European Medicines Agency
Medical ethics committee approves of anti-Covid drug Lagevrio
Ljubljana – Slovenia’s national medical ethics committee has no reservations towards Lagevrio, a medicine also known as molnupiravir. The committee maintains that the drug brings significant progress in fighting the coronavirus epidemic, as it prevents a severe course of Covid-19 or death.
The EMA has Authorized Merck's Pill against COVID-19 in EU only for Emergencies
On Friday, the EU medicines supervisor said countries could use Merck's covid pill in emergencies caused by the growing number of cases before treatment is officially approved across the bloc.
Only One-third of Innovative Medicines Authorised by EMA Availble in Bulgaria
Just one-third (32 per cent) of the innovative medicines authorized by the European Medicines Agency (EMA) are available in Bulgaria, according to a report of the European Federation of Pharmaceutical Industries and Associations (EFPIA). It was presented to the media at Monday's workshop on "How can we close the East-West healthcare investment gap in Europe?".
CNCAV: Romania will continue vaccination campaign with all vaccines authorized at European level
In Romania, the immunization campaign will continue with all the vaccines against COVID-19 currently authorized at the European level, according to the National Coordinating Committee for Vaccination Activities against COVID-19 (CNCAV).
Sputnik V Creators Demand Apology from EMA for Calling Vaccine “Russian Roulette”
The creators of the Russian vaccine "Sputnik V" demand an apology from the chairman of the European Medicines Agency (EMA) Christa Virtumer-Hohe, who compared the prospect of an emergency approval of the Russian vaccine in Austria, following the example of Hungary, to "Russian roulette".
EMA Starts Testing Sputnik V Efficacy, Safety as Russia Seeks Acceptance
The European Medicines Agency (EMA) on Thursday (4 March) began a rolling review of Russia's Sputnik V vaccine in a first step towards granting the approval of the jab across the EU.
The agency's human medicines committee (CHMP) said it would review Sputnik V, a COVID-19 vaccine developed by Russia's Gamaleya national centre of epidemiology and microbiology.
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.
EU may soon approve new use of Pfizer vaccine increasing doses by 20%, says source
The European drugs regulator could soon give the go ahead for an extra sixth dose to be extracted from Pfizer-BioNTech Covid-19 vaccine vials, an EU official told Reuters on Wednesday, lifting the number of available shots at a time when supplies are short.
EU regulator gives conditional approval to COVID-19 vaccine
The European Medicines Agency says an expert committee has recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union, weeks after the shot was first granted permission under emergency provisions in Britain and the United States.
EU states to start Covid-19 vaccinations from Dec. 27, Germany says
European Union member states will begin vaccinations against Covid-19 in 10 days, Germany said, as Europe tries to catch up with Britain and the United States after what some have criticized as a slow EU approval process for the jabs.