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17/09/2021 COVID-19

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021

Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. The Committee adopted a positive opinion for Artesunate Amivas * (artesunate), for the initial...

17/09/2021

New add-on treatment for rare autoimmune inflammatory disorder

EMA has recommended granting an extension of indication to Nucala (mepolizumab) as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA), a rare disorder...

10/09/2021

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021

CVMP opinions on veterinary medicinal products The Committee adopted by majority a positive opinion for a marketing authorisation application for Felpreva (tigolaner / emodepside / praziquantel) , from Vetoquinol S.A., a new product for cats with,...

09/09/2021 COVID-19

Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer

EMA’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. One site, located in Frankfurt am Main, Germany, is operated by Sanofi-Aventis...

06/09/2021 COVID-19

EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their...

03/09/2021 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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CHMP highlights: September 2021

CHMP highlights: September 2021

Increase in manufacturing capacity of Comirnaty

Increase in manufacturing capacity of Comirnaty

Monthly safety updates for COVID-19 vaccines

Monthly safety updates for COVID-19 vaccines

EMA evaluating data on booster dose of Comirnaty

EMA evaluating data on booster dose of Comirnaty

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021

New add-on treatment for rare autoimmune inflammatory disorder

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021

Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer

EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021

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