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Pagina dedicata alle informazioni sui farmaci di competenza dell'EMA, relativa alle autorizzazioni e alle segnalazioni di farmacovigilanza

(covid 19[All Fields]) AND (vaccine[All Fields])

(covid 19[All Fields]) AND (vaccine[All Fields]): Latest results from PubMed

NUOVI FARMACI, SEGNALAZIONI EMA

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021, PRAC, 03/09/2021 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021, PRAC, 03/09/2021 COVID-19 vaccines: EMA reviewing cases of multisystem inflammatory syndromeEMA’s safety committee (PRAC) is assessing whether there is a risk of...

Source: News and press releases
Created on: Sep 17, 2021 | 14:00 pm

News and press releases | Sep 17, 2021 | 14:00 pm
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021, CHMP, 17/09/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021, CHMP, 17/09/2021 Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting....

Source: News and press releases
Created on: Sep 17, 2021 | 12:15 pm

News and press releases | Sep 17, 2021 | 12:15 pm
New add-on treatment for rare autoimmune inflammatory disorder, CHMP, 17/09/2021 New add-on treatment for rare autoimmune inflammatory disorder, CHMP, 17/09/2021 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...

Source: News and press releases
Created on: Sep 17, 2021 | 12:14 pm

News and press releases | Sep 17, 2021 | 12:14 pm
Summary of opinion: Zepatier,elbasvir,grazoprevir, 16/09/2021, Positive Summary of opinion: Zepatier,elbasvir,grazoprevir, 16/09/2021, Positive Summary of opinion: Zepatier,elbasvir,grazoprevir, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Brukinsa,zanubrutinib, 16/09/2021, Positive Summary of opinion: Brukinsa,zanubrutinib, 16/09/2021, Positive Summary of opinion: Brukinsa,zanubrutinib, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Vumerity,diroximel fumarate, 16/09/2021, Positive Summary of opinion: Vumerity,diroximel fumarate, 16/09/2021, Positive Summary of opinion: Vumerity,diroximel fumarate, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Hukyndra,adalimumab, 16/09/2021, Positive Summary of opinion: Hukyndra,adalimumab, 16/09/2021, Positive Summary of opinion: Hukyndra,adalimumab, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Sugammadex Mylan,sugammadex, 16/09/2021, Positive Summary of opinion: Sugammadex Mylan,sugammadex, 16/09/2021, Positive Summary of opinion: Sugammadex Mylan,sugammadex, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Libmyris,adalimumab, 16/09/2021, Positive Summary of opinion: Libmyris,adalimumab, 16/09/2021, Positive Summary of opinion: Libmyris,adalimumab, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Noxafil,posaconazole, 16/09/2021, Positive Summary of opinion: Noxafil,posaconazole, 16/09/2021, Positive Summary of opinion: Noxafil,posaconazole, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Nucala,mepolizumab, 16/09/2021, Positive Summary of opinion: Nucala,mepolizumab, 16/09/2021, Positive Summary of opinion: Nucala,mepolizumab, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Jyseleca,filgotinib, 16/09/2021, Positive Summary of opinion: Jyseleca,filgotinib, 16/09/2021, Positive Summary of opinion: Jyseleca,filgotinib, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Steglatro,ertugliflozin, 16/09/2021, Positive Summary of opinion: Steglatro,ertugliflozin, 16/09/2021, Positive Summary of opinion: Steglatro,ertugliflozin, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Opdivo,nivolumab, 16/09/2021, Positive Summary of opinion: Opdivo,nivolumab, 16/09/2021, Positive Summary of opinion: Opdivo,nivolumab, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Segluromet,ertugliflozin,metformin hydrochloride, 16/09/2021, Positive Summary of opinion: Segluromet,ertugliflozin,metformin hydrochloride, 16/09/2021, Positive Summary of opinion: Segluromet,ertugliflozin,metformin hydrochloride, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Rivaroxaban Mylan,rivaroxaban, 16/09/2021, Positive Summary of opinion: Rivaroxaban Mylan,rivaroxaban, 16/09/2021, Positive Summary of opinion: Rivaroxaban Mylan,rivaroxaban, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Gavreto,pralsetinib, 16/09/2021, Positive Summary of opinion: Gavreto,pralsetinib, 16/09/2021, Positive Summary of opinion: Gavreto,pralsetinib, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Firmagon,degarelix, 16/09/2021, Positive Summary of opinion: Firmagon,degarelix, 16/09/2021, Positive Summary of opinion: Firmagon,degarelix, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Raylumis,tanezumab, 16/09/2021, Negative Summary of opinion: Raylumis,tanezumab, 16/09/2021, Negative Summary of opinion: Raylumis,tanezumab, 16/09/2021, Negative

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Keytruda,pembrolizumab, 16/09/2021, Positive Summary of opinion: Keytruda,pembrolizumab, 16/09/2021, Positive Summary of opinion: Keytruda,pembrolizumab, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Adempas,riociguat, 16/09/2021, Positive Summary of opinion: Adempas,riociguat, 16/09/2021, Positive Summary of opinion: Adempas,riociguat, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Artesunate Amivas,artesunate, 15/09/2021, Positive Summary of opinion: Artesunate Amivas,artesunate, 15/09/2021, Positive Summary of opinion: Artesunate Amivas,artesunate, 15/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Summary of opinion: Qinlock,ripretinib, 16/09/2021, Positive Summary of opinion: Qinlock,ripretinib, 16/09/2021, Positive Summary of opinion: Qinlock,ripretinib, 16/09/2021, Positive

Source: New medicines and SMOPs: human
Created on: Sep 17, 2021 | 12:00 pm

New medicines and SMOPs: human | Sep 17, 2021 | 12:00 pm
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021, CVMP, 10/09/2021 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021, CVMP, 10/09/2021 CVMP opinions on veterinary medicinal productsThe Committee adopted by majority a positive opinion for a marketing authorisation application for Felpreva...

Source: News and press releases
Created on: Sep 10, 2021 | 12:00 pm

News and press releases | Sep 10, 2021 | 12:00 pm
Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer, CHMP, 09/09/2021 Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer, CHMP, 09/09/2021 EMA’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by...

Source: News and press releases
Created on: Sep 9, 2021 | 17:40 pm

News and press releases | Sep 9, 2021 | 17:40 pm
Human medicines highlights - September 2021 Human medicines highlights - September 2021 Human medicines highlights - September 2021

Source: Human medicine highlights newsletter
Created on: Sep 7, 2021 | 13:24 pm

Human medicine highlights newsletter | Sep 7, 2021 | 13:24 pm
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines, , 02/09/2021 ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines, , 02/09/2021 Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general...

Source: News and press releases
Created on: Sep 2, 2021 | 10:00 am

News and press releases | Sep 2, 2021 | 10:00 am
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna, CHMP, 24/08/2021 Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna, CHMP, 24/08/2021 EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU....

Source: News and press releases
Created on: Aug 24, 2021 | 15:00 pm

News and press releases | Aug 24, 2021 | 15:00 pm

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