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Find all new and updated information published on our website in one place below. Filters are available to narrow results down based on your interests, such as whether it relates to human or veterinary medicines or specific topics. Information on medicines and related procedures includes a reference to relevant substances: INN or common name, active substance, and English common name for herbal products. This overview covers up to two months back. 

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Results (191)

Date Content Status
10/04/2026
Orphan: EU/3/25/3186 - orphan designation for treatment of primary IgA nephropathy N-[5-(2H-1,3-Benzodioxol-5-yl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-N'-(2-methoxyethyl)sulfuric diamide
New
10/04/2026
Orphan: EU/3/25/3187 - orphan designation for treatment of multiple system atrophy 2-[[(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazol-5-ol
New
10/04/2026
Orphan: EU/3/25/3180 - orphan designation for diagnosis of ovarian cancer aminolevulinic acid hydrochloride
New
10/04/2026
Orphan: EU/3/25/3179 - orphan designation for treatment of primary hyperoxaluria lanthanum carbonate octahydrate
New
10/04/2026
Orphan: EU/3/25/3189 - orphan designation for treatment of osteosarcoma sirolimus
New
10/04/2026
PIP: EMEA-001811-PIP03-20 - paediatric investigation plan ligelizumab
Updated
10/04/2026
Medicine: Mysimba naltrexone; bupropion
Updated
10/04/2026
Orphan: EU/3/25/3191 - orphan designation for treatment of BAG3 dilated cardiomyopathy Adeno-associated virus serotype ATC-0187 vector containing the human BAG3 gene
New
10/04/2026
Orphan: EU/3/25/3190 - orphan designation for treatment of osteosarcoma domatinostat
New
10/04/2026
Orphan: EU/3/25/3181 - orphan designation for treatment of Fanconi anaemia autologous human T cells transduced with a lentiviral vector encoding a chimeric antigen receptor against the ERBB family
New
10/04/2026
Orphan: EU/3/25/3193 - orphan designation for treatment of central serous chorioretinopathy spironolactone
New
10/04/2026
Medicine: Equidormin midazolam
New
10/04/2026
Orphan: EU/3/25/3188 - orphan designation for treatment of idiopathic pulmonary fibrosis Phe-Thr-Thr-Phe-Thr-Val-Thr
New
10/04/2026
Orphan: EU/3/25/3192 - orphan designation for treatment of extrapulmonary neuroendocrine carcinoma opamtistomig
New
10/04/2026
Medicine: Evrenzo roxadustat
Updated
10/04/2026
Orphan: EU/3/26/3197 - orphan designation for treatment of spinal cord injury (4Z,7R,8E,10E,12Z,14S,16Z,19Z)-7,14-Dihydroxydocosa-4,8,10,12,16,19-hexaenoic acid
New
10/04/2026
Medicine: Mycophenolate mofetil Teva mycophenolate mofetil
Updated
10/04/2026
Orphan: EU/3/26/3203 - orphan designation for treatment of limbal stem cell deficiency spironolactone
New
10/04/2026
Medicine: Olumiant baricitinib
Updated
10/04/2026
Orphan: EU/3/26/3201 - orphan designation for treatment of mesothelioma Measles virus Schwarz strain (live, attenuated)
New
10/04/2026
Orphan: EU/3/26/3196 - orphan designation for treatment of glioma Humanised IgG1 kappa monoclonal antibody against erythropoietin isoform EV-3
New
10/04/2026
Orphan: EU/3/26/3204 - orphan designation for treatment of erythromelalgia N-[(1S)-1-(4-Tert-butylphenyl) ethyl]-2-(6,7-difluoro-1H-benzimidazol-1-yl)acetamide
New
10/04/2026
Orphan: EU/3/25/3146 - orphan designation for treatment of Glb1-related disorders autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the murine Glb1 gene
New
10/04/2026
Orphan: EU/3/25/3149 - orphan designation for treatment of KCNT1-related epilepsy and neurodevelopmental disorders (S)-1-(2,2-Difluoroethyl)-3-(difluoromethyl)-N-(1-(3-(2-methoxypyridin-4-yl)-1,2,4-oxadiazol-5-yl)ethyl)-1H-pyrazole-5-carboxamide
New
10/04/2026
Orphan: EU/3/25/3153 - orphan designation for treatment of pancreatic cancer vopimetostat
New
10/04/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
 New
10/04/2026
Medicine: Myfenax mycophenolate mofetil
Updated
10/04/2026
PIP: EMEA-003268-PIP01-22 - paediatric investigation plan 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3- fluorophenyl)ethan-1-one (BBP-671)
Updated
10/04/2026
PSUSA: PSUSA/00003170/202508 - periodic safety update report single assessment hexoprenaline sulfate
New
10/04/2026
Orphan: EU/3/25/3103 - orphan designation for treatment of idiopathic pulmonary fibrosis admilparant
New
10/04/2026
Orphan: EU/3/25/3104 - orphan designation for treatment of acute myeloid leukaemia 4-(2-{[2-Amino-6-(3-chloro-2-methylphenyl)pyrimidin-4-yl]amino}ethyl)benzene-1-sulfonamide
New
10/04/2026
Orphan: EU/3/25/3107 - orphan designation for treatment of congenital athymia allogeneic cultured postnatal thymus-derived tissue
New
10/04/2026
Orphan: EU/3/25/3115 - orphan designation for treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene gildeuretinol, gildeuretinol acetate
New
10/04/2026
Orphan: EU/3/25/3114 - orphan designation for treatment of alpha-1 antitrypsin deficiency RNA editing antisense oligonucleotide against the Z mutation of the human SERPINA1 mRNA transcript, sodium salt
New
10/04/2026
Orphan: EU/3/25/3133 - orphan designation for treatment of NDP gene-related disorders adeno-associated viral vector serotype ShH10 containing a codon-optimised human NDP gene
New
10/04/2026
Orphan: EU/3/25/3106 - orphan designation for treatment of multiple myeloma IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D
New
10/04/2026
Orphan: EU/3/25/3129 - orphan designation for treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3122 - orphan designation for treatment of uveal melanoma darovasertib
New
10/04/2026
Orphan: EU/3/25/3113 - orphan designation for treatment of hereditary cerebral amyloid angiopathies acetylcysteine amide
New
10/04/2026
Orphan: EU/3/25/3110 - orphan designation for treatment of spinal muscular atrophy emugrobart
New
10/04/2026
Orphan: EU/3/25/3105 - orphan designation for treatment of dystrophic myotonia RNA, [P-deoxy-P-(dimethylamino)](2',3'-dideoxy-2',3'-imino-2',3'-seco)(2'a->5') (C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-[2'a-[39-[[1-acetyl-L-prolyl-L-lysyl-L-lysyl-L-lysyl-L-arginyl-L-lysyl-L-valyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-(L-phenylalanylglycyl-L-phenylalanylglycyl-L-arginylglycyl-L-arginyl-L-gamma-glutamyl)-L-lysyl]amino]-1- oxo-4,7,10,13,16,19,22,25,28,31,34,37-dodecaoxanonatriacont-1-yl]]G), (8'->1')-lactam
New
10/04/2026
Orphan: EU/3/25/3120 - orphan designation for treatment of immunoglobulin G4-related disease rilzabrutinib
New
10/04/2026
Orphan: EU/3/25/3109 - orphan designation for treatment of NDP gene-related disorders adeno-associated virus serotype 9 vector containing the human NDP gene
New
10/04/2026
Orphan: EU/3/25/3124 - orphan designation for treatment of immune thrombocytopenia mezagitamab
New
10/04/2026
Orphan: EU/3/25/3128 - orphan designation for treatment of pancreatic cancer 7-ethyl-10-hydroxycamptothecin
New
10/04/2026
Orphan: EU/3/25/3111 - orphan designation for treatment of graft-versus-host disease pegtarazimod
New
10/04/2026
Orphan: EU/3/25/3102 - orphan designation for prevention of bronchopulmonary dysplasia mecasermin rinfabate
New
10/04/2026
Orphan: EU/3/25/3112 - orphan designation for treatment of methylmalonic acidaemia lentiviral vector containing the human MMUT transgene
New
10/04/2026
Orphan: EU/3/25/3152 - orphan designation for treatment of MECP2 duplication syndrome 2'-O-(2-Methoxyethyl) modified antisense oligonucleotide against MECP2 pre-mRNA
New
10/04/2026
Orphan: EU/3/25/3123 - orphan designation for treatment of common variable immunodeficiency (CVID) leniolisib
New
10/04/2026
Orphan: EU/3/25/3108 - orphan designation for treatment of acute myeloid leukaemia cladribine
New
10/04/2026
Orphan: EU/3/25/3148 - orphan designation for treatment of amyotrophic lateral sclerosis 2-(3-Chlorophenyl)-N-[6-(trifluoromethyl)-1,3-benzothiazol-2-yl]acetamide
New
10/04/2026
Orphan: EU/3/25/3118 - orphan designation for treatment of primary hyperoxaluria mRNA encoding Cas12HF endonuclease, Single guide RNA against the human HAO1 gene
New
10/04/2026
Orphan: EU/3/25/3117 - orphan designation for treatment of lymphoplasmacytic lymphoma 3-tert-butyl-N-{(1R)-1-[4-(6-{6-[4-({1-[4-(2,4-dioxo-1,3-diazinan-1-yl)phenyl]piperidin-4-yl}methyl)piperazin-1-yl]pyridin-3-yl}-7H-pyrrolo[2,3-d]pyrimidin-4-yl)-2-methylphenyl]ethyl}-1,2,4-oxadiazole-5-carboxamide
New
10/04/2026
Orphan: EU/3/25/3134 - orphan designation for treatment of non-syndromic macular dystrophy sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3121 - orphan designation for treatment of idiopathic inflammatory myopathy brepocitinib
New
10/04/2026
Orphan: EU/3/25/3154 - orphan designation for treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene antisense oligonucleotide against ABCA4 pre-mRNA
New
10/04/2026
Orphan: EU/3/25/3155 - orphan designation for treatment of oesophageal cancer zanidatamab
New
10/04/2026
Orphan: EU/3/25/3125 - orphan designation for treatment of glioma temozolomide
New
10/04/2026
Orphan: EU/3/25/3127 - orphan designation for treatment of soft tissue sarcoma varegacestat
New
10/04/2026
Orphan: EU/3/25/3119 - orphan designation for treatment of fibrodysplasia ossificans progressiva zilurgisertib
New
10/04/2026
Orphan: EU/3/25/3130 - orphan designation for treatment of syndromic inherited retinal dystrophies of the cone-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3131 - orphan designation for treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3135 - orphan designation for treatment of primary large B-cell lymphoma of immune-privileged sites methotrexate
New
10/04/2026
Orphan: EU/3/25/3132 - orphan designation for treatment of non-syndromic inherited retinal dystrophies of the cone-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
PIP: EMEA-003071-PIP02-23 - paediatric investigation plan cedazuridine; decitabine
Updated
10/04/2026
Page: CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device
 Updated
10/04/2026
Medicine: Mynzepli aflibercept
Updated
10/04/2026
Orphan: EU/3/25/3151 - orphan designation for treatment of primary sclerosing cholangitis leuconostoc citreum, strain G511, Live
New
10/04/2026
Medicine: Myclausen mycophenolate mofetil
Updated
10/04/2026
Orphan: EU/3/25/3159 - orphan designation for treatment of idiopathic pulmonary fibrosis orvepitant maleate
New
10/04/2026
Medicine: Abrysvo respiratory syncytial virus vaccine (bivalent, recombinant)
Updated
10/04/2026
Medicine: CellCept mycophenolate mofetil
Updated
10/04/2026
Page: Download medicine data
 Updated
10/04/2026
Page: Download website data in JSON data format
 Updated
10/04/2026
Medicine: Dupixent dupilumab
Updated
09/04/2026
Medicine: Cablivi caplacizumab
Updated
09/04/2026
Medicine: Tafinlar dabrafenib
Updated
09/04/2026
Medicine: Iclusig ponatinib
Updated
09/04/2026
Medicine: Sorafenib Accord sorafenib
Updated
09/04/2026
Medicine: Kayshild semaglutide
Updated
09/04/2026
Medicine: Fylrevy estetrol
Updated
09/04/2026
Page: Union Product Database
 Updated
09/04/2026
Medicine: Fintepla fenfluramine
Updated
09/04/2026
Medicine: Neofordex dexamethasone
Updated
09/04/2026
Medicine: Copiktra duvelisib
Updated
09/04/2026
Medicine: Ondibta insulin glargine
Updated
09/04/2026
Page: Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline
 Updated
09/04/2026
Page: Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline
 Updated
09/04/2026
Document: Template for sharing EMA documents by Industry to support reliance
 Updated
09/04/2026
Document: Clinical Trial Information System (CTIS) - Sponsor Frequently Asked Questions (FAQ)
 Updated
09/04/2026
Medicine: Theralugand lutetium (177Lu) chloride
Updated
09/04/2026
Page: PRIME: priority medicines
 Updated
09/04/2026
Medicine: Sibnayal potassium citrate; potassium hydrogen carbonate
Updated
09/04/2026
Document: List of medicines currently in PRIME scheme
 Updated
09/04/2026
Medicine: Darzalex daratumumab
Updated
09/04/2026
Document: List of eligible industry stakeholder organisations
 Updated
08/04/2026
Page: Vaccines: concerns, questions and false claims
 Updated
08/04/2026
Page: COVID-19 vaccines: key facts
 Updated
08/04/2026
Medicine: Supemtek trivalent influenza vaccine (recombinant, prepared in cell culture)
Updated
08/04/2026
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
08/04/2026
Medicine: Blenrep belantamab mafodotin
Updated
08/04/2026
Medicine: Yellox bromfenac
Updated
08/04/2026
Medicine: Fycompa perampanel
Updated
08/04/2026
Medicine: Agamree vamorolone
Updated
08/04/2026
Medicine: Rebif interferon beta-1a
Updated
08/04/2026
Medicine: Aripiprazole Zentiva aripiprazole
Updated
08/04/2026
Medicine: Poteligeo mogamulizumab
Updated
08/04/2026
Event: Breakthrough medical devices: information session
 Updated
08/04/2026
Medicine: Crysvita burosumab
Updated
08/04/2026
Medicine: Rezzayo rezafungin
Updated
08/04/2026
Medicine: Doptelet avatrombopag
Updated
08/04/2026
Referral: Levamisole-containing medicinal products - referral levamisole
Updated
08/04/2026
Event: European Platform for Regulatory Science Research meeting
 New
08/04/2026
Page: Maximum residue limits (MRLs): Questions and answers
 New
08/04/2026
Page: Substances exempt from maximum residue limit evaluation
 New
08/04/2026
Page: Submitting a maximum residue limit application
 New
08/04/2026
Page: Establishing maximum residue limits for veterinary medicines
 New
08/04/2026
Page: Maximum residue limits (MRL)
 Updated
08/04/2026
Page: Animal health practitioners
 Updated
08/04/2026
Page: Veterinary medicine safety day
 New
08/04/2026
Document: Veterinary medicine safety day 2026: Image carousel
 New
08/04/2026
Document: Veterinary medicine safety day 2026: Campaign poster
 New
08/04/2026
Document: Veterinary medicine safety day: How to check veterinary medicines are working
 New
08/04/2026
Document: Veterinary medicine safety day 2026: Expert presentation
 New
08/04/2026
Document: Veterinary medicine safety day: Why read veterinary medicines package leaflet
 New
08/04/2026
Document: Veterinary medicine safety day: How to dispose of unused veterinary medicines
 New
08/04/2026
Document: CHMP PROM minutes for the meeting on 6 October 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 8 September 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 14 July 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 10 June 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 12 May 2025
 Updated
07/04/2026
Medicine: Viramune nevirapine
Updated
07/04/2026
PSUSA: PSUSA/00002042/202507 - periodic safety update report single assessment metronidazole / miconazole, chlorquinaldol / metronidazole
Updated
07/04/2026
PSUSA: PSUSA/00002661/202507 - periodic safety update report single assessment ropinirole
New
07/04/2026
Page: Plasma master file certificates
 Updated
07/04/2026
Medicine: Imcivree setmelanotide
Updated
07/04/2026
Medicine: Neupro rotigotine
Updated
07/04/2026
Medicine: Kavigale sipavibart
Updated
07/04/2026
Medicine: Aerinaze desloratadine; pseudoephedrine
Updated
07/04/2026
Document: Public engagement highlights 2025
 New
07/04/2026
Medicine: Zokinvy lonafarnib
Updated
07/04/2026
Medicine: Rezurock belumosudil
Updated
07/04/2026
Event: Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2026
 Updated
07/04/2026
Medicine: Opdualag relatlimab; nivolumab
Updated
07/04/2026
Medicine: Adtralza tralokinumab
Updated
07/04/2026
Medicine: Eurneffy epinephrine
Updated
07/04/2026
Page: Data protection and privacy at EMA
 Updated
07/04/2026
Document: European Medicines Agency's data protection notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme
 New
07/04/2026
Event: SPOR and XEVMPD status update webinar - Q2 2026
 Updated
07/04/2026
Page: Industry Standing Group
 Updated
07/04/2026
Document: Highlights - EMA - European Alliance of Associations for Rheumatology (EULAR) bilateral meeting - March 2026
 New
07/04/2026
Event: European Medicines Regulatory Network (EMRN) workshop on Geographic Atrophy endpoints
 Updated
07/04/2026
Event: Electronic application form (eAF) Q&A clinic
 Updated
07/04/2026
Document: Notices and alerts per role - CTIS Training Programme - Module 07
 Updated
07/04/2026
DHPC: Avtozma - direct healthcare professional communication (DHPC) tocilizumab
New
07/04/2026
Page: PRAC recommendations on safety signals
 Updated
07/04/2026
Document: New product information wording - Extracts from PRAC recommendations on signals adopted at the 9-12 March 2026 PRAC
 New
07/04/2026
Document: PRAC recommendations on signals adopted at the 9-12 March 2026 PRAC meeting
 New
07/04/2026
Document: List of signals discussed at PRAC since September 2012
 Updated
01/04/2026
Medicine: Keppra levetiracetam
Updated
01/04/2026
Medicine: Ryzneuta efbemalenograstim alfa
Updated
01/04/2026
Medicine: Ilumira lutetium (177Lu) chloride
Updated
01/04/2026
Medicine: Beyfortus nirsevimab
Updated
01/04/2026
Medicine: RoActemra tocilizumab
Updated
01/04/2026
Medicine: Firazyr icatibant
Updated
01/04/2026
Document: Minutes of the COMP meeting 17-19 February 2026
 New
01/04/2026
Event: ACT EU webinar on draft guidance on the conduct of clinical trials during public health emergencies
 Updated
01/04/2026
Document: Joint Controllership Arrangement with regard to the Union product database (UPD)
 Updated
01/04/2026
Document: Records of data processing activity for the Union Product Database
 Updated
01/04/2026
Document: Policy 82: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products
 Updated
01/04/2026
Document: European Medicines Agency’s data protection notice for the exchange of information during the Critical Medicines Vulnerability Assessment exercise
 New
01/04/2026
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 March 2026
 New
01/04/2026
Event: Management Board meeting: 12 March 2026
 Updated
01/04/2026
Page: Medicines for human use under evaluation
 Updated
01/04/2026
Document: Orphan medical devices regular process: Guide for applicants
 New
01/04/2026
Document: Orphan medical devices regular process: 2026 timetable
 New
01/04/2026
Document: Clinical advice request: Template for applicants
 New
01/04/2026
Document: Orphan status request: Template for applicants
 New
01/04/2026
Medicine: Eliquis apixaban
Updated
01/04/2026
Medicine: Winrevair sotatercept
Updated
01/04/2026
Event: Workshop on the use of external controls for evidence generation in regulatory decision-making
 Updated
01/04/2026
Medicine: Remsima infliximab
Updated
01/04/2026
Medicine: LysaKare arginine; lysine
Updated
01/04/2026
Event: Workshop on Vulnerability Assessment
 Updated
01/04/2026
Page: Scientific Advisory Group on Immune and Inflammatory Diseases
 Updated
01/04/2026
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
 Updated
01/04/2026
Document: Implantable cardiac devices (various) - Notified body 2797 - 15/07/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
 New
01/04/2026
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
 Updated
01/04/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
01/04/2026
Document: List of centrally authorised products with safety-related changes to the product information
 Updated