-
CHMP highlights: September 2021
MEDICINES |COMMITTEESCHMP highlights: September 2021
-
CHMP highlights: September 2021
MEDICINES |COMMITTEESCHMP highlights: September 2021
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting
-
Increase in manufacturing capacity of Comirnaty
COVID-19 |VaccinesIncrease in manufacturing capacity of Comirnaty
-
Increase in manufacturing capacity of Comirnaty
COVID-19 |VaccinesIncrease in manufacturing capacity of Comirnaty
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
-
Monthly safety updates for COVID-19 vaccines
COVID-19 |VaccinesMonthly safety updates for COVID-19 vaccines
-
Monthly safety updates for COVID-19 vaccines
COVID-19 |VaccinesMonthly safety updates for COVID-19 vaccines
EMA has released safety update reports on all COVID-19 vaccines authorised in the EU. They provide an overview of the safety monitoring of these vaccines.
-
EMA evaluating data on booster dose of Comirnaty
COVID-19 |VaccinesEMA evaluating data on booster dose of Comirnaty
-
EMA evaluating data on booster dose of Comirnaty
COVID-19 |VaccinesEMA evaluating data on booster dose of Comirnaty
EMA has started evaluating an application for the use of a booster dose of COVID-19 vaccine Comirnaty to be given 6 months after the second dose in people aged 16 years and older
Latest news
-
List item17/09/2021 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...
-
List item17/09/2021
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...
-
List item10/09/2021
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,...
-
List item09/09/2021 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...
-
List item06/09/2021 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...
-
List item03/09/2021 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...
Information for
Key content
Services & databases
-
List item
Account Management portal
-
List item
eSubmission
-
List item
EudraVigilance (human)
-
List item
EU Veterinary Medicinal Product Database
-
List item
Suspected adverse drug reactions database
-
List item
Clinical data
-
List item
SPOR data management services
-
List item
Service Desk
-
List item
IRIS platform
-
List item
Public register of parallel distribution notices
-
List item
European Vaccination Information Portal