP reports on referral procedures
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) reported on a number of concluded referral procedures at its April 2009 meeting.
Ciclosporine IDL and associated products (ciclosporin) from the firm International Drug Licensing, used as an immunosuppressant drug, and Prokanazol and other drugs (itraconazole) from PRO.MED.CS Praha, intended for the treatment of certain fungal infections.
Both procedures were initiated because of concerns by some European Union member states over bioequivalence of the medicine with the reference products. In each case the CHMP concluded that bioequivalence had not been demonstrated and recommended the refusal of marketing authorization, as well as the suspension of approval in the member states where the product is currently authorized.
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