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

  New medicines and SMOPs: human Jan 25, 2021 | 16:38 pm

  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

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• Cyberattack on EMA - update 6, , 25/01/2021

  News and press releases Jan 25, 2021 | 16:10 pm

  Further to the cyberattack on EMA last year, some of the unlawfully accessed documents including email correspondence have been made public through the...

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• Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, Date of authorisation: 07/01/2021, Status: Authorised

  New medicines and SMOPs: human Jan 25, 2021 | 15:02 pm

  Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, Date of authorisation: 07/01/2021, Status: Authorised

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• Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021, CVMP, 22/01/2021

  News and press releases Jan 22, 2021 | 14:16 pm

  CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025CVMP opinions on veterinary medicinal productsThe Committee adopted by...

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• Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Influenza, Human, Date of authorisation: 07/01/2021, Status: Authorised

  New medicines and SMOPs: human Jan 22, 2021 | 12:58 pm

  Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Influenza, Human, Date of authorisation: 07/01/2021, Status: Authorised

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• Human medicines European public assessment report (EPAR): Roclanda, latanoprost / netarsudil, Glaucoma, Open-Angle,Ocular Hypertension, Date of authorisation: 07/01/2021, Status: Authorised

  New medicines and SMOPs: human Jan 21, 2021 | 10:39 am

  Human medicines European public assessment report (EPAR): Roclanda, latanoprost / netarsudil, Glaucoma, Open-Angle,Ocular Hypertension, Date of authorisation: 07/01/2021, Status: Authorised

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• Veterinary medicines: highlights of 2020, , 21/01/2021

  News and press releases Jan 21, 2021 | 10:00 am

  EMA has published anoverview of its key recommendations of 2020 regarding the authorisation and safety monitoring of veterinary medicines.In...

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• Human medicines: highlights of 2020, , 21/01/2021

  News and press releases Jan 21, 2021 | 10:00 am

  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...

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• Extra dose from vials of Comirnaty COVID-19 vaccine, , 08/01/2021

  News and press releases Jan 20, 2021 | 18:20 pm

  EMA’s human medicines committee (CHMP) has recommended updating theproduct information for Comirnaty to clarify that each vial contains 6 doses of...

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• Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines, , 19/01/2021

  News and press releases Jan 19, 2021 | 14:00 pm

  EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help...

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• Human medicines European public assessment report (EPAR): Qutavina, teriparatide, Osteoporosis, Date of authorisation: 27/08/2020, Status: Withdrawn

  New medicines and SMOPs: human Jan 18, 2021 | 17:25 pm

  Human medicines European public assessment report (EPAR): Qutavina, teriparatide, Osteoporosis, Date of authorisation: 27/08/2020, Status: Withdrawn

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• Cyberattack on EMA - update 5, , 15/01/2021

  News and press releases Jan 15, 2021 | 12:30 pm

  The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines...

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• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021, PRAC, 15/01/2021

  News and press releases Jan 15, 2021 | 12:00 pm

  First monthly summary safety report for COVID-19 vaccine ComirnatyStarting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports...

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• Human medicines European public assessment report (EPAR): Phesgo, pertuzumab,trastuzumab, Breast Neoplasms, Date of authorisation: 21/12/2020, Status: Authorised

  New medicines and SMOPs: human Jan 13, 2021 | 15:58 pm

  Human medicines European public assessment report (EPAR): Phesgo, pertuzumab,trastuzumab, Breast Neoplasms, Date of authorisation: 21/12/2020, Status: Authorised

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• Human medicines highlights - January 2021

  Human medicine highlights newsletter Jan 13, 2021 | 10:08 am

  Human medicines highlights - January 2021

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• Cyberattack on EMA - update 4, , 12/01/2021

  News and press releases Jan 12, 2021 | 15:30 pm

  The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines...

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• EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca, , 12/01/2021

  News and press releases Jan 12, 2021 | 08:30 am

  EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The...

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• Human medicines European public assessment report (EPAR): Fintepla, fenfluramine, Epilepsies, Myoclonic, Date of authorisation: 18/12/2020, Status: Authorised

  New medicines and SMOPs: human Jan 8, 2021 | 11:25 am

  Human medicines European public assessment report (EPAR): Fintepla, fenfluramine, Epilepsies, Myoclonic, Date of authorisation: 18/12/2020, Status: Authorised

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• Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, Date of authorisation: 18/12/2020, Status: Authorised

  New medicines and SMOPs: human Jan 7, 2021 | 17:14 pm

  Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, Date of authorisation: 18/12/2020, Status: Authorised

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• EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU , , 06/01/2021

  News and press releases Jan 6, 2021 | 16:40 pm

  COVID-19 Vaccine Moderna is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission...

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• Human medicines European public assessment report (EPAR): Leqvio, inclisiran, Hypercholesterolemia,Dyslipidemias, Date of authorisation: 09/12/2020, Status: Authorised

  New medicines and SMOPs: human Jan 6, 2021 | 15:37 pm

  Human medicines European public assessment report (EPAR): Leqvio, inclisiran, Hypercholesterolemia,Dyslipidemias, Date of authorisation: 09/12/2020, Status: Authorised

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• 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

  New medicines and SMOPs: human Jan 5, 2021 | 15:16 pm

  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

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• Human medicines European public assessment report (EPAR): Vocabria, cabotegravir, HIV Infections, Date of authorisation: 17/12/2020, Status: Authorised

  New medicines and SMOPs: human Jan 5, 2021 | 14:20 pm

  Human medicines European public assessment report (EPAR): Vocabria, cabotegravir, HIV Infections, Date of authorisation: 17/12/2020, Status: Authorised

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• Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, HIV Infections, Date of authorisation: 17/12/2020, Status: Authorised

  New medicines and SMOPs: human Jan 4, 2021 | 15:14 pm

  Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, HIV Infections, Date of authorisation: 17/12/2020, Status: Authorised

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• Update on rolling review of AstraZeneca’s COVID-19 vaccine, , 30/12/2020

  News and press releases Dec 30, 2020 | 18:00 pm

  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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