What’s new
- Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Breast Neoplasms, Date of authorisation: 22/05/2012, Revision: 15, Status: Authorised
- Human medicines European public assessment report (EPAR): Lyfnua, gefapixant, Cough, Date of authorisation: 15/09/2023, Status: Authorised
- COMP: Agendas, minutes and meeting reports
- Mefloquine : List of nationally authorised medicinal products - PSUSA/00001955/202302
- Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/202302
- Haemophilus type b conjugate vaccines : List of nationally authorised medicinal products - PSUSA/00001584/202302
- Ipratropium / salbutamol : List of nationally authorised medicinal products - PSUSA/00001781/202301
- Ipratropium : List of nationally authorised medicinal products - PSUSA/00001780/202301
- Sodium citrate (extracorporeal use) : List of nationally authorised medicinal products - PSUSA/00010986/202301
- Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202303
- Haemophilus type b and meningococcal group C conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/202302
- Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202303
- Fenoterol / ipratropium : List of nationally authorised medicinal products - PSUSA/00001367/202302
- Appendix 1: Acceptable intakes established for N-nitrosamines
- Human medicines European public assessment report (EPAR): Tyruko, natalizumab, Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Date of authorisation: 22/09/2023, Status: Authorised
News and press releases
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023, PRAC, 29/09/2023
- Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
- EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
- EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna, CHMP, 15/09/2023
- Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 14/09/2023
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 2023, CVMP, 08/09/2023
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023, PRAC, 01/09/2023
- PRAC recommends new measures to avoid topiramate exposure in pregnancy, PRAC, 01/09/2023
- Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5, CHMP, 30/08/2023
- EMA review of data on paternal exposure to valproate, PRAC, 16/08/2023
- EMA mourns passing of Noël Wathion, , 14/08/2023
- EMA business hours over Assumption Day, 15 August, , 11/08/2023
- Revocation of authorisation for sickle cell disease medicine Adakveo, CHMP, 26/05/2023
- Paving the way towards coordinated clinical trials in public health emergencies in the EU, , 25/07/2023
Human Medicines Highlights newsletter
- 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
- Human medicines highlights - December 2021
- Human medicines highlights - November 2021
- Human medicines highlights - October 2021
- Human medicines highlights - September 2021
- Human medicines highlights - August 2021
- Agenda - CHMP agenda of the 19-22 July 2021 meeting
Events
- Conversations on Cancer presents “Living with Metastatic Breast Cancer”, Online, 15:30 - 17:00 Amsterdam time (CEST), from 19/10/2023 to 19/10/2023
- Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP), Online, from 20/07/2023 to 20/07/2023
- Academia Info Day, European Medicines Agency, Amsterdam, 09:30 - 13:30 (CET), from 10/11/2023 to 10/11/2023
- Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), Online, 15:00 - 17:00 Amsterdam time (CEST), from 22/09/2023 to 22/09/2023
- Committee for Advanced Therapies (CAT): 12-14 July 2023, European Medicines Agency, Amsterdam, the Netherlands, from 12/07/2023 to 14/07/2023
- Committee for Orphan Medicinal Products (COMP): 11-13 July 2023, European Medicines Agency, Amsterdam, the Netherlands, from 11/07/2023 to 13/07/2023
- Joint EMA-ECDC press briefing on current state of respiratory diseases and treatments in the EU/EEA, Online, 14:30 – 15:00 Amsterdam time (CEST), from 21/09/2023 to 21/09/2023
- Sixth Industry Standing Group (ISG) meeting, from 21/09/2023 to 21/09/2023
- Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop – Smart regulation on a rapidly evolving world, European Medicines Agency, Amsterdam, the Netherlands, from 20/11/2023 to 20/11/2023
- Fifth European Medicines Agency - EuropaBio bilateral meeting, Virtual meeting, from 06/07/2023 to 06/07/2023
- Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2023, European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2023 to 14/09/2023
- Quarterly System Demo – Q3 2023, Online, 09:00 - 13:00 Amsterdam time (CEST), from 21/09/2023 to 21/09/2023
- Eleventh Nitrosamine Implementation Oversight Group (NIOG) meeting, Online, from 12/07/2023 to 12/07/2023
- LinkedIn Live interview with Ivo Claassen: Tomorrow's veterinary medicines for healthy animals and humans, Online, 13:15-13:45 Amsterdam time (CEST), from 07/09/2023 to 07/09/2023
- Third Veterinary Big Data Stakeholder Forum, Amsterdam, from 23/11/2023 to 23/11/2023
Regulatory and procedural guidelines (human and veterinary)
- Guidance on paediatric submissions
- The linguistic review process of product information in the centralised procedure - veterinary
- Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency
- Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)
- European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
- Guidance document on voting in the framework of discussion and adoption of CHMP opinions
- PRIME eligibility requests: 2024 deadlines for submission and timetable for assessment
- Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
- Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products
- Scientific advice under Art.107(6) of Reg.(EU)2019/6 for establishment of a list of antimicrobials which shall not be used in accordance with Art. 112, 113 and 114 or which shall only be used in accordance with these articles subject to certain conditions
- Guidance on paediatric submissions
- Good practices for industry for the prevention of human medicinal product shortages
- Guide for rapporteurs and coordinators on the multinational assessment teams
- 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 2023
- Guideline on computerised systems and electronic data in clinical trials
Scientific guidelines (human and veterinary)
- Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3
- DRAFT qualification opinion for GFR slope as a Surrogate Endpoint in RCT for CKD
- Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy
- ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - step 5 - Revision 4
- VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs)
- VICH GL35: Pharmacovigilance: electronic standards for transfer of data
- Guideline on influenza vaccines – submission and procedural requirements (Rev.2)
- ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b
- Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials - Accelerating Clinical Trials in the European Union (ACT EU)
- ICH guideline M10 on bioanalytical method validation and study sample analysis – Frequently Asked Questions (FAQ)
- ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5
- Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 3
- ICH: S 1 B 9R1): Testing for carcinogenicity of pharmaceuticals - Step 5
- Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates
- VICH GL15: Efficacy of anthelmintics: specific recommendations for equines - Revision 1
Agendas and Minutes
- Agenda of the HMPC meeting 18-20 September 2023
- Agenda - Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (22 September 2023)
- Agenda of the CAT meeting 6-8 September 2023
- Agenda - Strengthening life-sciences innovation across Europe: EU-Innovation Network conference
- Agenda of the HMPC meeting 17-19 July 2023
- Agenda - PDCO agenda of the 18-21 July 2023 meeting
- Agenda of the CAT meeting 12-14 July 2023
- Agenda of the CHMP meeting 17-20 July 2023
- Agenda - Fourth EMA-AESGP bilateral meeting
- Agenda of the Medicine Shortages (SPOC) Working Party 6 July 2023
- Agenda - Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
- Agenda of the CHMP meeting 19-22 June 2023
- Agenda of the CAT meeting 15 June 2023
- Agenda - ACT EU multi-stakeholder platform kick off workshop
- Agenda of the PRAC meeting 5-8 June 2023
European Union reference dates (EURD) list
Fees
- 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: 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
- Herbal medicinal product: Rhodiolae roseae rhizoma et radix, Rhodiolae roseae rhizoma et radix, F: Assessment finalised
Human medicines: European public assessment reports (EPARs) and summaries of opinion
- 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
- Human medicines European public assessment report (EPAR): Crixivan, indinavir, HIV Infections, Date of authorisation: 04/10/1996, Revision: 39, Status: Withdrawn
- Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, Date of authorisation: 31/08/2018, Revision: 4, Status: Authorised
- Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Prostatic Neoplasms, Date of authorisation: 13/11/2013, Revision: 12, Status: Authorised
- Human medicines European public assessment report (EPAR): Nemdatine, memantine, Alzheimer Disease, Date of authorisation: 22/04/2013, Date of refusal: 22/02/2013, Revision: 11, Status: Authorised
- Human medicines European public assessment report (EPAR): Ibandronic Acid Sandoz, ibandronic acid, Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone, Date of authorisation: 26/07/2011, Revision: 9, Status: Authorised
- Human medicines European public assessment report (EPAR): Sogroya, somapacitan, Growth, Date of authorisation: 31/03/2021, Revision: 1, Status: Authorised
- Human medicines European public assessment report (EPAR): Iressa, gefitinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 24/06/2009, Revision: 15, Status: Authorised
- Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate,umeclidinium,vilanterol, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 15/11/2017, Revision: 8, Status: Authorised
- Human medicines European public assessment report (EPAR): Senstend, lidocaine,prilocaine, Premature Ejaculation, Date of authorisation: 14/11/2019, Status: Withdrawn
- Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, Date of authorisation: 14/01/2015, Revision: 12, Status: Authorised
Inspections
- Annex III to procedure for conducting good-clinical-practice inspections requested by the EMA: Computer systems
- QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics
- Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 31 May 2023
- Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 31 May 2023
- Joint Audit Programme
- Mutual recognition agreements (MRA)
- International collaboration on GMP inspections
- Agenda - EMA IRIS industry training for GVP Inspections
- Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report
- QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page)
- QRD Appendix II - Medical Dictionary for Regulatory Activities (version 21.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics
- QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics
- Annual Report of the Good Clinical Practice Inspectors' Working Group 2020
- Good clinical practice (GCP) inspection procedures
- Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials
Maximum residue limits and opinions on maximum residue limits
- Rafoxanide (Bovine and ovine milk) - Summary opinion of the CVMP on the establishment of maximum residue limits
- Praziquantel (all ruminants except bovine, Equidae, fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits
- Bambermycin (poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP
- Ketoprofen (poultry) - Summary opinion of the CVMP on the extension of maximum residue limits
- Toltrazuril (poultry eggs) - Summary opinion of the CVMP on the extension of maximum residue limits
- Bambermycin (poultry) - Summary opinion of the CVMP on the establishment of maximum residue limits
New medicines: human
- Human medicines European public assessment report (EPAR): Pylclari, piflufolastat (18F), Prostatic Neoplasms, Date of authorisation: 24/07/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Pirfenidone AET, pirfenidone, Idiopathic Pulmonary Fibrosis, Date of authorisation: 20/06/2022, Status: Authorised
- Human medicines European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, COVID-19 vaccine (inactivated, adjuvanted, adsorbed), COVID-19 virus infection, Date of authorisation: 24/06/2022, Status: Authorised
- Summary of opinion: Enhertu,trastuzumab deruxtecan, 23/06/2022, Positive
- Summary of opinion: Pepaxti,melphalan flufenamide, 23/06/2022, Positive
- Summary of opinion: Lynparza,olaparib, 23/06/2022, Positive
- Summary of opinion: Rayvow,lasmiditan, 23/06/2022, Positive
- Summary of opinion: Vyvgart,efgartigimod alfa, 23/06/2022, Positive
- Summary of opinion: Crysvita,burosumab, 23/06/2022, Positive
- Summary of opinion: Scemblix,asciminib, 23/06/2022, Positive
- Summary of opinion: Imbruvica,ibrutinib, 23/06/2022, Positive
- Summary of opinion: Roctavian,Valoctocogene roxaparvovec, 23/06/2022, Positive
- Summary of opinion: Rinvoq,upadacitinib, 23/06/2022, Positive
- Summary of opinion: Sunlenca,lenacapavir, 23/06/2022, Positive
- Summary of opinion: Lonquex,lipegfilgrastim, 23/06/2022, Positive
Orphan designations
- Orphan designation: (S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one, Treatment of sickle cell disease, 19/10/2020, Positive
- Orphan designation: Talquetamab, Treatment of multiple myeloma, 20/08/2021, Positive
- Orphan designation: Celecoxib,Ciprofloxacin, Treatment of amyotrophic lateral sclerosis, 06/01/2021, Positive
- Orphan designation: 3-{[2,3,5,6-tetrafluoro-3'-(trifluoromethoxy)biphenyl-4-yl]carbamoyl}thiophene-2-carboxylic acid, Treatment of non-infectious uveitis, 19/06/2015, Positive
- Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt, Treatment of acute myeloid leukaemia, 23/03/2009, Positive
- Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1), Treatment of hypoparathyroidism, 19/10/2020, Positive
- Orphan designation: everolimus, Treatment of tuberous sclerosis, 04/08/2010, Expired
- Orphan designation: Dabrafenib mesylate, Treatment of glioma, 09/12/2020, Positive
- Orphan designation: Asunercept, Treatment of myelodysplastic syndromes, 23/08/2017, Positive
- Orphan designation: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule, Treatment of glioma, 28/01/2010, Positive
- Orphan designation: Mixture of seven synthetic fragments consisting of p21 RAS peptides, Treatment of pancreatic cancer, 05/08/2011, Positive
- Orphan designation: Pomalidomide, Treatment of multiple myeloma, 08/10/2009, Expired
- Orphan designation: Enzastaurin hydrochloride, Treatment of diffuse large B-cell lymphoma, 20/03/2007, Withdrawn
- Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Withdrawn
- Orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene, Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 17/01/2018, Withdrawn
Public consultations
- Guideline on safety and efficacy data requirements for 4 applications for immunological veterinary medicinal 5 products intended for limited markets but not eligible 6 for authorisation under Article 23 of Regulation (EU) 7 2019/6
- Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets
- 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
- Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
- Concept paper on the development of a guideline on the quality aspects of mRNA vaccines
- Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators
- Concept paper for the revision of the Guideline on live recombinant vector vaccines for veterinary use (EMEA/CVMP/004/04-FINAL)
- Concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use
- Call for scientific data for the use in HMPC assessment work on Maydis stigma
- Concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome
- Call for scientific data for the periodic review of the monograph on Combination: Species diureticae
- Call for scientific data for the periodic review of the monograph on Silybi mariani fructus
- Call for scientific data for the periodic review of the monograph on Mastic (Mastix, Pistaciae lentisci resina)
- Call for scientific data for the periodic review of the monograph on Allii sativi bulbus
- Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products
Withdrawn applications
- Withdrawn application: Vivjoa, Oteseconazole, Date of withdrawal: 24/08/2023, Initial authorisation
- Withdrawn application: SkyCovion, GBP510, Date of withdrawal: 01/09/2023, Initial authorisation
- Withdrawn application: Iclusig, ponatinib, Date of withdrawal: 11/08/2023, Post-authorisation
- Withdrawn application: Lutholaz, Date of withdrawal: 19/07/2023, Initial authorisation
- Withdrawn application: Jesduvroq, daprodustat, Date of withdrawal: 12/07/2023, Initial authorisation
- Withdrawn application: Gazyvaro, obinutuzumab, Date of withdrawal: 04/07/2023, Post-authorisation
- Withdrawn application: Gefzuris, gefapixant, Date of withdrawal: 14/07/2023, Initial authorisation
- Withdrawn application: Lagevrio, molnupiravir, Date of withdrawal: 21/06/2023, Initial authorisation
- Withdrawn application: Zefylti, filgrastim, Date of withdrawal: 08/06/2023, Initial authorisation
- Withdrawn application: Dyrupeg, pegfilgrastim, Date of withdrawal: 08/06/2023, Initial authorisation
- Withdrawn application: Tidhesco, ivosidenib, Date of withdrawal: 23/02/2023, Initial authorisation
- Withdrawn application: Asimtufii, aripiprazole, Date of withdrawal: 02/05/2023, Initial authorisation
- Withdrawn application: Susvimo, ranibizumab, Date of withdrawal: 02/05/2023, Initial authorisation
- Withdrawn application: Lumevoq, lenadogene nolparvovec, Date of withdrawal: 20/04/2023, Initial authorisation
- Withdrawn application: Feraheme, ferumoxytol, Date of withdrawal: 09/03/2023, Initial authorisation
Paediatric investigation plans
- Opinion/decision on a Paediatric investigation plan (PIP): Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA (Hologene 5), decision type: , therapeutic area: , PIP number: P/0375/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Ibrexafungerp citrate, decision type: , therapeutic area: , PIP number: P/0370/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli,Pegcetacoplan, decision type: , therapeutic area: , PIP number: P/0403/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Clazakizumab, decision type: , therapeutic area: , PIP number: P/0393/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Momelotinib, decision type: , therapeutic area: , PIP number: P/0157/2015
- Opinion/decision on a Paediatric investigation plan (PIP): Momelotinib, decision type: , therapeutic area: , PIP number: P/0249/2019
- Opinion/decision on a Paediatric investigation plan (PIP): Marstacimab, decision type: , therapeutic area: , PIP number: P/0443/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision type: , therapeutic area: , PIP number: P/0442/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja,Cefiderocol, decision type: , therapeutic area: , PIP number: P/0441/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112), decision type: , therapeutic area: , PIP number: P/0458/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo,Vosoritide, decision type: , therapeutic area: , PIP number: P/0453/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Finasteride,tadalafil, decision type: , therapeutic area: , PIP number: P/0461/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin (calcium),Telmisartan, decision type: , therapeutic area: , PIP number: P/0460/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Derivative of (3S,3'S,3a'S,10a'S)-3'-phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'- pyrrolo[2',3':4,5]pyrrolo[1,2-b]indazol]-2-one, decision type: , therapeutic area: , PIP number: P/0459/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Lidocaine (hydrochloride monohydrate), decision type: , therapeutic area: , PIP number: P/0419/2022