PRAC recommends new measures for methotrexate
Decisions include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials.
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Tag: PRAC
EMA’s PRAC to review Xeljanz and recommends fenspiride withdrawl
The committee has announced its latest meeting highlights.
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EMA recommends temporarily restricting Lemtrada use in MS
The review comes following new reports of immune-mediated conditions.
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EMA suspends fenspiride medicines due to heart rhythm risks
The EMA has announced an EU-wide suspension of fenspiride medicines due to a potential risk of heart rhythm problems.
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New prescriptions of Gideon Richter’s Esyma on hold
Doctors are not to prescribe Gedeon Richter’s Esmya for uterine fibroids in the UK while European regulators carry out a safety review of the drug.
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EU safety review backs continued use Uptravi for PAH
European regulators have ruled that Actelion’s Uptravi can continue to be used as per its prescribing information to treat patients with pulmonary arterial hypertension, a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs.
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EU regulators allow use of Uptravi during safety review
European regulators are advising that doctors can continue prescribing Actelion’s Uptravi for pulmonary arterial hypertension while an investigation into its safety is completed.
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- Storm Therapeutics and AlidaBio launch collaboration to advance RNA‑targeting cancer therapies
- Excellence adventure
- MHRA approves Nucala for eosinophilic COPD in adults on triple therapy
- Bial launches new sublingual Parkinson’s treatment in UK
- Acesion Pharma launches phase 2 trial of AP31969 in atrial fibrillation
