On 20 November 2020, the FAMHP recalled Marevan 60 tablets of 5 mg (manufactured by Therabel) at pharmacy level. The quality of the medicinal product can now be guaranteed, meaning that the recalled batches may be placed back on the market. As soon as its price is approved (by the FPS Economy), the medicinal product may be supplied to pharmacies.
Marevan (warfarin) is an anticoagulant. It is used to thin the blood in order to prevent the formation of clots (thrombosis) or to dissolve existing ones, thereby avoiding their migration into blood vessels (embolism).
On 20 November 2020, the FAMHP decided to recall Marevan 60 tablets of 5 mg (Therabel) from wholesalers and pharmacists, because the manufacturing of this product by a new manufacturer had not been authorised. Moreover, the new blister and package size had not been authorized. The FAMHP can only guarantee the quality and safety of a medicinal product if an authorisation procedure, with the associated strict requirements and inspections, has been carried out.
In the meantime, applications have been submitted to the relevant authorisations. After having carried out the appropriate analyses and quality inspections and having rectified the irregularities, the FAMHP can now guarantee that the product meets the required conditions of quality, safety and efficacy. All recalled batches may therefore be placed back on the market. As soon as its price is approved (by the FPS Economy), Marevan 60 tablets of 5 mg (Therabel) may be supplied to pharmacies.