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Outcome of the PRAC review of COVID-19 Vaccine JanssenCOVID-19 |Vaccines
Outcome of the PRAC review of COVID-19 Vaccine Janssen
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Outcome of the PRAC review of COVID-19 Vaccine JanssenCOVID-19 |Vaccines
Outcome of the PRAC review of COVID-19 Vaccine Janssen
EMA’s safety committee (PRAC) finds possible link to very rare cases of unusual blood clots with low blood platelets but overall benefit-risk remains positive
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EMA continues to monitor COVID-19 vaccine AstraZenecaCOVID-19 |Vaccines
EMA continues to monitor COVID-19 vaccine AstraZeneca
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EMA continues to monitor COVID-19 vaccine AstraZenecaCOVID-19 |Vaccines
EMA continues to monitor COVID-19 vaccine AstraZeneca
EMA to provide further context on risk of very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria
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PRAC highlights April 2021MEDICINES |COMMITTEES
PRAC highlights April 2021
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PRAC highlights April 2021MEDICINES |COMMITTEES
PRAC highlights April 2021
Outcomes from the April meeting cover all aspects of the risk management of the use of medicines, including COVID-19 vaccines
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Development, evaluation and monitoring of COVID-19 vaccinesCOVID-19 |VACCINES
Development, evaluation and monitoring of COVID-19 vaccines
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Development, evaluation and monitoring of COVID-19 vaccinesCOVID-19 |VACCINES
Development, evaluation and monitoring of COVID-19 vaccines
Read about how EMA is ensuring vaccines for COVID-19 meet the highest standards of quality, safety & efficacy while their development and approval is sped up due to the public health emergency.
Latest news
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List item20/04/2021 COVID-19
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
EMA confirms overall benefit-risk remains positive At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19...
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List item16/04/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
CVMP opinions on veterinary medicinal products The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for: Comfortis (grouped variations) Purevax Rabies Purevax RCP FeLV, Purevax...
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List item15/04/2021 COVID-19
EMA starts review of VIR-7831 for treating patients with COVID-19
EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of...
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List item14/04/2021 COVID-19
AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria (previously COVID-19 Vaccine AstraZeneca) . In line with a request from the EU’s Commissioner for Health and Food Safety following...
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List item14/04/2021 COVID-19
COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus...
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List item14/04/2021
IT systems intermittently unavailable from 16 to 18 April 2021
All European Medicines Agency (EMA) information technology (IT) systems apart from the corporate website ( www.ema.europa.eu ) will be intermittently unavailable from 18:00 on Friday 16 April to 11:00 on Sunday 18 April 2021 (Central European Summer...
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Account Management portal
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eSubmission
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EudraVigilance (human)
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EU Veterinary Medicinal Product Database
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Suspected adverse drug reactions database
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Clinical data
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Service Desk
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IRIS platform
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Public register of parallel distribution notices
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European Vaccination Information Portal