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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022
CHMP, Last updated: 24/06/2022Marketing-authorisation holder Janssen-Cilag International NV More information … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022
PRAC, Last updated: 10/06/2022 -
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News: EMA adopts first list of critical medicines for COVID-19
Last updated: 08/06/2022previously COVID-19 Vaccine Janssen) COVID-19 vaccine (Ad26.COV2-S … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
PRAC, Last updated: 08/04/2022 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
CHMP, Last updated: 25/03/2022Marketing-authorisation applicant Janssen-Cilag International NV Therapeutic … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
PRAC, Last updated: 11/03/2022COVID-19 Vaccine Janssen: small vessel vasculitis added … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022
PRAC, Last updated: 11/02/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
PRAC, Last updated: 14/01/2022xzevria and COVID-19 Vaccine Janssen: update on very rare cases … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
CHMP, Last updated: 17/12/2021dose of COVID-19 Vaccine Janssen may be considered at least … for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer … -
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News: Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer
CHMP, Last updated: 16/12/2021for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer … for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer … -
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News: COVID-19 Vaccine Janssen: EMA recommendation on booster dose
CHMP, Last updated: 15/12/2021COVID-19 Vaccine Janssen: EMA recommendation on booster … COVID-19 Vaccine Janssen: EMA recommendation on booster … -
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News: EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters
Last updated: 07/12/2021Vaxzevria and COVID-19 Vaccine Janssen; the first 3 require a two-dose … and authorised only for the Janssen COVID-19 vaccine) is followed … Vaxzevria, Comirnaty, SpikeVax, Janssen COVID-19 vaccine, Curevac’s … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
PRAC, Last updated: 03/12/2021 -
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News: EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
CHMP, Last updated: 22/11/2021dose of COVID-19 Vaccine Janssen … dose of COVID-19 Vaccine Janssen … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
PRAC, Last updated: 29/10/2021 -
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News: Additional manufacturing site for COVID-19 Vaccine Janssen
Last updated: 07/10/2021site for COVID-19 Vaccine Janssen … site for COVID-19 Vaccine Janssen … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
PRAC, Last updated: 01/10/2021thromboembolism with COVID-19 Vaccine Janssen The Pharmacovigilance Risk … VTE) with COVID-19 Vaccine Janssen. VTE is a condition in which … plan for COVID-19 Vaccine Janssen as a safety concern to be … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021necessary. COVID-19 Vaccine Janssen and venous thromboembolism … veins) with COVID-19 Vaccine Janssen. This safety issue is distinct … plan for COVID-19 Vaccine Janssen as a safety issue to be investigated … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021previously Paliperidone Janssen- Cilag International) INN … Marketing-authorisation holder Janssen-Cilag International N.V. More information … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
PRAC, Last updated: 06/08/202106/08/2021 COVID-19 Vaccine Janssen: update on safety issues The … information of COVID-19 Vaccine Janssen to include … -
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News: COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
PRAC, Last updated: 22/07/2021COVID-19 Vaccine Janssen: Guillain-Barré syndrome … previously COVID-19 Vaccine Janssen) and a warning will be included … between COVID-19 Vaccine Janssen and GBS is possible. Although … -
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News: EMA and ECDC update on COVID-19
Last updated: 14/07/2021dose with COVID-19 Vaccine Janssen. 2 Bernal JL, Andrews N … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021
PRAC, Last updated: 09/07/2021against use of COVID-19 Vaccine Janssen in people with history of … vaccinated with COVID-19 Vaccine Janssen . The Committee also recommended … received COVID-19 Vaccine Janssen, which occurred within two … -
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News: Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
PRAC, Last updated: 09/07/2021the EEA, COVID-19 Vaccine Janssen and Vaxzevria 1 , and the … -
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News: EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome
PRAC, Last updated: 09/07/2021against use of COVID-19 Vaccine Janssen in people with history of … previously COVID-19 Vaccine Janssen) . The Committee also recommended … received COVID-19 Vaccine Janssen, which occurred within 2 days …