In April 2018, the European Commission requested that the PRAC and the CMDh further consider any possible unmet medical need that could result from a suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures. After looking at these specific aspects, in May 2018 the PRAC confirmed its previous recommendation for suspension and sent a revised recommendation to the CMDh.
In April 2018, the European Commission prompted PRAC and CMDh to evaluate any unmet medical needs that might result from a suspension, along with the feasibility and likely impact of supplementary risk reduction strategies. After considering these aspects, in May 2018, PRAC maintained its previous recommendation for suspension and provided an updated proposal to CMDh.