Readers like you keep news free for everyone.

More than 5,000 readers have already pitched in to keep free access to The Journal.

For the price of one cup of coffee each week you can help keep paywalls away.

Support us today
Not now
Wednesday 6 December 2023 Dublin: 8°C

# European Medicines Agency

This year
Fake Ozempic pens circulating in Europe, watchdogs warn
The drug is in short supply internationally.
Last year
EU backs new Omicron vaccines for first jabs, and not just for boosters
The vaccines are currently only authorised as boosters but could now be used for people’s first vaccinations.
EU medicines watchdog approves vaccine targeting Omicron sub-variants
European nations have been keen to rush through the new generation of jabs so they can start booster campaigns ahead of a feared Covid surge in the latter part of this year.
European Medicines Agency approves first Omicron-specific Covid vaccines
The so-called “bivalent” vaccines protect against the earlier BA.1 strain of Omicron, but do not target the latest strains.
European health agencies say it's 'too early' for fourth Covid vaccine for general population
NIAC today recommended a second mRNA booster dose for people aged 65 or over and those who are immunocompromised.
European Medicines Agency recommends Pfizer booster for children over 12
It also announced that it has recommended the approval of the Spikevax vaccine for children aged between six and 11.
All time
EU health watchdog approves fifth Covid vaccine
This will be the fifth Covid-19 vaccine approved for use in the European Union.
EU watchdog says Omicron 'mostly mild' as WHO warns on vaccine hoarding
The European Medicines Agency also said that early data suggested the new variant is more infectious than Delta.
Pharma giant Novavax files for EU approval for Covid vaccine, decision expected 'within weeks'
If approved, it would be the fifth Covid jab authorised for use within the EU.
EMA approves two new antibody treatments to stop Covid-19 patients developing symptoms
The move adds to the European Union’s toolbox of drugs.
EU regulator approves Moderna vaccine for 12-17 year-olds
It is the first time the shot has been authorised for people under 18.
EU watchdog reviewing Janssen vaccine data after US regulator warns of rare neurological reaction
US experts said there had been reports of people who had the jab developing Guillain-Barre syndrome.
EU advises against AstraZeneca vaccine for people with blood vessel syndrome
The European Medicines Agency said it reviewed cases of six people who had capillary leak syndrome after they had received the vaccine.
Pfizer vaccine can be kept in fridges for up to a month rather than just five days, EU medicines regulator says
The European Medicines Agency said this could improve the flexibility in countries’ vaccine rollout.
EMA decision on Johnson & Johnson will influence whether Ireland spaces out Pfizer vaccine doses
It follows concerns that the vaccine could be linked to extremely rare blood clots.
UK releases new data about AstraZeneca-linked blood clots as EMA continues to support use of vaccine
Several European countries have paused the use of the jab.
EU medicine regulator evaluating Russia's Sputnik V vaccine for use in Europe
The EMA has also been in touch with representatives of the Chinese Sinopharm jab.
AstraZeneca vaccine not to blame for Austria death, says EU medicines agency
Austria announced it would stop using doses from an AstraZenca batch after the 49-year-old nurse died.
Covid-19: EMA to review Russian-developed vaccine as part of first step towards EU approval
Russia said it is ready to provide vaccines for 50 million Europeans.
Johnson & Johnson subsidiary applies to EMA for Covid-19 vaccine approval
The single-dose vaccine could be approved as early as next month.
European Medicines Agency confirms no deaths have been linked to the Pfizer/BioNTech vaccine
It followed reports in recent weeks that people had died after receiving the vaccine.
Ireland to receive 300,000 fewer vaccine doses to April due to supply issues
This is due to the “significant drop” in the expected deliveries from AstraZeneca.
European Medicines Agency head hopes for decision on Astrazeneca vaccine approval 'by end of this week'
Despite the supply issues, a European approval for the Astrazeneca vaccine this Friday will pave the way for its rollout in Ireland.
'Game-changer' AstraZeneca vaccine will NOT land in Ireland before it is approved
Health Minister Stephen Donnelly had said he had hoped it could arrive sooner.
EMA says shorter process can be used if vaccines have to be adapted for new strains
Developers have said they could adapt the vaccine quickly if a new variant is resistant to it.
Oxford/AstraZeneca Covid-19 vaccine applies for EU approval
A decision on its authorisation could be reached later this month.
Vaccines: EU could approve Oxford/AstraZeneca by end of January, UK gives green light to Moderna
The UK today approved its third Covid-19 vaccine.
EU regulator brings Moderna vaccine decision forward to 6 January
The date for a decision had been 12 January.
EU medicines regulator says data 'looks robust' as it plans toward Pfizer vaccine approval by end of month
A decision on the approval of the Pfizer/BioNtech is due on 29 December.
European Medicines Agency says it has been targeted in cyber attack
The agency says it has launched a full investigation.
EU agency insists it has the 'most appropriate' vaccine regulation process after UK approves Pfizer jab
The UK formally approved the vaccine yesterday.
Public warned not to buy fake medicines that claim to treat or prevent coronavirus
The European Medicines Agency said these falsified medicines can cause serious harm.
Epilepsy drug which has left 400 Irish children with disabilities to come under EU review today
An Irish woman whose three children have disabilities will give evidence at a public hearing today.
Frank Feighan wants the European Medicines Agency to move from Canary Wharf to Leitrim
Earlier this month the Department of Health confirmed that they are preparing for a bid to bring the EMA to Ireland.
Safety warning over giving codeine tablets to under-18s
The European Medicines Agency says codeine, which is converted to morphine in the body, can pose problems for kids.
European agency investigates Novartis drug following 11 deaths
The European Medicines Agency is investigating the drug Gilenya, used to treat a severe type of multiple sclerosis, to establish if it linked to the deaths of at least 11 patients.
European medicines watchdog says swine flu jab not suitable for children
The European Medicines Agency has said there is a link between the drug Pandemrix and the sleeping disorder narcolepsy in young people.
Diabetes drug withdrawn over heart safety fears
The medication has been taken off the market after European Medicines Agency ruled that the risks outweigh the benefits.