What’s new
- European Medicines Agency’s data protection notice for meeting registration forms via Microsoft Forms
- European Medicines Agency’s data protection notice for conducting surveys via Microsoft Forms
- European Medicines Agency’s data protection notice for conducting surveys via EUSurvey
- European Medicines Agency’s data protection notice for meeting registration forms via EUSurvey
- List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025
- Vyvgart
- Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products
- Antimicrobial Sales and Use (ASU) Platform: Release notes
- Summary report - Network Data Steering Group and industry stakeholders annual meeting
- Agenda - Network Data Steering Group and industry stakeholders annual meeting
- Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
- Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1
- First oral medicine targeting interleukin-23 receptor recommended for plaque psoriasis
- Summary of opinion: Riltrava Aerosphere, 23/07/2026 Positive
- New treatment option for neovascular age-related macular degeneration
News and press releases
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026
- EMA and EISMEA boost cooperation to accelerate health innovations
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2026
- EMA fast tracks review of a medicine for metastatic pancreatic cancer
- 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
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
- Network Data Steering Group and industry stakeholders annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 14 July 2026
- Paediatric Committee (PDCO): 19-22 May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 May 2026 to 22 May 2026
- Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2026, European Medicines Agency, Amsterdam, the Netherlands, from 20 July 2026 to 23 July 2026
- Cancer Medicines Forum: June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 23 June 2026
- Industry webinar on new electronic application form (eAF) version, Online, from 22 July 2026, 14:00 (CEST) to 22 July 2026, 16:00 (CEST)
- Enpr-EMA Coordinating Group meeting April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 April 2026, 14:00 (CEST) to 8 April 2026, 15:00 (CEST)
- eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course (Bucharest) - October 2026, Hotel Capital Plaza Bucharest, from 29 October 2026, 08:00 (CET) to 30 October 2026, 12:00 (CET)
- Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance system, Bucharest, Romania, from 26 October 2026 to 28 October 2026
- 17th Industry Standing Group (ISG) meeting, Online, from 29 June 2026, 09:30 (CEST) to 29 June 2026, 13:10 (CEST)
- Seventeenth Industry Standing Group (ISG) meeting, Online, from 29 June 2026, 09:30 (CEST) to 29 June 2026, 13:10 (CEST)
- 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)
Regulatory and procedural guidelines (human and veterinary)
- Questions and answers on Article 20 non-pharmacovigilance procedures
- Questions and answers on Article 13 referral procedures
- Questions and answers on Article 29(4) referral procedures
- Questions and answers on Article 30 referral procedures
- Questions and answers on Article 31 non-pharmacovigilance referrals
- Pre-notification check for type IB Variations
- Qualification of novel methodologies for medicinal product development: guidance to applicants
- 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
Scientific guidelines (human and veterinary)
- Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1
- Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1
- Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum
- 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
Agendas and Minutes
- Summary report - Network Data Steering Group and industry stakeholders annual meeting
- Agenda - Network Data Steering Group and industry stakeholders annual meeting
- Minutes - HMA-EMA joint Network Data Steering Group meeting - 16 June 2026
- Minutes – Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 12 June 2026
- Agenda - PDCO agenda of the 21-24 July 2026 meeting
- Minutes of the HMPC meeting 4-6 May 2026
- Agenda of the CVMP meeting 14-16 July 2026
- Agenda of the COMP Meeting 14-16 July 2026
- Minutes of the COMP meeting 11-12 May 2026
- Agenda - EMA/HMA European platform for regulatory science research platform meeting
- Minutes - Enpr-EMA Coordinating Group meeting, April 2026
- Agenda - EnprEMA Coordinating Group meeting, April 2026
- Agenda - Sixteenth industry stakeholder platform on research and development support
- EMA risk management information day
- Agenda of the PRAC meeting 6-9 July 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
- Direct healthcare professional communication (DHPC) : Tavneos (avacopan) – recommendation for revocation of the marketing authorisation in the EU due to unfavourable benefit-risk balance
- 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
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: infliximab Treatment of Kawasaki disease, 20/05/2026 Positive
- Orphan designation: allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 20/05/2026 Positive
- Orphan designation: allogeneic human Wharton's jelly-derived mesenchymal stem cells Treatment of Charcot-Marie-Tooth disease, 20/05/2026 Positive
- Orphan designation: humanised IgG1 monoclonal antibody against delta-like ligand 3, octakis(thioether) with N-[6-(2-mercapto-5-pyrimidinyl)-1-oxo-5-hexyn-1-yl]-L-valyl-N6,N6-dipropyl-L-lysyl-N-[[3-[(7S)-7-ethyl-7,8,11,13-tetrahydro-7-hydroxy-8,11-dioxo-10H-1,3-dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]propoxy]methyl]glycinamide Treatment of pulmonary neuroendocrine carcinoma, 20/05/2026 Positive
- Orphan designation: peptide-oligonucleotide conjugate against CNOT3 mRNA Treatment of inherited retinal dystrophies due to mutation in the PRPF31 gene, 20/05/2026 Positive
- Orphan designation: allogeneic peripheral blood mononuclear cells incubated in vitro with mitomycin C Treatment of in solid organ transplantation, 20/05/2026 Positive
- Orphan designation: copper metabolism disorder Treatment of Wilson's disease, 20/05/2026 Positive
- Orphan designation: alixorexton Treatment of narcolepsy, 20/05/2026 Positive
- Orphan designation: allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells Treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype, 20/05/2026 Positive
- Orphan designation: (S)-N-(2-(2-Cyclopropylpyridin-4-yl)-4,5,6,7-tetrahydrobenzo[d]oxazol-4-yl)-1-methyl-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide Treatment of KCNT1-related epilepsy, 20/05/2026 Positive
- Orphan designation: antisense oligonucleotide against USH2A pre-mRNA Treatment of inherited retinal disease due to dysfunction in the USH2A gene, 20/05/2026 Positive
- Orphan designation: quemliclustat Treatment of pancreatic cancer, 20/05/2026 Positive
- Orphan designation: igermetostat maleate Treatment of peripheral T-cell lymphoma, 20/05/2026 Positive
- Orphan designation: serabelisib Treatment of PIK3CA related overgrowth spectrum, 20/05/2026 Positive
- Orphan designation: 1-Deoxygalactonojirimycin hydrochloride Treatment of Fabry disease, 22/05/2006 Expired
Public consultations
- Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
- Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)
- Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1
- Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products
- Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths
- 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
Withdrawn applications
- Human medicines European public assessment report (EPAR): Azacitidine Adienne, azacitidine, Status: Application withdrawn
- 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
Paediatric investigation plans
- EMA/PE/0000235924
- EMA/PE/0000240621
- EMA/PE/0000241250
- EMA/PE/0000182809
- EMA/PE/0000232767
- EMEA-002828-PIP01-20
- EMEA-002004-PIP04-23
- EMA/PE/0000232778
- EMA/PE/0000232777
- EMA/PE/0000232760
- EMA/PE/0000236704
- EMA/PE/0000242278
- Opinion/decision on a Paediatric investigation plan (PIP): Filspari, sparsentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Uro-nephrology, PIP number: EMA/PE/0000226166
- Opinion/decision on a Paediatric investigation plan (PIP): Alofisel, darvadstrocel, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMA/PE/0000244768
- EMA/PE/0000184114