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    PRAC investigates heart inflammation reports with Pfizer vaccine

    During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine.   EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) wrapped up a review of reports of facial swelling in recipients of Pfizer’s COVID-19 vaccine, k...
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    "Very rare" thrombotic events with AZ vaccine, concludes EMA's PRAC

    AstraZeneca’s COVID-19 vaccine may have a “very rare” but serious side effect of unusual blood clotting with a low blood platelet account, concluded the safety committee of the European Medicines Agency (EMA). The benefits of receiving the vaccine still outweigh risks, said the committee, hewing to the line EMA has held to throughout the investigation into reports of clotting events with the AstraZeneca vaccine.   The conclusion reached by EMA’s Pharmacovigilance Ris...
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    EMA judges AstraZeneca vaccine safe after blood clot investigation

    After an all-day meeting that ran beyond its scheduled end, the safety committee of the European Medicines Agency (EMA) concluded Thursday that the benefits of receiving the AstraZeneca COVID-19 vaccine outweigh any potential risks of side effects, including thromboembolic events.   Overall, the rate of clotting events was not higher in vaccine recipients than in the general population. However, PRAC, EMA’s safety committee, is paying attention to a small subset of eve...
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    EMA Begins Review of Handling Errors Linked to Leuprorelin

    At the request of Germany’s BfArM, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of depot formulations of leuprorelin medicines because of reports of handling errors during preparation and administration that can cause some to receive insufficient amounts. EMA explains how depot formulations of leuprorelin medicines, which are better known by different brand names like Eligard, Lupron and Procren, release the...
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    EMA Begins Safety Review of MS Drug Lemtrada

    The European Medicines Agency (EMA) on Friday initiated a review of Sanofi’s multiple sclerosis (MS) drug Lemtrada (alemtuzumab) following new reports of immune-mediated conditions and problems with the heart and blood vessels of those taking the medicine, including deaths. “As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two di...
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    European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA’s Exit (7 December 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Stands Firm on Demand for UK to Pay for EMA’s London Exit The European Commission has reiterated its demand for the UK to cover the cost of the European Medicines Agency’s (EMA) withdrawal from London. That would mean the UK paying the €400 million ($470 million)-plus bill EMA will face as result of breaching its rental agreement. European officials first stated th...
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    EMA Restricts Use of Biogen MS Drug

    The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that have failed to respond to other drugs, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.  In addition, EMA said, "patients with liver injury must not be given the medicine. Starting treatment with ...
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    European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ENVI Urges Commission to Exclude Healthcare From Regulation of Professions A public health committee has urged the European Commission to exclude healthcare jobs from changes to the regulation of professions. The Committee on the Environment, Public Health and Food Safety (ENVI) is worried the proposed legislation is “too complex to implement” and involves “too much re...
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    EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines

    The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age.  The public element of the meeting means EU citizens will be invited to share their experiences with these medicines, which are approved nationally in the EU to ...
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    European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...
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    EMA Completes Postmarket Safety Review of Uptravi

    Less than two months after launching a safety review of Actelion Pharmaceuticals' pulmonary arterial hypertension (PAH) drug, Uptravi (salexipag), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) says it did not find an increased risk of death associated with the drug. In February, EMA advised doctors to closely follow the approved prescribing information for Uptravi after learning of the deaths of five patients taking the drug i...
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    European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...