News and press releases
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19, , 07/12/2021
Tue, 07 Dec 2021 11:32 +0100
‘Mix-and-match’ approach can be used for both initial courses and boostersThe EU is currently experiencing a rising number of infections in the ongoing...
ICMRA high-level meeting on global health emergencies and regulatory approaches, , 06/12/2021
Mon, 06 Dec 2021 16:00 +0100
On 1 and 2 December, International Coalition of Medicines Regulatory Authorities (ICMRA), a group of leading medicines regulatory authorities and experts...
EMA recommends approval for use of RoActemra in adults with severe COVID-19, CHMP, 06/12/2021
Mon, 06 Dec 2021 14:14 +0100
EMA’s human medicines committee (CHMP) has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-...
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic, , 03/12/2021
Fri, 03 Dec 2021 16:28 +0100
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of the practices...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021, PRAC, 03/12/2021
Fri, 03 Dec 2021 12:00 +0100
PRAC update on risk of myocarditis and pericarditis with mRNA vaccinesEMA’s safety committee (PRAC) has assessed recent data on the known risk of...
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001), CHMP, 02/12/2021
Thu, 02 Dec 2021 11:00 +0100
EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva. The CHMP’s decision to...
Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca, CHMP, 01/12/2021
Wed, 01 Dec 2021 15:38 +0100
EMA’s human medicines committee (CHMP) has approved a new site to manufacture Vaxzevria (previously COVID-19 Vaccine AstraZeneca) finished product. The...
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11, CHMP, 25/11/2021
Thu, 25 Nov 2021 11:40 +0100
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children...
A vision for use of real-world evidence in EU medicines regulation , , 24/11/2021
Wed, 24 Nov 2021 13:30 +0100
Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision...
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19, CHMP, 23/11/2021
Tue, 23 Nov 2021 16:40 +0100
EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). Lagevrio, which is being...
2011-2020: More than 40% decrease in sales of antimicrobials for use in animals, CVMP, 23/11/2021
Tue, 23 Nov 2021 14:00 +0100
The  annual report on the European Surveillance of Veterinary Antimicrobial Consumption published by EMA shows that European countries have...
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen, CHMP, 22/11/2021
Mon, 22 Nov 2021 14:00 +0100
EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose...
EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19, CHMP, 19/11/2021
Fri, 19 Nov 2021 16:00 +0100
EMA’s human medicines committee (CHMP) has issued advice on the use of Lagevrio (also known as molnupiravir or MK 4482) for the treatment of COVID-19....
EMA starts review of Paxlovid for treating patients with COVID-19 , CHMP, 19/11/2021
Fri, 19 Nov 2021 15:30 +0100
EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 developed by Pfizer. EMA is...
European Antibiotic Awareness Day: Fighting the silent pandemic, , 18/11/2021
Thu, 18 Nov 2021 12:20 +0100
Today is European Antibiotic Awareness Day (EAAD), the annual European health initiative to support and promote the prudent use of antibiotics.It is...
EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19, PRAC, 18/11/2021
Thu, 18 Nov 2021 10:49 +0100
EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Xevudy (sotrovimab). The applicant is GlaxoSmithKline...
EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19, CHMP, 18/11/2021
Thu, 18 Nov 2021 10:49 +0100
EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Xevudy (sotrovimab). The applicant is GlaxoSmithKline...
EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19, PDCO, 18/11/2021
Thu, 18 Nov 2021 10:49 +0100
EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Xevudy (sotrovimab). The applicant is GlaxoSmithKline...
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid, CHMP, 17/11/2021
Wed, 17 Nov 2021 14:30 +0100
EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373)....
COVID-19: EMA recommends authorisation of two monoclonal antibody medicines, CHMP, 11/11/2021
Fri, 12 Nov 2021 15:31 +0100
Ronapreve and Regkirona are now authorised in the EU. This follows the granting of marketing authorisations for these products by the European Commission...

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