What’s new
- List of medicines currently in PRIME scheme
- Records of data processing activity regarding EMA Account Management System (public)
- 2025-2028 Work plan for the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP)
- Agenda - Clinical trials information system information day webinar
- Agenda - Challenges in drug development, regulation and clinical practice in immune thrombocytopenia
- EMA/HMA European platform for regulatory science research platform meeting – draft agenda
- Appendix 1: Acceptable intakes established for N-nitrosamines
- Agenda of the PRAC meeting 8-11 June 2026
- Applications for new human medicines under evaluation: June 2026
- Presentations - EnprEMA& ACT EU workshop on paediatric clinical trials
- Data protection notice for legal entity and bank account validation regarding payments
- Agenda - Clinical trials information system information day webinar
- Minutes of PRAC meeting on 7-10 April 2026
- Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment
- PSUSA/00000491/202506
News and press releases
- EMA, AMA and African regulatory authorities join forces on Ebola outbreak response
- United for Health: EMA in WorldPride 2026
- ETF recommends updating COVID-19 vaccines to target XFG variant
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026
- EMA closed on Whit Monday, 25 May
- EU tracks progress towards 2030 clinical trial targets
- EMA actively monitoring cruise ship Hantavirus outbreak
- EMA business hours over Ascension Day holidays, 14 and 15 May
- EMA welcomes political agreement on Critical Medicines Act
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026
- New pilot to support development of ‘breakthrough’ medical devices
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
- New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026
- EMA recommends authorisation of first veterinary vaccine using RNA technology
Human Medicines Highlights newsletter
- Human medicines highlights - April 2024
- Human medicines highlights - March 2024
- Human medicines highlights - February 2024
- Human medicines highlights - January 2024
- Human medicines highlights - November-December 2023
- Human medicines highlights - October 2023
- Human medicines highlights - September 2023
- Human medicines highlights - August 2023
- Human medicines highlights - August 2022
- Human medicines highlights - June 2022
- Human medicines highlights - May 2022
- Human medicines highlights - April 2022
- Human medicines highlights - March 2022
- Human medicines highlights - February 2022
- Human medicines highlights - January 2022
Events
- Sixteenth industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 2 July 2026, 12:30 (CEST) to 2 July 2026, 17:30 (CEST)
- Updates to industry contact management for authorisation products (IRIS), Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 June 2026, 11:00 (CEST) to 11 June 2026, 12:15 (CEST)
- European platform for regulatory science research meeting: June 2026 , Online, from 16 June 2026, 14:00 (CEST) to 16 June 2026, 18:00 (CEST)
- SME info day - navigating EMA support: From development to market authorisation, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 6 November 2026, 09:15 (CET) to 6 November 2026, 15:30 (CET)
- Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on real-world data collection in duchenne muscular dystrophy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 September 2026, 09:00 (CEST) to 25 September 2026, 17:30 (CEST)
- European Medicines Agency (EMA) / European Chemicals Agency (ECHA) joint meeting with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 June 2026, 09:00 (CEST) to 9 June 2026, 12:00 (CEST)
- Second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection, Online, European Medicines Agency, Amsterdam, the Netherlands, 1 December 2026
- Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - November 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 November 2026, 14:00 (CET) to 26 November 2026, 18:00 (CET)
- Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - October 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2026, 09:00 (CEST) to 8 October 2026, 13:00 (CEST)
- Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, European Medicines Agency, Amsterdam, the Netherlands, from 14 September 2026 to 18 September 2026
- Webinar on new approach methodologies (NAMs) in ecotoxicology: In silico approaches for fish acute toxicity, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 May 2026, 14:00 (CEST) to 28 May 2026, 15:30 (CEST)
- EMA risk management information day, European Medicines Agency, Amsterdam, the Netherlands, from 8 September 2026, 09:00 (CEST) to 8 September 2026, 17:00 (CEST)
- Highlights from the second expert panels and notified bodies workshop, Online, 23 May 2025
- Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:00 (CEST) to 1 July 2026, 18:00 (CEST)
- Clinical Trials Information System (CTIS): Information day, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 June 2026, 12:30 (CEST) to 17 June 2026, 17:30 (CEST)
Regulatory and procedural guidelines (human and veterinary)
- Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 3
- Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2026/2027
- Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
- Notice to sponsors on validation and qualification of computerised systems used in clinical trials
- Names of the European Union / European Economic Area countries
- Tables of non-standard abbreviations to be used in the summary of product characteristics
- Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
- Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
- Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
- Guidance for applicants for the preparation of the precise scope section of the variation application form
- Validation checklist for Type II quality variations
- Plasma Master File (PMF) requirements - questions and answers for PMF holders
- Validation checklist for Type II (non) clinical variations
- EU reference instances (EDQM revision)
- Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026-2027
Scientific guidelines (human and veterinary)
- Concept paper on the development of a reflection paper on the use of External controls for evidence generation in regulatory decision-making
- Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
- Guideline on the plant testing strategy for veterinary medicinal products
- EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
- ICH M15 Guideline on general principles for model-informed drug development - Step 5
- Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes
- Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk
- Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
- Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
- Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
- ICH E22 Guideline on general considerations for patient preference studies - Step 2b
- Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3
- Questions and answers on post approval change management protocols (PACMP) - Revision 1
- Procedural advice for vaccine platform technology master file (vPTMF) certification
- Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)
Agendas and Minutes
- EMA/HMA European platform for regulatory science research platform meeting – draft agenda
- Agenda of the PRAC meeting 8-11 June 2026
- Minutes of PRAC meeting on 7-10 April 2026
- Agenda - Clinical trials information system information day webinar
- Agenda - Challenges in drug development, regulation and clinical practice in immune thrombocytopenia
- PDCO minutes of the 21-24 April 2026 meeting
- Minutes - HMA-EMA joint Network Data Steering Group meeting - 15 April 2026
- Agenda of the CVMP meeting 19-21 May 2026
- Annex to agenda of the CHMP meeting 18-21 May 2026
- Agenda of the CHMP meeting 18-21 May 2026
- Agenda of the CAT meeting 11-13 May 2026
- Agenda of the COMP Meeting 11-12 May 2026
- PDCO minutes of the 24-27 March 2026 meeting
- Minutes of PRAC meeting on 9-12 March 2026
- Agenda - EnprEMA & ACT EU workshop on paediatric clinical trials
European Union reference dates (EURD) list
- Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports
- List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Fees
- Fees payable to the European Medicines Agency: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices
- Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal products
- Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use
- Fees payable to the European Medicines Agency: General questions and answers
- Presentation - Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders
- Presentation - Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders
- New fee regulation: General questions and answers - Annex IV
- New Fee Regulation: webinar on Regulation (EU) 2024/568 and changes foreseen for industry stakeholders (H)
- Decision of the Executive Director on fee incentives for scientific advice, marketing authorisation applications and pre-authorisation inspections in the ATMP support pilot for academia
- Fees payable to the European Medicines Agency
- Decision of the Executive Director on fee reductions for scientific advice requests for medicines for COVID-19 not covered by Article 16(2) of Regulation (EU) 2022/123
- Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2022
- Fees payable to the European Medicines Agency
- Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
- How to pay
Herbal medicines for human use
- Herbal medicinal product: Prunus avium peduncleArray,Array, D: Draft under discussion
- Herbal medicinal product: Ricini oleum, Ricini oleum, F: Assessment finalised
- Herbal medicinal product: Rosae flos, Rosae flos, F: Assessment finalised
- Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised
- Call for scientific data for the periodic review of the monograph on Symphyti radix - Revision 1
- Call for scientific data for the periodic review of the monograph on Sisymbrii officinalis herba - Revision 1
- Call for scientific data for the periodic review of the monograph on Sideritis herba - Revision 1
- Herbal medicinal product: Sisymbrii officinalis herba, Sisymbrii officinalis herba, F: Assessment finalised
- Herbal medicinal product: Symphyti radix, Symphyti radix, F: Assessment finalised
- Herbal medicinal product: Sideritis herba, Sideritis herba, F: Assessment finalised
- Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
- Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
- Herbal medicinal product: Aloes folii succus siccatus, Aloes folii succus siccatus, F: Assessment finalised
- Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
- Herbal medicinal product: Urticae radix, Urticae radix, F: Assessment finalised
Human medicines: European public assessment reports (EPARs) and summaries of opinion
- Human medicines European public assessment report (EPAR): Yttriga, yttrium [90Y] chloride, Date of authorisation: 19/01/2006, Revision: 11, Status: Authorised
- Human medicines European public assessment report (EPAR): Tocilizumab STADA (previously Tofidence), tocilizumab, Date of authorisation: 20/06/2024, Revision: 4, Status: Authorised
- Summary of opinion: Hetlioz, 11/12/2025 Negative
- Human medicines European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals), pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted), Date of authorisation: 10/10/2009, Revision: 12, Status: Authorised
- Human medicines European public assessment report (EPAR): Cyanokit, hydroxocobalamin, Date of authorisation: 23/11/2007, Revision: 11, Status: Authorised
- Human medicines European public assessment report (EPAR): Lyvdelzi (previously Seladelpar Gilead), Seladelpar lysine dihydrate, Revision: 2, Status: Authorised
- Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), para-aminosalicylic acid, Date of authorisation: 07/04/2014, Revision: 13, Status: Authorised
- Human medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Dimethyl fumarate Teva, dimethyl fumarate, Date of authorisation: 12/12/2022, Date of refusal: 12/12/2023, Status: Withdrawn
- Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, Date of authorisation: 23/08/2018, Revision: 8, Status: Authorised
- Human medicines European public assessment report (EPAR): Gefzuris, gefapixant, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Lutholaz, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), pomalidomide, Date of authorisation: 05/08/2013, Revision: 24, Status: Authorised
Inspections
- QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics
- QRD Appendix V - Adverse-drug-reaction reporting details
- Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group
- Good Manufacturing Practice (GMP)/Distribution Practice Practice (GDP) Inspectors Working Group
- Good Clinical Practice Inspectors Working Group
- Quality systems framework for Good Manufacturing Practice (GMP) inspectorates
- Union format for a good manufacturing practice (GMP) certificate
- History of changes to the compilation of procedures
- Union format for registration of manufacturer, importer or distributor of active substance
- Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA
- Statement of non-compliance with good distribution practice of a distributor of active substances for use as starting materials in medicinal products
- Statement of non-compliance with good distribution practice
- Good distribution practice (GDP) inspection report – Union format
- Union format for a good distribution practice (GDP) certificate for active substances to be used as starting materials in medicinal products
- Union format for a wholesale distribution authorisation
Maximum residue limits and opinions on maximum residue limits
- Opinion of the CVMP on the establishment of maximum residue limits: Fluralaner ( EMEA/V/MRL/004380/EXTN/0002)
- Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)
- Ketoprofen: European public maximum-residue-limit assessment report (EPMAR) - CVMP
- Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide
- Rafoxanide (bovine and ovine milk): European Public MRL Assessment Report (EPMAR) - CVMP
- Opinion of the CVMP on the establishment of maximum residue limits: Ketoprofen
- Opinion of the CVMP on the establishment of maximum residue limits: Toltrazuril
- Toltrazuril (poultry eggs): European Public MRL Assessment Report (EPMAR) - CVMP
- Ketoprofen (poultry): European Public MRL Assessment Report (EPMAR) - CVMP
- Ketoprofen (all ruminants, porcine and Equidae) - Summary opinion of the CVMP on the extension of maximum residue limits
- Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - CVMP
- Lidocaine (porcine species): European Public MRL Assessment Report (EPMAR) - CVMP
- Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP
- Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
- Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
New medicines: human
- Human medicines European public assessment report (EPAR): Rhapsido, remibrutinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Blarcamesine Anavex, blarcamesine, Status: Opinion under re-examination
- Human medicines European public assessment report (EPAR): Anktiva, nogapendekin alfa inbakicept, Status: Opinion
- Human medicines European public assessment report (EPAR): Aumseqa, Aumolertinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Exdensur, depemokimab, Status: Opinion
- Human medicines European public assessment report (EPAR): Gotenfia, golimumab, Status: Opinion
- Human medicines European public assessment report (EPAR): mNexspike, COVID-19 mRNA vaccine, Status: Opinion
- Human medicines European public assessment report (EPAR): Ranluspec, ranibizumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Myqorzo, aficamten, Status: Opinion
- Summary of opinion: Metalyse, 14/12/2023 Positive
- Human medicines European public assessment report (EPAR): Skyclarys, Omaveloxolone, Status: Opinion
- Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion
- Human medicines European public assessment report (EPAR): Casgevy, Exagamglogene autotemcel, Status: Opinion
- Summary of opinion: Zinplava, 14/12/2023 Positive
- Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion
Orphan designations
- Orphan designation: daratumumab Treatment of plasma-cell myeloma, 17/07/2013 Expired
- Orphan designation: S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid Treatment of primary sclerosing cholangitis, 16/10/2017 Withdrawn
- Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) Treatment of sickle cell disease, 09/08/2012 Withdrawn
- Orphan designation: 5-Methyl-pyridine-2-sulfonic acid{6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-[2-(1H-tetrazol-5-yl)-pyridin-4-yl]-pyrimidin-4-yl}-amide sodium salt Treatment of aneurysmal subarachnoid haemorrhage, 12/12/2003 Withdrawn
- Orphan designation: oregovomab Treatment of ovarian cancer, 30/07/2002 Withdrawn
- Orphan designation: macitentan Treatment of idiopathic pulmonary fibrosis, 28/01/2010 Withdrawn
- Orphan designation: Mavoglurant Treatment of fragile X syndrome, 10/10/2012 Withdrawn
- Orphan designation: vutrisiran Treatment of Stargardt's disease, 10/08/2022 Withdrawn
- Orphan designation: ovine anti-colchicine polyclonal antibody fragments Treatment of colchicine poisoning, 17/12/2010 Withdrawn
- Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte-macrophage colony-stimulating factor Treatment of soft tissue sarcoma, 19/06/2013 Withdrawn
- Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor Treatment of malignant mesothelioma, 16/12/2014 Withdrawn
- Orphan designation: Treatment of Alagille syndrome, 09/08/2012 Withdrawn
- Orphan designation: macitentan Treatment of pulmonary arterial hypertension, 27/09/2011 Withdrawn
- Orphan designation: Human platelet antigen-1a immunoglobulin Prevention of fetal and neonatal alloimmune thrombocytopenia, 27/10/2011 Withdrawn
- Orphan designation: Copanlisib Treatment of marginal zone lymphoma, 24/08/2018 Withdrawn
Public consultations
- Concept paper on the need for revision of the guideline on the development of medicinal products for the treatment of smoking
- Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2
- Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products
- Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1
- Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ - Revision 2
- Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension
- Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
- Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies
- Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
- Draft guidance on the conduct of clinical trials during public health emergencies
- Draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products
- Draft guideline on quality aspects of mRNA vaccines for veterinary use
- Draft European Union herbal monograph on Ribes nigrum L., folium - Revision 2
- Concept paper for the revision of the guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021)
- Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis
Withdrawn applications
- Human medicines European public assessment report (EPAR): Viokat, diazoxide choline, Status: Application withdrawn
- Withdrawn application: Pluvicto, 23/04/2026
- Veterinary medicines European public assessment report (EPAR): Equidormin, midazolam, Status: Application withdrawn
- Veterinary medicines European public assessment report (EPAR): Cunitraxx, fenbendazole, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Zumrad, sasanlimab, Status: Application withdrawn
- Withdrawn application: Brilique, 15/12/2021
- Withdrawn application: Vectra 3D, 27/11/2024
- Human medicines European public assessment report (EPAR): Ohtuvayre, ensifentrine, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Insulin Aspart Injection, insulin aspart, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Datopotamab deruxtecan Daiichi Sankyo, datopotamab deruxtecan, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Hydrocortisone Aguettant, Status: Application withdrawn
- Withdrawn application: Sileo, 30/08/2022
- Veterinary medicines European public assessment report (EPAR): Equilis EHV 1+4, Equine herpesvirus vaccine (inactivated), Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Tuzodi, midazolam, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn