Category list : European Medicines Agency (EMA)
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First monoclonal antibody for migraine recommended for approval by EMA
The European Medicines Agency has recommended granting a marketing authorisation for erenumab for migraine prevention.
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Milan challenges EMA move to Amsterdam
The city of Milan is continuing to challenge the decision to relocate the European Medicines Agency’s headquarters from London to Amsterdam post-Brexit.
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EMA committee maintains recommendation to suspend hydroxyethyl-starch solutions for infusion
The EMA’s Pharmacovigilance Risk Assessment Committee has confirmed its recommendation to suspend hydroxyethyl-starch solutions for infusion in the European Union.
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EMA committee starts review of methotrexate dosing errors
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a review of the risk of dosing errors with methotrexate medicines, which are used to treat cancers and various inflammatory conditions.
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MHRA will lose EMA work before Brexit transition period
The UK will lose its involvement in evaluating medicines for the European Medicines Agency from the date it formally leaves the European Union in March 2019, despite plans for the UK to remain closely tied to the EU during a transition period lasting until the end of 2020.
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EMA recommends six medicines for approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended six medicines for approval, including two biosimilars and one orphan medicine.
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EMA endorses strengthened regulatory measures for valproate
The European Medicines Agency’s Coordination Group for Mutual Recognition and Decentralised Procedures — Human has endorsed strengthened measures to avoid valproate exposure during pregnancy.
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EMA to hold public hearing on quinolone and fluoroquinolone antibiotic safety
The European Medicines Agency (EMA) has announced that its Pharmacovigilance Risk Assessment Committee will hold a public hearing on quinolone and fluoroquinolone antibiotics, as part of an ongoing safety review into the drugs.
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‘Problem’ excipients: be cautious when making clinical decisions on formulation Subscription
We are writing in response to the article ‘How to identify and manage ‘problem’ excipients in medicines for children’, written by Sara Arthur and Anna Burgess and published in The Pharmaceutical Journal (2017;299(7903):42–45). The article helpfully raises awareness ...
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EMA publishes tool to track its progress to Amsterdam
The European Medicines Agency has produced a ‘tracker tool’ to follow progress of its move from London to Amsterdam.
