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NUOVI FARMACI, SEGNALAZIONI EMA
Human medicines European public assessment report (EPAR): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell, Date of authorisation: 14/12/2020, Status: Authorised
Read more...Further to the cyberattack on EMA last year, some of the unlawfully accessed documents including email correspondence have been made public through the...
Read more...Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, Date of authorisation: 07/01/2021, Status: Authorised
Read more...CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025CVMP opinions on veterinary medicinal productsThe Committee adopted by...
Read more...Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Influenza, Human, Date of authorisation: 07/01/2021, Status: Authorised
Read more...Human medicines European public assessment report (EPAR): Roclanda, latanoprost / netarsudil, Glaucoma, Open-Angle,Ocular Hypertension, Date of authorisation: 07/01/2021, Status: Authorised
Read more...EMA has published anoverview of its key recommendations of 2020 regarding the authorisation and safety monitoring of veterinary medicines.In...
Read more...EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use.In 2020, EMA...
Read more...EMA’s human medicines committee (CHMP) has recommended updating theproduct information for Comirnaty to clarify that each vial contains 6 doses of...
Read more...EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help...
Read more...Human medicines European public assessment report (EPAR): Qutavina, teriparatide, Osteoporosis, Date of authorisation: 27/08/2020, Status: Withdrawn
Read more...The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines...
Read more...First monthly summary safety report for COVID-19 vaccine ComirnatyStarting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports...
Read more...Human medicines European public assessment report (EPAR): Phesgo, pertuzumab,trastuzumab, Breast Neoplasms, Date of authorisation: 21/12/2020, Status: Authorised
Read more...Human medicines highlights - January 2021
Read more...The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines...
Read more...EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The...
Read more...Human medicines European public assessment report (EPAR): Fintepla, fenfluramine, Epilepsies, Myoclonic, Date of authorisation: 18/12/2020, Status: Authorised
Read more...Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, Date of authorisation: 18/12/2020, Status: Authorised
Read more...COVID-19 Vaccine Moderna is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission...
Read more...Human medicines European public assessment report (EPAR): Leqvio, inclisiran, Hypercholesterolemia,Dyslipidemias, Date of authorisation: 09/12/2020, Status: Authorised
Read more...Human medicines European public assessment report (EPAR): Trixeo Aerosphere, formoterol,glycopyrronium bromide,budesonide, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 09/12/2020, Status: Authorised
Read more...Human medicines European public assessment report (EPAR): Vocabria, cabotegravir, HIV Infections, Date of authorisation: 17/12/2020, Status: Authorised
Read more...Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, HIV Infections, Date of authorisation: 17/12/2020, Status: Authorised
Read more...EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. The Agency is...
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