What’s new

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.

As of 1 October 2025, 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.

Results (383)

Date	Content	Status
20/10/2025	Medicine: Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)	Updated
20/10/2025	Medicine: Herwenda trastuzumab	Updated
20/10/2025	Document: Union Product Database (UPD) - questions and answers for industry users	Updated
20/10/2025	Medicine: MiPet Easecto sarolaner	Updated
20/10/2025	Medicine: Tremfya guselkumab	Updated
20/10/2025	Medicine: Elevidys delandistrogene moxeparvovec	Updated
20/10/2025	Medicine: Vueway gadopiclenol	Updated
20/10/2025	Medicine: Imvanex smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)	Updated
20/10/2025	DHPC: Crysvita - direct healthcare professional communication (DHPC) burosumab	New
20/10/2025	Medicine: Pluvicto lutetium (177Lu) vipivotide tetraxetan	Updated
20/10/2025	Medicine: Herceptin trastuzumab	Updated
20/10/2025	Medicine: Diacomit stiripentol	Updated
20/10/2025	Medicine: Keppra levetiracetam	Updated
20/10/2025	Medicine: Onureg azacitidine	Updated
20/10/2025	Referral: Ipidacrine-containing medicinal products - referral ipidacrine	Updated
20/10/2025	Medicine: Briviact (in Italy: Nubriveo) brivaracetam	Updated
20/10/2025	Medicine: Yescarta axicabtagene ciloleucel	Updated
20/10/2025	Medicine: Insuman insulin human	Updated
20/10/2025	Herbal: Plantaginis lanceolatae folium - herbal medicinal product Ribwort Plantain	Updated
20/10/2025	PIP: EMEA-002972-PIP02-23 - paediatric investigation plan seralutinib	New
20/10/2025	PIP: EMEA-002705-PIP06-23 - paediatric investigation plan iptacopan	New
20/10/2025	PIP: EMEA-003009-PIP01-21-M01 - paediatric investigation plan zamtocabtagene autoleucel	Updated
20/10/2025	Event: Unlocking PMS API potential: Edit functionality training for MAHs	Updated
20/10/2025	Shortage: Pazenir paclitaxel	Updated
20/10/2025	PIP: EMEA-002899-PIP01-20-M03 - paediatric investigation plan sotrovimab	Updated
20/10/2025	PIP: EMEA-002818-PIP01-20-M01 - paediatric investigation plan Human plasma derived C1-inhibitor (OCTA-C1-INH)	Updated
20/10/2025	Event: Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines	New
20/10/2025	PIP: EMEA-002812-PIP02-20-M03 - paediatric investigation plan rimegepant	Updated
20/10/2025	PIP: EMEA-002713-PIP02-21-M02 - paediatric investigation plan etrasimod	Updated
20/10/2025	PIP: EMEA-002600-PIP03-21-M03 - paediatric investigation plan pegcetacoplan	Updated
20/10/2025	PIP: EMEA-002535-PIP04-21-M02 - paediatric investigation plan Ibrexafungerp citrate	Updated
17/10/2025	Medicine: Tryngolza olezarsen	Updated
17/10/2025	Medicine: Izamby denosumab	Updated
17/10/2025	Medicine: Mynzepli aflibercept	Updated
17/10/2025	Medicine: Skyrizi risankizumab	Updated
17/10/2025	Medicine: Qoyvolma ustekinumab	Updated
17/10/2025	Medicine: Kavigale sipavibart	Updated
17/10/2025	Medicine: Otulfi ustekinumab	Updated
17/10/2025	Medicine: Sapropterin Dipharma sapropterin	Updated
17/10/2025	Medicine: Tecartus brexucabtagene autoleucel	Updated
17/10/2025	Document: Clinical Trial Information System (CTIS) structured data form - Notifications, Annual Safety Report (ASR) and results	Updated
17/10/2025	PIP: EMEA-002475-PIP03-22-M01 - paediatric investigation plan spesolimab	Updated
17/10/2025	PIP: EMEA-002499-PIP03-24 - paediatric investigation plan tafasitamab	New
17/10/2025	PIP: EMEA-002350-PIP02-20-M01 - paediatric investigation plan Deucravacitinib	Updated
17/10/2025	PIP: EMEA-002341-PIP01-18-M03 - paediatric investigation plan Ganaxolone	Updated
17/10/2025	Medicine: Polivy polatuzumab vedotin	Updated
17/10/2025	Document: Start of Union reviews adopted during the CHMP meeting of 13-16 October 2025	New
17/10/2025	Medicine: Hydrocortisone Aguettant	New
17/10/2025	Post-authorisation: Paxlovid - opinion on variation to marketing authorisation nirmatrelvir; ritonavir	New
17/10/2025	Orphan: EU/3/19/2205 - orphan designation for treatment of graft-versus-host disease 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt	Updated
17/10/2025	News: First treatment for serious chronic lung disease	New
17/10/2025	Medicine: Austedo deutetrabenazine	Updated
17/10/2025	Medicine: Wayrilz rilzabrutinib	New
17/10/2025	Medicine: Rezurock Belumosudil	New
17/10/2025	Medicine: Brinsupri Brensocatib	New
17/10/2025	Referral: Oxbryta - referral voxelotor	Updated
17/10/2025	News: EMA confirms suspension of sickle cell disease medicine Oxbryta	New
17/10/2025	News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025	New
17/10/2025	PIP: EMEA-002319-PIP01-17-M03 - paediatric investigation plan rezafungin acetate	Updated
17/10/2025	Post-authorisation: Pyrukynd - opinion on variation to marketing authorisation mitapivat	New
17/10/2025	Post-authorisation: Gazyvaro - opinion on variation to marketing authorisation obinutuzumab	New
17/10/2025	Post-authorisation: Breyanzi - opinion on variation to marketing authorisation lisocabtagene maraleucel	New
17/10/2025	Post-authorisation: Libtayo - opinion on variation to marketing authorisation cemiplimab	New
17/10/2025	Post-authorisation: Cejemly - opinion on variation to marketing authorisation sugemalimab	New
17/10/2025	Post-authorisation: Scemblix - opinion on variation to marketing authorisation asciminib	New
17/10/2025	Post-authorisation: Tremfya - opinion on variation to marketing authorisation guselkumab	New
17/10/2025	EU-M4all: Fexinidazole Winthrop - opinion on medicine for use outside EU fexinidazole	Updated
17/10/2025	PIP: EMEA-002166-PIP01-17-M08 - paediatric investigation plan lasmiditan	Updated
17/10/2025	Medicine: Arava leflunomide	Updated
17/10/2025	Medicine: Scenesse afamelanotide	Updated
17/10/2025	PIP: EMEA-002152-PIP01-17-M04 - paediatric investigation plan Daratumumab	Updated
17/10/2025	PIP: EMEA-002133-PIP01-17-M04 - paediatric investigation plan cefiderocol	Updated
17/10/2025	PIP: EMEA-002106-PIP01-16-M03 - paediatric investigation plan leriglitazone	Updated
17/10/2025	Document: Minutes of the CVMP meeting 15-17 July 2025	New
17/10/2025	PIP: EMEA-001988-PIP01-16-M02 - paediatric investigation plan Macimorelin	Updated
16/10/2025	PIP: EMEA-003638-PIP01-24 - paediatric investigation plan rememulgene arelactibac	New
16/10/2025	PIP: EMEA-003632-PIP01-24 - paediatric investigation plan Empagliflozin / Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one (BI 690517)	New
16/10/2025	Event: Workshop on the use of external controls for evidence generation in regulatory decision-making	Updated
16/10/2025	PIP: EMEA-003629-PIP01-24 - paediatric investigation plan Montelukast sodium; rupatadine fumarate	New
16/10/2025	PIP: EMEA-003571-PIP01-23 - paediatric investigation plan rilonacept	New
16/10/2025	PIP: EMEA-003524-PIP01-23 - paediatric investigation plan adeno‐associated viral vector serotype 8 containing the 3' human otoferlin coding sequence / adeno‐associated viral vector serotype 8 containing the 5' human otoferlin coding sequence	New
16/10/2025	PIP: EMEA-003510-PIP01-23 - paediatric investigation plan recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody (STAR-0215)	New
16/10/2025	PIP: EMEA-003460-PIP01-23 - paediatric investigation plan mannose-1-phosphate (GLM101)	New
16/10/2025	PIP: EMEA-003425-PIP02-23 - paediatric investigation plan belumosudil	New
16/10/2025	PIP: EMEA-003388-PIP01-23 - paediatric investigation plan hydroxycarbamide	New
16/10/2025	PIP: EMEA-003258-PIP02-23 - paediatric investigation plan retatrutide	New
16/10/2025	Medicine: Plegridy peginterferon beta-1a	Updated
16/10/2025	Medicine: Avonex interferon beta-1a	Updated
16/10/2025	Medicine: Cosentyx secukinumab	Updated
16/10/2025	Event: Q&A clinic on web-based application form functionalities for CAPs and non-CAPs	Updated
16/10/2025	Medicine: Vaborem meropenem; vaborbactam	Updated
16/10/2025	Medicine: Mvasi bevacizumab	Updated
16/10/2025	Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)	Updated
16/10/2025	Document: Product Management Service (PMS) User Acceptance Testing (UAT) Application Programming Interface (API) registration process for industry - Chapter 1	New
16/10/2025	Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements for production environments	Updated
16/10/2025	Document: Minutes of the CVMP meeting 10-12 June 2025	New
16/10/2025	Document: Minutes of the CVMP meeting 9-10 September 2025	New
16/10/2025	Document: Process for the electronic submission of medicinal product information - Chapter 3	Updated
16/10/2025	Document: Management Board - Outcome of written procedures finalised during the period from 29 June to 22 September 2025	Updated
16/10/2025	Shortage: Fasturtec rasburicase	Updated
16/10/2025	Shortage: Ixiaro Japanese encephalitis vaccine (inactivated, adsorbed)	Updated
15/10/2025	Medicine: Duloxetine Viatris (previously Duloxetine Mylan) duloxetine	Updated
15/10/2025	Medicine: Zycortal desoxycortone	Updated
15/10/2025	Event: Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer's disease	Updated
15/10/2025	Event: ACT EU multi-stakeholder platform annual meeting	Updated
15/10/2025	Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - October 2025	Updated
15/10/2025	Document: Request for veterinary medicinal product classification	Updated
15/10/2025	Medicine: Zulvac SBV inactivated Schmallenberg virus, strain BH80/11-4	Updated
15/10/2025	Medicine: Zenalpha medetomidine hydrochloride; vatinoxan hydrochloride	Updated
15/10/2025	Medicine: Virbagen Omega interferon (omega)	Updated
15/10/2025	Medicine: Veraflox pradofloxacin	Updated
15/10/2025	Page: Scientific publications	Updated
15/10/2025	Medicine: Vepured E. coli verotoxoid vaccine (inactivated recombinant)	Updated
15/10/2025	Medicine: Vectra Felis pyriproxyfen; dinotefuran	Updated
15/10/2025	Medicine: Vectormune FP ILT + AE fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live)	Updated
15/10/2025	Medicine: Ponvory ponesimod	Updated
15/10/2025	Medicine: Kineret anakinra	Updated
15/10/2025	Medicine: Simponi golimumab	Updated
15/10/2025	Medicine: Zutectra human hepatitis B immunoglobulin	Updated
15/10/2025	Document: Guide for rapporteurs and coordinators on the multinational assessment teams	Updated
15/10/2025	Medicine: Nplate romiplostim	Updated
15/10/2025	Medicine: Zulvac BTV bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)	Updated
15/10/2025	Page: Frequently asked questions about parallel distribution	Updated
15/10/2025	Medicine: Ondexxya andexanet alfa	Updated
15/10/2025	Medicine: Mayzent siponimod	Updated
15/10/2025	Medicine: Ahzantive aflibercept	Updated
15/10/2025	Medicine: Firazyr icatibant	Updated
15/10/2025	Medicine: Baiama aflibercept	Updated
15/10/2025	Medicine: Qinlock ripretinib	Updated
15/10/2025	Medicine: Zulvac 1+8 Ovis inactivated bluetongue serotype 1+8 vaccine	Updated
15/10/2025	Medicine: Zulvac 1+8 Bovis inactivated bluetongue virus, serotypes 1 and 8	Updated
15/10/2025	Medicine: Zulvac 8 Ovis inactivated bluetongue virus, serotype 8	Updated
15/10/2025	Medicine: VarroMed oxalic acid dihydrate / formic acid	Updated
15/10/2025	PIP: EMEA-001720-PIP01-14-M04 - paediatric investigation plan patiromer sorbitex calcium	Updated
15/10/2025	Medicine: UpCard torasemide	Updated
15/10/2025	Medicine: Ultifend ND IBD Newcastle disease; infectious bursal disease; Marek's disease vaccine (live recombinant)	Updated
15/10/2025	PIP: EMEA-001733-PIP02-15-M03 - paediatric investigation plan gemtuzumab ozogamicin	Updated
15/10/2025	PIP: EMEA-001786-PIP01-15-M04 - paediatric investigation plan Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Updated
15/10/2025	PIP: EMEA-001930-PIP01-16-M06 - paediatric investigation plan Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid; N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid; N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid; N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW)	Updated
15/10/2025	Herbal: Maydis stigma - herbal medicinal product Corn silk	Updated
15/10/2025	PIP: EMEA-001531-PIP01-13-M06 - paediatric investigation plan tasimelteon	Updated
15/10/2025	PIP: EMEA-001426-PIP01-13-M03 - paediatric investigation plan recombinant varicella zoster virus glycoprotein E	Updated
15/10/2025	Document: Frequently asked questions about parallel distribution	Updated
14/10/2025	Medicine: Suvaxyn Circo porcine circovirus vaccine (inactivated, recombinant)	Updated
14/10/2025	Medicine: Suvaxyn Circo+MH RTU porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)	Updated
14/10/2025	Medicine: Suiseng Diff/A clostridioides difficile; clostridium perfringens vaccine, inactivated	Updated
14/10/2025	Medicine: Stelfonta tigilanol tiglate	Updated
14/10/2025	Medicine: Sevohale (previously Sevocalm) sevoflurane	Updated
14/10/2025	Medicine: Sedadex dexmedetomidine	Updated
14/10/2025	PIP: EMEA-002338-PIP01-18 - paediatric investigation plan Ianalumab	Updated
14/10/2025	PSUSA: PSUSA/00002698/202501 - periodic safety update report single assessment Sevoflurane	New
14/10/2025	Medicine: Orserdu elacestrant	Updated
14/10/2025	Medicine: Rabitec rabies vaccine (live, oral) for foxes and raccoon dogs	Updated
14/10/2025	Medicine: Bortezomib Sun bortezomib	Updated
14/10/2025	PIP: EMEA-000315-PIP02-15-M04 - paediatric investigation plan Osilodrostat	Updated
14/10/2025	PIP: EMEA-000157-PIP01-07-M06 - paediatric investigation plan belatacept	Updated
14/10/2025	Medicine: Ubac Streptococcus uberis vaccine (inactivated)	Updated
14/10/2025	Medicine: Tulissin tulathromycin	Updated
14/10/2025	Medicine: Tulinovet tulathromycin	Updated
14/10/2025	Medicine: Abrysvo respiratory syncytial virus vaccine (bivalent, recombinant)	Updated
14/10/2025	Medicine: Tulaven tulathromycin	Updated
14/10/2025	PIP: EMA/PE/0000227301 - paediatric investigation plan mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein, mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein, mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein, mRNA-1283	New
14/10/2025	Medicine: Menveo meningococcal group A, C, W-135 and Y conjugate vaccine	Updated
14/10/2025	Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants	Updated
14/10/2025	Medicine: Rabigen SAG2 live vaccine against rabies	Updated
14/10/2025	Medicine: Vaxelis diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)	Updated
14/10/2025	Medicine: Rhiniseng inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs	Updated
14/10/2025	Medicine: Rexxolide tulathromycin	Updated
14/10/2025	Medicine: Respiporc FLUpan H1N1 porcine influenza vaccine (inactivated)	Updated
14/10/2025	PIP: EMEA-001556-PIP02-24 - paediatric investigation plan aldesleukin	New
14/10/2025	Medicine: Arikayce liposomal amikacin	Updated
14/10/2025	Medicine: Quadrisol vedaprofen	Updated
14/10/2025	Document: Guide on access to unpublished documents	Updated
14/10/2025	Medicine: Okedi risperidone	Updated
14/10/2025	Document: Pool of patient and consumer experts: list for 2024-2029	Updated
14/10/2025	Document: Pool of healthcare professional experts: list for 2024-2029	Updated
14/10/2025	Medicine: Respiporc Flu3 inactivated influenza-A virus	Updated
14/10/2025	Medicine: ReproCyc ParvoFLEX porcine parvovirosis vaccine (inactivated)	Updated
14/10/2025	Medicine: Reconcile fluoxetine	Updated
14/10/2025	Document: Template for scientific document for paediatric investigation plan or product-specific waiver	Updated
14/10/2025	Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine	Updated
14/10/2025	Medicine: ProZinc insulin human	Updated
14/10/2025	Medicine: Evusheld tixagevimab; cilgavimab	Updated
14/10/2025	Medicine: Profender emodepside; praziquantel	Updated
14/10/2025	Medicine: Procox emodepside; toltrazuril	Updated
14/10/2025	Medicine: Prevomax maropitant	Updated
14/10/2025	DHPC: Leqembi - direct healthcare professional communication (DHPC) Lecanemab	New
14/10/2025	Event: EMA/HMA annual data forum	Updated
14/10/2025	Event: Refresher training webinar on post-authorisation procedure management in IRIS for marketing authorisation holders	Updated
14/10/2025	Shortage: Quetiapine	Updated
14/10/2025	Document: Agenda - Medicine Shortages (SPOC) Working Party meeting on 14-15 October 2025	New
14/10/2025	Document: Agenda - PDCO agenda of the 14-17 October 2025 meeting	New
14/10/2025	Document: Timetable: Type II variation and worksharing application monthly assessment	Updated
14/10/2025	Document: Timetable: Type II variation and worksharing application alternative monthly assessment	Updated
14/10/2025	Document: Timetable: Post-authorisation measure (PAM) assessed by PRAC	Updated
14/10/2025	Document: Respiporc Flu3 : EPAR - Medicine overview	Updated
14/10/2025	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
14/10/2025	Document: Respiporc Flu3 : EPAR - All Authorised presentations	Updated
14/10/2025	Document: Respiporc Flu3 : EPAR - Scientific Discussion	Updated
14/10/2025	Document: Suvaxyn Circo+MH RTU : EPAR - Public assessment report	Updated
13/10/2025	Medicine: Ilaris canakinumab	Updated
13/10/2025	Referral: Quarter-based selective dry cow therapy - referral	Updated
13/10/2025	Medicine: Oxlumo lumasiran	Updated
13/10/2025	Medicine: Mycamine micafungin	Updated
13/10/2025	Medicine: Eltrombopag Accord eltrombopag	Updated
13/10/2025	Medicine: Prac-tic pyriprole	Updated
13/10/2025	Medicine: Posatex orbifloxacin; mometasone furoate; posaconazole	Updated
13/10/2025	Document: Annex to agenda of the CHMP meeting 13-16 October 2025	New
13/10/2025	Document: Agenda of the CHMP meeting 13-16 October 2025	New
13/10/2025	Document: Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list	Updated
10/10/2025	Medicine: Syfovre pegcetacoplan	Updated
10/10/2025	Medicine: Teriparatide Sun teriparatide	Updated
10/10/2025	Page: European Shortages Monitoring Platform (ESMP)	Updated
10/10/2025	Page: Interoperability assessment at EMA	New
10/10/2025	Document: Presentation - The summary-of-product-characteristics guideline and paediatric aspects	Updated
10/10/2025	Page: Medicines for human use under evaluation	Updated
10/10/2025	Document: Applications for new human medicines under evaluation: October 2025	New
10/10/2025	Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 22-24 September 2025	New
10/10/2025	Event: PMS Product user interface (PUI) Training: Product data submission & bulk edit made easy	Updated
10/10/2025	Medicine: Vaxxitek HVT+IBD+H5 avian influenza vaccine (live recombinant)	New
10/10/2025	Medicine: Lenivia izenivetmab	New
10/10/2025	News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025	New
10/10/2025	Page: Data protection and privacy at EMA	Updated
10/10/2025	Event: European Medicines Agency (EMA) and European Respiratory Society (ERS) bilateral meeting	New
10/10/2025	Medicine: Carvykti ciltacabtagene autoleucel	Updated
10/10/2025	Page: ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline	Updated
10/10/2025	Document: ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5	New
10/10/2025	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	Updated
09/10/2025	Medicine: Novem meloxicam	Updated
09/10/2025	Medicine: Oncept IL-2 feline interleukin-2 recombinant canarypox virus (vCP1338 virus)	Updated
09/10/2025	Medicine: Osurnia terbinafine; florfenicol; betamethasone	Updated
09/10/2025	Medicine: Nobilis IB Primo QX avian infectious bronchitis virus strain D388	Updated
09/10/2025	Medicine: Nobivac Bb live vaccine against Bordetella bronchiseptica in cats	Updated
09/10/2025	Medicine: Novaquin meloxicam	Updated
09/10/2025	Medicine: Denbrayce denosumab	Updated
09/10/2025	Medicine: Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli) vaccine to provide passive immunity to the progeny against E. coli in pigs	Updated
09/10/2025	Medicine: Porcilis AR-T DF adjuvanted vaccine against progressive atrophic rhinitis in piglets	Updated
09/10/2025	Medicine: Melosus meloxicam	Updated
09/10/2025	Medicine: Meloxidolor meloxicam	Updated
09/10/2025	Medicine: Meloxidyl meloxicam	Updated
09/10/2025	Medicine: Pexion imepitoin	Updated
09/10/2025	Medicine: Loxicom meloxicam	Updated
09/10/2025	Medicine: Lydaxx tulathromycin	Updated
09/10/2025	Medicine: Masivet masitinib mesilate	Updated
09/10/2025	PIP: EMEA-002640-PIP01-19-M01 - paediatric investigation plan cendakimab	Updated
09/10/2025	PIP: EMEA-002944-PIP02-22 - paediatric investigation plan danuglipron	Updated
09/10/2025	Medicine: Comirnaty COVID-19 mRNA vaccine	Updated
09/10/2025	Medicine: Fulvestrant Mylan fulvestrant	Updated
09/10/2025	Medicine: Emgality galcanezumab	Updated
09/10/2025	Medicine: Zeposia ozanimod	Updated
09/10/2025	Medicine: Gardasil 9 human papillomavirus 9-valent vaccine (recombinant, adsorbed)	Updated
09/10/2025	Medicine: Scemblix asciminib	Updated
09/10/2025	Medicine: Nasym bovine respiratory syncytial virus vaccine (live)	Updated
09/10/2025	Medicine: MS-H Vaccine Mycoplasma synoviae (live)	Updated
09/10/2025	Medicine: Mirataz mirtazapine	Updated
09/10/2025	Medicine: Adasuve loxapine	Updated
09/10/2025	Document: Annual report of the Pharmacovigilance Inspectors Working Group for 2024	New
09/10/2025	Medicine: Tuznue trastuzumab	Updated
09/10/2025	Medicine: Memantine Accord memantine	Updated
09/10/2025	Medicine: Neptra florfenicol; terbinafine hydrochloride; mometasone furoate	Updated
09/10/2025	Medicine: OvuGel triptorelin	Updated
09/10/2025	Medicine: Zadenvi denosumab	Updated
09/10/2025	Medicine: Oxyglobin haemoglobin glutamer-200 (bovine)	Updated
09/10/2025	Medicine: Locatim (previously Serinucoli) locatim, oral solution for neonatal calves less than 12 hours of age	Updated
09/10/2025	Medicine: Letifend canine leishmaniasis vaccine (recombinant protein)	Updated
09/10/2025	Medicine: Kriptazen halofuginone	Updated
08/10/2025	PIP: EMEA-003463-PIP01-23 - paediatric investigation plan human alpha-1 proteinase inhibitor, modified (SerpinPC)	Updated
08/10/2025	Medicine: Ingelvac CircoFLEX inactivated porcine circovirus vaccine	Updated
08/10/2025	Medicine: Humira adalimumab	Updated
08/10/2025	Medicine: Azacitidine Accord azacitidine	Updated
08/10/2025	Medicine: Inflacam meloxicam	Updated
08/10/2025	Medicine: Briumvi ublituximab	Updated
08/10/2025	Medicine: Tecvayli teclistamab	Updated
08/10/2025	Document: Agenda of the CAT meeting 8-9 October 2025	Updated
08/10/2025	Medicine: Gazyvaro obinutuzumab	Updated
08/10/2025	Event: EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation	Updated
08/10/2025	Document: Union Product Database (UPD) - Quick guide for UPD notifications via the user interface and via email	Updated
08/10/2025	Event: EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures	New
08/10/2025	Medicine: Isemid torasemide	Updated
08/10/2025	Document: European Medicines Agency mid-year report 2025 (January-June 2025)	New
08/10/2025	Medicine: Ekterly sebetralstat	Updated
07/10/2025	PIP: EMEA-001073-PIP02-14 - paediatric investigation plan varicella-zoster virus (inactivated)	Updated
07/10/2025	PIP: EMEA-001207-PIP06-22 - paediatric investigation plan Obinutuzumab	Updated
07/10/2025	PSUSA: PSUSA/00010130/202502 - periodic safety update report single assessment potassium para-aminobenzoate	New
07/10/2025	Medicine: Bemrist Breezhaler indacaterol; mometasone	Updated
07/10/2025	Medicine: Selincro nalmefene	Updated
07/10/2025	Medicine: Benlysta belimumab	Updated
07/10/2025	Document: Minutes of the CHMP written procedure 18-21 August 2025	New
07/10/2025	Event: SPOR and XEVMPD status update webinar	Updated
07/10/2025	Medicine: Cinacalcet Viatris (previously Cinacalcet Mylan) cinacalcet	Updated
07/10/2025	Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2025	New
07/10/2025	Page: EU enlargement	Updated
07/10/2025	Medicine: Brukinsa zanubrutinib	Updated
07/10/2025	Document: HMA-EMA joint Network Data Steering Group meeting - 16 September 2025	New
07/10/2025	Event: Public webinar on shortages: putting patients first	Updated
07/10/2025	Document: Agenda - Instrument for Pre-accession Assistance (IPA) training on assessing medicinal products in the EU: A practical introduction	New
07/10/2025	Medicine: Daxas roflumilast	Updated
07/10/2025	Medicine: Halocur halofuginone	Updated
07/10/2025	Page: Website outages and upgrades	Updated
07/10/2025	Medicine: Tepadina thiotepa	Updated
07/10/2025	Medicine: Halagon halofuginone	Updated
07/10/2025	Medicine: Galliprant grapiprant	Updated
07/10/2025	Document: Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations - Revised 1st October 2025	Updated
07/10/2025	Document: Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 1st October 2025	Updated
07/10/2025	Document: Agenda of the CVMP meeting 7-9 October 2025	New
07/10/2025	DHPC: Finasteride / dutasteride - direct healthcare professional communication (DHPC) Finasteride; dutasteride	New
06/10/2025	PSUSA: PSUSA/00002413/202502 - periodic safety update report single assessment pimozide	New
06/10/2025	PSUSA: PSUSA/00003129/202501 - periodic safety update report single assessment warfarin	New
06/10/2025	Medicine: Minjuvi tafasitamab	Updated
06/10/2025	Medicine: Lenalidomide Mylan lenalidomide	Updated
06/10/2025	Medicine: Aplidin plitidepsin	Updated
06/10/2025	Medicine: Imnovid (previously Pomalidomide Celgene) pomalidomide	Updated
06/10/2025	Event: Q&A clinic on web-based electronic application form (eAF) functionalities for CAPs and non-CAPs	Updated
06/10/2025	Medicine: Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted)	Updated
06/10/2025	Page: CAT: Working parties and other groups	Updated
06/10/2025	Page: CVMP: Working parties and other groups	Updated
06/10/2025	Page: CHMP: Working parties and other groups	Updated
06/10/2025	Medicine: Imlygic talimogene laherparepvec	Updated
06/10/2025	Document: Agenda of the COMP meeting 7-8 October 2025	New
06/10/2025	Medicine: Anzupgo delgocitinib	Updated
06/10/2025	Medicine: Rixathon rituximab	Updated
06/10/2025	Page: Maximum residue limits (MRL)	Updated
06/10/2025	Document: Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782	New
06/10/2025	Medicine: Pregabalin Sandoz pregabalin	Updated
06/10/2025	Page: Business hours and holidays	Updated
06/10/2025	Medicine: Capvaxive pneumococcal polysaccharide conjugate vaccine (21-valent)	Updated
03/10/2025	Page: PRAC: Working parties and other groups of interest	New
03/10/2025	Page: PRAC Interest Group on Measuring the Impact of Pharmacovigilance Activities (PRAC IG Impact)	New
03/10/2025	Page: Granularity and Periodicity Advisory Group	New
03/10/2025	Document: Timetable: Companion diagnostic follow-up consultation	Updated
03/10/2025	Document: Timetable: Companion diagnostic follow-up consultation - ATMP	Updated
03/10/2025	Document: Timetable: Companion diagnostic initial consultation	Updated
03/10/2025	PSUSA: PSUSA/00001694/202503 - periodic safety update report single assessment hydroxyethyl starch / sodium chloride	New
03/10/2025	PSUSA: PSUSA/00001744/202503 - periodic safety update report single assessment influenza vaccine (surface antigen, inactivated)	New
03/10/2025	Document: SMS guidance for external users	Updated
03/10/2025	Document: Timetable: Companion diagnostic initial consultation - ATMP	Updated
03/10/2025	PSUSA: PSUSA/00010551/202501 - periodic safety update report single assessment mesterolone	New
03/10/2025	Document: Meeting summary - PCWP meeting, HCPWP meeting, joint PCWP/HCPWP meeting - 23-24 September 2025	New
03/10/2025	Document: QRD Appendix V - Adverse-drug-reaction reporting details	Updated
03/10/2025	Page: PRAC Risk Minimisation Alliance (PRISMA) Group	New
03/10/2025	PSUSA: PSUSA/00003133/202501 - periodic safety update report single assessment xipamide, triamterene / xipamide	New
03/10/2025	PSUSA: PSUSA/00001909/202501 - periodic safety update report single assessment lorazepam	New
03/10/2025	News: EMA Management Board: highlights of October 2025 meeting	New
03/10/2025	Post-authorisation: Sileo - withdrawal of application for variation to marketing authorisation dexmedetomidine	New
03/10/2025	PSUSA: PSUSA/00010289/202502 - periodic safety update report single assessment lisdexamfetamine	New
03/10/2025	PSUSA: PSUSA/00002982/202501 - periodic safety update report single assessment tofisopam	New
03/10/2025	PSUSA: PSUSA/00000901/202501 - periodic safety update report single assessment cyclophosphamide	New
03/10/2025	Page: Data in regulation: Big data and other sources	Updated
03/10/2025	Document: European Medicines Agencies Network Data Strategy - Increasing the value of data for the benefit of public and animal health	New
03/10/2025	Medicine: Ogsiveo nirogacestat	Updated
03/10/2025	News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025	New
03/10/2025	Herbal: Calendulae flos - herbal medicinal product Calendula Flower	Updated
02/10/2025	PSUSA: PSUSA/00001760/202501 - periodic safety update report single assessment interferon gamma	New
02/10/2025	PSUSA: PSUSA/00001028/202411 - periodic safety update report single assessment diamorphine	New
02/10/2025	Medicine: Elahere mirvetuximab soravtansine	Updated
02/10/2025	Medicine: Tyenne tocilizumab	Updated
02/10/2025	Page: VICH GL62 on target animal safety of veterinary monoclonal antibody products (VMAPs) St4	New
02/10/2025	Medicine: Zynlonta loncastuximab tesirine	Updated
02/10/2025	Medicine: Vivlipeg pegfilgrastim	New
02/10/2025	Medicine: Takhzyro lanadelumab	Updated
02/10/2025	Document: Agenda - Management Board meeting: 2 October 2025	Updated
02/10/2025	Medicine: Talvey talquetamab	Updated
02/10/2025	Page: Fees payable to the European Medicines Agency	Updated
02/10/2025	Page: Fees payable to the European Medicines Agency: Guidance for all applicants	Updated
02/10/2025	Page: Fees for veterinary medicines	Updated
02/10/2025	Page: Annual fees payable to the European Medicines Agency	Updated
02/10/2025	Page: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices	Updated
02/10/2025	Page: Fees for human medicines	Updated
02/10/2025	Document: HMPC: overview of assessment work - priority list	Updated
02/10/2025	Document: Minutes - Enpr-EMA Coordinating Group & networks meeting - June 2025	New
02/10/2025	News: Advice on end-of-year submission dates for type I variations in 2025	Updated
02/10/2025	Medicine: Leqembi lecanemab	Updated
02/10/2025	Medicine: Xtandi enzalutamide	Updated
01/10/2025	Page: Accessibility	Updated
01/10/2025	Document: Organisation chart: Advisory functions	Updated
01/10/2025	Medicine: Adcetris brentuximab vedotin	Updated
01/10/2025	Medicine: Nidlegy bifikafusp alfa; onfekafusp alfa	Updated
01/10/2025	Page: Paediatric clinical trials	Updated
01/10/2025	Page: Submitting results of paediatric studies	Updated
01/10/2025	Medicine: Farydak panobinostat	Updated
01/10/2025	Document: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level	Updated
01/10/2025	Page: In-use stability testing of veterinary medicinal products - Scientific guideline	Updated
01/10/2025	Document: Guideline on in-use stability testing of veterinary medicinal products	New

What’s new

Filter by

Results (383)