What’s new
- List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
- Draft guidance on the conduct of clinical trials during public health emergencies
- Records of data processing activity for the handling the contribution towards commuting costs
- Data Analysis and Real World Interrogation Network (DARWIN EU)
- DARWIN EU Advisory Board: Membership
- DARWIN EU data partners onboarded in phases I, II and III
- Darwin EU: Making health data count
- Darwin EU study: Co-prescribing medicines in pulmonary arterial hypertension
- Darwin EU study: Clozapine and the incidence of severe neutropenia over time
- Darwin EU study: Overall survival in patients with non-small cell lung cancer treated with selected immunotherapies
- Darwin EU study: Is there a link between blood clots and common painkillers in women who use hormonal birth control
- Darwin EU: How often respiratory syncytial virus (RSV) affects different age groups in Europe
- Darwin EU study: Use of higher-risk antibiotics from the WHO Watch list, including azithromycin
- Darwin EU study: Background incidence rates of selected vaccine adverse events of special in Europe
- Minutes of the CAT meeting 21-23 January 2026
News and press releases
- 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
- EMA recommends withdrawal of marketing authorisations for levamisole medicines
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 February 2026
- First treatment for rare thymidine kinase 2 deficiency
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026
- First immunotherapy-based treatment recommended for advanced anal cancer
- Ilona Reischl re-elected as chair of Committee for Advanced Therapies
- Carmen Purdel elected as new chair of the Committee for Herbal Medicinal Products
- Veterinary medicines in 2025
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 January 2026
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12 - 15 January 2026
- Human medicines in 2025
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
- 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 31 March 2026, 09:30 (CEST) to 31 March 2026, 10:30 (CEST)
- European Medicines Agency (EMA) and European Alliance of Associations for Rheumatology (EULAR) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 March 2026, 14:00 (CET) to 18 March 2026, 16:00 (CET)
- Meeting of the HMA-EMA group focused on AI with industry stakeholders - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 February 2026, 10:00 (CET) to 4 February 2026, 11:30 (CET)
- Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 March 2026 to 5 March 2026
- Cancer Medicines Forum: December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 2 December 2025, 16:00 (CET) to 2 December 2025, 17:00 (CET)
- Electronic application form (eAF) Q&A clinic, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 March 2026, 10:00 (CET) to 9 March 2026, 11:00 (CET)
- Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 January 2026, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026 to 15 January 2026
- Committee for Advanced Therapies (CAT): 18-20 February 2026, European Medicines Agency, Amsterdam, the Netherlands, from 18 February 2026 to 20 February 2026
- Committee for Orphan Medicinal Products (COMP): 17-19 February 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 February 2026 to 19 February 2026
- 16th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 31 March 2026, 13:00 (CEST) to 31 March 2026, 17:30 (CEST)
- Committee for Medicinal Products for Human Use (CHMP): 21-24 July 2025, European Medicines Agency, Amsterdam, the Netherlands, from 21 July 2025 to 24 July 2025
- Webinar on the use of platform approaches in the non-clinical and clinical domains, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 March 2026, 09:25 (CET) to 2 March 2026, 12:30 (CET)
- LinkedIn Live: How EMA supports innovation in medicine development, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 February 2026, 14:30 (CET) to 25 February 2026, 15:00 (CET)
- Committee for Advanced Therapies (CAT): 3-5 December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 3 December 2025 to 5 December 2025
- Third European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 9 February 2026
Regulatory and procedural guidelines (human and veterinary)
- 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
- Guide for rapporteurs and coordinators on the multinational assessment teams
- Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782
- Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer
Scientific guidelines (human and veterinary)
- 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
- Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks
- Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
Agendas and Minutes
- Minutes of the CAT meeting 21-23 January 2026
- Agenda of the HMPC meeting 2-4 March 2026
- Minutes of the Management Board meeting: 17-18 December 2025
- Agenda - Webinar on the use of platform approaches in the non-clinical and clinical domains
- Agenda - PDCO agenda of the 24-27 February 2026 meeting
- Agenda of the CHMP meeting 23-26 February 2026
- Annex to agenda of the CHMP meeting 23-26 February 2026
- Minutes of the CVMP meeting 13-15 January 2026
- Minutes of the CVMP meeting 2-4 December 2025
- Agenda of the CAT meeting 18-20 February 2026
- Agenda - Medicine Shortages SPOC Working Party meeting 17 February 2026
- Minutes of the CHMP meeting 19-22 May 2025
- HMA-EMA joint Network Data Steering Group meeting - 13 January 2026
- PDCO minutes of the 9-12 December 2025 meeting
- Minutes of the PRAC meeting 24 - 27 November 2025
European Union reference dates (EURD) list
- 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 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
- Notification of serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations
Maximum residue limits and opinions on maximum residue limits
- 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)
- Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel
- Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel
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: carfilzomib Treatment of multiple myeloma, 03/06/2008 Expired
- Orphan designation: Obinutuzumab Treatment of follicular lymphoma, 19/06/2015 Withdrawn
- Orphan designation: recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009 Withdrawn
- Orphan designation: botaretigene sparoparvovec Treatment of inherited retinal dystrophies due to defects in the RPGR gene, 23/07/2025 Positive
- Orphan designation: adeno-associated viral vector containing a modified U7 snRNA gene Treatment of Duchenne muscular dystrophy, 27/07/2005 Withdrawn
- Orphan designation: hydrocortisone Treatment of adrenal insufficiency, 20/03/2007 Withdrawn
- Orphan designation: nanatinostat,valganciclovir Treatment of peripheral T-cell lymphoma, 10/08/2022 Withdrawn
- Orphan designation: Interferon gamma Treatment of Friedreich's ataxia, 09/12/2011 Withdrawn
- Orphan designation: humanised IgG1 kappa monoclonal antibody against tyrosine-protein phosphatase non-receptor type substrate 1, signal-regulatory protein beta-1 and signal-regulatory protein gamma Treatment of haemophagocytic lymphohistiocytosis, 18/07/2025 Positive
- Orphan designation: allogeneic peripheral blood-derived T-cells, fratricide-resistant, transduced with a lentivirus vector expressing a chimeric antigen receptor against CD7 Treatment of acute lymphoblastic leukaemia, 18/07/2025 Positive
- Orphan designation: aglatimagene besadenovec Treatment of pancreatic cancer, 18/07/2025 Positive
- Orphan designation: methotrexate Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 18/07/2025 Positive
- Orphan designation: sonlicromanol hydrochloride Treatment of inherited mitochondrial oxidative phosphorylation defects, 18/07/2025 Positive
- Orphan designation: Ivosidenib Treatment of myelodysplastic syndromes, 18/07/2025 Positive
- Orphan designation: telitacicept Treatment of myasthenia gravis, 18/07/2025 Positive
Public consultations
- 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
- Draft guideline for the evaluation of efficacy of ectoparasiticides - general requirements
- Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Revision 1
- Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal products
- Call for user acceptance testers for the read functionality in the Public Product Management Service (PMS) Application Programming Interface (API)
Withdrawn applications
- 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
- Human medicines European public assessment report (EPAR): Amtagvi, lifileucel, Status: Application withdrawn
- Withdrawn application: Lutathera, 09/05/2025
Paediatric investigation plans
- EMA/PE/0000230484
- EMA/PE/0000227908
- Opinion/decision on a Paediatric investigation plan (PIP): Voydeya, danicopan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: EMA/PE/0000227558
- Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera), ceftobiprole medocaril (sodium), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: EMA/PE/0000227526
- EMA/PE/0000227462
- Opinion/decision on a Paediatric investigation plan (PIP): Vyvgart, efgartigimod alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: EMA/PE/0000227425
- Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor,ivacaftor, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000227394
- Opinion/decision on a Paediatric investigation plan (PIP): Vyvgart, efgartigimod alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: EMA/PE/0000226957
- EMA/PE/0000228283
- EMA/PE/0000226753
- EMA/PE/0000226657
- Opinion/decision on a Paediatric investigation plan (PIP): Rizmoic, naldemedine tosilate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: EMA/PE/0000226303
- EMEA-003618-PIP01-24
- EMEA-002109-PIP01-16
- EMEA-002572-PIP01-19