EMAからの5/21付でのCOVID-19関連情報です。
ただ、GMP Platform読者に関係しそうなものだけを取り上げていますことをご容赦ください。
また、必要に応じては、ECからの通知等も含めておりますことも、合せてご容赦ください。
関係者および興味のある方は、下記URLsのウェブサイトをご参照ください。
l5/21付News Release「EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19」
https://www.ema.europa.eu/en/news/ema-issues-advice-use-sotrovimab-vir-7831-treating-covid-19
l5/21付Referrals document「Sotrovimab (also known as VIR-7831 and GSK4182136) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring」
https://www.ema.europa.eu/en/documents/referral/sotrovimab-also-known-vir-7831-gsk4182136-covid19-article-53-procedure-conditions-use-conditions_en.pdf
l5/21付News Release「Vaxzevria: further advice on blood clots and low blood platelets」
https://www.ema.europa.eu/en/news/vaxzevria-further-advice-blood-clots-low-blood-platelets
l5/21付EPAR「Vaxzevria (previously COVID-19 Vaccine AstraZeneca)」
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
l5/21付Safety Update「COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 21 May 2021」
https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-vaxzevria-previously-covid-19-vaccine-astrazeneca-21-may-2021_en.pdf
l5/21付PRAC recommendation on signal「Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) adopted at PRAC meeting 3-6 May 2021」
https://www.ema.europa.eu/en/documents/prac-recommendation/signal-assessment-report-embolic-thrombotic-events-smq-covid-19-vaccine-janssen-ad26cov2-s_en-0.pdf
l5/21付Updated「COVID-19: latest updates」
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-latest-updates
l5/21付Updated「COVID-19 treatments: Article 5(3) reviews」
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/treatments-covid-19/covid-19-treatments-article-53-reviews
l5/21付Updated「Article 5(3) opinions」
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/article-53-opinions
ただ、GMP Platform読者に関係しそうなものだけを取り上げています
また、必要に応じては、ECからの通知等も含めておりますことも
関係者および興味のある方は、下記URLsのウェブサイトをご参
l5/21付News Release「EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19」
https://www.ema.europa.eu/en/
l5/21付Referrals document「Sotrovimab (also known as VIR-7831 and GSK4182136) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring」
https://www.ema.europa.eu/en/
l5/21付News Release「Vaxzevria: further advice on blood clots and low blood platelets」
https://www.ema.europa.eu/en/
l5/21付EPAR「Vaxzevria (previously COVID-19 Vaccine AstraZeneca)」
https://www.ema.europa.eu/en/
l5/21付Safety Update「COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 21 May 2021」
https://www.ema.europa.eu/en/
l5/21付PRAC recommendation on signal「Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) adopted at PRAC meeting 3-6 May 2021」
https://www.ema.europa.eu/en/
l5/21付Updated「COVID-19: latest updates」
https://www.ema.europa.eu/en/
l5/21付Updated「COVID-19 treatments: Article 5(3) reviews」
https://www.ema.europa.eu/en/
l5/21付Updated「Article 5(3) opinions」
https://www.ema.europa.eu/en/
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