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Review of Skycovion COVID-19 vaccine startedCOVID-19 |Vaccine
Review of Skycovion COVID-19 vaccine started
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Review of Skycovion COVID-19 vaccine startedCOVID-19 |Vaccine
Review of Skycovion COVID-19 vaccine started
EMA’s human medicines committee (CHMP) is reviewing a conditional marketing authorisation application for Skycovion, a vaccine to protect against COVID-19
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Call for companies to register their i-SPOCEXTENDED MANDATE |SHORTAGES
Call for companies to register their i-SPOC
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Call for companies to register their i-SPOCEXTENDED MANDATE |SHORTAGES
Call for companies to register their i-SPOC
Marketing authorisation holders are invited to register their Industry Single Point of Contact on shortages in EMA’s IRIS platform. Deadline for registration is 2 September 2022
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EMA’s response to monkeypoxMonkeypox |Extended mandate
EMA’s response to monkeypox
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EMA’s response to monkeypoxMonkeypox |Extended mandate
EMA’s response to monkeypox
Declaration of public health emergency triggers a series of new actions for a coordinated response
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EMA and ECDC update on COVID-19 booster dosesCOVID-19 |Vaccines
EMA and ECDC update on COVID-19 booster doses
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EMA and ECDC update on COVID-19 booster dosesCOVID-19 |Vaccines
EMA and ECDC update on COVID-19 booster doses
The two EU agencies recommended considering second boosters of mRNA vaccines in people aged 60 to 79 and those at risk of severe disease
Latest news
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List item18/08/2022 COVID-19
EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine
EMA’s human medicines committee (CHMP) has started a review of a conditional marketing authorisation application for Skycovion, a vaccine for protecting against COVID-19. The applicant, SK Chemicals GmbH, has submitted data on how well the vaccine...
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List item11/08/2022 COVID-19
EMA business hours over Assumption Day, 15 August
The European Medicines Agency's (EMA) office is closed on Monday 15 August 2022. Essential work related to the COVID -19 pandemic will continue on this day. Outside of working hours and on public holidays, it is possible to call the product...
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List item28/07/2022
Big data use for public health: publication of Big Data Steering Group workplan 2022-25
The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. The new workplan will allow to further enhance the efficient integration of...
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List item27/07/2022 COVID-19
EMA reviewing data on sabizabulin for COVID-19
EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19. The review will look at all available data, including data from a study involving hospitalised patients with moderate-to-severe COVID-19...
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List item27/07/2022
EMA response to the monkeypox public health emergency
The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on...
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List item25/07/2022
EMA Paediatric Committee elects Brian Aylward as its new Chair
At its July 2022 meeting, EMA’s Paediatric Committee (PDCO) elected Brian Aylward from Ireland as its new chair for a three-year mandate. Dr Aylward takes over from Professor Koenraad Norga from the Federal Agency for Medicines and Health Products (...
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