What’s new
- Orphan designation: N-[5-(2H-1,3-Benzodioxol-5-yl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-N'-(2-methoxyethyl)sulfuric diamide Treatment of primary IgA nephropathy, 09/01/2026 Positive
- Orphan designation: aminolevulinic acid hydrochloride Diagnosis of ovarian cancer, 09/01/2026 Positive
- Orphan designation: domatinostat Treatment of osteosarcoma, 09/01/2026 Positive
- Orphan designation: autologous human T cells transduced with a lentiviral vector encoding a chimeric antigen receptor against the ERBB family Treatment of Fanconi anaemia, 09/01/2026 Positive
- Orphan designation: opamtistomig Treatment of extrapulmonary neuroendocrine carcinoma, 09/01/2026 Positive
- PSUSA/00003170/202508
- Orphan designation: allogeneic cultured postnatal thymus-derived tissue Treatment of congenital athymia, 22/08/2025 Positive
- Orphan designation: mecasermin rinfabate Prevention of bronchopulmonary dysplasia, 22/08/2025 Positive
- Orphan designation: leniolisib Treatment of common variable immunodeficiency (CVID), 22/08/2025 Positive
- Orphan designation: zanidatamab Treatment of oesophageal cancer, 21/11/2025 Positive
- CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device
- Template for sharing EMA documents by Industry to support reliance
- Clinical Trial Information System (CTIS) - Sponsor Frequently Asked Questions (FAQ)
- List of medicines currently in PRIME scheme
- List of eligible industry stakeholder organisations
News and press releases
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
- EMA consults on virtual control groups to help reduce animal use in medicines development
- EMA business hours over Easter holiday period
- New treatment for relapsed extensive-stage small cell lung cancer
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026
- EMA recommends restricting use of Tecovirimat SIGA
- New PRIME tools to accelerate development of medicines in the EU
- EMA Management Board: highlights of March 2026 meeting
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 March 2026
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 March 2026
- New guidance on the conduct of clinical trials during public health emergencies in the EU
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026
- New medicine to treat paediatric low-grade glioma
- Recruitment procedure opens for next Executive Director of the European Medicines Agency
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 February 2026
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
- European Platform for Regulatory Science Research meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 30 April 2026
- Breakthrough medical devices: information session, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 April 2026, 15:00 (CEST) to 24 April 2026, 17:00 (CEST)
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 17 February 2026, 09:30 (CET) to 17 February 2026, 13:00 (CET)
- EnprEMA & ACT EU workshop on paediatric clinical trials, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 10:00 (CEST) to 12 May 2026, 17:00 (CEST)
- ACT EU webinar on draft guidance on the conduct of clinical trials during public health emergencies, Online, from 8 April 2026, 10:00 (CEST) to 8 April 2026, 11:30 (CEST)
- 20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP), Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 13:30 (CEST) to 30 June 2026, 17:30 (CEST)
- Paediatric Committee (PDCO): 24-27 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 March 2026 to 27 March 2026
- Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG), Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 March 2026, 09:00 (CET) to 23 March 2026, 10:00 (CET)
- EMA workshop on the challenges in drug development, regulation and clinical practice in immune thrombocytopenia, Online, 30 June 2026
- European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry, Online, from 14 April 2026, 10:00 (CEST) to 14 April 2026, 11:00 (CEST)
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, European Medicines Agency, Amsterdam, the Netherlands, from 16 March 2026, 10:00 (CET) to 17 March 2026, 16:00 (CET)
- Committee for Orphan Medicinal Products (COMP): 17-19 March 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 March 2026 to 19 March 2026
- Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 16 March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 March 2026, 14:00 (CET) to 16 March 2026, 16:00 (CET)
- Workshop on Vulnerability Assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 March 2026, 09:30 (CET) to 18 March 2026, 12:30 (CET)
- EMA - Alzheimer Europe (AE) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 January 2026, 14:00 (CET) to 20 January 2026, 15:00 (CET)
Regulatory and procedural guidelines (human and veterinary)
- 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
- Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
- Procedural advice for veterinary vaccine antigen master file (VAMF) certification
- Guidance for stepwise PIPs (sPIPs)
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Scientific guidelines (human and veterinary)
- 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)
- 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
- Guideline on in-use stability testing of veterinary medicinal products
Agendas and Minutes
- CHMP PROM minutes for the meeting on 6 October 2025
- CHMP PROM minutes for the meeting on 8 September 2025
- CHMP PROM minutes for the meeting on 14 July 2025
- CHMP PROM minutes for the meeting on 10 June 2025
- CHMP PROM minutes for the meeting on 12 May 2025
- Highlights - EMA - European Alliance of Associations for Rheumatology (EULAR) bilateral meeting - March 2026
- Minutes of the COMP meeting 17-19 February 2026
- Minutes – Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026
- Agenda - Medicine Shortages SPOC Working Party meeting 16-17 March 2026
- Minutes - HMA-EMA joint Network Data Steering Group meeting - 11 February 2026
- Minutes of the COMP meeting 20-22 January 2026
- Agenda of the CVMP meeting 10-12 March 2026
- Minutes of the PRAC meeting 12 - 15 January 2026
- Agenda - Management Board meeting: 12 March 2026
- Agenda of the PRAC meeting 9-12 March 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): 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
- Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif), human normal immunoglobulin, Date of authorisation: 23/07/2007, Revision: 19, 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: 2-[[(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazol-5-ol Treatment of multiple system atrophy, 09/01/2026 Positive
- Orphan designation: lanthanum carbonate octahydrate Treatment of primary hyperoxaluria, 09/01/2026 Positive
- Orphan designation: sirolimus Treatment of osteosarcoma, 09/01/2026 Positive
- Orphan designation: Adeno-associated virus serotype ATC-0187 vector containing the human BAG3 gene Treatment of BAG3 dilated cardiomyopathy, 09/01/2026 Positive
- Orphan designation: spironolactone Treatment of central serous chorioretinopathy, 09/01/2026 Positive
- Orphan designation: Phe-Thr-Thr-Phe-Thr-Val-Thr Treatment of idiopathic pulmonary fibrosis, 09/01/2026 Positive
- Orphan designation: (4Z,7R,8E,10E,12Z,14S,16Z,19Z)-7,14-Dihydroxydocosa-4,8,10,12,16,19-hexaenoic acid Treatment of spinal cord injury, 23/02/2026 Positive
- Orphan designation: spironolactone Treatment of limbal stem cell deficiency, 23/02/2026 Positive
- Orphan designation: Measles virus Schwarz strain (live, attenuated) Treatment of mesothelioma, 23/02/2026 Positive
- Orphan designation: Humanised IgG1 kappa monoclonal antibody against erythropoietin isoform EV-3 Treatment of glioma, 23/02/2026 Positive
- Orphan designation: N-[(1S)-1-(4-Tert-butylphenyl) ethyl]-2-(6,7-difluoro-1H-benzimidazol-1-yl)acetamide Treatment of erythromelalgia, 23/02/2026 Positive
- Orphan designation: autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the murine Glb1 gene Treatment of Glb1-related disorders, 22/10/2025 Positive
- Orphan designation: (S)-1-(2,2-Difluoroethyl)-3-(difluoromethyl)-N-(1-(3-(2-methoxypyridin-4-yl)-1,2,4-oxadiazol-5-yl)ethyl)-1H-pyrazole-5-carboxamide Treatment of KCNT1-related epilepsy and neurodevelopmental disorders, 21/11/2025 Positive
- Orphan designation: vopimetostat Treatment of pancreatic cancer, 21/11/2025 Positive
- Orphan designation: admilparant Treatment of idiopathic pulmonary fibrosis, 22/08/2025 Positive
Public consultations
- 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
- Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation
- Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development
- Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents
- Concept paper on the development of a guideline for using owner assessment as efficacy parameter
- Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees - Revision 2
Withdrawn applications
- 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
- Human medicines European public assessment report (EPAR): Ifinwil, eflornithine, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Aplidin, plitidepsin, Status: Application withdrawn
Paediatric investigation plans
- EMEA-001484-PIP01-13-M01
- EMEA-000814-PIP01-09
- EMEA-000811-PIP01-09
- EMEA-000815-PIP01-09-M01
- EMEA-000808-PIP01-09-M01
- EMEA-000806-PIP01-09
- EMEA-000807-PIP01-09
- EMEA-000812-PIP01-09
- P/28/2010
- Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, cannabidiol, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Neurology, PIP number: P/0095/2020
- EMEA-002142-PIP01-17
- EMEA-000977-PIP01-10
- Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0217/2015
- EMA/PE/0000226246
- Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMA/PE/0000226217