What’s new
- List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
- List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
- Tegsedi
- Medicine shortage communication (MSC): TEGSEDI® (inotersen sodium, 284 mg solution for injection in prefilled syringe): planned marketing cessation (discontinuation)
- EMEA-003489-PIP02-23
- Declaration of interests: Silvy da Rocha Dias
- Declaration of interests: Virginia Rojo Guerra
- Highlight report - Combination Products Operational Group (COMBO) - In Vitro Diagnostics stream - June 2026
- Organisation chart: Information Management
- Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
- Timetable: Type IB variation requiring linguistic review
- Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
- List of centrally authorised products with safety-related changes to the product information
- Timetable: Post-authorisation safety study (PASS) protocols and final results
- EMA/PE/0000232762
News and press releases
- EMA steps up efforts on medicines for women’s health
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026
- EMA Management Board: highlights of June 2026 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026
- EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
- 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
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
- Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandbox, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 September 2026, 13:30 (CEST) to 21 September 2026, 17:00 (CEST)
- Meeting of the HMA-EMA group focused on AI with industry stakeholders - June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 2 June 2026
- Multistakeholder workshop on women’s health, European Medicines Agency, Amsterdam, the Netherlands, from 28 September 2026, 09:30 (CEST) to 29 September 2026, 17:30 (CEST)
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 12 May 2026, 09:30 (CEST) to 12 May 2026, 13:30 (CEST)
- Workshop on advancing proof-of-concept data in paediatric oncology drug development , Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 13:00 (CEST) to 21 September 2026, 16:00 (CEST)
- HMA/EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 12 November 2026 to 13 November 2026
- Fifth European Medicines Agency and Nuclear Medicines Europe bilateral meeting, Online, 14 June 2024
- ETF-stakeholders meeting on biodistribution of mRNA vaccines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 June 2026, 14:00 (CEST) to 26 June 2026, 17:00 (CEST)
- Paediatric Committee (PDCO): 23-26 June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 June 2026 to 26 June 2026
- Sixteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 June 2026, 13:00 (CEST) to 15 June 2026, 18:00 (CEST)
- Committee for Advanced Therapies (CAT): 17-19 June 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 June 2026 to 19 June 2026
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, European Medicines Agency, Amsterdam, the Netherlands, from 16 June 2026, 10:00 (CEST) to 17 June 2026, 16:00 (CEST)
- First Advisory group on vaccine confidence meeting, European Medicines Agency, Amsterdam, the Netherlands, from 29 April 2026, 16:30 (CEST) to 29 April 2026, 18:00 (CEST)
- Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA / EMA Workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 September 2026, 10:00 (CEST) to 25 September 2026, 13:00 (CEST)
- Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 June 2026, 16:30 (CEST) to 12 June 2026, 17:30 (CEST)
Regulatory and procedural guidelines (human and veterinary)
- Committee for Advanced Therapies (CAT) rules of procedure
- 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)
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
- Agenda - PDCO agenda of the 23-26 June 2026 meeting
- Annex 22 expert workshop draft agenda: Day 1 - session with interested parties
- Minutes - HMA-EMA joint Network Data Steering Group meeting - 21 May 2026
- Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda
- 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
- Meeting summary - Medicine shortages SPOC working party meeting 15 April 2026
- 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
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: 1-Deoxygalactonojirimycin hydrochloride Treatment of Fabry disease, 22/05/2006 Expired
- 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
Public consultations
- Concept paper on the revision of the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease
- Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)
- Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin
- Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children
- 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
Withdrawn applications
- Withdrawn application: DuoResp Spiromax, 27/04/2026
- Withdrawn application: BiResp Spiromax, 27/04/2026
- 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
Paediatric investigation plans
- EMA/PE/0000234516
- EMA/PE/0000230610
- EMA/PE/0000238858
- EMA/PE/0000182225
- EMA/PE/0000237903
- EMA/PE/0000239753
- EMA/PE/0000229973
- EMA/PE/0000227014
- EMA/PE/0000230592
- EMA/PE/0000242035
- EMA/PE/0000237724
- Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, SARS-CoV-2, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: EMA/PE/0000234339
- Opinion/decision on a Paediatric investigation plan (PIP): Ocrevus, ocrelizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMA/PE/0000237224
- EMA/PE/0000228372
- Opinion/decision on a Paediatric investigation plan (PIP): Kerendia, finerenone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: EMA/PE/0000235999