Month: <span>November 2021</span>

Month: November 2021

Pharmacovigilance System Master File (PSMF)

The Pharmacovigilance System Master File (PSMF) is a document, designed to summarize the pharmacovigilance (PV) system of the marketing authorization holder (MAH). This document is named differently in many countries, namely, PvMF in India and in the EU, it is known as PSMF.  Objective of PSMF: Describe the pharmacovigilance (PV) …

UK-MHRA approves Merck’s Oral COVID-19 Antiviral Medicine

Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, receives first authorization in the world with trade name of Lagevrio (molnupiravir), by MHRA. Lagevrio is not intended to be used as a substitute for vaccination against COVID-19 but for the treatment of Mild-to-Moderate COVID-19 in adults with a positive SARS-CoV-2 …

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