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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
September 18, 2020The 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
March 17, 2020The 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
May 20, 2019The 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
April 29, 2019Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation…
Pharma Sources Insight January 2025
