On 05 February 2021, Swissmedic has evaluated 63 reports of suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland (in collaboration […]
Blog Archive
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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 […]
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Drug Safety Communication (FDA) – Risk of serious heart related problems and cancer (tofacitinib)
Drug Safety Communication (FDA) – Risk of serious heart-related problems and cancer (tofacitinib) On 04 Feb 2021, the U.S. Food and Drug […]
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GVP Module XVI Addendum II – Methods for effectiveness evaluation (Draft for Public Consultation)
On 01 Feb 2021, EMA has released a draft Regulatory and procedural guideline on “GVP Module XVI Addendum II – Methods for […]
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GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
On 01 Feb 2021, EMA has released draft Regulatory and procedural guideline on “GVP Module XVI – Risk minimisation measures: selection of […]
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Safety signal (Risk of acute adrenal insufficiency) Hydrocortisone
European Medicines Agency (EMA) has published Direct healthcare professional communications (DHPC) regarding the Risk of acute adrenal insufficiency when switching from crushed […]
