Request to take over the pyridoxine hydrochloride marketing authorisation

The company Pharmachemie B.V. has requested the Medicines Evaluation Board (MEB) to withdraw marketing authorisation for  pyridoxine hydrochloride for business-economic reasons. As a consequence, the medicinal product is to be removed definitively from the market. This concerns the 50 mg/ml solution for injection (RVG 51981).

The medicinal product compensates for a vitamin B6 deficiency which can lead to, for example, skin disorders, inflammation of the tongue, neuritis and seizures (in infants). Prescribers have indicated that there is a need to keep the medicinal product registered. This is because, among other things, the medicinal product is used off-label to treat young infants suffering from epileptic seizures. Although a parallel marketing authorisation exists, experience has shown that such an authorisation cannot always serve the entire market. As a consequence, pyridoxine hydrochloride is of social importance. The MEB is calling on other companies to take over the marketing authorisation of this medicinal product.

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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