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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation europeanpharmaceuticalreview
September 18, 2020
The EMA’s PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
EMA begins safety review of ifosfamide cancer medicines europeanpharmaceuticalreview
March 17, 2020
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
EMA’s PRAC to review Xeljanz and recommends fenspiride withdrawl pharmatimes
May 20, 2019
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fe
Strengthened guidance on follow-up and risk management for ATMP developers europeanpharmaceuticalreview
April 29, 2019
Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation…

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