NUOVI FARMACI, SEGNALAZIONI EMA

• Global regulators agree on key principles on adapting vaccines to tackle virus variants, , 01/07/2022 Global regulators agree on key principles on adapting vaccines to tackle virus variants, , 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of  COVID-19 vaccines as the SARS-COV-2 virus continues to...
  
  Source: News and press releases
  Created on: Jul 1, 2022 | 14:00 pm
  
  News and press releases | Jul 1, 2022 | 14:00 pm
• Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU, CVMP, 30/06/2022 Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU, CVMP, 30/06/2022 EMA and the European Food Safety Authority (EFSA) published a report on the development of a harmonised approach to the assessment of the dietary...
  
  Source: News and press releases
  Created on: Jun 30, 2022 | 16:00 pm
  
  News and press releases | Jun 30, 2022 | 16:00 pm
• Human medicines European public assessment report (EPAR): Pirfenidone AET, pirfenidone, Idiopathic Pulmonary Fibrosis, Date of authorisation: 20/06/2022, Status: Authorised Human medicines European public assessment report (EPAR): Pirfenidone AET, pirfenidone, Idiopathic Pulmonary Fibrosis, Date of authorisation: 20/06/2022, Status: Authorised Human medicines European public assessment report (EPAR): Pirfenidone AET, pirfenidone, Idiopathic Pulmonary Fibrosis, Date of authorisation: 20/06/2022, Status: Authorised
  
  Source: New medicines and SMOPs: human
  Created on: Jun 28, 2022 | 17:40 pm
  
  New medicines and SMOPs: human | Jun 28, 2022 | 17:40 pm
• Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability, , 28/06/2022 Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability, , 28/06/2022 Marketing authorisation holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and...
  
  Source: News and press releases
  Created on: Jun 28, 2022 | 17:13 pm
  
  News and press releases | Jun 28, 2022 | 17:13 pm
• Monkeypox: EMA starts review for Imvanex, CHMP, 28/06/2022 Monkeypox: EMA starts review for Imvanex, CHMP, 28/06/2022 EMA’s human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from...
  
  Source: News and press releases
  Created on: Jun 28, 2022 | 11:35 am
  
  News and press releases | Jun 28, 2022 | 11:35 am
• Hydroxyethyl-starch solutions for infusion recommended for suspension from the market, CMDh, 25/02/2022 Hydroxyethyl-starch solutions for infusion recommended for suspension from the market, CMDh, 25/02/2022 Update as of 25 May 2022:On 24 May 2022, the European Commission issued a legal decision confirming the suspension of the marketing authorisations of HES...
  
  Source: News and press releases
  Created on: Jun 27, 2022 | 09:52 am
  
  News and press releases | Jun 27, 2022 | 09:52 am
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022, CHMP, 24/06/2022 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022, CHMP, 24/06/2022 Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its June 2022 meeting.The ...
  
  Source: News and press releases
  Created on: Jun 24, 2022 | 12:10 pm
  
  News and press releases | Jun 24, 2022 | 12:10 pm
• Summary of opinion: Crysvita,burosumab, 23/06/2022, Positive Summary of opinion: Crysvita,burosumab, 23/06/2022, Positive Summary of opinion: Crysvita,burosumab, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Rayvow,lasmiditan, 23/06/2022, Positive Summary of opinion: Rayvow,lasmiditan, 23/06/2022, Positive Summary of opinion: Rayvow,lasmiditan, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Vyvgart,efgartigimod alfa, 23/06/2022, Positive Summary of opinion: Vyvgart,efgartigimod alfa, 23/06/2022, Positive Summary of opinion: Vyvgart,efgartigimod alfa, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Enhertu,trastuzumab deruxtecan, 23/06/2022, Positive Summary of opinion: Enhertu,trastuzumab deruxtecan, 23/06/2022, Positive Summary of opinion: Enhertu,trastuzumab deruxtecan, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Lynparza,olaparib, 23/06/2022, Positive Summary of opinion: Lynparza,olaparib, 23/06/2022, Positive Summary of opinion: Lynparza,olaparib, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Scemblix,asciminib, 23/06/2022, Positive Summary of opinion: Scemblix,asciminib, 23/06/2022, Positive Summary of opinion: Scemblix,asciminib, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Rinvoq,upadacitinib, 23/06/2022, Positive Summary of opinion: Rinvoq,upadacitinib, 23/06/2022, Positive Summary of opinion: Rinvoq,upadacitinib, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Ranivisio,ranibizumab, 23/06/2022, Positive Summary of opinion: Ranivisio,ranibizumab, 23/06/2022, Positive Summary of opinion: Ranivisio,ranibizumab, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Sunlenca,lenacapavir, 23/06/2022, Positive Summary of opinion: Sunlenca,lenacapavir, 23/06/2022, Positive Summary of opinion: Sunlenca,lenacapavir, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Zerbaxa,ceftolozane,tazobactam, 23/06/2022, Positive Summary of opinion: Zerbaxa,ceftolozane,tazobactam, 23/06/2022, Positive Summary of opinion: Zerbaxa,ceftolozane,tazobactam, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Roctavian,Valoctocogene roxaparvovec, 23/06/2022, Positive Summary of opinion: Roctavian,Valoctocogene roxaparvovec, 23/06/2022, Positive Summary of opinion: Roctavian,Valoctocogene roxaparvovec, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Lonquex,lipegfilgrastim, 23/06/2022, Positive Summary of opinion: Lonquex,lipegfilgrastim, 23/06/2022, Positive Summary of opinion: Lonquex,lipegfilgrastim, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Imbruvica,ibrutinib, 23/06/2022, Positive Summary of opinion: Imbruvica,ibrutinib, 23/06/2022, Positive Summary of opinion: Imbruvica,ibrutinib, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• Summary of opinion: Pepaxti,melphalan flufenamide, 23/06/2022, Positive Summary of opinion: Pepaxti,melphalan flufenamide, 23/06/2022, Positive Summary of opinion: Pepaxti,melphalan flufenamide, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 24, 2022 | 12:00 pm
  
  New medicines and SMOPs: human | Jun 24, 2022 | 12:00 pm
• EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU, CHMP, 23/06/2022 EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU, CHMP, 23/06/2022 COVID-19 Vaccine (inactivated, adjuvanted) Valneva is now authorised across the EU. This follows the granting of a marketing authorisation...
  
  Source: News and press releases
  Created on: Jun 23, 2022 | 16:00 pm
  
  News and press releases | Jun 23, 2022 | 16:00 pm
• EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, PDCO, 23/06/2022 EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, PDCO, 23/06/2022 EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in...
  
  Source: News and press releases
  Created on: Jun 23, 2022 | 16:00 pm
  
  News and press releases | Jun 23, 2022 | 16:00 pm
• EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, CHMP, 23/06/2022 EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, CHMP, 23/06/2022 EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in...
  
  Source: News and press releases
  Created on: Jun 23, 2022 | 16:00 pm
  
  News and press releases | Jun 23, 2022 | 16:00 pm
• Summary of opinion: Vegzelma,bevacizumab, 23/06/2022, Positive Summary of opinion: Vegzelma,bevacizumab, 23/06/2022, Positive Summary of opinion: Vegzelma,bevacizumab, 23/06/2022, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Jun 21, 2022 | 14:57 pm
  
  New medicines and SMOPs: human | Jun 21, 2022 | 14:57 pm
• Human medicines European public assessment report (EPAR): Zolsketil pegylated liposomal, doxorubicin, Ovarian Neoplasms;Sarcoma, Kaposi;Multiple Myeloma, Date of authorisation: 31/05/2022, Status: Authorised Human medicines European public assessment report (EPAR): Zolsketil pegylated liposomal, doxorubicin, Ovarian Neoplasms;Sarcoma, Kaposi;Multiple Myeloma, Date of authorisation: 31/05/2022, Status: Authorised Human medicines European public assessment report (EPAR): Zolsketil pegylated liposomal, doxorubicin, Ovarian Neoplasms;Sarcoma, Kaposi;Multiple Myeloma, Date of authorisation: 31/05/2022, Status: Authorised
  
  Source: New medicines and SMOPs: human
  Created on: Jun 20, 2022 | 17:57 pm
  
  New medicines and SMOPs: human | Jun 20, 2022 | 17:57 pm
• Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic, , 20/06/2022 Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic, , 20/06/2022 Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global regulatory...
  
  Source: News and press releases
  Created on: Jun 20, 2022 | 16:09 pm
  
  News and press releases | Jun 20, 2022 | 16:09 pm
• Human medicines European public assessment report (EPAR): Camcevi, leuprorelin, Prostatic Neoplasms, Date of authorisation: 24/05/2022, Status: Authorised Human medicines European public assessment report (EPAR): Camcevi, leuprorelin, Prostatic Neoplasms, Date of authorisation: 24/05/2022, Status: Authorised Human medicines European public assessment report (EPAR): Camcevi, leuprorelin, Prostatic Neoplasms, Date of authorisation: 24/05/2022, Status: Authorised
  
  Source: New medicines and SMOPs: human
  Created on: Jun 20, 2022 | 14:45 pm
  
  New medicines and SMOPs: human | Jun 20, 2022 | 14:45 pm
• EMA Management Board: highlights of June 2022 meeting, MB, 17/06/2022 EMA Management Board: highlights of June 2022 meeting, MB, 17/06/2022 At its 16 June 2022 meeting in Amsterdam, the European Medicines Agency's (EMA) Management Board elected Christelle Ratignier-Carbonneil as vice-Chair of...
  
  Source: News and press releases
  Created on: Jun 17, 2022 | 18:22 pm
  
  News and press releases | Jun 17, 2022 | 18:22 pm
• Start of rolling review for adapted Spikevax COVID-19 vaccine, CHMP, 17/06/2022 Start of rolling review for adapted Spikevax COVID-19 vaccine, CHMP, 17/06/2022 EMA has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that...
  
  Source: News and press releases
  Created on: Jun 17, 2022 | 15:16 pm
  
  News and press releases | Jun 17, 2022 | 15:16 pm