NUOVI FARMACI, SEGNALAZIONI EMA

• Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023 Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023 Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones...
  
  Source: News and press releases
  Created on: Sep 15, 2023 | 15:43 pm
  
  News and press releases | Sep 15, 2023 | 15:43 pm
• EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023 EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023 EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a...
  
  Source: News and press releases
  Created on: Sep 15, 2023 | 14:16 pm
  
  News and press releases | Sep 15, 2023 | 14:16 pm
• Summary of opinion: Aqumeldi,Enalapril maleate, 14/09/2023, Positive Summary of opinion: Aqumeldi,Enalapril maleate, 14/09/2023, Positive Summary of opinion: Aqumeldi,Enalapril maleate, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:11 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:11 pm
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023 Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting....
  
  Source: News and press releases
  Created on: Sep 15, 2023 | 12:10 pm
  
  News and press releases | Sep 15, 2023 | 12:10 pm
• Summary of opinion: Zoonotic Influenza Vaccine Seqirus,zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), 14/09/2023, Positive Summary of opinion: Zoonotic Influenza Vaccine Seqirus,zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), 14/09/2023, Positive Summary of opinion: Zoonotic Influenza Vaccine Seqirus,zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Kaftrio,ivacaftor,tezacaftor,elexacaftor, 14/09/2023, Positive Summary of opinion: Kaftrio,ivacaftor,tezacaftor,elexacaftor, 14/09/2023, Positive Summary of opinion: Kaftrio,ivacaftor,tezacaftor,elexacaftor, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Vanflyta,quizartinib, 14/09/2023, Positive Summary of opinion: Vanflyta,quizartinib, 14/09/2023, Positive Summary of opinion: Vanflyta,quizartinib, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Olumiant,baricitinib, 14/09/2023, Positive Summary of opinion: Olumiant,baricitinib, 14/09/2023, Positive Summary of opinion: Olumiant,baricitinib, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Takhzyro,lanadelumab, 14/09/2023, Positive Summary of opinion: Takhzyro,lanadelumab, 14/09/2023, Positive Summary of opinion: Takhzyro,lanadelumab, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Enhertu,trastuzumab deruxtecan, 14/09/2023, Positive Summary of opinion: Enhertu,trastuzumab deruxtecan, 14/09/2023, Positive Summary of opinion: Enhertu,trastuzumab deruxtecan, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Ebglyss,Lebrikizumab, 14/09/2023, Positive Summary of opinion: Ebglyss,Lebrikizumab, 14/09/2023, Positive Summary of opinion: Ebglyss,Lebrikizumab, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Herwenda,trastuzumab, 14/09/2023, Positive Summary of opinion: Herwenda,trastuzumab, 14/09/2023, Positive Summary of opinion: Herwenda,trastuzumab, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Adcetris,brentuximab vedotin, 14/09/2023, Positive Summary of opinion: Adcetris,brentuximab vedotin, 14/09/2023, Positive Summary of opinion: Adcetris,brentuximab vedotin, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Ryeqo,relugolix,estradiol,norethisterone acetate, 14/09/2023, Positive Summary of opinion: Ryeqo,relugolix,estradiol,norethisterone acetate, 14/09/2023, Positive Summary of opinion: Ryeqo,relugolix,estradiol,norethisterone acetate, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Voxzogo,vosoritide, 14/09/2023, Positive Summary of opinion: Voxzogo,vosoritide, 14/09/2023, Positive Summary of opinion: Voxzogo,vosoritide, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Yorvipath,Palopegteriparatide, 14/09/2023, Positive Summary of opinion: Yorvipath,Palopegteriparatide, 14/09/2023, Positive Summary of opinion: Yorvipath,Palopegteriparatide, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Nordimet,methotrexate, 14/09/2023, Positive Summary of opinion: Nordimet,methotrexate, 14/09/2023, Positive Summary of opinion: Nordimet,methotrexate, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Finlee,dabrafenib, 14/09/2023, Positive Summary of opinion: Finlee,dabrafenib, 14/09/2023, Positive Summary of opinion: Finlee,dabrafenib, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Kalydeco,ivacaftor, 14/09/2023, Positive Summary of opinion: Kalydeco,ivacaftor, 14/09/2023, Positive Summary of opinion: Kalydeco,ivacaftor, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Catiolanze,latanoprost, 14/09/2023, Positive Summary of opinion: Catiolanze,latanoprost, 14/09/2023, Positive Summary of opinion: Catiolanze,latanoprost, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 12:00 pm
  
  New medicines and SMOPs: human | Sep 15, 2023 | 12:00 pm
• Summary of opinion: Keytruda,pembrolizumab, 14/09/2023, Positive Summary of opinion: Keytruda,pembrolizumab, 14/09/2023, Positive Summary of opinion: Keytruda,pembrolizumab, 14/09/2023, Positive
  
  Source: New medicines and SMOPs: human
  Created on: Sep 15, 2023 | 09:18 am
  
  New medicines and SMOPs: human | Sep 15, 2023 | 09:18 am
• Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 14/09/2023 Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 14/09/2023 EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.The vaccine —...
  
  Source: News and press releases
  Created on: Sep 14, 2023 | 16:00 pm
  
  News and press releases | Sep 14, 2023 | 16:00 pm
• Human medicines highlights - September 2023 Human medicines highlights - September 2023 Human medicines highlights - September 2023
  
  Source: Human medicine highlights newsletter
  Created on: Sep 11, 2023 | 16:06 pm
  
  Human medicine highlights newsletter | Sep 11, 2023 | 16:06 pm
• Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 2023, CVMP, 08/09/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 2023, CVMP, 08/09/2023 CVMP opinions on veterinary medicinal productsUnder Regulation (EC) No 726/2004, the Committee adopted by consensus a positive opinion for a marketing...
  
  Source: News and press releases
  Created on: Sep 8, 2023 | 12:30 pm
  
  News and press releases | Sep 8, 2023 | 12:30 pm
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023, PRAC, 01/09/2023 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023, PRAC, 01/09/2023 PRAC recommends new measures to avoid topiramate exposure in pregnancyEMA’s safety committee (PRAC) recommends new measures to avoid exposure of children...
  
  Source: News and press releases
  Created on: Sep 1, 2023 | 12:00 pm
  
  News and press releases | Sep 1, 2023 | 12:00 pm
• PRAC recommends new measures to avoid topiramate exposure in pregnancy, PRAC, 01/09/2023 PRAC recommends new measures to avoid topiramate exposure in pregnancy, PRAC, 01/09/2023 Further restrictions on use; pregnancy prevention programme to be put in placeEMA’s safety committee (PRAC) recommends new measures to avoid exposure of...
  
  Source: News and press releases
  Created on: Sep 1, 2023 | 12:00 pm
  
  News and press releases | Sep 1, 2023 | 12:00 pm
• Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 30/08/2023 Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 30/08/2023 EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.The vaccine –...
  
  Source: News and press releases
  Created on: Aug 30, 2023 | 14:00 pm
  
  News and press releases | Aug 30, 2023 | 14:00 pm