https://www.ema.europa.eu/en/homepageWhat's newen-gbCopyright: (C) European Medicines AgencySat, 27 Apr 2024 05:10:20 +0200Fri, 26 Apr 2024 17:54:00 +0200https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-20-previously-apexxnarHuman medicines European public assessment report (EPAR): Prevenar 20 (previously Apexxnar), pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), Date of authorisation: 14/02/2022, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-20-previously-apexxnarFri, 26 Apr 2024 17:54:00 +0200What's newhttps://www.ema.europa.eu/en/events/product-management-service-pms-info-dayProduct Management Service (PMS) Info-Day, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2024, 09:15 (CEST) to 16 April 2024, 17:30 (CEST)https://www.ema.europa.eu/en/events/product-management-service-pms-info-dayFri, 26 Apr 2024 15:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xevudyHuman medicines European public assessment report (EPAR): Xevudy, sotrovimab, Date of authorisation: 17/12/2021, Revision: 15, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xevudyFri, 26 Apr 2024 15:39:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema-organisational-chart_website_source_masterorgchart_a3_v47-en.pdfOrganisation chart of the European Medicines Agencyhttps://www.ema.europa.eu/system/files/documents/other/ema-organisational-chart_website_source_masterorgchart_a3_v47-en.pdfFri, 26 Apr 2024 15:28:28 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answersGuidance on good manufacturing practice and good distribution practice: Questions and answershttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answersFri, 26 Apr 2024 15:17:00 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-april-2024Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-april-2024Fri, 26 Apr 2024 15:07:00 +0200What's newhttps://www.ema.europa.eu/en/development-guideline-safety-nanoparticles-context-establishment-maximum-residue-limits-veterinary-marketing-authorisationsDevelopment of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisationshttps://www.ema.europa.eu/en/development-guideline-safety-nanoparticles-context-establishment-maximum-residue-limits-veterinary-marketing-authorisationsFri, 26 Apr 2024 15:00:00 +0200What's newhttps://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicinesScientific guidelines for veterinary medicineshttps://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicinesFri, 26 Apr 2024 14:51:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/concept-paper-development-guideline-safety-nanoparticle_en.pdfConcept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisationshttps://www.ema.europa.eu/system/files/documents/scientific-guideline/concept-paper-development-guideline-safety-nanoparticle_en.pdfFri, 26 Apr 2024 14:30:00 +0200What's newhttps://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-republic-koreaConfidentiality arrangement between the EU and the Republic of Koreahttps://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-republic-koreaFri, 26 Apr 2024 14:23:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/2024-04-25-working-arrangement-between-ministry-food-drug-safety-republic-korea_en.pdfWorking arrangement between the Ministry of Food and Drug Safety of the Republic of Korea and the Directorate-General for Health and Food Safety of the European Commission and EMA for the Exchange of Non-Public Information on Medicinal Productshttps://www.ema.europa.eu/system/files/documents/other/2024-04-25-working-arrangement-between-ministry-food-drug-safety-republic-korea_en.pdfFri, 26 Apr 2024 14:15:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/process-rmp-guidance-preparation-publication-post-approval-redaction-en.pdfGuidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/process-rmp-guidance-preparation-publication-post-approval-redaction-en.pdfFri, 26 Apr 2024 13:41:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/qrd-form-2-checklist-submission-day-25-files-veterinary-en.docxQRD Form 2 and checklist for the submission of day +25 files - veterinaryhttps://www.ema.europa.eu/system/files/documents/template-form/qrd-form-2-checklist-submission-day-25-files-veterinary-en.docxFri, 26 Apr 2024 13:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/alecensaSummary of opinion: Alecensa, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/alecensaFri, 26 Apr 2024 12:50:56 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/rybrevantSummary of opinion: Rybrevant, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/rybrevantFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/sirturoSummary of opinion: Sirturo, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/sirturoFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/rozlytrekSummary of opinion: Rozlytrek, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/rozlytrekFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/opdivo-3Summary of opinion: Opdivo, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/opdivo-3Fri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/reyatazSummary of opinion: Reyataz, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/reyatazFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/triumeqSummary of opinion: Triumeq, 25/04/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/triumeqFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/wezenlaHuman medicines European public assessment report (EPAR): Wezenla, ustekinumab, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/wezenlaFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/truqapHuman medicines European public assessment report (EPAR): Truqap, capivasertib, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/truqapFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/obgemsaHuman medicines European public assessment report (EPAR): Obgemsa, vibegron, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/obgemsaFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/jeraygoHuman medicines European public assessment report (EPAR): Jeraygo, aprocitentan, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/jeraygoFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/gegantHuman medicines European public assessment report (EPAR): GeGant, Germanium (68Ge) chloride,Gallium (68Ga) chloride, Status: Withdrawn applicationhttps://www.ema.europa.eu/en/medicines/human/EPAR/gegantFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024Fri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/eribulin-baxterHuman medicines European public assessment report (EPAR): Eribulin Baxter, eribulin, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/eribulin-baxterFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/altuvoctHuman medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/altuvoctFri, 26 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/support-smes/sme-regulation-reportsSME Regulation and reportshttps://www.ema.europa.eu/en/about-us/support-smes/sme-regulation-reportsFri, 26 Apr 2024 11:24:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/report/sme-office-annual-report-2023_en.pdfSmall and medium-sized enterprise (SME) office annual report 2023https://www.ema.europa.eu/system/files/documents/report/sme-office-annual-report-2023_en.pdfFri, 26 Apr 2024 11:18:00 +0200What's newhttps://www.ema.europa.eu/en/events/follow-ema-eortc-multi-stakeholder-workshop-soft-tissue-bone-sarcomaFollow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma, Online, European Medicines Agency, Amsterdam, the Netherlands, 24 May 2024https://www.ema.europa.eu/en/events/follow-ema-eortc-multi-stakeholder-workshop-soft-tissue-bone-sarcomaFri, 26 Apr 2024 11:14:14 +0200What's newhttps://www.ema.europa.eu/en/about-us/procurementProcurementhttps://www.ema.europa.eu/en/about-us/procurementFri, 26 Apr 2024 10:54:54 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/spikevax-previously-covid-19-vaccine-modernaHuman medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 45, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/spikevax-previously-covid-19-vaccine-modernaFri, 26 Apr 2024 09:49:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-medicinal-products-veterinary-use-cvmp-12-14-march-2024Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 March 2024, European Medicines Agency, Amsterdam, the Netherlands, from 12 March 2024 to 14 March 2024https://www.ema.europa.eu/en/events/committee-medicinal-products-veterinary-use-cvmp-12-14-march-2024Fri, 26 Apr 2024 09:21:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/03-cvmp-march-2024-minutes_en.pdfMinutes of the CVMP meeting 12-13 March 2024https://www.ema.europa.eu/system/files/documents/minutes/03-cvmp-march-2024-minutes_en.pdfFri, 26 Apr 2024 09:14:06 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xtandiHuman medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xtandiThu, 25 Apr 2024 17:12:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-medicinal-products-veterinary-use-cvmp-16-18-april-2024Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2024 to 18 April 2024https://www.ema.europa.eu/en/events/committee-medicinal-products-veterinary-use-cvmp-16-18-april-2024Thu, 25 Apr 2024 17:09:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-h5Veterinary medicines European public assessment report (EPAR): Innovax-ND-H5, Turkey herpesvirus, strain HVT-ND-H5 (cell-associated), expressing fusion protein gene of Newcastle disease virus and haemagglutinin gene of Avian influenza virus subtype H5, Status: Opinionhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-h5Thu, 25 Apr 2024 16:36:24 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/list-centrally-authorised-products-requiring-notifications-change-updated-annexes_en.pdfList of centrally authorised products requiring a notification of a change for update of annexeshttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/list-centrally-authorised-products-requiring-notifications-change-updated-annexes_en.pdfThu, 25 Apr 2024 16:11:00 +0200What's newhttps://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/non-clinical-working-partyNon-clinical Working Partyhttps://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/non-clinical-working-partyThu, 25 Apr 2024 16:08:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/guide-access-unpublished-documents_en_1.pdfGuide on access to unpublished documentshttps://www.ema.europa.eu/system/files/documents/other/guide-access-unpublished-documents_en_1.pdfThu, 25 Apr 2024 16:05:00 +0200What's newhttps://www.ema.europa.eu/en/events/spor-status-updateSPOR Status Update, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 April 2024, 10:00 (CEST) to 10 April 2024, 12:30 (CEST)https://www.ema.europa.eu/en/events/spor-status-updateThu, 25 Apr 2024 15:39:00 +0200What's newhttps://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-hemoglobinopathiesEMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2024, 14:00 (CEST) to 1 July 2024, 18:00 (CEST)https://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-hemoglobinopathiesThu, 25 Apr 2024 15:28:33 +0200What's newhttps://www.ema.europa.eu/en/events/joint-hma-ema-big-data-steering-group-workshop-rwe-methodsJoint HMA/EMA Big Data Steering Group workshop on RWE methods, Online, European Medicines Agency, Amsterdam, the Netherlands, 14 June 2024https://www.ema.europa.eu/en/events/joint-hma-ema-big-data-steering-group-workshop-rwe-methodsThu, 25 Apr 2024 15:22:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/agenda-joint-hma-ema-workshop-rwe-methods_en.pdfAgenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methodshttps://www.ema.europa.eu/system/files/documents/agenda/agenda-joint-hma-ema-workshop-rwe-methods_en.pdfThu, 25 Apr 2024 15:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-accordHuman medicines European public assessment report (EPAR): Teriflunomide Accord, teriflunomide, Date of authorisation: 09/11/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-accordThu, 25 Apr 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sifrolHuman medicines European public assessment report (EPAR): Sifrol, pramipexole, Date of authorisation: 13/10/1997, Revision: 39, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sifrolThu, 25 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/quviviqHuman medicines European public assessment report (EPAR): Quviviq, daridorexant, Date of authorisation: 29/04/2022, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/quviviqThu, 25 Apr 2024 11:59:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nepextoHuman medicines European public assessment report (EPAR): Nepexto, etanercept, Date of authorisation: 20/05/2020, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nepextoThu, 25 Apr 2024 10:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bimervaxHuman medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bimervaxThu, 25 Apr 2024 10:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tecartusHuman medicines European public assessment report (EPAR): Tecartus, Brexucabtagene autoleucel, Date of authorisation: 14/12/2020, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tecartusWed, 24 Apr 2024 17:51:07 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-eligible-industry-stakeholder-organisations_en_0.pdfList of eligible industry stakeholder organisationshttps://www.ema.europa.eu/system/files/documents/other/list-eligible-industry-stakeholder-organisations_en_0.pdfWed, 24 Apr 2024 16:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-astrazeneca-previously-pandemic-influenza-vaccine-h5n1-medimmuneHuman medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune), pandemic influenza vaccine (H5N1) (live attenuated, nasal), Date of authorisation: 20/05/2016, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-astrazeneca-previously-pandemic-influenza-vaccine-h5n1-medimmuneWed, 24 Apr 2024 16:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/spedraHuman medicines European public assessment report (EPAR): Spedra, avanafil, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/spedraWed, 24 Apr 2024 16:09:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/2024-04-29_-agenda_ema-aesgp-bilateral-meeting_en.pdfAgenda - Fourth EMA-AESGP bilateral meetinghttps://www.ema.europa.eu/system/files/documents/agenda/2024-04-29_-agenda_ema-aesgp-bilateral-meeting_en.pdfWed, 24 Apr 2024 14:50:24 +0200What's newhttps://www.ema.europa.eu/en/events/fifth-european-medicines-agency-ema-association-european-self-medication-industry-aesgp-bilateral-meetingFifth European Medicines Agency (EMA) and the Association of the European Self-Medication Industry (AESGP) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 29 April 2024, 10:00 (CEST) to 29 April 2024, 12:00 (CEST)https://www.ema.europa.eu/en/events/fifth-european-medicines-agency-ema-association-european-self-medication-industry-aesgp-bilateral-meetingWed, 24 Apr 2024 14:46:55 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/240424-minimum-inhibitory-concentration-mic-breakpoints_en_0.xlsxMinimum inhibitory concentration (MIC) breakpointshttps://www.ema.europa.eu/system/files/documents/other/240424-minimum-inhibitory-concentration-mic-breakpoints_en_0.xlsxWed, 24 Apr 2024 14:27:00 +0200What's newhttps://www.ema.europa.eu/en/events/psychedelics-their-therapeutic-use-linkedin-live-interview-steffen-thirstrup-emas-chief-medical-officerPsychedelics and their therapeutic use - Linkedin Live interview with Steffen Thirstrup, EMA's Chief Medical Officer, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 May 2024, 11:30 (CEST) to 7 May 2024, 12:00 (CEST)https://www.ema.europa.eu/en/events/psychedelics-their-therapeutic-use-linkedin-live-interview-steffen-thirstrup-emas-chief-medical-officerWed, 24 Apr 2024 12:30:05 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqlaHuman medicines European public assessment report (EPAR): Fruzaqla, fruquintinib, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqlaWed, 24 Apr 2024 09:41:18 +0200What's newhttps://www.ema.europa.eu/en/partners-networks/patients-consumers/training-resources-patients-consumersTraining and resources for patients and consumershttps://www.ema.europa.eu/en/partners-networks/patients-consumers/training-resources-patients-consumersTue, 23 Apr 2024 16:58:00 +0200What's newhttps://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/republic-koreaRepublic of Koreahttps://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/republic-koreaTue, 23 Apr 2024 16:43:23 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pramipexole-tevaHuman medicines European public assessment report (EPAR): Pramipexole Teva, pramipexole, Date of authorisation: 18/12/2008, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pramipexole-tevaTue, 23 Apr 2024 16:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sivextroHuman medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Date of authorisation: 23/03/2015, Revision: 22, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sivextroTue, 23 Apr 2024 16:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ontozryHuman medicines European public assessment report (EPAR): Ontozry, cenobamate, Date of authorisation: 26/03/2021, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ontozryTue, 23 Apr 2024 16:19:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/emendHuman medicines European public assessment report (EPAR): Emend, aprepitant, Date of authorisation: 11/11/2003, Revision: 31, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/emendTue, 23 Apr 2024 15:50:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/shortage/emend-aprepitant-supply-shortage-rev1_en.pdfEmend (aprepitant) supply shortagehttps://www.ema.europa.eu/system/files/documents/shortage/emend-aprepitant-supply-shortage-rev1_en.pdfTue, 23 Apr 2024 15:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kaftrioHuman medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation: 21/08/2020, Revision: 19, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kaftrioTue, 23 Apr 2024 15:16:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-accordHuman medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Accord, sitagliptin,metformin hydrochloride, Date of authorisation: 22/07/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-accordTue, 23 Apr 2024 15:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/revatioHuman medicines European public assessment report (EPAR): Revatio, sildenafil, Date of authorisation: 28/10/2005, Revision: 52, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/revatioTue, 23 Apr 2024 14:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/oyavasHuman medicines European public assessment report (EPAR): Oyavas, bevacizumab, Date of authorisation: 26/03/2021, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/oyavasTue, 23 Apr 2024 14:00:00 +0200What's newhttps://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicinesNew recommendations to strengthen supply chains of critical medicineshttps://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicinesTue, 23 Apr 2024 13:31:26 +0200What's newhttps://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steering-group-shortages-medicinal-productsExecutive Steering Group on Shortages and Safety of Medicinal Productshttps://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steering-group-shortages-medicinal-productsTue, 23 Apr 2024 13:28:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/mssg-recommendations-address-vulnerabilities-supply-chain_en.pdfMSSG recommendations to strengthen supply chains of critical medicinal productshttps://www.ema.europa.eu/system/files/documents/other/mssg-recommendations-address-vulnerabilities-supply-chain_en.pdfTue, 23 Apr 2024 13:27:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/hukyndraHuman medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/hukyndraTue, 23 Apr 2024 12:59:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/member-states-contact-points-review-national-versions-content-mobile-scanni_en.pdfMember states contact points for review of national versions of the content of mobile scanning and other technologieshttps://www.ema.europa.eu/system/files/documents/other/member-states-contact-points-review-national-versions-content-mobile-scanni_en.pdfTue, 23 Apr 2024 12:18:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/contact-details-national-competent-authorities-requests-use-sticker-place-uni_en_0.pdfContact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved productshttps://www.ema.europa.eu/system/files/documents/other/contact-details-national-competent-authorities-requests-use-sticker-place-uni_en_0.pdfTue, 23 Apr 2024 12:18:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/contact-details-national-competent-authorities-requests-translation-exemptions_en.pdfContact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortageshttps://www.ema.europa.eu/system/files/documents/other/contact-details-national-competent-authorities-requests-translation-exemptions_en.pdfTue, 23 Apr 2024 12:17:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/labelling-exemption-request_en.pdfTable of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Grouphttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/labelling-exemption-request_en.pdfTue, 23 Apr 2024 12:08:00 +0200What's newhttps://www.ema.europa.eu/en/events/paediatric-committee-pdco-23-26-april-2024Paediatric Committee (PDCO): 23-26 April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 April 2024 to 26 April 2024https://www.ema.europa.eu/en/events/paediatric-committee-pdco-23-26-april-2024Tue, 23 Apr 2024 11:59:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-pdco-agenda-23-26-april-2024-ready-publication_en.pdfAgenda - PDCO agenda of the 23-26 April 2024 meetinghttps://www.ema.europa.eu/system/files/documents/agenda/draft-pdco-agenda-23-26-april-2024-ready-publication_en.pdfTue, 23 Apr 2024 11:55:44 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-chmp-agenda-annex-22-25-april-2024-corr1-publication_en.pdfAgenda of the CHMP meeting 22-25 April 2024https://www.ema.europa.eu/system/files/documents/agenda/draft-chmp-agenda-annex-22-25-april-2024-corr1-publication_en.pdfTue, 23 Apr 2024 09:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lunsumioHuman medicines European public assessment report (EPAR): Lunsumio, mosunetuzumab, Date of authorisation: 03/06/2022, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lunsumioMon, 22 Apr 2024 16:31:03 +0200What's newhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_rev-121-april-2024_en.xlsxList of medicinal products under additional monitoringhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_rev-121-april-2024_en.xlsxMon, 22 Apr 2024 16:01:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_rev-121-april-2024_en.pdfList of medicinal products under additional monitoringhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_rev-121-april-2024_en.pdfMon, 22 Apr 2024 16:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lorviquaHuman medicines European public assessment report (EPAR): Lorviqua, lorlatinib, Date of authorisation: 06/05/2019, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lorviquaMon, 22 Apr 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tofidenceHuman medicines European public assessment report (EPAR): Tofidence, tocilizumab, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/tofidenceMon, 22 Apr 2024 15:53:27 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring/list-medicines-under-additional-monitoringList of medicines under additional monitoringhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring/list-medicines-under-additional-monitoringMon, 22 Apr 2024 15:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/jentaduetoHuman medicines European public assessment report (EPAR): Jentadueto, linagliptin,metformin hydrochloride, Date of authorisation: 19/07/2012, Revision: 22, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/jentaduetoMon, 22 Apr 2024 14:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-ahclHuman medicines European public assessment report (EPAR): Posaconazole AHCL, posaconazole, Date of authorisation: 25/07/2019, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-ahclMon, 22 Apr 2024 14:05:00 +0200What's newhttps://www.ema.europa.eu/en/events/information-qa-session-updated-caps-web-based-eafInformation and Q&A session on updated CAPs in web-based eAF, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 May 2024, 10:00 (CEST) to 7 May 2024, 11:00 (CEST)https://www.ema.europa.eu/en/events/information-qa-session-updated-caps-web-based-eafMon, 22 Apr 2024 14:04:06 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-accordHuman medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Date of authorisation: 25/07/2019, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-accordMon, 22 Apr 2024 14:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lemtradaHuman medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lemtradaMon, 22 Apr 2024 12:48:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steering-group-shortages-medicinal-products/executive-steering-group-shortages-safety-medicinal-products-mssg-meetingsExecutive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetingshttps://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steering-group-shortages-medicinal-products/executive-steering-group-shortages-safety-medicinal-products-mssg-meetingsMon, 22 Apr 2024 12:35:00 +0200What's newhttps://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-bitesize-talk-how-submit-transitional-trial-ctis-0Clinical Trials Information System (CTIS) Bitesize Talk: How to submit a transitional trial in CTIS, Online, Broadcast, from 29 February 2024, 16:30 (CET) to 29 February 2024, 18:00 (CET)https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-bitesize-talk-how-submit-transitional-trial-ctis-0Mon, 22 Apr 2024 12:27:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/granupas-previously-para-aminosalicylic-acid-lucaneHuman medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), para-aminosalicylic acid, Date of authorisation: 07/04/2014, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/granupas-previously-para-aminosalicylic-acid-lucaneMon, 22 Apr 2024 12:20:00 +0200What's newhttps://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-april-2024Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 April 2024, 09:00 (CEST) to 23 April 2024, 10:00 (CEST)https://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-april-2024Mon, 22 Apr 2024 12:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accordHuman medicines European public assessment report (EPAR): Nintedanib Accord, nintedanib, Date of authorisation: 19/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accordMon, 22 Apr 2024 11:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lymphoseekHuman medicines European public assessment report (EPAR): Lymphoseek, tilmanocept, Date of authorisation: 19/11/2014, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lymphoseekFri, 19 Apr 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/events/paediatric-oncology-strategy-forum-24-25-october-2024Paediatric Oncology Strategy Forum: 24-25 October 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 October 2024 to 25 October 2024https://www.ema.europa.eu/en/events/paediatric-oncology-strategy-forum-24-25-october-2024Fri, 19 Apr 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tevimbraHuman medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tevimbraFri, 19 Apr 2024 15:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cyramzaHuman medicines European public assessment report (EPAR): Cyramza, ramucirumab, Date of authorisation: 19/12/2014, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cyramzaFri, 19 Apr 2024 15:30:02 +0200What's newhttps://www.ema.europa.eu/en/events/industry-update-webinar-regulatory-procedure-management-product-lifecycle-management-iriIndustry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRI, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 June 2024, 10:00 (CEST) to 13 June 2024, 11:30 (CEST)https://www.ema.europa.eu/en/events/industry-update-webinar-regulatory-procedure-management-product-lifecycle-management-iriFri, 19 Apr 2024 15:25:28 +0200What's newhttps://www.ema.europa.eu/en/events/network-update-webinar-regulatory-procedure-management-product-lifecycle-management-irisNetwork Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 June 2024, 10:00 (CEST) to 18 June 2024, 11:30 (CEST)https://www.ema.europa.eu/en/events/network-update-webinar-regulatory-procedure-management-product-lifecycle-management-irisFri, 19 Apr 2024 15:15:19 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/respivac-trtVeterinary medicines European public assessment report (EPAR): Respivac TRT, Turkey rhinotracheitis virus, strain 1062, live, Status: Opinionhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/respivac-trtFri, 19 Apr 2024 15:12:51 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/annex-ii-call-proposals_vendor-identification-form_en.docxAnnex II to the call for proposals - Vendor financial identification formhttps://www.ema.europa.eu/system/files/documents/template-form/annex-ii-call-proposals_vendor-identification-form_en.docxFri, 19 Apr 2024 15:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/product-management-service-pms-product-ui-api-training-access-navigationProduct Management Service (PMS) Product UI and API training (access & navigation), Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 June 2024, 10:00 (CEST) to 3 June 2024, 11:30 (CEST)https://www.ema.europa.eu/en/events/product-management-service-pms-product-ui-api-training-access-navigationFri, 19 Apr 2024 14:59:42 +0200What's newhttps://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-psychedelics-towards-eu-regulatory-frameworkEMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2024, 13:00 (CEST) to 17 April 2024, 16:00 (CEST)https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-psychedelics-towards-eu-regulatory-frameworkFri, 19 Apr 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-medicinal-products-human-use-chmp-19-22-february-2024Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024, European Medicines Agency, Amsterdam, the Netherlands, from 19 February 2024 to 22 February 2024https://www.ema.europa.eu/en/events/committee-medicinal-products-human-use-chmp-19-22-february-2024Fri, 19 Apr 2024 14:26:11 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-accordHuman medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Date of authorisation: 26/04/2021, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-accordFri, 19 Apr 2024 14:18:00 +0200What's newhttps://www.ema.europa.eu/en/events/spor-status-update-0SPOR Status Update, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 July 2024, 10:00 (CEST) to 10 July 2024, 12:30 (CEST)https://www.ema.europa.eu/en/events/spor-status-update-0Fri, 19 Apr 2024 13:41:34 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-safety-signal_en.xlsxTimetable: Safety signal - Assessment of responses to request for supplementary information (RSI)https://www.ema.europa.eu/system/files/documents/other/timetable-safety-signal_en.xlsxFri, 19 Apr 2024 11:42:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-safety-signal-atmp_en.xlsxTimetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-safety-signal-atmp_en.xlsxFri, 19 Apr 2024 11:41:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-paediatric-art-46-submission-atmp_en.xlsxTimetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-paediatric-art-46-submission-atmp_en.xlsxFri, 19 Apr 2024 11:35:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-assessed-chmp_en.xlsxTimetable: Post-authorisation measure (PAM) assessed by CHMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-assessed-chmp_en.xlsxFri, 19 Apr 2024 11:34:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-assessed-prac_en.xlsxTimetable: Post-authorisation measure (PAM) assessed by PRAChttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-assessed-prac_en.xlsxFri, 19 Apr 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-assessed-prac-atmp_en.xlsxTimetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-post-authorisation-measure-pam-assessed-prac-atmp_en.xlsxFri, 19 Apr 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-accelerated-assessment-timetables_en_0.xlsxTimetable: Initial (full) marketing authorisation application accelerated assessment timetableshttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-accelerated-assessment-timetables_en_0.xlsxFri, 19 Apr 2024 11:15:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application_en.xlsxTimetable: Initial (full) marketing authorisation application assessmenthttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application_en.xlsxFri, 19 Apr 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-informed-consent-multiple-application_en.xlsxTimetable: Informed consent and multiple applicationhttps://www.ema.europa.eu/system/files/documents/other/timetable-informed-consent-multiple-application_en.xlsxFri, 19 Apr 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-accelerated-assessment-atmp_en_0.xlsxTimetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)https://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-accelerated-assessment-atmp_en_0.xlsxThu, 18 Apr 2024 17:31:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-extension-application_en.xlsxTimetable: Extension applicationhttps://www.ema.europa.eu/system/files/documents/other/timetable-extension-application_en.xlsxThu, 18 Apr 2024 17:20:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-accelerated-assessment-request-initial-marketing-authorisations_en_0.xlsxTimetable accelerated assessment request for initial marketing authorisation applicationshttps://www.ema.europa.eu/system/files/documents/other/timetable-accelerated-assessment-request-initial-marketing-authorisations_en_0.xlsxThu, 18 Apr 2024 16:29:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-extension-application-atmp_en.xlsxTimetable: Extension application - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-extension-application-atmp_en.xlsxThu, 18 Apr 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-mylanHuman medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan, sitagliptin hydrochloride monohydrate,metformin hydrochloride, Date of authorisation: 16/02/2022, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-mylanThu, 18 Apr 2024 15:50:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-initial-consultation-atmp_en.xlsxTimetable: Companion diagnostic initial consultation - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-initial-consultation-atmp_en.xlsxThu, 18 Apr 2024 15:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/inflectraHuman medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 30, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/inflectraThu, 18 Apr 2024 15:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lenvimaHuman medicines European public assessment report (EPAR): Lenvima, lenvatinib, Date of authorisation: 28/05/2015, Revision: 21, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lenvimaThu, 18 Apr 2024 15:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cystagonHuman medicines European public assessment report (EPAR): Cystagon, mercaptamine bitartrate, Date of authorisation: 23/06/1997, Revision: 18, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cystagonThu, 18 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ponvoryHuman medicines European public assessment report (EPAR): Ponvory, ponesimod, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ponvoryThu, 18 Apr 2024 15:25:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kisplyxHuman medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 22, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kisplyxThu, 18 Apr 2024 15:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ayvakytHuman medicines European public assessment report (EPAR): Ayvakyt, avapritinib, Date of authorisation: 24/09/2020, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ayvakytThu, 18 Apr 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/alymsysHuman medicines European public assessment report (EPAR): Alymsys, bevacizumab, Date of authorisation: 26/03/2021, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/alymsysThu, 18 Apr 2024 14:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/javlorHuman medicines European public assessment report (EPAR): Javlor, vinflunine, Date of authorisation: 21/09/2009, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/javlorThu, 18 Apr 2024 14:45:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-accelerated-assessment-request-initial-marketing-authorisations-atmp_en.xlsxTimetable: Accelerated assessment request for initial marketing authorisations - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-accelerated-assessment-request-initial-marketing-authorisations-atmp_en.xlsxThu, 18 Apr 2024 14:25:00 +0200What's newhttps://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-march-2024Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 March 2024, 10:00 (CET) to 19 March 2024, 12:00 (CET)https://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-march-2024Thu, 18 Apr 2024 14:05:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platformEuropean Shortages Monitoring Platformhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platformThu, 18 Apr 2024 14:03:13 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/menquadfiHuman medicines European public assessment report (EPAR): MenQuadfi, meningococcal group A, C, W-135 and Y conjugate vaccine, Date of authorisation: 18/11/2020, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/menquadfiThu, 18 Apr 2024 13:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/betmigaHuman medicines European public assessment report (EPAR): Betmiga, mirabegron, Date of authorisation: 20/12/2012, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/betmigaThu, 18 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/template-hmpc-ar-development-eu-monographs_en.pdfDraft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6https://www.ema.europa.eu/system/files/documents/template-form/template-hmpc-ar-development-eu-monographs_en.pdfThu, 18 Apr 2024 11:45:09 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/hmpc-guideline-gacp_en.pdfDraft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1https://www.ema.europa.eu/system/files/documents/scientific-guideline/hmpc-guideline-gacp_en.pdfThu, 18 Apr 2024 11:31:51 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zinplavaHuman medicines European public assessment report (EPAR): Zinplava, bezlotoxumab, Date of authorisation: 18/01/2017, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zinplavaThu, 18 Apr 2024 11:06:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kinzalkombHuman medicines European public assessment report (EPAR): Kinzalkomb, telmisartan,hydrochlorothiazide, Date of authorisation: 19/04/2002, Revision: 40, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kinzalkombThu, 18 Apr 2024 10:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-leon-farmaHuman medicines European public assessment report (EPAR): Dabigatran Etexilate Leon Farma, dabigatran etexilate, Date of authorisation: 19/02/2024, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-leon-farmaThu, 18 Apr 2024 10:50:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-accelerated-assessment-atmp_en.xlsxTimetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)https://www.ema.europa.eu/system/files/documents/other/timetable-initial-full-marketing-authorisation-application-accelerated-assessment-atmp_en.xlsxThu, 18 Apr 2024 10:13:00 +0200What's newhttps://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-may-2024Clinical Trials Information System (CTIS): Walk-in clinic - May 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 May 2024, 16:00 (CEST) to 15 May 2024, 17:00 (CEST)https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-may-2024Thu, 18 Apr 2024 09:59:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/takhzyroHuman medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/takhzyroThu, 18 Apr 2024 09:36:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/report/2024-03-human-maa-paa-report_en.pdfMedicinal products for human use: monthly figures - March 2024https://www.ema.europa.eu/system/files/documents/report/2024-03-human-maa-paa-report_en.pdfWed, 17 Apr 2024 18:02:12 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-follow-consultation_en.xlsxTimetable: Companion diagnostic follow-up consultationhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-follow-consultation_en.xlsxWed, 17 Apr 2024 16:52:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-follow-consultation-_atmp_en.xlsxTimetable: Companion diagnostic follow-up consultation - ATMPhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-follow-consultation-_atmp_en.xlsxWed, 17 Apr 2024 16:51:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-initial-consultation_en.xlsxTimetable: Companion diagnostic initial consultationhttps://www.ema.europa.eu/system/files/documents/other/timetable-companion-diagnostic-initial-consultation_en.xlsxWed, 17 Apr 2024 16:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xolairHuman medicines European public assessment report (EPAR): Xolair, omalizumab, Date of authorisation: 25/10/2005, Revision: 50, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xolairWed, 17 Apr 2024 16:03:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002981-pip01-21EMEA-002981-PIP01-21https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002981-pip01-21Wed, 17 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/talzennaHuman medicines European public assessment report (EPAR): Talzenna, talazoparib, Date of authorisation: 20/06/2019, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/talzennaWed, 17 Apr 2024 15:24:00 +0200What's newhttps://www.ema.europa.eu/en/events/ema-fve-info-session-restrictions-use-certain-antimicrobials-animalsEMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)https://www.ema.europa.eu/en/events/ema-fve-info-session-restrictions-use-certain-antimicrobials-animalsWed, 17 Apr 2024 15:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tepkinlyHuman medicines European public assessment report (EPAR): Tepkinly, epcoritamab, Date of authorisation: 22/09/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tepkinlyWed, 17 Apr 2024 13:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ocalivaHuman medicines European public assessment report (EPAR): Ocaliva, obeticholic acid, Date of authorisation: 12/12/2016, Revision: 20, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ocalivaWed, 17 Apr 2024 13:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/orserduHuman medicines European public assessment report (EPAR): Orserdu, elacestrant, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/orserduWed, 17 Apr 2024 10:29:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/venclyxtoHuman medicines European public assessment report (EPAR): Venclyxto, venetoclax, Date of authorisation: 04/12/2016, Revision: 18, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/venclyxtoWed, 17 Apr 2024 10:26:00 +0200What's newhttps://www.ema.europa.eu/en/news/covid-19-vaccine-strain-updates-global-regulators-agree-timing-data-requirementsCOVID-19 vaccine strain updates: Global regulators agree on timing and data requirementshttps://www.ema.europa.eu/en/news/covid-19-vaccine-strain-updates-global-regulators-agree-timing-data-requirementsWed, 17 Apr 2024 10:00:00 +0200What's newhttps://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmraInternational Coalition of Medicines Regulatory Authorities (ICMRA)https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmraWed, 17 Apr 2024 09:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler-previously-budesonide-formoterol-teva-pharma-bvHuman medicines European public assessment report (EPAR): GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.), budesonide,formoterol fumarate dihydrate, Date of authorisation: 03/04/2020, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler-previously-budesonide-formoterol-teva-pharma-bvTue, 16 Apr 2024 17:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/orkambiHuman medicines European public assessment report (EPAR): Orkambi, lumacaftor,ivacaftor, Date of authorisation: 19/11/2015, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/orkambiTue, 16 Apr 2024 16:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/briviact-italy-nubriveoHuman medicines European public assessment report (EPAR): Briviact (in Italy: Nubriveo), brivaracetam, Date of authorisation: 13/01/2016, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/briviact-italy-nubriveoTue, 16 Apr 2024 16:37:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-submitting-documentsPaediatric investigation plans: submitting documentshttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-submitting-documentsTue, 16 Apr 2024 16:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/entyvioHuman medicines European public assessment report (EPAR): Entyvio, vedolizumab, Date of authorisation: 22/05/2014, Revision: 27, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/entyvioTue, 16 Apr 2024 16:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/evrenzoHuman medicines European public assessment report (EPAR): Evrenzo, roxadustat, Date of authorisation: 18/08/2021, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/evrenzoTue, 16 Apr 2024 16:25:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/veozaHuman medicines European public assessment report (EPAR): Veoza, fezolinetant, Date of authorisation: 07/12/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/veozaTue, 16 Apr 2024 16:22:16 +0200What's newhttps://www.ema.europa.eu/en/events/ema-traineeship-programme-informative-sessionEMA traineeship programme informative session, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 23 April 2024, 10:00 (CEST) to 23 April 2024, 11:00 (CEST)https://www.ema.europa.eu/en/events/ema-traineeship-programme-informative-sessionTue, 16 Apr 2024 16:20:16 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zoonotic-influenza-vaccine-seqirusHuman medicines European public assessment report (EPAR): Zoonotic Influenza Vaccine Seqirus, Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted), Date of authorisation: 09/10/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zoonotic-influenza-vaccine-seqirusTue, 16 Apr 2024 12:43:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-supportClinical Trials Information System: training and supporthttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-supportTue, 16 Apr 2024 12:42:00 +0200What's newhttps://www.ema.europa.eu/en/events/clinical-trials-information-system-webinar-last-year-transitionClinical Trials Information System Webinar: Last Year of Transition, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 March 2024, 13:00 (CET) to 25 March 2024, 17:30 (CET)https://www.ema.europa.eu/en/events/clinical-trials-information-system-webinar-last-year-transitionTue, 16 Apr 2024 12:24:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/final-minutes-big-data-steering-group-26-february-2024_en.pdfFinal Minutes – HMA-EMA joint Big Data Steering Group teleconference - 26 February 2024https://www.ema.europa.eu/system/files/documents/minutes/final-minutes-big-data-steering-group-26-february-2024_en.pdfTue, 16 Apr 2024 11:34:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-17-19-april-2024Committee for Advanced Therapies (CAT): 17-19 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 17 April 2024 to 19 April 2024https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-17-19-april-2024Tue, 16 Apr 2024 10:50:00 +0200What's newhttps://www.ema.europa.eu/en/events/act-eu-clinical-trials-analytics-workshop-january-2024ACT EU Clinical Trials Analytics Workshop - January 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 January 2024, 13:00 (CET) to 26 January 2024, 13:00 (CET)https://www.ema.europa.eu/en/events/act-eu-clinical-trials-analytics-workshop-january-2024Tue, 16 Apr 2024 10:45:34 +0200What's newhttps://www.ema.europa.eu/en/events/committee-orphan-medicinal-products-comp-16-18-april-2024Committee for Orphan Medicinal Products (COMP): 16-18 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2024 to 18 April 2024https://www.ema.europa.eu/en/events/committee-orphan-medicinal-products-comp-16-18-april-2024Tue, 16 Apr 2024 09:57:00 +0200What's newhttps://www.ema.europa.eu/en/events/simultaneous-national-scientific-advice-information-training-webinarSimultaneous National Scientific Advice - information and training webinar , European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 April 2024, 10:00 (CEST) to 19 April 2024, 12:30 (CEST)https://www.ema.europa.eu/en/events/simultaneous-national-scientific-advice-information-training-webinarTue, 16 Apr 2024 09:52:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/advisory-functions-chart_source_masterorgchart_a3_v48_2_en.pdfOrganisation chart: Advisory functionshttps://www.ema.europa.eu/system/files/documents/other/advisory-functions-chart_source_masterorgchart_a3_v48_2_en.pdfTue, 16 Apr 2024 09:21:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/stakeholder-communication-division-chart_source_masterorgchart_a3_v46_2_en.pdfOrganisation chart: Stakeholders and Communicationhttps://www.ema.europa.eu/system/files/documents/other/stakeholder-communication-division-chart_source_masterorgchart_a3_v46_2_en.pdfTue, 16 Apr 2024 09:16:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-template-cover-letter_sign-transferor_vet_en.pdfTemplate - Application for transfer of marketing authorisation from transferor to transferee, cover letterhttps://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-template-cover-letter_sign-transferor_vet_en.pdfMon, 15 Apr 2024 17:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/translarnaHuman medicines European public assessment report (EPAR): Translarna, ataluren, Date of authorisation: 31/07/2014, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/translarnaMon, 15 Apr 2024 15:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/scemblixHuman medicines European public assessment report (EPAR): Scemblix, asciminib, Date of authorisation: 25/08/2022, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/scemblixMon, 15 Apr 2024 15:03:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/jakaviHuman medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 30, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/jakaviMon, 15 Apr 2024 13:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vargatefHuman medicines European public assessment report (EPAR): Vargatef, nintedanib, Date of authorisation: 21/11/2014, Revision: 19, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vargatefMon, 15 Apr 2024 13:04:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xospataHuman medicines European public assessment report (EPAR): Xospata, gilteritinib, Date of authorisation: 24/10/2019, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xospataMon, 15 Apr 2024 12:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/holoclarHuman medicines European public assessment report (EPAR): Holoclar, ex vivo expanded autologous human corneal epithelial cells containing stem cells, Date of authorisation: 17/02/2015, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/holoclarMon, 15 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/meeting-medicine-shortages-single-point-contact-spoc-working-party-12Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 14 February 2024, 10:00 (CET) to 14 February 2024, 13:30 (CET)https://www.ema.europa.eu/en/events/meeting-medicine-shortages-single-point-contact-spoc-working-party-12Mon, 15 Apr 2024 11:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/pilosellae-herba-cum-radiceHerbal medicinal product: Pilosellae herba cum radiceArray, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/pilosellae-herba-cum-radiceMon, 15 Apr 2024 11:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/eucalypti-aetheroleumHerbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/eucalypti-aetheroleumMon, 15 Apr 2024 10:53:00 +0200What's newhttps://www.ema.europa.eu/en/template-european-union-herbal-monographTemplate for a European Union herbal monographhttps://www.ema.europa.eu/en/template-european-union-herbal-monographMon, 15 Apr 2024 09:54:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/template-hmpc-european-union-herbal-monograph_en.pdfTemplate for a European Union herbal monographhttps://www.ema.europa.eu/system/files/documents/template-form/template-hmpc-european-union-herbal-monograph_en.pdfMon, 15 Apr 2024 09:49:48 +0200What's newhttps://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-meeting-interested-parties-may-2023Committee for Advanced Therapies (CAT) meeting with interested parties, May 2023, Online, European Medicines Agency, Amsterdam, the Netherlands, 16 May 2023https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-meeting-interested-parties-may-2023Fri, 12 Apr 2024 18:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/darzalexHuman medicines European public assessment report (EPAR): Darzalex, daratumumab, Date of authorisation: 20/05/2016, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/darzalexFri, 12 Apr 2024 17:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zeposiaHuman medicines European public assessment report (EPAR): Zeposia, ozanimod, Date of authorisation: 20/05/2020, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zeposiaFri, 12 Apr 2024 15:44:00 +0200What's newhttps://www.ema.europa.eu/en/events/cancer-medicines-forum-february-2024Cancer Medicines Forum: February 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, 26 February 2024https://www.ema.europa.eu/en/events/cancer-medicines-forum-february-2024Fri, 12 Apr 2024 15:07:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/how-we-work/big-dataBig datahttps://www.ema.europa.eu/en/about-us/how-we-work/big-dataFri, 12 Apr 2024 14:25:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/guidance-real-world-evidence-provided-ema_en.pdfGuidance on real-world evidence provided by EMA: support for regulatory decision-makinghttps://www.ema.europa.eu/system/files/documents/other/guidance-real-world-evidence-provided-ema_en.pdfFri, 12 Apr 2024 14:24:18 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/minutes-122nd-meeting-ema-management-board_en.pdfMinutes of the 122nd meeting of the Management Board, 13-14 December 2023https://www.ema.europa.eu/system/files/documents/minutes/minutes-122nd-meeting-ema-management-board_en.pdfFri, 12 Apr 2024 13:53:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/eladynos-0Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/eladynos-0Fri, 12 Apr 2024 12:02:00 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024Fri, 12 Apr 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/pharmaceutical-quality-inhalation-nasal-products-scientific-guidelinePharmaceutical quality of inhalation and nasal products - Scientific guidelinehttps://www.ema.europa.eu/en/pharmaceutical-quality-inhalation-nasal-products-scientific-guidelineFri, 12 Apr 2024 10:09:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/guideline-pharmaceutical-quality-inhalation-nasal-products-adopted-prom-12_en.pdfDraft guideline on the pharmaceutical quality of inhalation and nasal medicinal productshttps://www.ema.europa.eu/system/files/documents/scientific-guideline/guideline-pharmaceutical-quality-inhalation-nasal-products-adopted-prom-12_en.pdfFri, 12 Apr 2024 10:03:09 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/draft-hma-ema-guidance-document-identification-personal-data-commercially-confiden_en.pdfDraft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossierhttps://www.ema.europa.eu/system/files/documents/other/draft-hma-ema-guidance-document-identification-personal-data-commercially-confiden_en.pdfFri, 12 Apr 2024 09:28:07 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/oip-guideline-march-prom-adoption_7_final_en.pdfDraft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)https://www.ema.europa.eu/system/files/documents/scientific-guideline/oip-guideline-march-prom-adoption_7_final_en.pdfFri, 12 Apr 2024 09:12:50 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000727-pip01-09-m07Opinion/decision on a Paediatric investigation plan (PIP): Bosulif, Bosutinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0336/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000727-pip01-09-m07Thu, 11 Apr 2024 16:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/wegovyHuman medicines European public assessment report (EPAR): Wegovy, semaglutide, Date of authorisation: 06/01/2022, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/wegovyThu, 11 Apr 2024 15:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rybelsusHuman medicines European public assessment report (EPAR): Rybelsus, semaglutide, Date of authorisation: 03/04/2020, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rybelsusThu, 11 Apr 2024 15:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ozempicHuman medicines European public assessment report (EPAR): Ozempic, semaglutide, Date of authorisation: 08/02/2018, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ozempicThu, 11 Apr 2024 15:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1714Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1714Thu, 11 Apr 2024 15:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1236Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1236Thu, 11 Apr 2024 15:24:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/hma-ema-joint-big-data-steering-group-membership-list_en.pdfMembership list: HMA-EMA joint Big Data Steering Grouphttps://www.ema.europa.eu/system/files/documents/other/hma-ema-joint-big-data-steering-group-membership-list_en.pdfThu, 11 Apr 2024 15:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2873Orphan designation: 3,3-Dimethyl-N-(6-methyl-5-{[2-(1-methyl-1H-pyrazol-4-yl)pyridine-4-yl]oxy}pyridine-2-yl)-2-oxopyrrolidine-1-carboxamide hydrochloride hydrate Treatment of tenosynovial giant cell tumour, localised and diffuse type, 13/12/2023 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2873Thu, 11 Apr 2024 15:23:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-17-1861Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-17-1861Thu, 11 Apr 2024 15:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2723Orphan designation: Upifitamab rilsodotin Treatment of ovarian cancer, 09/12/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2723Thu, 11 Apr 2024 15:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2265Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2265Thu, 11 Apr 2024 15:16:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1515Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1515Thu, 11 Apr 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2184Orphan designation: N-((R)-2,3-dihydroxypropoxyl)-3,4-difluro-2-(2-fluoro-4-iodo-phenylamino)-benzamide Treatment of neurofibromatosis type 1, 25/07/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2184Thu, 11 Apr 2024 15:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-05-317Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-05-317Thu, 11 Apr 2024 15:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/yorvipathHuman medicines European public assessment report (EPAR): Yorvipath, Palopegteriparatide, Date of authorisation: 17/11/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/yorvipathThu, 11 Apr 2024 15:11:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-10-756Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-10-756Thu, 11 Apr 2024 15:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2319Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate Treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, 21/08/2020 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2319Thu, 11 Apr 2024 14:59:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2311Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 21/08/2020 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2311Thu, 11 Apr 2024 14:59:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2010Orphan designation: branaplam Treatment of spinal muscular atrophy, 16/04/2018 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2010Thu, 11 Apr 2024 14:54:00 +0200What's newhttps://www.ema.europa.eu/en/events/focus-group-veterinary-pharmacovigilance-reporting-aquacultureFocus group on veterinary pharmacovigilance reporting in aquaculture, European Medicines Agency, Amsterdam, the Netherlands, from 22 November 2023, 10:00 (CET) to 22 November 2023, 17:00 (CET)https://www.ema.europa.eu/en/events/focus-group-veterinary-pharmacovigilance-reporting-aquacultureThu, 11 Apr 2024 14:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/myclausenHuman medicines European public assessment report (EPAR): Myclausen, mycophenolate mofetil, Date of authorisation: 07/10/2010, Revision: 16, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/myclausenThu, 11 Apr 2024 14:51:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-17-1938Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-17-1938Thu, 11 Apr 2024 14:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2080Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2080Thu, 11 Apr 2024 14:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/febuxostat-viatris-previously-febuxostat-mylanHuman medicines European public assessment report (EPAR): Febuxostat Viatris (previously Febuxostat Mylan), febuxostat, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/febuxostat-viatris-previously-febuxostat-mylanThu, 11 Apr 2024 14:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2897Orphan designation: Repagermanium Treatment of focal segmental glomerulosclerosis, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2897Thu, 11 Apr 2024 14:40:37 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-ucbHuman medicines European public assessment report (EPAR): Lacosamide UCB, lacosamide, Date of authorisation: 26/08/2019, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-ucbThu, 11 Apr 2024 14:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2901Orphan designation: Andecaliximab Treatment of fibrodysplasia ossificans progressiva, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2901Thu, 11 Apr 2024 14:37:19 +0200What's newhttps://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-march-2024Clinical Trials Information System (CTIS): Walk-in clinic - March 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 12 March 2024, 16:00 (CET) to 12 March 2024, 17:00 (CET)https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-march-2024Thu, 11 Apr 2024 14:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2890Orphan designation: Raludotatug deruxtecan Treatment of ovarian cancer, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2890Thu, 11 Apr 2024 14:35:42 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2892Orphan designation: Treatment of small cell lung cancer, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2892Thu, 11 Apr 2024 14:28:33 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cellceptHuman medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Date of authorisation: 14/02/1996, Revision: 39, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cellceptThu, 11 Apr 2024 14:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2891Orphan designation: carboplatin Treatment of glioma, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2891Thu, 11 Apr 2024 14:26:03 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2899Orphan designation: Plerixafor Treatment of acute respiratory distress syndrome (ARDS), 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2899Thu, 11 Apr 2024 14:24:15 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/padcevHuman medicines European public assessment report (EPAR): Padcev, enfortumab vedotin, Date of authorisation: 13/04/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/padcevThu, 11 Apr 2024 14:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2898Orphan designation: Donidalorsen Treatment of hereditary angioedema, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2898Thu, 11 Apr 2024 14:10:54 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2900Orphan designation: Autologous CD3-positive T-cells expressing a chimeric antigen receptor against B cell maturation agent Treatment of AL amyloidosis, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2900Thu, 11 Apr 2024 14:08:27 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2896Orphan designation: Human IgG1 monoclonal antibody targeting amyloid transthyretin Treatment of ATTR amyloidosis, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2896Thu, 11 Apr 2024 14:06:05 +0200What's newhttps://www.ema.europa.eu/en/events/eighth-industry-standing-group-isg-meetingEighth Industry Standing Group (ISG) meeting, European Medicines Agency, Amsterdam, the Netherlands, 25 March 2024https://www.ema.europa.eu/en/events/eighth-industry-standing-group-isg-meetingThu, 11 Apr 2024 14:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2887Orphan designation: Gorilla adenovirus vector expressing HPV6 and HPV11 antigens Treatment of recurrent respiratory papillomatosis, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2887Thu, 11 Apr 2024 14:00:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2888Orphan designation: Recombinant human heparan-N-sulfatase Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome), 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2888Thu, 11 Apr 2024 13:58:46 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2881Orphan designation: Ziftomenib Treatment of acute myeloid leukaemia, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2881Thu, 11 Apr 2024 13:56:56 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2877Orphan designation: Apilimod dimesilate Treatment of amyotrophic lateral sclerosis, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2877Thu, 11 Apr 2024 13:55:24 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2884Orphan designation: Adeno-associated viral vector serotype 9 containing the human MECP2 gene, an intron encoding a miRNA generating sequence, and complementary miRNA binding sites Treatment of Rett syndrome, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2884Thu, 11 Apr 2024 13:52:52 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2883Orphan designation: cutamesine alpha-thalassaemia X-linked intellectual disability syndrome (due to mutations in the ATRX gene), 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2883Thu, 11 Apr 2024 13:49:52 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2876Orphan designation: Tarlatamab Treatment of small cell lung cancer, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2876Thu, 11 Apr 2024 13:47:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/glivecHuman medicines European public assessment report (EPAR): Glivec, imatinib, Date of authorisation: 07/11/2001, Revision: 48, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/glivecThu, 11 Apr 2024 12:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/fampridine-accordHuman medicines European public assessment report (EPAR): Fampridine Accord, fampridine, Date of authorisation: 24/09/2020, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/fampridine-accordThu, 11 Apr 2024 12:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xromiHuman medicines European public assessment report (EPAR): Xromi, hydroxycarbamide, Date of authorisation: 01/07/2019, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xromiThu, 11 Apr 2024 12:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/entecavir-viatris-previously-entecavir-mylanHuman medicines European public assessment report (EPAR): Entecavir Viatris (previously Entecavir Mylan), entecavir, Date of authorisation: 18/09/2017, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/entecavir-viatris-previously-entecavir-mylanThu, 11 Apr 2024 12:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2885Orphan designation: motixafortide Treatment of patients undergoing haematopoietic stem cell transplantation, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2885Thu, 11 Apr 2024 12:13:52 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2889Orphan designation: mitapivat sulfate Treatment of thalassaemia intermedia and major, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2889Thu, 11 Apr 2024 12:11:57 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2875Orphan designation: Thiophene methylimidazole pentahydrogen Diagnosis of glioma, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2875Thu, 11 Apr 2024 12:07:22 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2879Orphan designation: Ersodetug Treatment of insulinoma, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2879Thu, 11 Apr 2024 12:05:25 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2882Orphan designation: Methyl-(1-{[6-{[(1S)-1-cyclopropylethyl]amino}-2-(pyrazolo[5,1-b][1,3]thiazol-7-yl)-pyrimidin-4-yl]carbonyl}piperidin-4-yl)carbamate mono(4-methylbenzenesulfonate) Treatment of eosinophilic granulomatosis with polyangiitis, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2882Thu, 11 Apr 2024 12:00:42 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2878Orphan designation: golcadomide hydrochloride Treatment of diffuse large B-cell lymphoma, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2878Thu, 11 Apr 2024 11:58:53 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2886Orphan designation: Human coagulation factor X Treatment of acquired factor X deficiency, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2886Thu, 11 Apr 2024 11:52:40 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2874Orphan designation: (4R)-3-(4-fluoro-2-hydroxyphenyl)-4-methyl-4,5-dihydro-1H-pyrazole-1-carboximidamide hydrochloride Treatment of systemic sclerosis, 12/01/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2874Thu, 11 Apr 2024 11:47:57 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2894Orphan designation: mRNA encoding the human CFTR gene Treatment of cystic fibrosis, 19/02/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2894Thu, 11 Apr 2024 11:37:10 +0200What's newhttps://www.ema.europa.eu/en/events/cancer-medicines-forum-workshop-april-2024Cancer Medicines Forum workshop: April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 5 April 2024, 13:00 (CEST) to 5 April 2024, 18:00 (CEST)https://www.ema.europa.eu/en/events/cancer-medicines-forum-workshop-april-2024Thu, 11 Apr 2024 11:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/gardasil-9Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus 9-valent vaccine (recombinant, adsorbed), Date of authorisation: 10/06/2015, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/gardasil-9Thu, 11 Apr 2024 11:09:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zaltrapHuman medicines European public assessment report (EPAR): Zaltrap, aflibercept, Date of authorisation: 01/02/2013, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zaltrapThu, 11 Apr 2024 10:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ambrisentan-mylanHuman medicines European public assessment report (EPAR): Ambrisentan Mylan, ambrisentan, Date of authorisation: 20/06/2019, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ambrisentan-mylanThu, 11 Apr 2024 10:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/tessieVeterinary medicines European public assessment report (EPAR): Tessie, tasipimidine, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/tessieThu, 11 Apr 2024 10:34:00 +0200What's newhttps://www.ema.europa.eu/en/news-and-events/publications/scientific-publicationsScientific publicationshttps://www.ema.europa.eu/en/news-and-events/publications/scientific-publicationsThu, 11 Apr 2024 09:41:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/myfenaxHuman medicines European public assessment report (EPAR): Myfenax, mycophenolate mofetil, Date of authorisation: 21/02/2008, Revision: 28, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/myfenaxWed, 10 Apr 2024 13:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mycophenolate-mofetil-tevaHuman medicines European public assessment report (EPAR): Mycophenolate mofetil Teva, mycophenolate mofetil, Date of authorisation: 21/02/2008, Revision: 26, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/mycophenolate-mofetil-tevaWed, 10 Apr 2024 13:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ranexa-previously-latixaHuman medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Date of authorisation: 08/07/2008, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ranexa-previously-latixaWed, 10 Apr 2024 13:31:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/members-coordinating-group-enpr-ema_en_0.pdfMembers of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)https://www.ema.europa.eu/system/files/documents/other/members-coordinating-group-enpr-ema_en_0.pdfWed, 10 Apr 2024 12:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cancidas-previously-caspofungin-msdHuman medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin, Date of authorisation: 23/10/2001, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cancidas-previously-caspofungin-msdWed, 10 Apr 2024 11:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/gavretoHuman medicines European public assessment report (EPAR): Gavreto, pralsetinib, Date of authorisation: 18/11/2021, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/gavretoWed, 10 Apr 2024 11:33:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nivestimHuman medicines European public assessment report (EPAR): Nivestim, filgrastim, Date of authorisation: 07/06/2010, Revision: 29, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nivestimWed, 10 Apr 2024 10:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abilify-maintenaHuman medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Date of authorisation: 14/11/2013, Revision: 21, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abilify-maintenaWed, 10 Apr 2024 10:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sarclisaHuman medicines European public assessment report (EPAR): Sarclisa, isatuximab, Date of authorisation: 30/05/2020, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sarclisaWed, 10 Apr 2024 10:22:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kyprolisHuman medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Date of authorisation: 19/11/2015, Revision: 21, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kyprolisWed, 10 Apr 2024 09:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aerinazeHuman medicines European public assessment report (EPAR): Aerinaze, desloratadine,pseudoephedrine, Date of authorisation: 30/07/2007, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aerinazeWed, 10 Apr 2024 08:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ninlaroHuman medicines European public assessment report (EPAR): Ninlaro, ixazomib, Date of authorisation: 21/11/2016, Revision: 18, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ninlaroTue, 09 Apr 2024 16:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tepadinaHuman medicines European public assessment report (EPAR): Tepadina, thiotepa, Date of authorisation: 15/03/2010, Revision: 21, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tepadinaTue, 09 Apr 2024 16:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dupixentHuman medicines European public assessment report (EPAR): Dupixent, dupilumab, Date of authorisation: 26/09/2017, Revision: 32, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/dupixentTue, 09 Apr 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/events/update-webinar-regulatory-procedure-management-product-lifecycle-management-irisUpdate webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS, Online, from 13 February 2024, 10:00 (CET) to 13 February 2024, 11:30 (CET)https://www.ema.europa.eu/en/events/update-webinar-regulatory-procedure-management-product-lifecycle-management-irisTue, 09 Apr 2024 15:27:00 +0200What's newhttps://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-veterinary-medicines/variations-not-requiring-assessment-veterinary-medicinesVariations not requiring assessment (veterinary medicines)https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-veterinary-medicines/variations-not-requiring-assessment-veterinary-medicinesTue, 09 Apr 2024 15:24:00 +0200What's newhttps://www.ema.europa.eu/en/events/focus-group-veterinary-pharmacovigilance-reporting-poultryFocus group on veterinary pharmacovigilance reporting in poultry, European Medicines Agency, Amsterdam, the Netherlands, 11 October 2023https://www.ema.europa.eu/en/events/focus-group-veterinary-pharmacovigilance-reporting-poultryTue, 09 Apr 2024 15:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2090Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2090Tue, 09 Apr 2024 14:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-10-830Orphan designation: Veliparib Treatment of ovarian cancer, 17/12/2010 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-10-830Tue, 09 Apr 2024 14:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1265Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1265Tue, 09 Apr 2024 14:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-11-902Orphan designation: Eflornithine Treatment of neuroblastoma, 27/09/2011 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-11-902Tue, 09 Apr 2024 14:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1808Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1808Tue, 09 Apr 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2334Orphan designation: Adeno-associated viral vector serotype 9 encoding a codon-optimised human aspartylglucosaminidase transgene Treatment of aspartylglucosaminuria, 19/10/2020 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2334Tue, 09 Apr 2024 14:51:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1736Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1736Tue, 09 Apr 2024 14:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2070Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid Treatment of dermatomyositis Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2070Tue, 09 Apr 2024 14:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2324Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile Treatment of von Hippel-Lindau disease, 21/08/2020 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2324Tue, 09 Apr 2024 14:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2309Orphan designation: Bis-(3-deoxy-3-(4-(3-fluorophenyl)-1H-1,2,3-triazol-1-yl)-beta-D-galactopyranosyl) sulfane Treatment of idiopathic pulmonary fibrosis, 21/08/2020 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2309Tue, 09 Apr 2024 14:46:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-09-632Orphan designation: Adeno-associated viral vector containing porphobilinogen deaminase gene Treatment of acute intermittent porphyria, 29/04/2009 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-09-632Tue, 09 Apr 2024 14:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-12-974Orphan designation: Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate-aminotransferase gene Treatment of primary hyperoxaluria type 1, 21/03/2012 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-12-974Tue, 09 Apr 2024 14:43:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-09-663Orphan designation: Adeno-associated viral vector containing modified U1 snRNA Treatment of Duchenne muscular dystrophy, 08/10/2009 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-09-663Tue, 09 Apr 2024 14:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1631Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1631Tue, 09 Apr 2024 14:41:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1632Orphan designation: Florilglutamic acid (18F) Diagnosis of hepatocellular carcinoma, 21/03/2016 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1632Tue, 09 Apr 2024 14:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2593Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2593Tue, 09 Apr 2024 14:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2341Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding galactosidase alpha Treatment of Fabry disease, 19/10/2020 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2341Tue, 09 Apr 2024 14:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2326Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta Treatment of Gaucher disease, 21/08/2020 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2326Tue, 09 Apr 2024 14:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2015Orphan designation: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII Treatment of haemophilia A, 25/05/2018 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2015Tue, 09 Apr 2024 14:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/komboglyzeHuman medicines European public assessment report (EPAR): Komboglyze, saxagliptin,metformin hydrochloride, Date of authorisation: 24/11/2011, Revision: 22, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/komboglyzeTue, 09 Apr 2024 12:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/myozymeHuman medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Date of authorisation: 28/03/2006, Revision: 29, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/myozymeTue, 09 Apr 2024 12:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/braftoviHuman medicines European public assessment report (EPAR): Braftovi, encorafenib, Date of authorisation: 19/09/2018, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/braftoviTue, 09 Apr 2024 12:15:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/minutes-prac-meeting-05-08-february-2024_en.pdfMinutes of the PRAC meeting 5-8 February 2024https://www.ema.europa.eu/system/files/documents/minutes/minutes-prac-meeting-05-08-february-2024_en.pdfTue, 09 Apr 2024 12:13:12 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bondronatHuman medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Date of authorisation: 25/06/1996, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bondronatMon, 08 Apr 2024 17:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bonvivaHuman medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Date of authorisation: 23/02/2004, Revision: 30, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bonvivaMon, 08 Apr 2024 16:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xydalbaHuman medicines European public assessment report (EPAR): Xydalba, dalbavancin, Date of authorisation: 19/02/2015, Revision: 16, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xydalbaMon, 08 Apr 2024 16:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2135Orphan designation: Allogeneic cultured postnatal thymus-derived tissue Treatment of DiGeorge syndrome, 26/02/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2135Mon, 08 Apr 2024 16:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2136Orphan designation: Allogeneic cultured postnatal thymus-derived tissue Treatment of CHARGE syndrome, 26/02/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2136Mon, 08 Apr 2024 16:43:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2568Orphan designation: Azithromycin dihydrate Prevention of bronchopulmonary dysplasia, 14/01/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2568Mon, 08 Apr 2024 16:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2183Orphan designation: Mavorixafor Treatment of WHIM syndrome, 25/07/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2183Mon, 08 Apr 2024 16:35:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/agenda-prac-meeting-8-11-april-2024_en.pdfAgenda of the PRAC meeting 8-11 April 2024https://www.ema.europa.eu/system/files/documents/agenda/agenda-prac-meeting-8-11-april-2024_en.pdfMon, 08 Apr 2024 16:33:20 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2271Orphan designation: haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate Treatment in haematopoietic stem cell transplantation, 20/04/2020 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2271Mon, 08 Apr 2024 16:31:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1534Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid Treatment of Rett syndrome, 10/08/2015 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1534Mon, 08 Apr 2024 16:29:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1529Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid Treatment of fragile X syndrome, 28/07/2015 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-15-1529Mon, 08 Apr 2024 16:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2203Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} Treatment of Netherton syndrome, 17/10/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2203Mon, 08 Apr 2024 16:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2214Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2214Mon, 08 Apr 2024 16:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2511Orphan designation: Adeno-associated virus serotype rh10 containing the human GALC gene Treatment of Krabbe disease, 15/10/2021 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2511Mon, 08 Apr 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1759Orphan designation: Recombinant adeno-associated viral vector encoding a human micro-dystrophin gene under the control of a muscle specific promoter Treatment of Duchenne muscular dystrophy, 14/10/2016 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1759Mon, 08 Apr 2024 16:03:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2563Orphan designation: Olorofim Treatment of invasive Scopulariopsis, 14/01/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2563Mon, 08 Apr 2024 15:59:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-12-978Orphan designation: melatonin Treatment of perinatal asphyxia, 02/04/2012 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-12-978Mon, 08 Apr 2024 15:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2407Orphan designation: Autologous CD34+ cells transduced with a lentiviral RNA vector that results in integrated cDNA encoding for functional cystinosin Treatment of cystinosis, 19/02/2021 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2407Mon, 08 Apr 2024 15:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2449Orphan designation: imatinib Treatment of pulmonary arterial hypertension, 21/06/2021 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2449Mon, 08 Apr 2024 15:46:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-07-434Orphan designation: idebenone Treatment of Leber's hereditary optic neuropathy, 16/02/2007 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-07-434Mon, 08 Apr 2024 15:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2354Orphan designation: Alisitol, retinol palmitate, zinc gluconate Treatment of microvillus inclusion disease, 13/11/2020 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2354Mon, 08 Apr 2024 15:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2606Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia A, 13/04/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2606Mon, 08 Apr 2024 15:35:05 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2232Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2232Mon, 08 Apr 2024 15:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2715Orphan designation: rovatirelin Treatment of spinocerebellar ataxia, 11/11/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2715Mon, 08 Apr 2024 15:29:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/viagraHuman medicines European public assessment report (EPAR): Viagra, sildenafil, Date of authorisation: 13/09/1998, Revision: 47, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/viagraMon, 08 Apr 2024 14:36:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/contacts-european-medicines-agencyContacts at the European Medicines Agencyhttps://www.ema.europa.eu/en/about-us/contacts-european-medicines-agencyMon, 08 Apr 2024 14:17:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/how-we-work/services-databasesServices and databaseshttps://www.ema.europa.eu/en/about-us/how-we-work/services-databasesMon, 08 Apr 2024 14:16:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/enjaymoHuman medicines European public assessment report (EPAR): Enjaymo, sutimlimab, Date of authorisation: 15/11/2022, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/enjaymoMon, 08 Apr 2024 14:07:00 +0200What's newhttps://www.ema.europa.eu/en/news/ema-systems-disruption-expected-11-17-aprilEMA systems disruption expected from 11 to 17 Aprilhttps://www.ema.europa.eu/en/news/ema-systems-disruption-expected-11-17-aprilMon, 08 Apr 2024 10:58:31 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/orenciaWithdrawn application: Orencia, 19/02/2024https://www.ema.europa.eu/en/medicines/human/variation/orenciaMon, 08 Apr 2024 10:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001821-pip01-15-m06EMEA-001821-PIP01-15-M06https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001821-pip01-15-m06Mon, 08 Apr 2024 10:22:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002063-pip01-16-m02Opinion/decision on a Paediatric investigation plan (PIP): Trixeo Aerosphere, Budesonide,Formoterol (fumarate),Glycopyrronium bromide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: P/0068/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002063-pip01-16-m02Mon, 08 Apr 2024 09:56:05 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002070-pip01-16-m07Opinion/decision on a Paediatric investigation plan (PIP): Evrysdi, Risdiplam (RO7034067), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0086/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002070-pip01-16-m07Mon, 08 Apr 2024 09:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002079-pip01-16-m03EMEA-002079-PIP01-16-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002079-pip01-16-m03Mon, 08 Apr 2024 09:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003170-pip01-21-m01EMEA-003170-PIP01-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003170-pip01-21-m01Mon, 08 Apr 2024 09:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cibinqoHuman medicines European public assessment report (EPAR): Cibinqo, abrocitinib, Date of authorisation: 09/12/2021, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cibinqoMon, 08 Apr 2024 09:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000334-pip01-08-m11EMEA-000334-PIP01-08-M11https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000334-pip01-08-m11Fri, 05 Apr 2024 17:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000576-pip01-09-m14Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0102/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000576-pip01-09-m14Fri, 05 Apr 2024 17:31:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000997-pip01-10-m06Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0088/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000997-pip01-10-m06Fri, 05 Apr 2024 17:27:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001220-pip01-11-m07Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0063/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001220-pip01-11-m07Fri, 05 Apr 2024 17:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003238-pip01-22EMEA-003238-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003238-pip01-22Fri, 05 Apr 2024 17:11:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003241-pip01-22EMEA-003241-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003241-pip01-22Fri, 05 Apr 2024 17:07:21 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003245-pip01-22EMEA-003245-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003245-pip01-22Fri, 05 Apr 2024 17:01:36 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/imfinziHuman medicines European public assessment report (EPAR): Imfinzi, durvalumab, Date of authorisation: 21/09/2018, Revision: 19, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/imfinziFri, 05 Apr 2024 16:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003317-pip02-22EMEA-003317-PIP02-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003317-pip02-22Fri, 05 Apr 2024 16:54:29 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aspaveliHuman medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aspaveliFri, 05 Apr 2024 16:51:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/strimvelisHuman medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence, Date of authorisation: 26/05/2016, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/strimvelisFri, 05 Apr 2024 16:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003032-pip01-21-m01EMEA-003032-PIP01-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003032-pip01-21-m01Fri, 05 Apr 2024 16:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lonsurfHuman medicines European public assessment report (EPAR): Lonsurf, trifluridine,tipiracil, Date of authorisation: 25/04/2016, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lonsurfFri, 05 Apr 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/perjetaHuman medicines European public assessment report (EPAR): Perjeta, pertuzumab, Date of authorisation: 04/03/2013, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/perjetaFri, 05 Apr 2024 16:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001809-pip01-15-m03Opinion/decision on a Paediatric investigation plan (PIP): Recarbrio, relebactam (MK-7655A),cilastatin sodium,imipenem monohydrate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0090/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001809-pip01-15-m03Fri, 05 Apr 2024 16:04:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001744-pip01-14-m02EMEA-001744-PIP01-14-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001744-pip01-14-m02Fri, 05 Apr 2024 15:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001734-pip01-14-m06Opinion/decision on a Paediatric investigation plan (PIP): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: P/0103/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001734-pip01-14-m06Fri, 05 Apr 2024 15:31:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003237-pip01-22EMEA-003237-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003237-pip01-22Fri, 05 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003218-pip01-22EMEA-003218-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003218-pip01-22Fri, 05 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003171-pip01-21EMEA-003171-PIP01-21https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003171-pip01-21Fri, 05 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001332-pip01-12-m06Opinion/decision on a Paediatric investigation plan (PIP): Lydisilka, Estetrol,drospirenone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0071/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001332-pip01-12-m06Fri, 05 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001429-pip01-13-m07Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology;Oncology, PIP number: P/0079/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001429-pip01-13-m07Fri, 05 Apr 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001371-pip03-22EMEA-001371-PIP03-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001371-pip03-22Fri, 05 Apr 2024 14:30:43 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/p-0096-2023-ema-decision-10-march-2023-granting-product-specific-waiver-pembrolizumab-keytruda-emea-001474-pip03-22Opinion/decision on a Paediatric investigation plan (PIP): Keytruda, Pembrolizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0096/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/p-0096-2023-ema-decision-10-march-2023-granting-product-specific-waiver-pembrolizumab-keytruda-emea-001474-pip03-22Fri, 05 Apr 2024 14:10:35 +0200What's newhttps://www.ema.europa.eu/en/events/third-european-medicines-agency-affordable-medicines-europe-bilateral-meetingThird European Medicines Agency and Affordable Medicines Europe bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 10 April 2024https://www.ema.europa.eu/en/events/third-european-medicines-agency-affordable-medicines-europe-bilateral-meetingFri, 05 Apr 2024 12:09:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/recruitment/traineeship-faq-2020_en.pdfTraineeship - Frequently asked questions (FAQs)https://www.ema.europa.eu/system/files/documents/recruitment/traineeship-faq-2020_en.pdfFri, 05 Apr 2024 11:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002690-pip02-22Opinion/decision on a Paediatric investigation plan (PIP): Lumykras, sotorasib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0089/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002690-pip02-22Fri, 05 Apr 2024 11:44:31 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003166-pip01-21EMEA-003166-PIP01-21https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003166-pip01-21Fri, 05 Apr 2024 11:35:24 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003215-pip01-22EMEA-003215-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003215-pip01-22Fri, 05 Apr 2024 11:28:01 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/instanylHuman medicines European public assessment report (EPAR): Instanyl, fentanyl, Date of authorisation: 20/07/2009, Revision: 37, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/instanylFri, 05 Apr 2024 10:22:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answersTransfer of marketing authorisation: questions and answershttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answersThu, 04 Apr 2024 17:34:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-industry-smes-planned-calls_en.pdfList of industry subject matter experts and list of planned calls for industry subject matter expertshttps://www.ema.europa.eu/system/files/documents/other/list-industry-smes-planned-calls_en.pdfThu, 04 Apr 2024 16:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/pseudoephedrine-containing-medicinal-productsReferral: Pseudoephedrine-containing medicinal products, pseudoephedrine Article 31 referrals European Commission final decision, 25/01/2024, 27/03/2024, 04/04/2024https://www.ema.europa.eu/en/medicines/human/referrals/pseudoephedrine-containing-medicinal-productsThu, 04 Apr 2024 15:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/niapelfHuman medicines European public assessment report (EPAR): Niapelf, paliperidone, Date of authorisation: 31/03/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/niapelfThu, 04 Apr 2024 15:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/opdivoHuman medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 58, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/opdivoThu, 04 Apr 2024 14:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13Human medicines European public assessment report (EPAR): Prevenar 13, pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed), Date of authorisation: 09/12/2009, Revision: 47, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13Thu, 04 Apr 2024 14:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-mylanHuman medicines European public assessment report (EPAR): Abiraterone Mylan, abiraterone acetate, Date of authorisation: 20/08/2021, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-mylanThu, 04 Apr 2024 14:01:00 +0200What's newhttps://www.ema.europa.eu/en/events/paediatric-committee-pdco-20-23-february-2024Paediatric Committee (PDCO): 20-23 February 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 February 2024 to 23 February 2024https://www.ema.europa.eu/en/events/paediatric-committee-pdco-20-23-february-2024Thu, 04 Apr 2024 13:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudaHuman medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Date of authorisation: 17/07/2015, Revision: 56, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudaThu, 04 Apr 2024 12:02:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pecfentHuman medicines European public assessment report (EPAR): PecFent, fentanyl, Date of authorisation: 31/08/2010, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pecfentThu, 04 Apr 2024 11:39:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/day-80-assessment-report-clinical-template-guidance-rev-0424-revamp_en.docxDay 80 assessment report - Clinical template with guidance - Rev.04.24 Revamphttps://www.ema.europa.eu/system/files/documents/template-form/day-80-assessment-report-clinical-template-guidance-rev-0424-revamp_en.docxThu, 04 Apr 2024 11:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/effentoraHuman medicines European public assessment report (EPAR): Effentora, fentanyl, Date of authorisation: 04/04/2008, Revision: 29, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/effentoraThu, 04 Apr 2024 11:31:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dovatoHuman medicines European public assessment report (EPAR): Dovato, dolutegravir,lamivudine, Date of authorisation: 10/06/2022, Revision: 15, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/dovatoThu, 04 Apr 2024 11:23:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vfendHuman medicines European public assessment report (EPAR): Vfend, voriconazole, Date of authorisation: 19/03/2002, Revision: 56, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vfendThu, 04 Apr 2024 11:14:00 +0200What's newhttps://www.ema.europa.eu/en/assessment-templates-guidanceAssessment templates and guidancehttps://www.ema.europa.eu/en/assessment-templates-guidanceThu, 04 Apr 2024 11:12:00 +0200What's newhttps://www.ema.europa.eu/en/reflection-papers-regulatory-requirements-development-medicinal-products-chronic-non-infectious-liver-diseases-pbc-psc-nash-scientific-guidelineReflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guidelinehttps://www.ema.europa.eu/en/reflection-papers-regulatory-requirements-development-medicinal-products-chronic-non-infectious-liver-diseases-pbc-psc-nash-scientific-guidelineThu, 04 Apr 2024 09:51:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-prime-products-march-2024-en_0.xlsxList of medicines currently in PRIME schemehttps://www.ema.europa.eu/system/files/documents/other/list-prime-products-march-2024-en_0.xlsxWed, 03 Apr 2024 16:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rubracaHuman medicines European public assessment report (EPAR): Rubraca, rucaparib, Date of authorisation: 23/05/2018, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rubracaWed, 03 Apr 2024 16:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sixmoHuman medicines European public assessment report (EPAR): Sixmo, buprenorphine, Date of authorisation: 19/06/2019, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sixmoWed, 03 Apr 2024 16:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ertapenem-sunHuman medicines European public assessment report (EPAR): Ertapenem SUN, ertapenem, Date of authorisation: 15/07/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ertapenem-sunWed, 03 Apr 2024 16:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-nasalgen-cVeterinary medicines European public assessment report (EPAR): Bovilis Nasalgen-C, bovine coronavirus, strain CA25, live, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-nasalgen-cWed, 03 Apr 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sorafenib-accordHuman medicines European public assessment report (EPAR): Sorafenib Accord, sorafenib, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sorafenib-accordWed, 03 Apr 2024 14:23:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/levodopa-carbidopa-entacapone-orionHuman medicines European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion, levodopa,carbidopa,entacapone, Date of authorisation: 23/08/2011, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/levodopa-carbidopa-entacapone-orionWed, 03 Apr 2024 13:19:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/revestiveHuman medicines European public assessment report (EPAR): Revestive, teduglutide, Date of authorisation: 30/08/2012, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/revestiveWed, 03 Apr 2024 13:06:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/yuflymaHuman medicines European public assessment report (EPAR): Yuflyma, adalimumab, Date of authorisation: 11/02/2021, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/yuflymaWed, 03 Apr 2024 13:05:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-orphan-medicinal-products-comp-13-15-february-2024Committee for Orphan Medicinal Products (COMP): 13-15 February 2024, European Medicines Agency, Amsterdam, the Netherlands, from 13 February 2024 to 15 February 2024https://www.ema.europa.eu/en/events/committee-orphan-medicinal-products-comp-13-15-february-2024Wed, 03 Apr 2024 12:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abecmaHuman medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Date of authorisation: 18/08/2021, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abecmaWed, 03 Apr 2024 12:40:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/marketing-authorisation-templatesMarketing authorisation templateshttps://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/marketing-authorisation-templatesWed, 03 Apr 2024 11:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/celdoxome-pegylated-liposomalHuman medicines European public assessment report (EPAR): Celdoxome pegylated liposomal, doxorubicin hydrochloride, Date of authorisation: 15/09/2022, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/celdoxome-pegylated-liposomalTue, 02 Apr 2024 17:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sutentHuman medicines European public assessment report (EPAR): Sutent, sunitinib, Date of authorisation: 19/07/2006, Revision: 40, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sutentTue, 02 Apr 2024 16:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsiHuman medicines European public assessment report (EPAR): Pedmarqsi, sodium thiosulfate, Date of authorisation: 26/05/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsiTue, 02 Apr 2024 16:11:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pylclariHuman medicines European public assessment report (EPAR): Pylclari, piflufolastat (18F), Date of authorisation: 27/11/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pylclariTue, 02 Apr 2024 16:07:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/data-protection-privacyData protection and privacyhttps://www.ema.europa.eu/en/about-us/data-protection-privacyTue, 02 Apr 2024 15:26:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/medical-devicesMedical deviceshttps://www.ema.europa.eu/en/human-regulatory-overview/medical-devicesTue, 02 Apr 2024 14:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/locametzHuman medicines European public assessment report (EPAR): Locametz, gozetotide, Date of authorisation: 09/12/2022, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/locametzTue, 02 Apr 2024 14:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/teriparatide-sunHuman medicines European public assessment report (EPAR): Teriparatide Sun, teriparatide, Date of authorisation: 18/11/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/teriparatide-sunTue, 02 Apr 2024 14:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cometriqHuman medicines European public assessment report (EPAR): Cometriq, cabozantinib, Date of authorisation: 21/03/2014, Revision: 28, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cometriqTue, 02 Apr 2024 13:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-610Orphan designation: Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt (cabozantinib) Treatment of medullary thyroid carcinoma, 06/02/2009 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-610Tue, 02 Apr 2024 13:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/vitis-viniferae-foliumHerbal medicinal product: Vitis viniferae foliumArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/vitis-viniferae-foliumTue, 02 Apr 2024 11:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/verbasci-flosHerbal medicinal product: Verbasci flosArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/verbasci-flosTue, 02 Apr 2024 11:48:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishmentProcedures for monograph and list entry establishmenthttps://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishmentTue, 02 Apr 2024 11:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/oenotherae-oleumHerbal medicinal product: Oenotherae oleumArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/oenotherae-oleumTue, 02 Apr 2024 11:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/uvae-ursi-foliumHerbal medicinal product: Uvae ursi foliumArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/uvae-ursi-foliumTue, 02 Apr 2024 11:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/myrrhaHerbal medicinal product: MyrrhaArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/myrrhaTue, 02 Apr 2024 11:46:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/melissae-foliumHerbal medicinal product: Melissae foliumArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/melissae-foliumTue, 02 Apr 2024 11:46:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/meliloti-herbaHerbal medicinal product: Meliloti herbaArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/meliloti-herbaTue, 02 Apr 2024 11:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/cynarae-foliumHerbal medicinal product: Cynarae foliumArray,Array, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/cynarae-foliumTue, 02 Apr 2024 11:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/curcumae-longae-rhizomaHerbal medicinal product: Curcumae longae rhizomaArray, C: ongoing call for scientific datahttps://www.ema.europa.eu/en/medicines/herbal/curcumae-longae-rhizomaTue, 02 Apr 2024 11:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/metalyseHuman medicines European public assessment report (EPAR): Metalyse, tenecteplase, Date of authorisation: 23/02/2001, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/metalyseTue, 02 Apr 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-signals-discussed-prac-september-2012_en_4.xlsxList of signals discussed at PRAC since September 2012https://www.ema.europa.eu/system/files/documents/other/list-signals-discussed-prac-september-2012_en_4.xlsxTue, 02 Apr 2024 11:13:00 +0200What's new