Search Tag: European Medicines Agency (EMA)
GE Healthcare's Stress Agent Rapiscan Approved for Use in Stress Cardiac Magnetic Resonance Imaging
2022 15 Feb
Already used in Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) for adult patients, Rapiscan is now approved for use in stress Cardiac Magnetic Resonance Imaging (CMR) Rapiscan, a pharmacological stress agent, is an alternative for patients who cannot exercise GE Healthcare has announced that... Read more
EMA’s Conclusion on Janssen Vaccine and Blood Clots
2021 21 Apr
The European Medicines Agency has completed its safety review for Johnson & Johnson’s COVID-19 Vaccine Janssen giving conclusions similar to those on AstraZeneca’s Vaxzevria. You might also like: EMA announced that the single dose Covid-19 vaccine has been approved for use in individuals 18 years of age and older in the European... Read more
Perfect Storm for AstraZeneca COVID-19 Vaccine in EU
2021 14 Mar
AstraZeneca’s COVID-19 vaccine has been the centre of attention in Europe over the past few days. Several countries has suspended its administration after reports of a number of thromboembolic events and several deaths. This has been exacerbated by the company’s inability to meet its contractual obligations in the EU on the medicine delivery.... Read more
EMA: Developments for Sputnik V and Janssen COVID-19 Vaccines
2021 05 Mar
The European Medicines Agency (EMA) has launched a rolling review of the Russian Sputnik V vaccine and is convening to potentially finalise the COVID-19 Vaccine Janssen’s marketing authorisation. You might also like: The European Ombudsman is investigating the European Commission’s refusal to give public access to... Read more
FDA & MHRA Revoke COVID-19 Authorisations for Hydroxychloroquine
2020 16 Jun
The U.S. Food and Drug Administration has revoked its emergency use authorisation for chloroquine and hydroxychloroquine as treatments for COVID-19. The U.K. Medicines and Healthcare products Regulatory Agency has followed suit, but Brazil criticised the decision and expanded the drugs’ use. You might also like: Warnings about Potential... Read more
EMA Fast-Tracking Procedures for COVID-19 Medicines
2020 11 May
The European Medicines Agency (EMA) has published an overview of initiatives for acceleration of the regulatory procedures. This is aimed at making COVID-19-related medicines’ marketing authorisation available in the shortest possible timeframes. You may also like: COVID-19: No Approval for Chloroquine from EMA ... Read more