MEB confirms current legal status of supply ibuprofen 200 mg

The Medicines Evaluation Board (MEB) has evaluated whether the recent European review of the adverse events on heart and blood vessels (cardiovascular) of high doses of ibuprofen (2400 mg and higher) should have any consequences on the legal status of supply, namely General Sale (GS). The MEB has concluded that the findings from the European procedure are in line with the deliberations in the MEB ruling from 2009 to award the GS legal status of supply to ibuprofen 200 mg in a package up to 12 tablets.

The European assessment by the PRAC and CMDh confirmed an increased risk of cardiovascular adverse events with high doses of ibuprofen (2400 mg and higher) with prolonged use. This risk is described in the current product information (SmPC and package leaflet). No increase in the risk of cardiovascular adverse events is observed for a daily dose not exceeding 1200 mg (the highest dose available without a prescription in the EU or in NL). All things considered, the MEB currently does not see any reason to change the legal status of supply for ibuprofen.

Medicinal products in the category GS are generally available. This means that these medicinal products are not only available from the pharmacy and drugstore, but also potentially from retail outlets such as the supermarket and petrol station. Ibuprofen for self-care is only intended for short-term use at low dosages. The current categorisation in the GS category is already based on risk-limitation measures such as a lower concentration and smaller package. The MEB recommends that you read the instructions for use in the package leaflet carefully if you use ibuprofen.