Request to take over the Fucidin marketing authorisation

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The company Leo Pharma B.V. has informed the Medicines Evaluation Board (MEB) that the production of the antibiotic fucidin  ( sodium fusidate) is to be terminated for the Dutch market for business-economic reasons. This concerns the 250 mg film-coated tablet (RVG 01369).

The tablets are used for treatment of infections caused by certain bacteria (Staphylococcus). Despite the fact that the medicinal product is only used on a limited basis, prescribers still feel the need to keep it registered. The guideline of the Dutch Working Party on Antibiotic Policy (in Dutch: Stichting Werkgroep Antibioticabeleid, SWAB) refers to fusidic acid as an important supplement to the treatment of complicated MRSA carrier infections. As a consequence, Fucidin is of social importance. Fucidin ointment and cream will remain available. The MEB is calling on other companies to take over the Fucidin marketing authorisation or to acquire the product from abroad via parallel importation.

The MEB can withdraw marketing authorisation of a medicinal product at the request of the authorisation holder. Sometimes this cannot be avoided, even when clinical practice indicates that there is still a need for the product in question. In such a case, the definitive withdrawal of the authorisation takes place only six months after the announcement. In the meantime, a different company can take over the authorisation.



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