Medical device safety information produced by the MHRA On 12 Feb 2021, MHRA provided updates on Medical device safety information related to […]
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USPI label updates January 2021
The United States Prescription Information (USPI) is a key tool for sharing the benefits and risks of a prescription drug approved by […]
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FDA Approved Drugs January 2021
Here you can find FDA Approved Drugs in January 2021 This report includes NDAs, BLAs, ANDAs, approvals, and approved supplements to these […]
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Ethiopia Pharmacovigilance guidelines
In September 2020, Ethiopian Food and Drug Authority issued Pharmacovigilance Directive in accordance with Article 71 sub article (2) of the Ethiopian […]
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Updates on labelling, package leaflet and variations (EMA)
On 09 Feb 2021, European Medicines Agency (EMA) has provided updates on labelling and package leaflet and variations. Here you can find […]
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PRAC recommendations on signals
On 8 February 2021, Pharmacovigilance Risk Assessment Committee (PRAC) provided recommendations on the signals discussed during the meeting of 11-14 January 2021. […]
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Potential Risk of Encephalopathy using Ceftriaxone-containing products (Health Canada)
On 03 February 2021, Health Canada issued a Summary Safety Review of potential risk of encephalopathy using Ceftriaxone-containing products. This review was […]
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FDA alerts: Potential risks associated with the compounding of remdesivir drug products
On 22 October 2020, FDA approved a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients […]
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Update on COVID-19 vaccines suspected adverse reactions (63) in Switzerland
On 05 February 2021, Swissmedic has evaluated 63 reports of suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland (in collaboration […]
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Update on EU Additional monitoring Medicines (January 2021)
The list of medicinal products subject to additional monitoring includes medicinal products authorised in the European Union (EU) which are subject to […]
