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Https://web.archive. Org/web/202111142153 56/https://www.ema.e Uropa.eu/en/document S/rmp-summary/comirn Aty-epar-risk-manage Ment-pla.pdf

comirnaty-epar-risk-management-plan_en.pdf
Preview of https://web.archive. org/web/202111142153 56/https://www.ema.e uropa.eu/en/document s/rmp-summary/comirn aty-epar-risk-manage ment-pla
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📊 Size: 23.28 MB
👤 Author: Pfizer
⬇️ Downloads: 71

Summary

COMIRNATY (COVID-19 mRNA VACCINE) RISK MANAGEMENT PLAN, version 2.3, includes updates on myocarditis and pericarditis risks, with data lock points of 18 June 2021 for safety databases, and submission dates of 13 March 2021 and 23 October 2020 for clinical databases. The plan outlines risk management strategies, pharmacovigilance activities, and post-authorisation safety studies, with changes made to align with the updated EU SmPC and addition of new important identified risks.

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Description

COMIRNATY (COVID-19 mRNA VACCINE) RISK MANAGEMENT PLAN, version 2.3, includes updates on myocarditis and pericarditis risks, with data lock points of 18 June...

Technical Information

  • File Format: PDF
  • File Size: 23.28 MB
  • Pages: 158
  • Language: EN
  • Author: Pfizer
  • Total Downloads: 71
  • Last Updated: 3 weeks ago

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