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PRAC highlights September 2021
MEDICINES |COMMITTEESPRAC highlights September 2021
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PRAC highlights September 2021
MEDICINES |COMMITTEESPRAC highlights September 2021
Outcomes from the September meeting: updates on the safety of COVID-19 vaccines and blood-cancer treatment Imbruvica.
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EMA and ECDC update on COVID-19 vaccination
COVID-19 |VaccinesEMA and ECDC update on COVID-19 vaccination
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EMA and ECDC update on COVID-19 vaccination
COVID-19 |VaccinesEMA and ECDC update on COVID-19 vaccination
EMA and ECDC have published a third joint statement highlighting considerations for additional and booster doses of COVID-19 vaccines
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Annual report 2020
EMA |About usAnnual report 2020
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Annual report 2020
EMA |About usAnnual report 2020
EMA’s Annual Report 2020 provides an overview of the Agency’s major achievements, key figures and contributions to public health in Europe. #AnnualReportEMA
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CTIS Sponsor Handbook
Clinical trials |RegulatoryCTIS Sponsor Handbook
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CTIS Sponsor Handbook
Clinical trials |RegulatoryCTIS Sponsor Handbook
This compilation of key guidance, technical information, recommendations and references will help clinical trials sponsors to get ready for the use of the Clinical Trial Information System (CTIS). #CTIS4EU
Latest news
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List item03/09/2021 COVID-19
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
COVID-19 vaccines: EMA reviewing cases of multisystem inflammatory syndrome EMA’s safety committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of MIS with Comirnaty...
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List item02/09/2021 COVID-19
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued yesterday by the European Centre for Disease...
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List item24/08/2021 COVID-19
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Additional manufacturing site and scaled-up process for Comirnaty CHMP has approved an additional...
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List item16/08/2021 COVID-19
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra...
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List item16/08/2021
Artificial intelligence in medicine regulation
The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published...
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List item06/08/2021 COVID-19
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
COVID-19 Vaccine Janssen: update on safety issues The PRAC recommended updating the product information of COVID-19 Vaccine Janssen to include immune thrombocytopenia as an adverse reaction, as well as a warning to alert healthcare professionals and...
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