What’s new
- Cyanokit
- Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi, canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi/L4, live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated, Status: Authorised
- Trametinib product-specific bioequivalence guideline
- Article 57 product data
- Alofisel
- Human medicines European public assessment report (EPAR): Vanflyta, quizartinib, Date of authorisation: 06/11/2023, Revision: 3, Status: Authorised
- Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568
- Assessment templates and guidance (veterinary medicines)
- Template - CVMP member comments on rapporteur’s reports
- Dexmedetomidine Accord
- Highlights - Seventh European Medicines Agency (EMA) EFPIA bilateral meeting
- List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
- Periodic safety update reports (PSURs)
- Highlights - Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting
News and press releases
- A common EU approach to data transparency in medicine regulation
- Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulation
- EMA business hours over holiday period
- Successful pilot paves the way for implementation of ePI
- EMA Management Board: highlights of December 2024 meeting
- First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024
- First treatment recommended for rare progressive lung conditions in children and adolescents
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
- European Shortages Monitoring Platform enables better monitoring of shortages in the EU
- EMA encourages companies to submit type I variations for 2024 by end November 2024
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
- EMA encourages companies to submit type I variations for 2024 by end November 2024
- Leqembi recommended for treatment of early Alzheimer’s disease
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/FVE webinar on veterinary prescription: conditions for using certain antimicrobials under the 'cascade', European Medicines Agency, Amsterdam, the Netherlands, from 16 January 2025, 14:00 (CET) to 16 January 2025, 15:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS - 17 Jan 2025, Online, from 17 January 2025, 10:00 (CET) to 17 January 2025, 11:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS - 8 Jan 2025, Online, from 8 January 2025, 14:00 (CET) to 8 January 2025, 15:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS, Online, from 8 January 2025, 14:00 (CET) to 8 January 2025, 15:00 (CET)
- Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion , European Medicines Agency, Amsterdam, the Netherlands, from 14 January 2025, 10:00 (CET) to 14 January 2025, 11:00 (CET)
- Clinical Trials Information System (CTIS): Walk-in clinic - January 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 January 2025, 16:00 (CET) to 29 January 2025, 17:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS - 19 Dec 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 December 2024, 11:00 (CET) to 19 December 2024, 12:00 (CET)
- Q&A clinic on post-authorisation procedure management in IRIS, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 December 2024, 11:00 (CET) to 19 December 2024, 12:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS (2), Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 December 2024, 11:00 (CET) to 19 December 2024, 12:00 (CET)
- European Commission/EMA meeting with stakeholders on Translarna (ataluren), Online, from 10 December 2024, 11:00 (CET) to 10 December 2024, 12:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS - 11 Dec 2024, Online, from 11 December 2024, 11:00 (CET) to 11 December 2024, 12:00 (CET)
- Q&A Clinic on post-authorisation procedure management in IRIS (1), Online, from 11 December 2024, 11:00 (CET) to 11 December 2024, 12:00 (CET)
- 2024 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA), Online, European Medicines Agency, Amsterdam, the Netherlands, 1 October 2024
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 5 December 2024, 09:30 (CET) to 5 December 2024, 13:30 (CET)
- Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 December 2024, European Medicines Agency, Amsterdam, the Netherlands, from 3 December 2024 to 5 December 2024
Regulatory and procedural guidelines (human and veterinary)
- 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
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
- European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
- European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
- Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
- Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
- European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
- Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements
- QRD veterinary v.9.1 – Implementation plan
- Guidance for applicants seeking scientific support and advice on traditional herbal medicinal products
- List of substances and products subject to worksharing for signal management
Scientific guidelines (human and veterinary)
- 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
- Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets
- Concept paper for the revision of the guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkeys and geese
- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
Agendas and Minutes
- Minutes of the CHMP meeting 22-25 July 2024
- Minutes - HMA-EMA joint Big Data Steering Group teleconference - 15 November 2024
- Programme of the 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA)
- Agenda - PDCO agenda of the 10-13 December 2024 meeting
- Agenda of the CHMP meeting 9-12 December 2024
- Agenda - Medicine Shortages (SPOC) Working Party 5 December 2024
- Agenda of the COMP meeting 3-5 December 2024
- Agenda of the CVMP meeting 3-5 December 2024
- Agenda of the CAT meeting 4-6 December 2024
- Minutes - PDCO minutes of the 15-18 October 2024 meeting
- Minutes of the CHMP meeting 24-27 June 2024
- Minutes of the CAT meeting 9-11 October 2024
- Minutes of the PRAC meeting on 30 September - 03 October 2024
- Agenda of the PRAC meeting 25-28 November 2024
- Minutes of the HMPC meeting 23-25 September 2024
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
- 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: 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
- Praziquantel (fin fish): European public MRL assessment report (EPMAR) - CVMP
- Opinion of the CVMP on the establishment of maximum residue limits: Sodium salicylate
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
- 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: Zinplava, 14/12/2023 Positive
- 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: tiratricol Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017 Positive
- Orphan designation: Seladelpar Treatment of primary biliary cholangitis, 16/10/2017 Positive
- Orphan designation: Human monoclonal IgG1 antibody against tissue factor pathway inhibitor Treatment of haemophilia A, 14/10/2016 Withdrawn
- Orphan designation: pasireotide Treatment of acromegaly, 08/10/2009 Expired
- Orphan designation: Ketoconazole Treatment of Cushing's syndrome, 23/04/2012 Expired
- Orphan designation: Avenciguat Treatment of systemic sclerosis, 11/11/2024 Positive
- Orphan designation: Curcumin E100, Resveratrol Treatment of Dercum disease, 11/11/2024 Positive
- Orphan designation: 4-[[(4-Methoxyphenyl)thio]methyl]-N,N-dimethyl-1H-1,2,3-triazole-1-ethanamine Treatment of non-syndromic inherited retinal dystrophies with a rod-dominant phenotype, 11/11/2024 Positive
- Orphan designation: 3-chloro-4-fluorophenyl-(4-fluoro-4-(((5-methylpyrimidin-2-ylmethyl)amino)methyl)piperidin-1yl)methanone Treatment of fragile X syndrome, 11/11/2024 Positive
- Orphan designation: Felzartamab Treatment of primary IgA nephropathy, 11/11/2024 Positive
- Orphan designation: H-L-Tryptophanyl-L-seryl-glycyl-L-tryptophanyl-L-seryl-L-seryl-L-cysteinyl-L-seryl-L-arginyl-L-seryl-L-cysteinyl-glycyl-OH (disulfide bond), acetate salt Treatment of amyotrophic lateral sclerosis, 10/11/2024 Positive
- Orphan designation: Navenibart Treatment of hereditary angioedema, 10/11/2024 Positive
- Orphan designation: Genetically modified human adenovirus encoding human PH20 hyaluronidase Treatment of retinoblastoma, 10/11/2024 Positive
- Orphan designation: Sodium selenate Treatment of frontotemporal dementia, 10/11/2024 Positive
- Orphan designation: Ivosidenib Treatment of chondrosarcoma, 10/11/2024 Positive
Public consultations
- 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
- Guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities
- EMA policy on handling of competing interests of scientific committee members and experts: Draft for public consultation
- Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (draft)
- Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3
- Consolidated 3-year rolling work plan for the Haematology Working Party (HAEMWP) : January 2025 - December 2027
- Consolidated 3-year rolling work plan for the Oncology Working Party : January 2025 - December 2027
Withdrawn applications
- 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
- Withdrawn application: Orencia, 19/02/2024
- Withdrawn application: Adcetris, 23/02/2024
- Withdrawn application: Iclusig, 11/08/2023
- Withdrawn application: Bylvay, odevixibat, Date of withdrawal: 22/10/2023, Post-authorisation
- Withdrawn application: Vijoice, alpelisib, Date of withdrawal: 30/10/2023, Initial authorisation
- Withdrawn application: RoActemra, 13/09/2023
Paediatric investigation plans
- Opinion/decision on a Paediatric investigation plan (PIP): Paxlovid, nirmatrelvir,nirmatrelvir / ritonavir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0447/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology;Immunology-Rheumatology-Transplantation, PIP number: P/0452/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi, Lisocabtagene maraleucel, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0448/2023
- EMEA-002776-PIP01-20-M02
- EMEA-002763-PIP01-20-M01
- EMEA-002705-PIP02-19-M01
- Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0423/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Plegridy, peginterferon beta-1a, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0419/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant,Palonosetron, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0418/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0417/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Giapreza, Angiotensin II (LJPC-501), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0415/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0416/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, Onasemnogene abeparvovec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0412/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0414/2023
- EMEA-003479-PIP01-23