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 instructed PRAC and CMDh to reassess any unmet medical needs that could occur with a suspension, as well as the practicality and potential effectiveness of additional risk mitigation measures. Following this review, in May 2018, PRAC upheld its previous recommendation for suspension and submitted an updated proposal to CMDh.