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22/09/2021

Call for expressions of interest for civil society representatives to participate in work of EMA

The European Commission has launched calls for expressions of interest to represent patient, healthcare professional and veterinarian organisations in EMA's Management Board and Pharmacovigilance Risk Assessment Committee (PRAC). Representatives of...

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-...

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...

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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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Call for expressions of interest for civil society representatives to participate in work of EMA

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

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