Risk of serious liver failure with Ulipristal On 18 February 2021, MHRA issued drug safety update on Ulipristal acetate 5mg (Esmya). Esmya […]
Blog Archive
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EMA issued DHPC for Lomitapide
European Medicines Agency (EMA) has published Direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the […]
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Medical device safety information produced by the MHRA
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 […]
