What’s new
- Agenda of the PRAC meeting 10-13 March 2025
- Frequently asked questions on the European Shortages Monitoring Platform (ESMP)
- Agenda of the CVMP meeting 11-13 March 2025
- European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities
- European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML)
- European Shortages Monitoring Platform (ESMP) Application Programming Interface (API) specifications
- European Shortages Monitoring Platform (ESMP) data access policy - Annex A: Data elements accessible by ESMP access level
- European Shortages Monitoring Platform (ESMP) data access policy
- European Shortages Monitoring Platform (ESMP) User guide for national competent authorities
- Human medicines European public assessment report (EPAR): Entecavir Viatris (previously Entecavir Mylan), entecavir, Date of authorisation: 18/09/2017, Revision: 9, Status: Authorised
- European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders
- European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders
- PSUSA/00010199/202405
- PSUSA/00001761/202404
- PSUSA/00000048/202406
News and press releases
- New clinical trial map launched in the EU
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025
- EMA earns certification for its environmental efforts
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-12 February 2025
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025
- EMA establishes regular procedure for scientific advice on certain high-risk medical devices
- Clinical Trials Regulation becomes fully applicable
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025
- One Health: EU agencies unite to tackle azole fungicide resistance in Aspergillus fungi
- European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU
- EMA celebrates 30 years of progress in science and medicines in the European Union
- Veterinary medicines in 2024
- Two new vaccines against bluetongue recommended for approval
- Two new vaccines against bluetongue recommended for approval
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 January 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
- ADRA project - information session for veterinary pharmaceutical industry, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2025, 14:30 (CEST) to 22 May 2025, 16:00 (CEST)
- Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 March 2025, European Medicines Agency, Amsterdam, the Netherlands, from 11 March 2025 to 13 March 2025
- Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 March 2025, 11:00 (CET) to 25 March 2025, 12:00 (CET)
- Q&A clinic on human variations web-based electronic application form (eAF), European Medicines Agency, Amsterdam, the Netherlands, from 14 November 2024, 10:00 (CET) to 14 November 2024, 10:30 (CET)
- Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 June 2025, 11:00 (CEST) to 17 June 2025, 12:00 (CEST)
- Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 May 2025, 15:00 (CEST) to 19 May 2025, 16:00 (CEST)
- Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 April 2025, 11:00 (CEST) to 29 April 2025, 12:00 (CEST)
- 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work plan, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 April 2024, 09:30 (CEST) to 2 April 2024, 10:30 (CEST)
- European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 March 2025, 14:00 (CET) to 24 March 2025, 16:00 (CET)
- Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V), Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 April 2025, 12:30 (CEST) to 10 April 2025, 13:00 (CEST)
- Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V), Online, from 27 March 2025, 12:30 (CET) to 27 March 2025, 13:00 (CET)
- Certificates Processing System: Demo & Q&A session for industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 12:30 (CET) to 13 March 2025, 13:00 (CET)
- Finding clinical trials with the ACT EU Trial Map, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 March 2025, 13:30 (CET) to 7 March 2025, 14:30 (CET)
- European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025 to 2 April 2025
- Product Management Service (PMS) webinar : Unlocking Integration – MAH & Software Developers to explore PMS API Machine-to-Machine Connection, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 March 2025, 10:30 (CET) to 14 March 2025, 12:00 (CET)
Regulatory and procedural guidelines (human and veterinary)
- Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications: document with track changes
- Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
- Guidance on Irish language derogation ending on 1 January 2022
- EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications
- European Medicines Agency Write PMS API implementation Guide (zip)
- European Medicines Agency Write PMS API implementation Guide
- Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers
- IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
- Good practice guidance for communication to the public on medicines’ availability issues
- Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics - Revision 1
- EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
- EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 2
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications: document with track changes
Scientific guidelines (human and veterinary)
- Implementation strategy of ICH Guideline M12 on drug interaction studies
- Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
- Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
- ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 5
- Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater
- VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens – gallus gallus (Revision 1)
- VICH GL20 Efficacy of anthelmintics: specific recommendations for felines (Revision 1)
- VICH GL19 Efficacy of anthelmintics: specific recommendations for canines (Revision 1)
- VICH GL16 Efficacy of anthelmintics: specific recommendations for porcines (Revision 1)
- VICH GL15 Efficacy of anthelmintics: specific recommendations for equines (Revision 1)
- VICH GL14 Efficacy of anthelmintics: specific recommendations for caprines (Revision 1)
- VICH GL13 Efficacy of anthelmintics: specific recommendations for ovines (Revision 1)
- VICH GL12: Efficacy of anthelmintics: specific recommendations for bovines (Revision 1)
- VICH GL7 Efficacy of anthelmintics: general requirements - Revision 1
- Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products
Agendas and Minutes
- Agenda of the PRAC meeting 10-13 March 2025
- Agenda of the CVMP meeting 11-13 March 2025
- Minutes of the CHMP meeting on 14-17 October 2024
- Minutes of the CHMP meeting 11-14 November 2024
- Minutes of the CAT meeting 22-24 January 2025
- Agenda - PDCO agenda of the 25-28 February 2025 meeting
- Annex to 24-27 February 2025 CHMP Agenda
- Agenda of the CHMP meeting 24-27 February 2025
- Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 26 February 2025
- Minutes of the CVMP meeting 14-15 January 2025
- Minutes - DARWIN EU Advisory Board - 3 May 2024
- Agenda of the CAT meeting 19-21 February 2025
- Agenda - ACT EU workshop on ICH E6 (R3)
- Programme - EMA's Open Door Day
- Agenda of the COMP meeting 18-19 February 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
- 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): 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
- Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Psoriasis, Date of authorisation: 24/03/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Ammonaps, sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosphate Synthase I Deficiency Disease, Date of authorisation: 07/12/1999, Revision: 21, Status: Authorised
- Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests;Helicobacter Infections, Date of authorisation: 14/08/1997, Revision: 18, Status: Authorised
- Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, Date of authorisation: 30/05/2017, Revision: 6, Status: Authorised
- Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 29/05/2006, Revision: 31, Status: Authorised
Inspections
- 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
- Statement of non-compliance with good manufacturing practice (GMP)
- Union format for a good distribution practice (GDP) certificate
Maximum residue limits and opinions on maximum residue limits
- 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
- Praziquantel (fin fish): European public MRL assessment report (EPMAR) - CVMP
New medicines: human
- 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
- Human medicines European public assessment report (EPAR): Velsipity, Etrasimod, Status: Opinion
- Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive
- Human medicines European public assessment report (EPAR): Rimmyrah, ranibizumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Omjjara, momelotinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Rystiggo, Rozanolixizumab, Status: Opinion
- Summary of opinion: Talzenna, 09/11/2023 Positive
- Summary of opinion: Jardiance, 09/11/2023 Positive
- Summary of opinion: Evkeeza, 09/11/2023 Positive
- Human medicines European public assessment report (EPAR): Uzpruvo, ustekinumab, Status: Opinion
Orphan designations
- Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns, 07/11/2008 Expired
- Orphan designation: Adeno-associated virus serotype 9 containing the human RPE65 gene inherited retinal dystrophy due to defects in the RPE65 gene, 16/01/2025 Positive
- Orphan designation: Lomitapide Treatment of familial chylomicronaemia, 17/12/2010 Positive
- Orphan designation: Rilzabrutinib Treatment of autoimmune haemolytic anaemia, 16/01/2025 Positive
- Orphan designation: Clofutriben Treatment of Cushing's syndrome of endogenous origin, 16/01/2025 Positive
- Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene (etuvetidigene autotemcel) Treatment of Wiskott-Aldrich syndrome, 07/10/2013 Withdrawn
- Orphan designation: Adeno-associated viral vector serotype 9 containing the human iduronate-2-sulfatase gene Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 10/08/2015 Withdrawn
- Orphan designation: Adeno-associated viral vector serotype 9 containing the human N-acetylglucosaminidase-alpha gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 24/01/2013 Withdrawn
- Orphan designation: N-(2-Methoxyethyl)-6-methyl-N-[(3-methyl-2-thienyl)methyl]-2-oxo-1,2-dihydropyridine-4-carboxamide Treatment of glycogen storage disease type IV, 16/01/2025 Positive
- Orphan designation: volixibat potassium Treatment of primary biliary cholangitis, 16/01/2025 Positive
- Orphan designation: Allogenic umbilical cord-derived osteoblast cells Treatment of non-traumatic osteonecrosis, 16/01/2025 Positive
- Orphan designation: Elraglusib Treatment of soft tissue sarcoma, 16/01/2025 Positive
- Orphan designation: [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine Treatment of gastrointestinal stromal tumours, 16/01/2025 Positive
- Orphan designation: Elraglusib Treatment of pancreatic cancer, 16/01/2025 Positive
- Orphan designation: Alvelestat Treatment of congenital alpha-1 antitrypsin deficiency, 16/01/2025 Positive
Public consultations
- Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
- Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues
- Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
- Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance
- Draft reflection paper on the qualification of non-mutagenic impurities
- Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use
- Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials
- Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control
- Draft of Data Quality Framework for EU medicines regulation application to real-world data
- Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
- Draft concept paper on the European Platform for Regulatory Science Research
- Draft Regulatory Science Research Needs - 2024 update
- Draft European Medicines Agencies Network Data Strategy - Increasing the value of data for the benefit of public and animal health
- Revised list of enabling tools
- Draft consolidated 3-year rolling work plan for the Vaccine Working Party (VWP) - 2025-2027
Withdrawn applications
- Withdrawn application: Dupixent, 18/02/2025
- Human medicines European public assessment report (EPAR): Rilonacept FGK Representative Service GmbH , rilonacept, Status: Application withdrawn
- Withdrawn application: Bimervax, 05/02/2025
- Human medicines European public assessment report (EPAR): Pelgraz Paediatric, pegfilgrastim, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Nugalviq, govorestat, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Skycovion, GBP510, Status: Withdrawn application (before opinion)
- Human medicines European public assessment report (EPAR): Izelvay, avacincaptad pegol, Status: Withdrawn application (before opinion)
- Withdrawn application: Inaqovi, 06/11/2024
- Human medicines European public assessment report (EPAR): Epixram, levetiracetam, Status: Withdrawn application (before opinion)
- Withdrawn application: Sialanar, 06/09/2024
- Human medicines European public assessment report (EPAR): Durysta, bimatoprost, Status: Withdrawn application (before opinion)
- Withdrawn application: Ontilyv, 12/03/2024
- Human medicines European public assessment report (EPAR): Upstelda, ustekinumab, Status: Withdrawn application (before opinion)
- Withdrawn application: Scenesse, 24/04/2024
- Withdrawn application: Ongentys, 12/03/2024
Paediatric investigation plans
- EMEA-003470-PIP01-23
- EMEA-003476-PIP01-23
- EMEA-003475-PIP01-23
- Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Nervous system disorders, PIP number: P/0471/2023
- EMEA-003498-PIP01-23
- EMEA-003466-PIP01-23
- EMEA-003238-PIP02-22
- EMEA-003237-PIP02-22
- Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0470/2023
- EMEA-000325-PIP01-08-M11
- Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrine disorders, PIP number: P/0468/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0467/2023
- EMEA-002963-PIP01-21-M01
- Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (177Lu) oxodotreotide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0461/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiac disorders, PIP number: P/0457/2023