EMA:Ema: Meeting Highlights From The Pharmacovigilance Risk Assessment Committee (Prac) 30 August – 2 September 2021: 03/09/2021.Ema Says Covid-19 Vaccines: Ema Reviewing Cases Of Multisystem Inflammatory Syndrome Relating To Pfizer Shot.Ema Says Some Cases Of Mis Were Also Reported In Eea Following Vaccination With Other Covid-19 Vaccines.Ema: At This Stage, There Is No Change To The Current Eu Recommendations For The Use Of Covid-19 Vaccines.Ema: Prac Is Reviewing Data On Cases Of Venous Thromboembolism (Blood Clots In The Veins) With Covid-19 Vaccine Janssen..Ema - Will Now Assess Available Data On Mis To Determine Whether Condition Can Be Caused By Vaccine And Recommend Whether Any Changes To Product Info.Ema: Prac To Assess Additional Data From 2 Large Clinical Trials Of Vaccine, Which Are To Be Submitted Shortly By Marketing Authorisation Holder Of Vaccine Janssen.Ema - Prac Discussed A Direct Healthcare Professional Communication (Dhpc) Containing Important Safety Information For Imbruvica..Ema: Prac Reviewing Signal For Patients With Cll Currently Receiving Ibrutinib Plus Rituximab Together With Ace Inhibitor, Advises Reconsider Treatment Strategy.Ema Says Venous Thromboembolism Was Included In The Risk Management Plan For Covid-19 Vaccine Janssen As A Safety Issue To Be Investigated.Ema-For Patients With Cll On Ace-Inhibitors Who Have Not Yet Started Treatment With Ibrutinib Plus Rituximab, Treatment Strategy Should Be Reconsidered.
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