What’s new
- PSUSA/00002774/202408
- PSUSA/00000027/202407
- Human medicines European public assessment report (EPAR): Pirfenidone Viatris, pirfenidone, Date of authorisation: 10/01/2023, Revision: 3, Status: Authorised
- Medicine evaluation figures
- EMA Agile governance model
- Medicinal products for human use: monthly figures - March 2025
- ICH M15 guideline on general principles for model-informed drug development - Step 2b - Scientific guideline
- Report - Industry stakeholders and EU network experts surveys on early engagement fostering innovation
- European Medicines Agency’s Data Protection Notice for the operation of video-surveillance (CCTV) system
- Record of data processing activity for video-surveillance (CCTV) system
- Minutes of the CVMP meeting 11-13 March 2025
- 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
- Assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product - Scientific guideline
- PSUSA/00002920/202408
- 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
News and press releases
- EMA business hours over Easter holiday period
- Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025
- Clinical Trials Information System designated as WHO primary registry
- EU recommendations for 2025/2026 seasonal flu vaccine composition
- Streamlining development and assessment of biosimilar medicines
- First report on EU-wide sales and use of antimicrobials in animals
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025
- EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples
- Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
- First vaccine against epizootic haemorrhagic disease recommended for approval
- EMA Management Board: highlights of March 2025 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 March 2025
- Unregulated advanced therapy medicinal products pose serious risks to health
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
- EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 October 2025, 09:30 (CEST) to 17 October 2025, 13:30 (CEST)
- Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 April 2025, 10:00 (CEST) to 9 April 2025, 15:30 (CEST)
- ICMRA Summit 2025, European Medicines Agency, Amsterdam, the Netherlands, from 21 October 2025 to 24 October 2025
- EMA’s 30th anniversary scientific conference - Medicines, regulation and the future, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 June 2025, 10:00 (CEST) to 25 June 2025, 16:00 (CEST)
- Clinical Trials Information System (CTIS): Information day, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 May 2025, 12:30 (CEST) to 22 May 2025, 17:30 (CEST)
- Clinical Trials Information System (CTIS): Walk-in clinic - May 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 May 2025, 16:00 (CEST) to 14 May 2025, 17:00 (CEST)
- Second EMA / Alliance for Regenerative Medicine bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 May 2025, 14:00 (CEST) to 8 May 2025, 16:00 (CEST)
- EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)
- EMA traineeship programme informative session, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 April 2025, 10:00 (CEST) to 14 April 2025, 11:00 (CEST)
- European Organisation for Research and Treatment of Cancer (EORTC) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 9 April 2025
- Management Board meeting: 13 March 2025, European Medicines Agency, Amsterdam, the Netherlands, 13 March 2025
- Cancer Medicines Forum: December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 December 2024, 13:00 (CET) to 16 December 2024, 15:00 (CET)
- 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)
Regulatory and procedural guidelines (human and veterinary)
- Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026
- European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
- Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
- Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026
- IRIS guide to registration and RPIs
- Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool
- European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
- 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
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
- Minutes of the CVMP meeting 11-13 March 2025
- Agenda of the CAT meeting 14-16 April 2025
- Minutes - PDCO minutes of the 25-28 February 2025 meeting
- Minutes of the PRAC meeting 10-13 February 2025
- Agenda of the CVMP meeting 8-10 April 2025
- Minutes of the CAT meeting 19-21 February 2025
- Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 1 April 2025
- Minutes of the COMP meeting 18-19 February 2025
- Agenda - PDCO agenda of the 25-28 March 2025 meeting
- Minutes of the CVMP meeting 11-12 February 2025
- Annex to 24-27 March 2025 CHMP Agenda
- Agenda of the CHMP meeting 24-27 March 2025
- Minutes of the HMPC meeting 20-22 January 2025
- Agenda of the CAT meeting 19-21 March 2025
- Agenda of the HMPC meeting 17-19 March 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): 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
- 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
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: single guide RNA containing a sequence complementary to human ALB locus gene, intron 1, target region, Ziclumeran Treatment of haemophilia B, 25/03/2025 Positive
- Orphan designation: povetacicept Treatment of primary IgA nephropathy, 25/03/2025 Positive
- Orphan designation: extract from Cannabis flower, containing high levels of cannabidiolic acid and <0.3% of tetrahydrocannabinol, Extraction solvent: olive oil, virgin Treatment of Rett syndrome, 25/03/2025 Positive
- Orphan designation: allopurinol Treatment of Marfan syndrome, 25/03/2025 Positive
- Orphan designation: adeno-associated virus vector serotype 8 containing the human F9 gene Treatment of haemophilia B, 25/03/2025 Positive
- Orphan designation: bexmarilimab Treatment of myelodysplastic syndromes, 25/03/2025 Positive
- Orphan designation: ixodes ricinus contact phase inhibitor Treatment of non-traumatic spontaneous intracerebral haemorrhage, 25/03/2025 Positive
- Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains Treatment of multiple myeloma, 04/06/2020 Withdrawn
- Orphan designation: deucrictibant monohydrate Treatment of bradykinin-mediated angioedema, 25/03/2025 Positive
- Orphan designation: Givinostat Treatment of Duchenne muscular dystrophy, 04/07/2012 Positive
- Orphan designation: Trehalose Treatment of neuronal ceroid lipofuscinosis, 19/10/2020 Withdrawn
- Orphan designation: Ornithine phenylacetate Treatment of acute liver failure, 20/02/2025 Positive
- Orphan designation: Magrolimab Treatment of myelodysplastic syndromes, 26/06/2020 Withdrawn
- Orphan designation: Magrolimab Treatment of acute myeloid leukaemia, 11/11/2015 Withdrawn
- Orphan designation: Tafasitamab Treatment of follicular lymphoma, 26/02/2025 Positive
Public consultations
- Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herba
- Quality Review of Documents (QRD) annotated template v11: Draft for public consultation
- Quality Review of Documents (QRD) annotated template v11: Draft for public consultation - track changes
- Key information section in package leaflet of centrally authorised medicinal products: Public consultation
- ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b
- Reflection paper on a tailored clinical approach in biosimilar development
- Call for scientific data for the periodic review of the monograph on Valerianae radix and Lupuli flos
- Call for scientific data for the periodic review of the monograph on Salicis cortex
- Call for scientific data for the periodic review of the monograph on Psyllii semen
- Call for scientific data for the periodic review of the monograph on Harpagophyti radix
- Call for scientific data for the periodic review of the monograph on Hamamelidis folium et cortex aut ramunculus destillatum
- Call for scientific data for the periodic review of the monograph on Hamamelidis folium
- Call for scientific data for the periodic review of the monograph on Hamamelidis cortex
- Call for scientific data for the periodic review of the monograph on Equiseti herba
- Call for scientific data for the periodic review of the monograph on Carvi fructus
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
- Opinion/decision on a Paediatric investigation plan (PIP): Tenkasi (previously Orbactiv), oritavancin (diphosphate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0074/2024
- Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0076/2024
- Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Metabolism and nutrition disorders, PIP number: P/0077/2024
- EMEA-002741-PIP01-20-M02
- EMEA-002338-PIP04-23
- Opinion/decision on a Paediatric investigation plan (PIP): VidPrevtyn Beta, SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Vaccines, PIP number: P/0072/2024
- EMEA-003420-PIP01-23
- EMEA-003423-PIP02-23
- EMEA-002656-PIP01-19-M01
- EMEA-002565-PIP02-19-M01
- EMEA-000551-PIP04-21-M03
- Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0054/2024
- Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vascular disorders, PIP number: P/0053/2024
- EMEA-002234-PIP01-17-M02
- EMEA-003523-PIP01-23