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 authorised. 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 the 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 6 months after the announcement. In the meantime, a different company can take over the marketing authorisation.