LONDON (Reuters) – AstraZeneca said it has submitted full information to pursue conditional marketing authorisation from the European Medicines Agency for its COVID-19 vaccine, however the regulator said it still requires more info for approval.
An EMA official stated previously in the week that more information was needed and that AstraZeneca had not provided adequate information to necessitate a conditional marketing licence for the shot it has established with Oxford University.
” We can validate that we have sent a complete information package to support an application for conditional marketing authorisation for the AstraZeneca COVID-19 vaccine to the European Medicines Company,” an AstraZeneca spokesperson stated.
” AstraZeneca has actually been sending information on a rolling basis and will continue to work closely with the EMA to support the start of an official CMA application process.”
However the EMA stated that it still did not have enough information to evaluate the shot, which was approved for emergency usage in Britain on Wednesday.
” The most recent medical package was received on 21 December and is currently being assessed,” the EMA stated in a declaration.
” Additional clinical details on issues related to quality, safety and efficacy of the vaccine is deemed essential to support the rigour needed for a conditional marketing authorisation and this has been asked for from the company.”
for-phone-only for-tablet-portrait-up for-tablet-landscape-up for-desktop-up for-wide-desktop-up
http://phlebotomycareertraining.org/astrazeneca-states-has-sent-complete-data-for-european-approval-of-covid-shot/
No comments:
Post a Comment