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Notes
PRAC = Pharmacovigilance Risk Assessment Committee
CMDh = Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
Reference
European Medicines Agency. Withdrawal of marketing authorisations for fenspiride medicines. Internet Document : [2 pages], 17 May 2019. Available from: URL: https://www.ema.europa.eu/en/news/withdrawal-marketing-authorisations-fenspiride-medicines
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PRAC recommends withdrawing MAAs for fenspiride in EU. Reactions Weekly 1755, 6 (2019). https://doi.org/10.1007/s40278-019-62560-7
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DOI: https://doi.org/10.1007/s40278-019-62560-7