Marketing authorisation
Prices for essential medicines in Romania to be set against average of lowest three in EU
Health Minister Ioana Mihaila signed on Thursday an order amending regulations for the calculation and approval of caps on medicines for human use in Romania, so as to ensure market availability in Romania of some essential medicines for patients.
J&J likely to seek EU approval for Covid-19 vaccine in February, says lawmaker
US firm Johnson & Johnson is likely to apply for EU approval for its Covid-19 vaccine candidate in February, a top lawmaker said on Wednesday.
Clinical data of the vaccine, which Johnson & Johnson is developing through its subsidiary Janssen, have been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.