DateContentStatus
31/05/2024 Medicine: LytenavaUpdated
31/05/2024 Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm+EDSUpdated
31/05/2024 Medicine: Divence TetraUpdated
31/05/2024 Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 6 June 2024New
31/05/2024 Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 27 June 2024New
31/05/2024 Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 13 June 2024New
31/05/2024 Event: Q&A clinic on Product Management Service (PMS) Product User Interface - 20 June 2024New
31/05/2024 Medicine: Divence PentaUpdated
31/05/2024 Medicine: Enteroporc ColiUpdated
31/05/2024 Event: Eighth Industry Standing Group (ISG) meetingUpdated
31/05/2024 Event: Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonistsNew
31/05/2024 Document: User guide for micro, small and medium-sized enterprisesUpdated
31/05/2024 Medicine: MeloxoralUpdated
31/05/2024 Medicine: LibrelaUpdated
31/05/2024 Post-authorisation: Dupixent - opinion on variation to marketing authorisationNew
31/05/2024 Medicine: Pomalidomide KrkaUpdated
31/05/2024 Medicine: KinhartoNew
31/05/2024 Document: Minutes of the CVMP meeting 16-18 April 2024New
31/05/2024 Event: Cancer Medicines Forum workshop: April 2024Updated
31/05/2024 Referral: Mysimba - referralUpdated
31/05/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024New
31/05/2024 Medicine: AkantiorNew
31/05/2024 Document: Questions and answers on the outcome of assessment to extend the use of Valdoxan (agomelatine)New
31/05/2024 Post-authorisation: Scenesse - withdrawal of application for variation to marketing authorisationNew
31/05/2024 News: First vaccine to protect adults from ChikungunyaNew
31/05/2024 Post-authorisation: Tevimbra - opinion on variation to marketing authorisationNew
31/05/2024 Post-authorisation: Skyrizi - opinion on variation to marketing authorisationNew
31/05/2024 Medicine: ApexelsinNew
31/05/2024 Medicine: AdzynmaNew
31/05/2024 Post-authorisation: Kinpeygo - opinion on variation to marketing authorisationNew
31/05/2024 Medicine: ZegalogueNew
31/05/2024 Medicine: DurveqtixNew
31/05/2024 Medicine: Dasatinib Accord HealthcareNew
31/05/2024 Medicine: Pomalidomide ZentivaNew
31/05/2024 Medicine: AvziviNew
31/05/2024 Medicine: Pomalidomide AccordNew
31/05/2024 Medicine: GalliaPharmNew
31/05/2024 Medicine: CejemlyNew
31/05/2024 Post-authorisation: Eliquis - opinion on variation to marketing authorisationNew
31/05/2024 Medicine: IxchiqNew
31/05/2024 Post-authorisation: Tagrisso - opinion on variation to marketing authorisationNew
31/05/2024 Post-authorisation: Livmarli - opinion on variation to marketing authorisationNew
31/05/2024 Medicine: FluenzNew
31/05/2024 Page: Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Scientific guidelineUpdated
31/05/2024 News: New gene therapy treatment for haemophilia BNew
31/05/2024 Document: Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan AfricaUpdated
31/05/2024 Page: Frequently asked questions about parallel distributionUpdated
31/05/2024 Document: Checklist for initial notifications for parallel distribution: guidance for industryUpdated
31/05/2024 Document: Checklist for annual updates for parallel distribution: guidance for industryUpdated
31/05/2024 Document: Frequently asked questions about parallel distributionUpdated
30/05/2024 Medicine: TecartusUpdated
30/05/2024 Medicine: BaqsimiUpdated
30/05/2024 Page: Scientific publicationsUpdated
30/05/2024 Medicine: KapruviaUpdated
30/05/2024 Medicine: AvamysUpdated
30/05/2024 PIP: EMEA-003104-PIP02-22 - paediatric investigation planNew
30/05/2024 PIP: EMEA-003063-PIP02-22 - paediatric investigation planNew
30/05/2024 PIP: EMEA-003024-PIP01-21 - paediatric investigation planNew
30/05/2024 PIP: EMEA-002559-PIP07-22 - paediatric investigation planNew
30/05/2024 Medicine: OrgalutranUpdated
30/05/2024 News: Annual report highlights progress in science, medicines and health in 2023New
30/05/2024 Page: Annual reports and work programmesUpdated
30/05/2024 Document: Annexes - 2023 annual report of the European Medicines AgencyNew
30/05/2024 Document: Annex 10 - 2023 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indicationNew
30/05/2024 Document: 2023 annual report of the European Medicines AgencyNew
30/05/2024 PSUSA: PSUSA/00000996/202308 - periodic safety update report single assessmentNew
30/05/2024 Referral: Micrazym and associated names - referralUpdated
30/05/2024 Event: European Medicines Agency (EMA) Healthcare Professionals' (HCPWP) Working Party meetingNew
30/05/2024 Page: Patients' and Consumers' Working PartyUpdated
30/05/2024 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 guidelineNew
30/05/2024 Document: ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2bNew
29/05/2024 Event: EU NTC ten year anniversary eventUpdated
29/05/2024 Referral: Procaine benzylpenicillin - referralUpdated
29/05/2024 Document: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national levelUpdated
29/05/2024 Medicine: YescartaUpdated
29/05/2024 Medicine: MounjaroUpdated
29/05/2024 Medicine: NimenrixUpdated
29/05/2024 Medicine: Voriconazole Hikma (previously Voriconazole Hospira)Updated
29/05/2024 Event: European Shortages Monitoring Platform Essentials and Industry Reporting RequirementsUpdated
29/05/2024 Medicine: JyselecaUpdated
29/05/2024 Medicine: ZesslyUpdated
29/05/2024 Medicine: IsturisaUpdated
29/05/2024 Medicine: AdvateUpdated
29/05/2024 Medicine: VyeptiUpdated
29/05/2024 Document: Annex XV - List of topiramate containing medicinal products in the European UnionNew
29/05/2024 Page: List of medicines under additional monitoringUpdated
29/05/2024 Document: Annex XV - List of topiramate containing medicinal products in the European UnionNew
29/05/2024 Document: List of medicinal products under additional monitoringUpdated
29/05/2024 Document: List of medicinal products under additional monitoringUpdated
29/05/2024 Medicine: RixubisUpdated
29/05/2024 Medicine: DzuveoUpdated
29/05/2024 Medicine: HemlibraUpdated
29/05/2024 Medicine: DynastatUpdated
29/05/2024 Page: National registers of authorised medicinesUpdated
29/05/2024 Medicine: Zolsketil pegylated liposomalUpdated
29/05/2024 Document: EU 4 AMA: leveraging European expertise for medicines regulation in AfricaNew
29/05/2024 Medicine: OmlycloUpdated
28/05/2024 PIP: EMEA-002427-PIP01-18-M02 - paediatric investigation planUpdated
28/05/2024 Medicine: Zoonotic Influenza Vaccine SeqirusUpdated
28/05/2024 PIP: EMEA-002246-PIP01-17-M03 - paediatric investigation planUpdated
28/05/2024 PSUSA: PSUSA/00001642/202309 - periodic safety update report single assessmentNew
28/05/2024 Medicine: FilspariUpdated
28/05/2024 PIP: EMEA-002233-PIP01-17-M02 - paediatric investigation planUpdated
28/05/2024 PIP: EMEA-002166-PIP01-17-M07 - paediatric investigation planUpdated
28/05/2024 PIP: EMEA-001679-PIP01-14-M03 - paediatric investigation planUpdated
28/05/2024 PIP: EMEA-001652-PIP01-14-M05 - paediatric investigation planUpdated
28/05/2024 Medicine: TruvadaUpdated
28/05/2024 Medicine: XromiUpdated
28/05/2024 Page: Clinical Trials Information System: training and supportUpdated
28/05/2024 Medicine: ReagilaUpdated
28/05/2024 Document: Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMPNew
28/05/2024 Event: Clinical Trials Information System (CTIS) sponsor end user training programme - November 2024New
28/05/2024 Event: Clinical Trials Information System (CTIS) sponsor end user training programme - October 2024New
28/05/2024 Medicine: SarclisaUpdated
28/05/2024 Event: Clinical Trials Information System (CTIS) sponsor end user training programme - September 2024New
28/05/2024 Medicine: Filgrastim HexalUpdated
28/05/2024 Event: Paediatric Committee (PDCO): 28-31 May 2024Updated
28/05/2024 Document: Agenda - PDCO agenda of the 28-31 May 2024 meetingNew
28/05/2024 Page: Data Analysis and Real World Interrogation Network (DARWIN EU)Updated
28/05/2024 Event: DARWIN EU Advisory Board meeting: 3 May 2024New
28/05/2024 Document: DARWIN EU Advisory Board: MembershipUpdated
28/05/2024 Event: DARWIN EU Advisory Board meeting - 11 December 2023Updated
28/05/2024 Document: Careers at EMA user-guideUpdated
28/05/2024 Medicine: ZarzioUpdated
28/05/2024 Medicine: RetsevmoUpdated
28/05/2024 Medicine: BetmigaUpdated
28/05/2024 Event: EMA/FVE info session on restrictions for the use of certain antimicrobials in animalsUpdated
28/05/2024 Medicine: NuceivaUpdated
27/05/2024 Medicine: LoargysUpdated
27/05/2024 Document: Agenda of the CHMP meeting 27-30 May 2024New
27/05/2024 Medicine: Vectormune FP ILTUpdated
27/05/2024 Medicine: RonapreveUpdated
27/05/2024 Medicine: RotarixUpdated
24/05/2024 Medicine: SotyktuUpdated
24/05/2024 Medicine: Tenofovir disoproxil ZentivaUpdated
24/05/2024 Medicine: VyvgartUpdated
24/05/2024 Medicine: RinvoqUpdated
24/05/2024 Medicine: Vyxeos liposomal (previously known as Vyxeos)Updated
24/05/2024 Medicine: SaphneloUpdated
24/05/2024 Medicine: NexviadymeUpdated
24/05/2024 Medicine: BenlystaUpdated
24/05/2024 Event: Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024Updated
24/05/2024 Medicine: OrserduUpdated
24/05/2024 Medicine: SkyriziUpdated
24/05/2024 Medicine: TachoSilUpdated
24/05/2024 Medicine: LocametzUpdated
24/05/2024 Medicine: SprycelUpdated
24/05/2024 Page: Support for industry on clinical data publicationUpdated
24/05/2024 Document: Anonymisation report form instructionsNew
24/05/2024 Document: Anonymisation report form templateNew
24/05/2024 Medicine: Atazanavir Viatris (previously Atazanavir Mylan)Updated
24/05/2024 Post-authorisation: Bluevac BTV (previously known as Bluevac BTV8) - opinion on variation to marketing authorisationNew
24/05/2024 Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOmNew
24/05/2024 Medicine: Nobilis Multriva RT+IBm+ND+EDSNew
24/05/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024New
24/05/2024 Medicine: Darunavir Viatris (previously Darunavir Mylan)Updated
24/05/2024 Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questionsUpdated
24/05/2024 Document: List of centrally authorised products requiring a notification of a change for update of annexesUpdated
24/05/2024 Page: Industry annual bilateral meetingsUpdated
24/05/2024 Event: Seventh European Medicines Agency - Medicines for Europe annual bilateral meetingNew
24/05/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - May 2024Updated
23/05/2024 Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicantsUpdated
23/05/2024 Medicine: BinocritUpdated
23/05/2024 Medicine: Epoetin Alfa HexalUpdated
23/05/2024 Medicine: AbseamedUpdated
23/05/2024 Medicine: SpravatoUpdated
23/05/2024 Medicine: TizveniUpdated
23/05/2024 Event: Environmental Risk Assessment (ERA) Assessors TrainingNew
23/05/2024 Medicine: StrangvacUpdated
23/05/2024 Page: SME Regulation and reportsUpdated
23/05/2024 Medicine: LumykrasUpdated
23/05/2024 Medicine: ArexvyUpdated
23/05/2024 Herbal: Rhodiolae roseae rhizoma et radix - herbal medicinal productUpdated
23/05/2024 Medicine: LysaKareUpdated
23/05/2024 Medicine: Zonisamide MylanUpdated
23/05/2024 Medicine: Enerzair BreezhalerUpdated
23/05/2024 Medicine: LoxitabUpdated
23/05/2024 DHPC: Giapreza - direct healthcare professional communication (DHPC)New
23/05/2024 Medicine: EluracatUpdated
23/05/2024 Medicine: OxmaxUpdated
23/05/2024 Medicine: Atectura BreezhalerUpdated
23/05/2024 Medicine: CerezymeUpdated
22/05/2024 Medicine: IbranceUpdated
22/05/2024 Medicine: NubeqaUpdated
22/05/2024 Medicine: ImvanexUpdated
22/05/2024 Medicine: FlixabiUpdated
22/05/2024 Event: New Fee Regulation: webinar for veterinary Marketing Authorisation HoldersNew
22/05/2024 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
22/05/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - September 2024New
22/05/2024 Document: EVVet3 EVWeb Production – Release notesUpdated
22/05/2024 Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7Updated
22/05/2024 Medicine: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)Updated
22/05/2024 Medicine: AmgevitaUpdated
22/05/2024 Medicine: KrazatiUpdated
22/05/2024 Medicine: TevimbraUpdated
22/05/2024 Medicine: SpexotrasUpdated
22/05/2024 Medicine: RoclandaUpdated
22/05/2024 Page: Website outages and upgradesUpdated
22/05/2024 Medicine: StayveerUpdated
22/05/2024 Medicine: Fulvestrant MylanUpdated
22/05/2024 Medicine: MekinistUpdated
22/05/2024 Document: Agenda of the CAT meeting 22-24 May 2024New
22/05/2024 Medicine: ViagraUpdated
21/05/2024 PIP: EMEA-003273-PIP02-22 - paediatric investigation planNew
21/05/2024 PSUSA: PSUSA/00000958/202309 - periodic safety update report single assessmentNew
21/05/2024 PIP: EMEA-003090-PIP02-22 - paediatric investigation planNew
21/05/2024 PIP: EMEA-003355-PIP01-22 - paediatric investigation planNew
21/05/2024 Medicine: TafinlarUpdated
21/05/2024 PIP: EMEA-002247-PIP03-17-M01 - paediatric investigation planUpdated
21/05/2024 Medicine: FinleeUpdated
21/05/2024 Medicine: TecentriqUpdated
21/05/2024 Medicine: QuviviqUpdated
21/05/2024 Medicine: ErleadaUpdated
21/05/2024 Medicine: TepmetkoUpdated
21/05/2024 Event: Product Management Service (PMS) Product UI training (access & navigation)Updated
21/05/2024 Medicine: Palonosetron AccordUpdated
21/05/2024 News: EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine TranslarnaUpdated
21/05/2024 News: Medical devices: new guidance for industry and notified bodiesNew
21/05/2024 Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)Updated
21/05/2024 Medicine: MysildecardUpdated
21/05/2024 Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changesUpdated
21/05/2024 Medicine: Apremilast AccordUpdated
21/05/2024 Document: CTIS newsflash - 17 May 2024New
21/05/2024 Medicine: CresembaUpdated
21/05/2024 Medicine: Temozolomide SunUpdated
21/05/2024 Document: Agenda of the CVMP meeting 21-23 May 2024New
21/05/2024 Document: Agenda of the COMP meeting 21-23 May 2024New
21/05/2024 Medicine: EvenityUpdated
21/05/2024 Medicine: RekambysUpdated
21/05/2024 News: Have your say and help shape EMA’s future communicationsNew
20/05/2024 News: European medicines network designated as WHO listed authorityNew
17/05/2024 Document: Minimum inhibitory concentration (MIC) breakpointsUpdated
17/05/2024 Referral: Ibuprofen NVT - referralUpdated
17/05/2024 PSUSA: PSUSA/00010768/202310 - periodic safety update report single assessmentNew
17/05/2024 Medicine: TrepulmixUpdated
17/05/2024 Medicine: AjovyUpdated
17/05/2024 Medicine: VoydeyaUpdated
17/05/2024 Event: Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portalNew
17/05/2024 Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data servicesUpdated
17/05/2024 Medicine: Onivyde pegylated liposomal (previously known as Onivyde)Updated
17/05/2024 Page: Outcomes of imposed non-interventional post-authorisation safety studiesUpdated
17/05/2024 Document: European Medicines Agency’s data protection notice for the EMA Help DeskUpdated
17/05/2024 Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1Updated
17/05/2024 Medicine: Miglustat Gen.OrphUpdated
17/05/2024 News: Hydroxyprogesterone caproate medicines to be suspended from the EU marketNew
17/05/2024 Referral: Hydroxyprogesterone caproate-containing medicinal products - referralUpdated
17/05/2024 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024New
17/05/2024 Medicine: TracleerUpdated
17/05/2024 Medicine: ZepatierUpdated
16/05/2024 PSUSA: PSUSA/00002569/202309 - periodic safety update report single assessmentNew
16/05/2024 PSUSA: PSUSA/00000034/202309 - periodic safety update report single assessmentNew
16/05/2024 PSUSA: PSUSA/00010806/202310 - periodic safety update report single assessmentNew
16/05/2024 Document: Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/202304 New
16/05/2024 Medicine: NplateUpdated
16/05/2024 Medicine: KalydecoUpdated
16/05/2024 Medicine: Temozolomide TevaUpdated
16/05/2024 Document: PDCO minutes of the 19-22 March 2024 meetingNew
16/05/2024 News: EMA closed on Whit Monday, 20 MayNew
16/05/2024 Medicine: ColobreatheUpdated
16/05/2024 Medicine: Fingolimod AccordUpdated
16/05/2024 Document: Meeting Summary of the Medicine Shortages (SPOC) Working Party - 14 March 2024New
16/05/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 14 March 2024New
16/05/2024 Event: Information and Q&A session on updated CAPs in web-based eAFUpdated
16/05/2024 Document: Records of data processing activity for study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period”New
16/05/2024 Event: EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory frameworkUpdated
16/05/2024 Document: EudraVigilance registration documentsUpdated
16/05/2024 Document: EudraVigilance Form AUpdated
16/05/2024 Document: New Organization First User QPPV/RP or Change of EU QPPV/RPUpdated
16/05/2024 Document: European Medicines Agency's data protection notice on the study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period”New
16/05/2024 Medicine: Pregabalin SandozUpdated
16/05/2024 Page: Network PortfolioUpdated
16/05/2024 Event: Quarterly System Demo – Q2 2024New
16/05/2024 Medicine: Pregabalin MylanUpdated
16/05/2024 Document: Organisation chart: Information ManagementUpdated
16/05/2024 Medicine: Ibuprofen Gen.OrphUpdated
15/05/2024 Medicine: BrukinsaUpdated
15/05/2024 Document: Policy 78: EMA environmental policyUpdated
15/05/2024 Medicine: TasignaUpdated
15/05/2024 Medicine: RyzneutaUpdated
15/05/2024 Medicine: ImcivreeUpdated
15/05/2024 Medicine: NeuraceqUpdated
15/05/2024 Medicine: LyricaUpdated
15/05/2024 Medicine: KaftrioUpdated
15/05/2024 Referral: Azithromycin-containing medicinal products for systemic use - referralUpdated
15/05/2024 Medicine: UptraviUpdated
14/05/2024 Event: Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 May 2024Updated
14/05/2024 Document: Agenda of the PRAC meeting 13-16 May 2024Updated
14/05/2024 Document: Guidebook for tenderersUpdated
14/05/2024 Document: Article 57 product dataUpdated
14/05/2024 Medicine: Thalidomide LipomedUpdated
14/05/2024 Medicine: MayzentUpdated
14/05/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - July 2024Updated
14/05/2024 Medicine: Olanzapine MylanUpdated
14/05/2024 Document: Minutes of the PRAC meeting 4-7 March 2024New
14/05/2024 Medicine: VegzelmaUpdated
14/05/2024 Medicine: PoteligeoUpdated
14/05/2024 Medicine: AspaveliUpdated
14/05/2024 Document: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation GuideUpdated
13/05/2024 Medicine: GONAL-fUpdated
13/05/2024 Medicine: AgamreeUpdated
13/05/2024 Medicine: AxuminUpdated
13/05/2024 Medicine: BexseroUpdated
13/05/2024 Medicine: Ghryvelin (previously Macimorelin Aeterna Zentaris)Updated
13/05/2024 Medicine: ScenesseUpdated
13/05/2024 Medicine: Anagrelide Viatris (previously Anagrelide Mylan)Updated
13/05/2024 Medicine: MyozymeUpdated
13/05/2024 Medicine: FabrazymeUpdated
13/05/2024 Medicine: KaulivUpdated
13/05/2024 Medicine: OnglyzaUpdated
13/05/2024 Medicine: Rasagiline MylanUpdated
13/05/2024 Medicine: Plerixafor AccordUpdated
13/05/2024 Medicine: AtrianceUpdated
13/05/2024 Medicine: SpinrazaUpdated
13/05/2024 Medicine: Granupas (previously Para-aminosalicylic acid Lucane)Updated
13/05/2024 Medicine: VyndaqelUpdated
13/05/2024 Medicine: DupixentUpdated
13/05/2024 Medicine: Telmisartan ActavisUpdated
13/05/2024 Medicine: LuxturnaUpdated
13/05/2024 Medicine: LeqvioUpdated
13/05/2024 Medicine: Heplisav BUpdated
13/05/2024 Medicine: OrkambiUpdated
13/05/2024 Medicine: ReblozylUpdated
13/05/2024 Medicine: AbrysvoUpdated
13/05/2024 Medicine: KeytrudaUpdated
13/05/2024 Medicine: TresibaUpdated
13/05/2024 Medicine: IsentressUpdated
13/05/2024 Medicine: RyzodegUpdated
08/05/2024 Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23Updated
08/05/2024 Document: Timetable: Post-authorisation safety study (PASS) protocols and final resultsUpdated
08/05/2024 Document: Timetable: Initial (Full) marketing authorisation application - ATMPUpdated
07/05/2024 Document: Organisation chart: Advisory functionsUpdated
07/05/2024 Page: Need for maximum residue limit (MRL) evaluation for biological substances - Scientific guidelineUpdated
07/05/2024 Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca)Updated
07/05/2024 Herbal: Hippocastani cortex - herbal medicinal productUpdated
07/05/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024Updated
07/05/2024 News: EMA closed 9-10 MayNew
07/05/2024 Event: Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa"New
07/05/2024 Page: PRIME: priority medicinesUpdated
07/05/2024 Document: List of medicines currently in PRIME schemeUpdated
07/05/2024 Medicine: EmblaveoUpdated
07/05/2024 News: One Health: a joint framework for action published by five EU agenciesNew
07/05/2024 Event: Product Management Service (PMS) Info-DayUpdated
07/05/2024 Page: COVID-19 vaccines: key factsUpdated
06/05/2024 Document: Record of data processing activity relating to Security Access Control SystemUpdated
06/05/2024 Document: Records of data processing activity for audiovisual tool for checking presence in meeting roomsNew
06/05/2024 Document: European Medicines Agency’s privacy statement for the operation of the Security Access Control SystemUpdated
06/05/2024 Document: European Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting roomsNew
06/05/2024 Page: ProcurementUpdated
06/05/2024 Event: EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcomaUpdated
06/05/2024 PSUSA: PSUSA/00002310/202308 - periodic safety update report single assessmentNew
06/05/2024 Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma WorkshopNew
06/05/2024 Document: Minutes of the COMP meeting 12-14 March 2024New
06/05/2024 Referral: Synapse - referralUpdated
06/05/2024 Medicine: AdynoviUpdated
06/05/2024 Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationUpdated
06/05/2024 Document: List of signals discussed at PRAC since September 2012Updated
06/05/2024 Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meetingNew
03/05/2024 Medicine: MenQuadfiUpdated
03/05/2024 PIP: EMEA-002754-PIP01-19 - paediatric investigation planUpdated
03/05/2024 PIP: EMEA-002693-PIP01-19 - paediatric investigation planUpdated
03/05/2024 PIP: EMEA-003157-PIP01-21 - paediatric investigation planUpdated
03/05/2024 PIP: EMEA-001666-PIP01-14-M01 - paediatric investigation planUpdated
03/05/2024 Document: Agenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methodsUpdated
03/05/2024 Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesUpdated
03/05/2024 Event: Third European Medicines Agency and Affordable Medicines Europe bilateral meetingUpdated
03/05/2024 PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessmentNew
03/05/2024 Medicine: BriumviUpdated
03/05/2024 Document: Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23Updated
03/05/2024 Medicine: SivextroUpdated
03/05/2024 Medicine: TalzennaUpdated
03/05/2024 Page: Plasma master file certificatesUpdated
03/05/2024 Page: ICH M10 on bioanalytical method validation - Scientific guidelineUpdated
03/05/2024 Page: Real-world evidenceNew
03/05/2024 Page: Big dataUpdated
03/05/2024 Page: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guidelineNew
03/05/2024 Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidenceNew
02/05/2024 Document: Template for scientific document (part B-F)Updated
02/05/2024 Event: CVMP Interested Parties’ meetingNew
02/05/2024 Document: Scientific recommendations on classification of advanced therapy medicinal productsUpdated
02/05/2024 Document: Appendix 1: Acceptable intakes established for N-nitrosaminesUpdated
02/05/2024 Page: Information ManagementUpdated
02/05/2024 Herbal: Malvae sylvestris flos - herbal medicinal productUpdated
02/05/2024 Medicine: PelmegUpdated
02/05/2024 Medicine: NoxafilUpdated
02/05/2024 Medicine: Teriflunomide AccordUpdated
02/05/2024 Medicine: ByoovizUpdated
02/05/2024 Medicine: PluvictoUpdated
02/05/2024 Medicine: RotaTeqUpdated
02/05/2024 Document: Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS ProcedureNew
02/05/2024 Medicine: VolibrisUpdated
02/05/2024 Herbal: Malvae folium - herbal medicinal productUpdated
02/05/2024 Medicine: VafseoUpdated
02/05/2024 Medicine: IncellipanUpdated
02/05/2024 Page: Handling competing interestsUpdated
02/05/2024 Medicine: CelldemicUpdated
02/05/2024 Medicine: ZynyzUpdated
02/05/2024 Document: CAT quarterly highlights and approved ATMPs - February - April 2024New
02/05/2024 Page: Quality of medicines questions and answers: Part 1Updated
02/05/2024 Page: Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guidelineUpdated
02/05/2024 Document: Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productsNew
02/05/2024 Medicine: MirapexinUpdated
02/05/2024 Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to LabellingNew
02/05/2024 Document: List of eligible industry stakeholder organisationsUpdated