Withdrawal of marketing authorisations for fenspiride medicines!
- 24 мая 2019
- benefit-risk balance, CMDh, cough, EMA, EU, fenspiride, heart rhythm problems, MA, medicinal product, medicines, negative, PRAC, QT prolongation, supply, suspended, symptomatic treatment, syrup, tablet, torsades de pointes, withdrawal of MA, withdrawal of marketing authorisation, дополнительные исследования, удлинение интервалов QT на электрокардиограмме, фенспирид,
EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that has confirmed that these cough medicines could cause heart rhythm problems. Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness