What's new

Date	Content
31/07/2023	EPAR - Risk-management-plan summary: Slenyto : EPAR - Risk-management-plan summary
31/07/2023	Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union
31/07/2023	Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, 24, Authorised
31/07/2023	Accelerated assessment
31/07/2023	Obtaining an EU marketing authorisation, step-by-step
31/07/2023	Certification procedures for advanced therapies under development by micro-, small- and medium-sized enterprises (SMEs)
31/07/2023	Regulatory and procedural guideline: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
31/07/2023	Herbal medicinal product: Capsici fructus, Capsici fructus, F: Assessment finalised
31/07/2023	Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
31/07/2023	Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
31/07/2023	Template or form: Letter of intent for the submission of a consultation to the European Medicines Agency by a notified body on a companion diagnostic in accordance with Regulation (EU) 2017/746
31/07/2023	Other: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
31/07/2023	Other: Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device
31/07/2023	Scientific advice and protocol assistance
31/07/2023	Changing the labelling and package leaflet (Article 61(3) notifications)
31/07/2023	Transfer of marketing authorisation: questions and answers
31/07/2023	Type-II variations: questions and answers
31/07/2023	Human medicines European public assessment report (EPAR): Sogroya, Somapacitan, Growth, 31/03/2021, , , 2, Authorised
31/07/2023	Orphan designation: Ganaxolone for the: Treatment of CDKL5 deficiency disorder, 13/11/2019, Positive
31/07/2023	Human medicines European public assessment report (EPAR): Ztalmy, Ganaxolone, Epileptic Syndromes; Spasms, Infantile, 26/07/2023, , , Authorised
31/07/2023	Type-IB variations: questions and answers
31/07/2023	Type-IA variations: questions and answers
31/07/2023	Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease, 23/08/2012, 28, Authorised
31/07/2023	Worksharing: questions and answers
31/07/2023	Overview of comments: Overview of comments on draft Qualification Opinion for Stride velocity 95th centile as a primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy
31/07/2023	Scientific guideline: Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies
31/07/2023	Medicines for older people
31/07/2023	Clinical Trials Information System (CTIS): Walk-in clinic - July 2023 , Online, 16:00 - 17:00 Amsterdam time (CEST), from 19/07/2023 to 19/07/2023
31/07/2023	Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders; Autistic Disorder, 20/09/2018, 8, Authorised
31/07/2023	Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, 18, Authorised
31/07/2023	Orphan designation: Humanised IgG1 monoclonal antibody against SEZ6 linked to N-acetyl-calicheamicin for the: Treatment of small cell lung cancer, 15/10/2021, Withdrawn
31/07/2023	Human medicines European public assessment report (EPAR): Oprymea, pramipexole dihydrochloride monohydrate, Parkinson Disease, 12/09/2008, , 22, Authorised
31/07/2023	Orphan designation: Tobramycin for the: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 17/03/2003, Expired
31/07/2023	Human medicines European public assessment report (EPAR): Rotarix, human rotavirus, live attenuated, Immunization; Rotavirus Infections, 21/02/2006, 41, Authorised
31/07/2023	EMA multi-stakeholder workshop on Acute Respiratory Distress Syndrome , Online / Amsterdam, from 21/11/2023 to 21/11/2023
31/07/2023	Human medicines European public assessment report (EPAR): Omvoh, Mirikizumab, Colitis, Ulcerative, 26/05/2023, , 1, Authorised
31/07/2023	PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting
31/07/2023	PRAC recommendation on signal: PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting
28/07/2023	Summary of opinion: Krazati, adagrasib, 20/07/2023, Negative
28/07/2023	Work programme: Workplan 2023-2025 - HMA / EMA joint Big Data Steering Group
28/07/2023	Human medicines European public assessment report (EPAR): Terrosa, teriparatide, Osteoporosis, 04/01/2017, , , 6, Authorised
28/07/2023	Human medicines European public assessment report (EPAR): Qutenza, capsaicin, Neuralgia, 15/05/2009, 17, Authorised
28/07/2023	Human medicines European public assessment report (EPAR): Pylclari, Piflufolastat (18F), Prostatic Neoplasms, 24/07/2023, , Authorised
28/07/2023	Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 22, Authorised
28/07/2023	Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa, 22/11/2018, , , 7, Authorised
28/07/2023	Nitrosamine impurities
28/07/2023	Template or form: Step 2 - Nitrosamine detected response template
28/07/2023	Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
27/07/2023	Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 19/11/2015, 32, Authorised
27/07/2023	Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 17-20 July 2023
27/07/2023	Other: DARWIN EU Advisory Board: Mandate
27/07/2023	Human medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Hepatitis B, 18/02/2021, , 4, Authorised
27/07/2023	Other: DARWIN EU Advisory Board: Membership
27/07/2023	Human medicines European public assessment report (EPAR): Cabazitaxel Accord, cabazitaxel, Prostatic Neoplasms, Castration-Resistant, 28/08/2020, , 5, Authorised
27/07/2023	Human medicines European public assessment report (EPAR): Gefitinib Mylan, gefitinib, Carcinoma, Non-Small-Cell Lung, 27/09/2018, , 6, Authorised
27/07/2023	Human medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases, 18/08/2021, , , , 6, Authorised
27/07/2023	Orphan designation: Itraconazole for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Withdrawn
27/07/2023	Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 23, Authorised
27/07/2023	Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, , , 22, Authorised
27/07/2023	Human medicines European public assessment report (EPAR): Sohonos, Palovarotene, Myositis Ossificans, 17/07/2023, , Refused
27/07/2023	Emergency Task Force (ETF)
27/07/2023	Other: Superseded - Composition of the Emergency Task Force (ETF) for the therapeutic response to the COVID-19 and Monkeypox Public Health Emergencies
27/07/2023	Work programme: Consolidated 3-year work plan for the Emergency Task Force (ETF)
27/07/2023	Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 16/12/2016, , 14, Authorised
27/07/2023	Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, , 25, Authorised
27/07/2023	Human medicines European public assessment report (EPAR): Xofluza, Baloxavir marboxil, Influenza, Human, 07/01/2021, , 4, Authorised
27/07/2023	Other: Timetable: Informed consent and multiple application
27/07/2023	Human medicines European public assessment report (EPAR): Jyseleca, filgotinib maleate, Arthritis, Rheumatoid, 24/09/2020, , , 10, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Supemtek, Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human, 16/11/2020, , 3, Authorised
26/07/2023	Orphan designation: Mavorixafor for the: Treatment of WHIM syndrome, 25/07/2019, Positive
26/07/2023	Human medicines European public assessment report (EPAR): Vaborem, meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated, 20/11/2018, 7, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell, 11/02/2021, , 4, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis, 21/08/2020, , , 15, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer, 18/12/2007, , 31, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Multiple Myeloma, 25/05/2022, , , , 4, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, 12, Authorised
26/07/2023	Other: Organisation chart: Human Medicines
26/07/2023	Regulatory and procedural guideline: Guidance document on voting in the framework of discussion and adoption of CHMP opinions
26/07/2023	Newsletter: News bulletin for small and medium-sized enterprises - Issue 59
26/07/2023	Other: EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines [OBSOLETE]
26/07/2023	Other: Timetable: Initial (Full) marketing authorisation application - ATMP
26/07/2023	Other: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)
26/07/2023	Other: Timetable: Extension application - ATMP
26/07/2023	Other: Timetable: Accelerated assessment request for initial marketing authorisations - ATMP
26/07/2023	Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Gaucher Disease, 18/02/2019, , 7, Authorised
26/07/2023	Human medicines European public assessment report (EPAR): Rydapt, Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis, 18/09/2017, , 11, Authorised
25/07/2023	Guidance on good manufacturing practice and good distribution practice: Questions and answers
25/07/2023	Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG) , Online, 15:30 - 16:30 Amsterdam time (CEST), from 19/06/2023 to 19/06/2023
25/07/2023	Minutes: Minutes of the HMPC 10-12 May 2023 meeting
25/07/2023	Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, , 20, Authorised
25/07/2023	Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesilate, Thyroid Neoplasms, 28/05/2015, , , 19, Authorised
25/07/2023	News and press releases: Paving the way towards coordinated clinical trials in public health emergencies in the EU
25/07/2023	European Medicines Agency / Emergency Task Force and European Commission workshop on lessons learned on clinical trials in public health emergencies , from 09/06/2023 to 09/06/2023
25/07/2023	Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia, 10/06/2015, 22, Authorised
25/07/2023	Human medicines European public assessment report (EPAR): Qaialdo, spironolactone, Edema; Heart Failure; Liver Cirrhosis; Ascites; Nephrotic Syndrome; Hyperaldosteronism; Essential Hypertension, 26/05/2023, Authorised
25/07/2023	Orphan designation: Iodine (124I) evuzamitide for the: Diagnosis of ATTR amyloidosis, 09/12/2022, Positive
25/07/2023	Orphan designation: Iodine (124I) evuzamitide for the: Diagnosis of AL amyloidosis, 11/11/2022, Positive
25/07/2023	Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid, 01/10/2009, 47, Authorised
25/07/2023	Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma, 20/09/2017, 22, Authorised
25/07/2023	Human medicines European public assessment report (EPAR): Sifrol, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease, 13/10/1997, 37, Authorised
25/07/2023	Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease, 23/02/1998, 40, Authorised
25/07/2023	Procedural timetables
25/07/2023	Other: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)
25/07/2023	Other: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
25/07/2023	Other: HMPC: overview of assessment work - priority list
24/07/2023	Human medicines European public assessment report (EPAR): Accofil, filgrastim, Neutropenia, 17/09/2014, , 14, Authorised
24/07/2023	Enpr-EMA Coordinating Group and networks meeting , from 06/06/2023 to 06/06/2023
24/07/2023	Work programme: European collaboration between regulators and health technology assessment bodies - Joint work plan (2021-2023) between EMA and European HTA bodies facilitated through EUnetHTA21
24/07/2023	Report: CAT quarterly highlights and approved ATMPs - July 2023
24/07/2023	Newsletter: CTIS newsflash - 21 July 2023
21/07/2023	Second European Medicines Agency & MedTech Europe bilateral meeting , European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 11/04/2023
21/07/2023	Minutes: Highlights - Second European Medicines Agency & MedTech Europe bilateral meeting
21/07/2023	Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 10, Authorised
21/07/2023	Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight, 26/03/2015, , 25, Authorised
21/07/2023	Demonstration of efficacy of ectoparasiticides - Scientific guideline
21/07/2023	Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Scientific guideline
21/07/2023	Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - Scientific guideline
21/07/2023	Development, production, characterisation and specifications for monoclonal antibodies and related products - Scientific guideline
21/07/2023	Radiopharmaceuticals - Scientific guideline
21/07/2023	Development of a reflection paper on the availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals
21/07/2023	Excipients in the dossier for application for marketing authorisation for veterinary medicinal products - Scientific guideline
21/07/2023	Stability testing of existing active substances and related finished products - Scientific guideline
21/07/2023	Orphan designation: Codon-optimised human cystic fibrosis transmembrane conductance regulator messenger ribonucleic acid complexed with lipid-based nanoparticles, pomulmeran for the: Treatment of cystic fibrosis, 01/04/2019, Withdrawn
21/07/2023	Orphan designation: Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the: treatment of metachromatic leukodystrophy, 26/06/2020, Withdrawn
21/07/2023	News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023
21/07/2023	Summary of opinion: Yesafili, aflibercept, 20/07/2023, Positive
21/07/2023	Withdrawn application: Gazyvaro, obinutuzumab, Date of withdrawal: 04/07/2023, Post-authorisation
21/07/2023	Summary of opinion: Enrylaze, crisantaspase, 20/07/2023, Positive
21/07/2023	Summary of opinion: Bylvay, odevixibat, 20/07/2023, Positive
21/07/2023	Summary of opinion: Tevimbra, tislelizumab, 20/07/2023, Positive
21/07/2023	Summary of opinion: Tepkinly, epcoritamab, 20/07/2023, Positive
21/07/2023	Summary of opinion: Tyenne, tocilizumab, 20/07/2023, Positive
21/07/2023	Minutes: Minutes of the CVMP meeting 13-15 June 2023
21/07/2023	Summary of opinion: Orserdu, elacestrant, 20/07/2023, Positive
21/07/2023	Summary of opinion: Degarelix Accord, degarelix acetate, 20/07/2023, Positive
21/07/2023	News and press releases: First RSV vaccine to protect infants up to 6 months of age and older adults
21/07/2023	Withdrawn application: Gefzuris, gefapixant, Date of withdrawal: 14/07/2023, Initial authorisation
21/07/2023	Withdrawn application: Jesduvroq, daprodustat, Date of withdrawal: 12/07/2023, Initial authorisation
21/07/2023	Summary of opinion: Inaqovi, cedazuridine, decitabine, 20/07/2023, Positive
21/07/2023	Human medicines European public assessment report (EPAR): Tepmetko, Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung, 16/02/2022, , 1, Authorised
21/07/2023	Other: 2023/2024 Work plan for the European Sales and Use of Antimicrobials in veterinary medicine Working Group (ESUAvet WG)
21/07/2023	Human medicines European public assessment report (EPAR): Nulibry, fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors, 15/09/2022, , , 2, Authorised
21/07/2023	Orphan designation: Dersimelagon for the: Treatment of erythropoietic protoporphyria, 16/03/2022, Positive
21/07/2023	Orphan designation: edaravone for the: Treatment of amyotrophic lateral sclerosis, 19/06/2015, Positive
21/07/2023	EPAR - Product Information: Tecvayli : EPAR - Product Information
20/07/2023	News and press releases: OPEN framework extended to a wider range of medicines
20/07/2023	Human medicines European public assessment report (EPAR): Tavneos, Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis, 11/01/2022, , , 3, Authorised
20/07/2023	Referral: Procaine benzylpenicillin , Article 82, Procedure started, 18/02/2022, 20/07/2023
20/07/2023	Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, 14/11/2013, 20, Authorised
20/07/2023	Other: Record of data processing activity for Interactive Regulatory Information System (IRIS) (public)
20/07/2023	Human medicines European public assessment report (EPAR): NutropinAq, somatropin, Turner Syndrome; Dwarfism, Pituitary, 15/02/2001, 20, Authorised
20/07/2023	Tenth industry stakeholder platform on research and development support , from 11/07/2023 to 11/07/2023
20/07/2023	Orphan designation: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] (ponatinib) for the: Treatment of acute lymphoblastic leukaemia, 02/02/2010, Expired
20/07/2023	Orphan designation: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] (ponatinib) for the: Treatment of chronic myeloid leukaemia, 02/02/2010, Expired
20/07/2023	Agenda: Agenda of the HMPC meeting 17-19 July 2023
19/07/2023	Scientific guideline: Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1
19/07/2023	Regulatory and procedural guideline: Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1
19/07/2023	Other: Questions and answers on the guideline on the SPC for VMPs containing antimicrobial substances – antibiotic clinical breakpoints that may be included in section 4.2 of the SPC for generic VMPs
19/07/2023	Agenda: Agenda - PDCO agenda of the 18-21 July 2023 meeting
19/07/2023	Supply shortage: Amoxicillin and amoxicillin/clavulanic acid supply shortage
19/07/2023	Supply shortage: Insuman Rapid, Basal and Comb 25 (insulin human) solution for injection, prefilled pen supply shortage
19/07/2023	ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
19/07/2023	Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma; Urticaria, 25/10/2005, 46, Authorised
19/07/2023	Report: Annual activity report 2022
19/07/2023	Other: European Medicine Agency's data protection notice for the Interactive Regulatory Information System (IRIS)
19/07/2023	Human medicines European public assessment report (EPAR): Givlaari, Givosiran, Porphyrias, Hepatic, 02/03/2020, , , 5, Authorised
19/07/2023	Other: Scientific recommendations on classification of advanced therapy medicinal products (January 2021 - June 2023)
19/07/2023	Leaflet: Infosheet: EMA review of real-world data studies
19/07/2023	Human medicines European public assessment report (EPAR): Carbaglu, carglumic acid, Amino Acid Metabolism, Inborn Errors; Propionic Acidemia, 24/01/2003, 19, Authorised
19/07/2023	Report: Real-world evidence framework to support EU regulatory decision-making: Report on the experience gained with regulator-led studies from September 2021 to February 2023
19/07/2023	Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 33, Authorised
19/07/2023	Human medicines European public assessment report (EPAR): Vabysmo, Faricimab, Wet Macular Degeneration; Macular Edema; Diabetes Complications, 15/09/2022, , 1, Authorised
19/07/2023	The use of Artificial Intelligence (AI) in the medicinal product lifecycle
19/07/2023	Multidisciplinary: artificial intelligence (AI)
19/07/2023	News and press releases: Reflection paper on the use of artificial intelligence in the lifecycle of medicines
19/07/2023	Big data
19/07/2023	Orphan designation: Human embryonic stem-cell-derived retinal pigment epithelial cells for the: Treatment of Stargardt's disease, 21/06/2011, Withdrawn
18/07/2023	Human medicines European public assessment report (EPAR): Sugammadex Piramal, sugammadex sodium, Neuromuscular Blockade, 23/06/2023, , Authorised
18/07/2023	Withdrawn application: Susvimo, ranibizumab, Date of withdrawal: 02/05/2023, Initial authorisation
18/07/2023	Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans; Protein C Deficiency, 16/07/2001, 19, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, , 15, Authorised
18/07/2023	Periodic safety update single assessment: Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009182/202212
18/07/2023	Periodic safety update single assessment: Amlodipine / indapamide, amlodipine / indapamide / perindopril: List of nationally authorised medicinal products - PSUSA/00010358/202211
18/07/2023	Periodic safety update single assessment: Bromperidol: List of nationally authorised medicinal products - PSUSA/00000439/202211
18/07/2023	Human medicines European public assessment report (EPAR): Rozlytrek, Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung, 31/07/2020, , , 7, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Zinplava, Bezlotoxumab, Enterocolitis, Pseudomembranous, 18/01/2017, 10, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Yuflyma, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid, 11/02/2021, , 10, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Xospata, gilteritinib fumarate, Leukemia, Myeloid, Acute, 24/10/2019, , , 4, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 19, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Suliqua, insulin glargine, lixisenatide, Diabetes Mellitus, Type 2, 11/01/2017, 12, Authorised
18/07/2023	Orphan designation: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib) for the: Treatment of biliary tract cancer, 01/04/2019, Positive
18/07/2023	Human medicines European public assessment report (EPAR): Lytgobi, Futibatinib, Cholangiocarcinoma, 04/07/2023, , , Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Columvi, Glofitamab, Lymphoma, Large B-Cell, Diffuse, 07/07/2023, , , , Authorised
18/07/2023	Orphan designation: Glofitamab for the: Treatment of diffuse large B-cell lymphoma, 15/10/2021, Positive
18/07/2023	Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Melanoma, 17/02/2012, 24, Authorised
18/07/2023	Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta, Neuroblastoma, 08/05/2017, , , , 15, Authorised
18/07/2023	Orphan designation: Recombinant human acid sphingomyelinase (also known as olipudase alfa) for the: Treatment of Niemann-Pick disease, 24/06/2022, Positive
18/07/2023	Orphan designation: (1R,2R)-octanoic acid[2-(2',3'-dihydro-benzo[1,4] dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-L-tartaric acid salt (eliglustat) for the: Treatment of Gaucher disease, 04/12/2007, Positive
18/07/2023	Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran) for the: Treatment of haemophilia A, 29/07/2014, Positive
18/07/2023	Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran) for the: Treatment of haemophilia B, 29/07/2014, Positive
18/07/2023	Orphan designation: for the: Treatment of Fabry disease, 22/08/2014, Positive
18/07/2023	Orphan designation: (3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbaNmate (venglustat) for the: Treatment of Gaucher disease, 19/11/2014, Positive
18/07/2023	Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab) for the: Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive
18/07/2023	Orphan designation: sutimlimab for the: Treatment of immune thrombocytopenia, 28/02/2020, Positive
18/07/2023	Orphan designation: Rilzabrutinib for the: Treatment of immune thrombocytopenia, 04/06/2020, Positive
18/07/2023	Orphan designation: Venglustat for the: Treatment of GM2 gangliosidosis, 21/08/2020, Positive
18/07/2023	Orphan designation: Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 for the: Treatment of achondroplasia, 21/06/2021, Positive
18/07/2023	Orphan designation: Humanised IgG4 monoclonal antibody against active complement component 1, subcomponent s for the: Treatment of autoimmune haemolytic anaemia, 18/07/2022, Positive
17/07/2023	Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative, 15/01/2009, 44, Authorised
17/07/2023	Other: EMA’s individual stakeholder database: patients, consumers, healthcare professionals and academia - Frequently asked questions
17/07/2023	Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Giant Lymph Node Hyperplasia, 22/05/2014, , , 13, Authorised
17/07/2023	Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, , 9, Authorised
17/07/2023	Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Lupus Erythematosus, Systemic, 14/02/2022, , 2, Authorised
17/07/2023	Minutes: Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (19 June 2023)
17/07/2023	Report: Medicinal products for human use: monthly figures - June 2023
17/07/2023	Report: Applications for new human medicines under evaluation by the CHMP: July 2023
17/07/2023	News and press releases: European Health Union: EU steps up action to prevent shortages of antibiotics for next winter
17/07/2023	CVMP recommendations on limited market classification and eligibility for authorisation under Article 23
17/07/2023	Human medicines European public assessment report (EPAR): HyQvia, Human normal immunoglobulin, Immunologic Deficiency Syndromes, 16/05/2013, 20, Authorised
17/07/2023	Human medicines European public assessment report (EPAR): Iressa, gefitinib, Carcinoma, Non-Small-Cell Lung, 24/06/2009, 16, Authorised
17/07/2023	Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 36, Authorised
17/07/2023	Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 10/09/2013, , 36, Authorised
17/07/2023	Orphan designation: Cyclic pyranopterin monophosphate (fosdenopterin) for the: Treatment of molybdenum-cofactor deficiency type A, 20/09/2010, Positive
17/07/2023	Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 18/07/2014, 24, Authorised
17/07/2023	Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid; COVID-19 virus infection, 08/03/2002, 34, Authorised
17/07/2023	Minutes: Minutes of the CHMP meeting 22-25 May 2023
17/07/2023	Other: Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products on the availability of a subset of antibiotics
17/07/2023	Agenda: Agenda of the CAT meeting 12-14 July 2023
17/07/2023	Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone; Neoplasm Metastasis, 13/07/2011, 24, Authorised
17/07/2023	Newsletter: Human medicines highlights - July 2023
17/07/2023	Human medicines European public assessment report (EPAR): Fareston, toremifene, Breast Neoplasms, 14/02/1996, 25, Authorised
17/07/2023	Agenda: Agenda of the CHMP meeting 17-20 July 2023
14/07/2023	Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 15/09/2008, , 18, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Spravato, esketamine hydrochloride, Depressive Disorder, 18/12/2019, , 8, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia; Bipolar Disorder, 06/10/2008, , 19, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Oyavas, bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, 26/03/2021, , , 5, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Hypercalcemia; Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone, 25/06/1996, 32, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, 18, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Carcinoma, Non-Small-Cell Lung, 21/09/2018, , 17, Authorised
14/07/2023	Human medicines European public assessment report (EPAR): Arixtra, fondaparinux sodium, Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable, 20/03/2002, 35, Authorised
14/07/2023	Summary of opinion: YURVAC RHD, Rabbit haemorrhagic disease virus, capsid protein antigen, recombinant, 13/07/2023, Positive
14/07/2023	Summary of opinion: NexGard Combo, esafoxolaner, eprinomectin, praziquantel, 13/07/2023, Positive
14/07/2023	News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023
14/07/2023	Regulatory and procedural guideline: PRIME eligibility requests: 2024 deadlines for submission and timetable for assessment
14/07/2023	Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing, 18/05/2018, , 11, Authorised
13/07/2023	Agenda: Agenda - Fourth EMA-AESGP bilateral meeting
13/07/2023	Other: Highlights of EMA-AESGP Bilateral meeting of 18th April 2023 meeting
13/07/2023	Other: All applications received to speak (interventions from the application form) - EMA public stakeholder meeting on COVID-19
13/07/2023	Human medicines European public assessment report (EPAR): Jivi, Damoctocog alfa pegol, Hemophilia A, 22/11/2018, , 5, Authorised
13/07/2023	Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023