What’s new
- Minutes of the PRAC meeting 4-7 July 2022
- Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1
- CTIS newsflash – 31 March 2023
- PRIME regulatory roadmap and product development tracker
- European Medicines Agency guidance to support the preparation of the PRIME kick-off meeting and submission readiness meeting
- European Medicines Agency guidance for applicants seeking access to PRIME scheme
- Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2023
- 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
- Minutes of the PRAC meeting 24-27 October 2022
- Summary of opinion: Pedmarqsi,sodium thiosulfate, 30/03/2023, Positive
- Summary of opinion: Omvoh,mirikizumab, 30/03/2023, Positive
- Summary of opinion: Qaialdo,spironolactone, 30/03/2023, Positive
- Summary of opinion: Briumvi,ublituximab, 30/03/2023, Positive
- Summary of opinion: Entresto,sacubitril,valsartan, 30/03/2023, Positive
- Summary of opinion: Wegovy ,semaglutide, 30/03/2023, Positive
News and press releases
- Regulatory information – adjusted fees for applications to EMA from 1 April 2023, , 31/03/2023
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023, CHMP, 31/03/2023
- EMA recommends approval of Bimervax as a COVID-19 booster vaccine, CHMP, 30/03/2023
- DARWIN EU® has completed its first studies and is calling for new data partners, , 28/03/2023
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023, CVMP, 24/03/2023
- Advancing regulatory science in the EU – mid-point report published, , 22/03/2023
- EMA Management Board: highlights of March 2023 meeting, MB, 17/03/2023
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023, PRAC, 17/03/2023
- EMA pilots scientific advice for certain high-risk medical devices, , 27/02/2023
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23 February 2023, CHMP, 24/02/2023
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023, CVMP, 17/02/2023
- Veterinary medicines: highlights of 2022, , 16/02/2023
- Human medicines: highlights of 2022, , 16/02/2023
- PRAC starts safety review of pseudoephedrine-containing medicines, , 10/02/2023
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023, PRAC, 10/02/2023
Human Medicines Highlights newsletter
- 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
- Agenda - CAT agenda of the 14-16 July 2021 meeting
- Agenda - COMP agenda of the 13-15 July 2021 meeting
Events
- Union Product Database – Volume of sales webinar for UPD industry users, Online, 14:00 - 15:00 Amsterdam time (CEST), from 24/04/2023 to 24/04/2023
- Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission, Online, 15:30 - 17:00 Amsterdam time (CEST), from 10/05/2023 to 10/05/2023
- CVMP Interested Parties’ meeting, European Medicines Agency, Amsterdam, the Netherlands, 10:00-12:00 CEST (Amsterdam time), from 24/05/2023 to 24/05/2023
- Focus group meeting on bacteriophages, European Medicines Agency , 09:30-16:30 CEST (Amsterdam time), from 11/05/2023 to 11/05/2023
- Fifth EMA-EFPIA annual bilateral meeting, Hybrid, 14:00 - 16:00 Amsterdam time (CET), from 07/02/2023 to 07/02/2023
- Cancer Medicines Forum: June 2022, Online, from 28/06/2022 to 28/06/2022
- Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS - February 2023, Online, 14:30 - 16:00 Amsterdam time (CET), from 23/02/2023 to 23/02/2023
- Enpr-EMA Coordinating Group meeting , Online, 15:00 - 16:30 Amsterdam time (CET), from 15/02/2023 to 15/02/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - December 2023, Online, 16:00 - 17:00 Amsterdam time (CET), from 13/12/2023 to 13/12/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - November 2023, Online, 16:00 - 17:00 Amsterdam time (CET), from 15/11/2023 to 15/11/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - October 2023, Online, 16:00 - 17:00 Amsterdam time (CEST), from 10/10/2023 to 10/10/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - September 2023, Online, 16:00 - 17:00 Amsterdam time (CEST), from 20/09/2023 to 20/09/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - August 2023, Online, 16:00 - 17:00 Amsterdam time (CEST), from 23/08/2023 to 23/08/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - July 2023, Online, 16:00 - 17:00 Amsterdam time (CEST), from 19/07/2023 to 19/07/2023
- Clinical Trials Information System (CTIS): Walk-in clinic - June 2023, Online, 16:00 - 17:00 Amsterdam time (CEST), from 14/06/2023 to 14/06/2023
Regulatory and procedural guidelines (human and veterinary)
- Guideline on computerised systems and electronic data in clinical trials
- European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
- Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
- Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation
- Validation checklist for Type II quality variations
- Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP)
- Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7
- Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency
- European Medicines Agency certificates of medicinal products - instructions on how to fill in the application form
- Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
- Validation checklist for Type II (non) clinical variations
- Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised, mutual recognition, decentralised procedures and national procedures
- EudraVigilance registration documents
- ICH guideline Q3C (R8) on impurities: guideline for residual solvents - Step 5
- Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
Scientific guidelines (human and veterinary)
- 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
- VICH GL12: Efficacy of anthelmintics: specific recommendations for bovines - Revision 1
- VICH GL16: Efficacy of anthelmintics: specific recommendations for porcines - Revision 1
- VICH GL13: Efficacy of anthelmintics: specific recommendations for ovines - Revision 1
- VICH GL14: Efficacy of anthelmintics: specific recommendations for caprines - Revision 1
- VICH GL21: Efficacy of anthelmintics: specific recommendations for chickens – gallus gallus - Revision 1
- VICH GL16: Efficacy of anthelmintics: specific recommendations for porcines - Revision 1
- VICH GL19: Efficacy of anthelmintics: specific recommendations for canines - Revision 1
Agendas and Minutes
- Agenda - Union Product Database – Volume of sales webinar for UPD industry users
- Agenda of the CVMP meeting 21-23 March 2023
- Agenda for the 119th meeting of the Management Board: 16 March 2023
- Agenda of the PRAC meeting 13-16 March 2023
- Agenda of the HMPC meeting 13-15 March 2023
- Agenda of the CHMP meeting 20-23 February 2023
- Agenda of the COMP meeting 14-16 February 2023
- CHMP PROM agenda for the meeting on 5 December 2022
- Agenda of the CHMP meeting 23-26 January 2023
- Agenda of the PDCO meeting 17-20 January 2023
- Agenda - Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023
- CHMP PROM agenda for the meeting on 3 October 2022
- Agenda of the COMP meeting 17-19 January 2023
- Agenda - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (11 January 2022)
- CHMP PROM agenda for the meeting on 31 October 2022
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): 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
- Human medicines European public assessment report (EPAR): Filsuvez, birch bark extract, Epidermolysis Bullosa Dystrophica;Epidermolysis Bullosa, Junctional, Date of authorisation: 21/06/2022, Status: Authorised
Inspections
- 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
- Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents
- Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)
- Annex I to procedure for conducting GCP inspections requested by the CHMP: Investigator site
- Annex II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories
Maximum residue limits and opinions on 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): 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
- Summary of opinion: Ranivisio,ranibizumab, 23/06/2022, Positive
Orphan designations
- Orphan designation: Iodine (131I) iobenguane, Treatment of neuroblastoma, 31/01/2008, Positive
- Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide hydrochloride, Treatment of maternally-inherited diabetes and deafness, 28/06/2019, Positive
- Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride, Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 10/08/2015, Positive
- Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride, Treatment of Leigh syndrome, 15/10/2014, Positive
- Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive
- Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3, Treatment of achondroplasia, 27/02/2017, Withdrawn
- Orphan designation: miglustat, Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Withdrawn
- Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding the human NCF1 gene, Treatment of chronic granulomatous disease, 13/01/2023, Positive
- Orphan designation: Adeno-associated viral vector serotype 2 containing the human SLC6A3 gene, Treatment of dopamine transporter deficiency syndrome, 13/01/2023, Positive
- Orphan designation: Efzofitimod, Treatment of sarcoidosis, 13/01/2023, Positive
- Orphan designation: Opelconazole, Treatment of invasive aspergillosis, 13/01/2023, Positive
- Orphan designation: Retifanlimab, Treatment of Merkel cell carcinoma, 13/01/2023, Positive
- Orphan designation: Nanatinostat,Valganciclovir, Treatment of diffuse large B-cell lymphoma, 13/01/2023, Positive
- Orphan designation: Autologous hematopoietic cells genetically modified with a lentiviral vector containing the human RAG2 gene, Treatment of recombination-activating gene 2 deficient severe combined immunodeficiency, 13/01/2023, Positive
- Orphan designation: N1,N14-diethyl-3S,12S-dihydroxyhomospermine tetrahydrochloride, Treatment of pancreatic cancer, , Positive
Public consultations
- 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
- Call for scientific data for the periodic review of the monograph on Malvae folium
- Call for scientific data for the periodic review of the monograph on Malvae sylvestris flos
- Call for scientific data for the periodic review of the monograph on Soiae oleum raffinatum
- Call for scientific data for the periodic review of the monograph on Matricariae aetheroleum
- Call for scientific data for the periodic review of the monograph on Lecithinum ex soya - Revision 1
- Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1
- Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies
- Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘cough and cold’
- Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites
- Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops)
- Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy
- Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy
- Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances
- ICH M11 technical specification - Step 2b
Withdrawn applications
- Withdrawn application: Feraheme, ferumoxytol, Date of withdrawal: 09/03/2023, Initial authorisation
- Withdrawn application: Raltegravir Viatris, raltegravir potassium, Date of withdrawal: 22/02/2023, Initial authorisation
- Withdrawn application: Garsun, artesunate, Date of withdrawal: 08/12/2022, Initial authorisation
- Withdrawn application: Buvidal, buprenorphine, Date of withdrawal: 13/02/2023, Post-authorisation
- Withdrawn application: Imbruvica, ibrutinib, Date of withdrawal: 13/12/2022, Post-authorisation
- Withdrawn application: Versiguard SARS CoV2, Recombinant SARS CoV2 spike protein, Date of withdrawal: 15/09/2022, Initial authorisation
- Withdrawn application: Olumiant, baricitinib, Date of withdrawal: 07/12/2022, Post-authorisation
- Withdrawn application: Imbarkyd, bardoxolone methyl, Date of withdrawal: 09/11/2022, Initial authorisation
- Withdrawn application: Febseltiq, infigratinib, Date of withdrawal: 10/10/2022, Initial authorisation
- Withdrawn application: Ilaris, canakinumab, Date of withdrawal: 26/10/2022, Post-authorisation
- Withdrawn application: Orepaxam, treprostinil diolamine, Date of withdrawal: 11/10/2022, Initial authorisation
- Withdrawn application: Gavreto, pralsetinib, Date of withdrawal: 03/11/2022, Post-authorisation
- Withdrawn application: Hervelous, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation
- Withdrawn application: Tuznue, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation
- Withdrawn application: Exkivity, mobocertinib, Date of withdrawal: 20/07/2022, Initial authorisation
Paediatric investigation plans
- Opinion/decision on a Paediatric investigation plan (PIP): Verquvo,Vericiguat, decision type: , therapeutic area: , PIP number: P/0454/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Givinostat, decision type: , therapeutic area: , PIP number: P/0513/2022
- Opinion/decision on a Paediatric investigation plan (PIP): Xofluza,Baloxavir marboxil, decision type: , therapeutic area: , PIP number: P/0486/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi,Larotrectinib, decision type: , therapeutic area: , PIP number: P/0487/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide, decision type: , therapeutic area: , PIP number: P/0490/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat, decision type: , therapeutic area: , PIP number: P/0491/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra,Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], decision type: , therapeutic area: , PIP number: P/0492/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate),histidine,tryptophan,aspartic acid,n-acetyl-histidine (monohydrate),glycine,alpha-ketoglutaric acid,arginine,potassium chloride,magnesium chloride (hexahydrate),calcium chloride (dihydrate),sodium chloride,alanine,3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N), decision type: , therapeutic area: , PIP number: P/0484/2021
- 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: , therapeutic area: , PIP number: P/0483/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Verquvo,Vericiguat, decision type: , therapeutic area: , PIP number: P/0476/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Aimovig,erenumab, decision type: , therapeutic area: , PIP number: P/0475/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Besponsa,inotuzumab ozogamicin, decision type: , therapeutic area: , PIP number: P/0478/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium sulfate, decision type: , therapeutic area: , PIP number: P/0479/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca),COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222), decision type: , therapeutic area: , PIP number: P/0559/2021
- Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi,Lisocabtagene maraleucel, decision type: , therapeutic area: , PIP number: P/0558/2021