About: European Medicines Agency

Coronavirus 09-09-2021

Nerve disorder listed as ‘very rare’ side effect of AstraZeneca jab

The European Medicines Agency has listed the neurological disorder Guillain-Barre syndrome, which can cause temporary paralysis, as a "very rare" side effect of the AstraZeneca COVID-19 vaccine.
Global Europe 13-07-2021

EU efforts to assess Russia’s Sputnik V vaccine stymied by data gaps

The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process, according to five people with knowledge of EU efforts to assess the drug.
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Health 17-06-2021

Good Off-Label Use Practice of Medicines

Before a drug makes it onto the market it is vigorously tested and needs to be authorized, either by a national competent authority or EMA, the European Medicines Agency. All the information on when a medicinal product can and cannot...
Health 27-05-2021

EU drug regulator reviewing woman’s death in Belgium after getting J&J shot

The European Union's drug regulator said it is reviewing the death of a woman in Belgium who suffered a blood clot and low platelets after receiving Johnson & Johnson's COVID-19 vaccine, the first report of a fatality following the vaccine.
Coronavirus 11-05-2021

EU could quickly approve Pfizer jab for 12-15 year olds, says EMA chief

The head of the European Medicines Agency said Monday (10 May) that BioNTech/Pfizer's jab against Covid-19 could be approved in the EU for 12- to 15-year-olds soon, perhaps as early as this month.
Global Europe 29-04-2021

EU report accuses Russia, China of sowing mistrust in Western vaccines

Russian and Chinese media are systematically seeking to sow mistrust in Western COVID-19 vaccines in their latest disinformation campaigns aimed at dividing the West, a European report said on Wednesday (29 April).
Health 22-04-2021

EU countries ready to start using J&J shot as deliveries resume

European countries prepared on Wednesday (21 April) to start using Johnson & Johnson's COVID-19 vaccine and speed up their vaccination campaigns after Europe's drug regulator backed the shot and deliveries started trickling in after a week-long pause.
Health 14-04-2021

Denmark drops AstraZeneca vaccine for good, in European first

Denmark announced Tuesday (13 April) it would stop using the AstraZeneca Covid-19 vaccine altogether, becoming the first European country to do so over suspected rare but serious side effects.
Health 14-04-2021

EU worried by J&J vaccine ‘following AstaZeneca’s path’

The European Commission is seeking clarification from Johnson & Johnson about the company's "completely unexpected" announcement of delays in COVID-19 vaccine deliveries to the EU, an EU official told Reuters on Tuesday (13 April).
Health 12-04-2021

Johnson and Johnson vaccine probe deepens Europe’s COVID woes

Europe's stuttering vaccine rollout faced multiple hurdles as EU regulators said they were reviewing side effects of the Johnson & Johnson (Janssen) shot and France further limited its use of the AstraZeneca jab.
Health 08-04-2021

EU countries fail to reach a common position on how to use the AstraZeneca jab

EU member countries have adopted different tactics on how to use the AstraZeneca vaccine, despite the Commission’s push for a coordinated approach.
Coronavirus 07-04-2021

No data currently available on mixing COVID vaccines, says EMA

There are currently no guidelines on the "mixing and matching" of COVID-19 vaccines, the European Medicines Agency (EMA) clarified on Wednesday (7 April), as several European countries are now considering mixed vaccination strategies.
Brexit 22-03-2021

UK warns EU vaccine export ban would be ‘counter-productive’

Britain on Sunday (21 March) warned the European Union against halting exports of AstraZeneca's Covid-19 vaccines if the bloc does not receive promised deliveries, saying such a move would be "counter-productive".
Coronavirus 16-03-2021

Cyprus to purchase Russia’s Sputnik vaccine

The Cypriot government will purchase 50,000 doses of Russia’s Sputnik V vaccine once it’s approved by the European Medicines Agency (EMA), a government official in Nicosia has said.
Health 16-03-2021

Major EU nations halt AstraZeneca while WHO insists the jab is safe

The EU's largest countries joined a stream of states halting their rollouts of AstraZeneca jabs on Monday (15 March) over blood clot fears, as the World Health Organization and Europe's medicines watchdog insisted it was safe to use.
12-03-2021

Bulgaria suspends AstraZeneca vaccine use

Bulgarian Prime Minister Boyko Borissov on Friday (12 March) suspended use of AstraZeneca's Covid-19 vaccine, following similar steps in Denmark, Iceland and Norway over safety concerns.
Global Europe 11-03-2021

Spain’s Zendal interested in producing Sputnik V vaccine, government says

Spanish biopharmaceutical group Zendal wrote to Spain's industry minister declaring its interest in producing Russia's Sputnik V coronavirus vaccine in the country, an industry ministry spokeswoman said on Wednesday (10 March).
Global Europe 09-03-2021

Russia’s Sputnik V could be made in Europe for first time after Italy deal signed

Russia's Sputnik V vaccine against COVID-19 could be produced in Europe for the first time after a commercial deal to produce it in Italy was signed by the Moscow-based RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne.
Global Europe 08-03-2021

EU regulator urges caution on Sputnik COVID-19 vaccine

A senior European Medicines Agency (EMA) official urged European Union members on Sunday (7 March) to refrain from granting national approvals for Russian COVID-19 vaccine Sputnik V while the agency reviews its safety and effectiveness.
Health 01-03-2021

EU to clear Johnson and Johnson vaccine in March, says French minister

A single-shot Covid-19 vaccine by US drugmaker Johnson and Johnson is likely to be approved for use in the European Union in early March, a French minister said Sunday (28 February).
Global Europe 19-02-2021

Slovak party derails plan to buy Russian vaccine without EU registration

Slovakia has dumped a plan to negotiate with Russia to buy the Sputnik V vaccine, after a junior coalition partner vetoed buying a product which has not been registered by the European Medicines Agency, Prime Minister Igor Matovič said.
Health 07-01-2021

EU to approve extraction of sixth dose from Pfizer-BioNTech vaccine vials

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, lifting the number of available shots at a time when supplies are short.
Health 06-01-2021

EU watchdog gives green light for second Covid jab

The EU's medicines watchdog approved on Wednesday (6 January) a coronavirus jab by US firm Moderna, giving a shot in the arm for Europe's slow-moving vaccine roll-out.
Health 06-01-2021

EU could authorise a second vaccine ‘in coming hours’

The European Union could authorise a second coronavirus vaccine "in the coming hours", European Council chief Charles Michel said Tuesday (5 January), adding that leaders would hold a virtual summit on the health crisis later this month.