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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021, PRAC, 07/05/2021 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021, PRAC, 07/05/2021 This month EMA’s safety committee (PRAC) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine...

Source: News and press releases
Created on: May 7, 2021 | 12:50 pm

News and press releases | May 7, 2021 | 12:50 pm

EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19, CHMP, 07/05/2021 EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19, CHMP, 07/05/2021 EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal...

Source: News and press releases
Created on: May 7, 2021 | 11:00 am

News and press releases | May 7, 2021 | 11:00 am

International regulators and WHO call for wider public access to clinical data , , 07/05/2021 International regulators and WHO call for wider public access to clinical data , , 07/05/2021 The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to...

Source: News and press releases
Created on: May 7, 2021 | 10:00 am

News and press releases | May 7, 2021 | 10:00 am

Confidentiality arrangement between EU and Brazilian regulatory authorities , , 06/05/2021 Confidentiality arrangement between EU and Brazilian regulatory authorities , , 06/05/2021 The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a...

Source: News and press releases
Created on: May 6, 2021 | 14:10 pm

News and press releases | May 6, 2021 | 14:10 pm

Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Prostatic Neoplasms, Date of authorisation: 26/04/2021, Status: Authorised Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Prostatic Neoplasms, Date of authorisation: 26/04/2021, Status: Authorised Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Prostatic Neoplasms, Date of authorisation: 26/04/2021, Status: Authorised

Source: New medicines and SMOPs: human
Created on: May 5, 2021 | 10:40 am

New medicines and SMOPs: human | May 5, 2021 | 10:40 am

EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, CHMP, 04/05/2021 EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, CHMP, 04/05/2021 EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co.,...

Source: News and press releases
Created on: May 4, 2021 | 11:00 am

News and press releases | May 4, 2021 | 11:00 am

Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, Date of authorisation: 26/03/2021, Status: Authorised Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, Date of authorisation: 26/03/2021, Status: Authorised Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, Date of authorisation: 26/03/2021, Status: Authorised

Source: New medicines and SMOPs: human
Created on: May 4, 2021 | 09:24 am

New medicines and SMOPs: human | May 4, 2021 | 09:24 am

EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 , CHMP, 03/05/2021 EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 , CHMP, 03/05/2021 EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15.Comirnaty is a...

Source: News and press releases
Created on: May 3, 2021 | 14:00 pm

News and press releases | May 3, 2021 | 14:00 pm

Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Endometrial Neoplasms, Date of authorisation: 21/04/2021, Status: Authorised Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Endometrial Neoplasms, Date of authorisation: 21/04/2021, Status: Authorised Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Endometrial Neoplasms, Date of authorisation: 21/04/2021, Status: Authorised

Source: New medicines and SMOPs: human
Created on: May 3, 2021 | 12:15 pm

New medicines and SMOPs: human | May 3, 2021 | 12:15 pm

Human medicines European public assessment report (EPAR): Sibnayal, potassium citrate,potassium hydrogen carbonate, Acidosis, Renal Tubular, Date of authorisation: 30/04/2021, Status: Authorised Human medicines European public assessment report (EPAR): Sibnayal, potassium citrate,potassium hydrogen carbonate, Acidosis, Renal Tubular, Date of authorisation: 30/04/2021, Status: Authorised Human medicines European public assessment report (EPAR): Sibnayal, potassium citrate,potassium hydrogen carbonate, Acidosis, Renal Tubular, Date of authorisation: 30/04/2021, Status: Authorised

Source: New medicines and SMOPs: human
Created on: May 3, 2021 | 09:57 am

New medicines and SMOPs: human | May 3, 2021 | 09:57 am

Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation,Neoplasms, Date of authorisation: 26/03/2021, Status: Authorised Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation,Neoplasms, Date of authorisation: 26/03/2021, Status: Authorised Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation,Neoplasms, Date of authorisation: 26/03/2021, Status: Authorised

Source: New medicines and SMOPs: human
Created on: Apr 30, 2021 | 11:41 am

New medicines and SMOPs: human | Apr 30, 2021 | 11:41 am

EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen, CHMP, 29/04/2021 EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen, CHMP, 29/04/2021 EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10...

Source: News and press releases
Created on: Apr 29, 2021 | 16:00 pm

News and press releases | Apr 29, 2021 | 16:00 pm

EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe, , 26/04/2021 EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe, , 26/04/2021 The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) today kicked off a new initiative aimed at...

Source: News and press releases
Created on: Apr 26, 2021 | 16:00 pm

News and press releases | Apr 26, 2021 | 16:00 pm

Summary of opinion: Maviret,glecaprevir,pibrentasvir, 22/04/2021, Positive Summary of opinion: Maviret,glecaprevir,pibrentasvir, 22/04/2021, Positive Summary of opinion: Maviret,glecaprevir,pibrentasvir, 22/04/2021, Positive

Source: New medicines and SMOPs: human
Created on: Apr 26, 2021 | 09:33 am

New medicines and SMOPs: human | Apr 26, 2021 | 09:33 am

Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Carcinoma, Non-Small-Cell Lung,Thyroid Neoplasms, Date of authorisation: 11/02/2021, Status: Authorised Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Carcinoma, Non-Small-Cell Lung,Thyroid Neoplasms, Date of authorisation: 11/02/2021, Status: Authorised Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Carcinoma, Non-Small-Cell Lung,Thyroid Neoplasms, Date of authorisation: 11/02/2021, Status: Authorised

Source: New medicines and SMOPs: human
Created on: Apr 23, 2021 | 16:26 pm

New medicines and SMOPs: human | Apr 23, 2021 | 16:26 pm

AstraZeneca’s COVID-19 vaccine: benefits and risks in context, CHMP, 23/04/2021 AstraZeneca’s COVID-19 vaccine: benefits and risks in context, CHMP, 23/04/2021 Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can...

Source: News and press releases
Created on: Apr 23, 2021 | 15:50 pm

News and press releases | Apr 23, 2021 | 15:50 pm

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna, CHMP, 23/04/2021 Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna, CHMP, 23/04/2021 EMA’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply of COVID-19...

Source: News and press releases
Created on: Apr 23, 2021 | 14:20 pm

News and press releases | Apr 23, 2021 | 14:20 pm

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021, CHMP, 23/04/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021, CHMP, 23/04/2021 Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2021 meeting.The...

Source: News and press releases
Created on: Apr 23, 2021 | 12:05 pm

News and press releases | Apr 23, 2021 | 12:05 pm

Summary of opinion: DuoResp Spiromax,budesonide,formoterol, 22/04/2021, Positive Summary of opinion: DuoResp Spiromax,budesonide,formoterol, 22/04/2021, Positive Summary of opinion: DuoResp Spiromax,budesonide,formoterol, 22/04/2021, Positive

Source: New medicines and SMOPs: human
Created on: Apr 23, 2021 | 12:00 pm