News & events

What's new

RSS
May 2023 (407) Apr 2023 (440) Mar 2023 (534) Feb 2023 (404) Jan 2023 (391) Dec 2022 (294) Nov 2022 (319) Oct 2022 (222) Sep 2022 (263) Aug 2022 (156) Jul 2022 (249) Jun 2022 (336) May 2022 (16)
Date Content
28/04/2023 Template or form: CHMP protocol assistance scientific advice briefing document template
28/04/2023 Human medicines European public assessment report (EPAR): Zejula, Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 20, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Glioma, 07/09/2007, 8, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Palynziq, Pegvaliase, Phenylketonurias, 03/05/2019, Orphan, Additional monitoring, 7, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections, 21/06/2018, 16, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms, 17/07/2015, 50, Authorised
28/04/2023 Newsletter: CTIS newsflash - 28 April 2023
28/04/2023 Other: Timetable: Companion diagnostic initial consultation - ATMP
28/04/2023 Human medicines European public assessment report (EPAR): Emend, Aprepitant, Vomiting; Postoperative Nausea and Vomiting; Cancer, 11/11/2003, 30, Authorised
28/04/2023 Report: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022
28/04/2023 Work programme: Work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2021-2023
28/04/2023 Minutes: Minutes of the CVMP meeting of 21-22 March 2023
28/04/2023 Pharmacovigilance (veterinary medicines)
28/04/2023 Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast for the: Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive
28/04/2023 Orphan designation: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast for the: Treatment of Duchenne muscular dystrophy, 31/07/2018, Positive
28/04/2023 Orphan designation: Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp for the: Treatment of multiple system atrophy, 19/11/2018, Positive
28/04/2023 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 23/07/2012, Accelerated assessment, 35, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Beyfortus, nirsevimab, 31/10/2022, Additional monitoring, 2, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 34, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias; Hypercholesterolemia, 17/07/2015, 24, Authorised
28/04/2023 Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor for the: Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive
28/04/2023 Human medicines European public assessment report (EPAR): Firazyr, icatibant, Angioedemas, Hereditary, 11/07/2008, 23, Authorised
28/04/2023 Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, 17, Authorised
28/04/2023 Orphan designation: Tazemetostat for the: Treatment of follicular lymphoma, 21/03/2018, Positive
28/04/2023 Orphan designation: Tazemetostat for the: Treatment of malignant mesothelioma, 21/03/2018, Positive
28/04/2023 Orphan designation: Tazemetostat for the: Treatment of diffuse large B-cell lymphoma, 21/03/2018, Positive
28/04/2023 Human medicines European public assessment report (EPAR): Ronapreve, casirivimab, imdevimab, COVID-19 virus infection, 12/11/2021, Additional monitoring, 4, Authorised
28/04/2023 Newsletter: News bulletin for small and medium-sized enterprises - Issue 58
28/04/2023 Medicine QA: Questions and answers on the outcome of assessment on use of Epidyolex (cannabidiol)
26/04/2023 Biosimilar medicines: Overview
26/04/2023 Summary of opinion: Orkambi, lumacaftor, ivacaftor, 26/04/2023, Positive
26/04/2023 Other: Q&A on the Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU
26/04/2023 Summary of opinion: Ronapreve, casirivimab, imdevimab, 26/04/2023, Positive
26/04/2023 Summary of opinion: Revestive, teduglutide, 26/04/2023, Positive
26/04/2023 Summary of opinion: Tidhesco, ivosidenib, 23/02/2023, Positive
26/04/2023 Summary of opinion: Spikevax (previously COVID-19 Vaccine Moderna), elasomeran, imelasomeran and elasomeran, davesomeran and elasomeran, COVID-19 mRNA vaccine (nucleoside-modified), 26/04/2023, Positive
26/04/2023 News and press releases: First vaccine to protect older adults from respiratory syncytial virus (RSV) infection
26/04/2023 Summary of opinion: Camzyos, mavacamten, 26/04/2023, Positive
26/04/2023 Withdrawn application: Lumevoq, lenadogene nolparvovec, Date of withdrawal: 20/04/2023, Initial authorisation
26/04/2023 Summary of opinion: Yervoy, ipilimumab, 26/04/2023, Positive
26/04/2023 Summary of opinion: Sugammadex Piramal, sugammadex, 26/04/2023, Positive
26/04/2023 Summary of opinion: Opfolda, miglustat, 26/04/2023, Positive
26/04/2023 Summary of opinion: Adempas, riociguat, 26/04/2023, Positive
26/04/2023 Public Statement: Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU
26/04/2023 Summary of opinion: Jaypirca, pirtobrutinib, 26/04/2023, Positive
26/04/2023 Summary of opinion: Bimzelx, bimekizumab, 26/04/2023, Positive
26/04/2023 Summary of opinion: Bimzelx, bimekizumab, 26/04/2023, Positive
26/04/2023 Summary of opinion: Arexvy, recombinant, adjuvanted, 26/04/2023, Positive
26/04/2023 Summary of opinion: Opdivo, nivolumab, 26/04/2023, Positive
26/04/2023 Summary of opinion: Vemlidy, tenofovir alafenamide, 26/04/2023, Positive
26/04/2023 Summary of opinion: Columvi, glofitamab, 26/04/2023, Positive
26/04/2023 Summary of opinion: Cosentyx, secukinumab, 25/04/2023, Positive
26/04/2023 Summary of opinion: Lytgobi, futibatinib, 26/04/2023, Positive
26/04/2023 Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), Para-aminosalicylic acid, Tuberculosis, 07/04/2014, Orphan, 11, Authorised
26/04/2023 Human medicines European public assessment report (EPAR): Axura, memantine hydrochloride, Alzheimer Disease, 17/05/2002, 27, Authorised
26/04/2023 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia, 19/11/2015, Generic, 15, Authorised
26/04/2023 Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Hyperkalemia, 22/03/2018, 9, Authorised
26/04/2023 Human medicines European public assessment report (EPAR): Ambrisentan Mylan, ambrisentan, Hypertension, Pulmonary, 20/06/2019, Generic, 4, Authorised
26/04/2023 Human medicines European public assessment report (EPAR): Ravicti, glycerol phenylbutyrate, Urea Cycle Disorders, Inborn, 26/11/2015, Orphan, 16, Authorised
26/04/2023 List of medicines under additional monitoring
26/04/2023 Medicines under additional monitoring: List of medicinal products under additional monitoring
26/04/2023 Medicines under additional monitoring: List of medicinal products under additional monitoring
26/04/2023 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union
26/04/2023 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
26/04/2023 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
26/04/2023 Medicines under additional monitoring: Annex XIV - List of Retinoid-containing medicinal products and related substances (acitretin, alitretinoin and isotretinoin) in the European Union
26/04/2023 Medicines under additional monitoring: Annex XIV - List of Retinoid-containing medicinal products and related substances (acitretin, alitretinoin and isotretinoin) in the European Union
26/04/2023 Medicines under additional monitoring: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
26/04/2023 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union
26/04/2023 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
26/04/2023 Human medicines European public assessment report (EPAR): NexoBrid, proteolytic enzymes enriched in bromelain, Debridement, 18/12/2012, Additional monitoring, 15, Authorised
25/04/2023 Referral: Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names , Butafosfan, Cyanocobalamin, Article 33, 15/02/2023, 03/04/2023
25/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): abelacimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0127/2022
25/04/2023 Human medicines European public assessment report (EPAR): Nemdatine, memantine, Alzheimer Disease, 22/04/2013, 22/02/2013, Generic, 12, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Lyumjev (previously Liumjev), insulin lispro, Diabetes Mellitus, 24/03/2020, Additional monitoring, 5, Authorised
25/04/2023 Other: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data
25/04/2023 Referral: Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names , Butafosfan, Cyanocobalamin, Article 33, 15/02/2023, 03/04/2023
25/04/2023 Human medicines European public assessment report (EPAR): Vumerity, Diroximel fumarate (BIIB098), Multiple Sclerosis, Relapsing-Remitting, 15/11/2021, 3, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis; Keratitis, 06/07/2018, Orphan, Accelerated assessment, 7, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 18/07/2014, 23, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Stocrin, efavirenz, HIV Infections, 28/05/1999, 49, Authorised
25/04/2023 Support for industry on clinical data publication
25/04/2023 Clinical data publication
25/04/2023 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
25/04/2023 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
25/04/2023 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
25/04/2023 Pre-authorisation guidance
25/04/2023 Extensions of marketing authorisations: questions and answers
25/04/2023 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
25/04/2023 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 22, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Evotaz, cobicistat, atazanavir, HIV Infections, 13/07/2015, 14, Authorised
25/04/2023 News and press releases: EMA business hours over King's Day and Labour Day, 27 April and 1 May
25/04/2023 Orphan designation: thymidine, deoxycytidine for the: Treatment of mitochondrial DNA depletion syndrome, myopathic form, 20/04/2017, Positive
25/04/2023 Orphan designation: Fenfluramine hydrochloride for the: Treatment of Lennox-Gastaut syndrome, 27/02/2017, Positive
25/04/2023 Orphan designation: Fenfluramine hydrochloride for the: Treatment of Dravet syndrome, 18/12/2013, Positive
25/04/2023 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative; Crohn Disease, 22/05/2014, 24, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Sarclisa, Isatuximab, Multiple Myeloma, 30/05/2020, Additional monitoring, 7, Authorised
25/04/2023 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 22, Authorised
25/04/2023 Regulatory and procedural guideline: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
24/04/2023 Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings
24/04/2023 Human medicines European public assessment report (EPAR): Nexium Control, esomeprazole, Gastroesophageal Reflux, 26/08/2013, 17, Authorised
24/04/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:30 - 11:00 Amsterdam time (CET), from 15/03/2023 to 15/03/2023
24/04/2023 Minutes: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (15 March 2023)
24/04/2023 Newsletter: Clinical Trials Highlights - April 2023
24/04/2023 Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, Patient safety, Additional monitoring, 12, Authorised
24/04/2023 Supply shortage: Menopur (menotropin) supply shortage
24/04/2023 Human medicines European public assessment report (EPAR): Artesunate Amivas, artesunate, Malaria, 22/11/2021, Orphan, Additional monitoring, 1, Authorised
24/04/2023 Legal framework: orphan designation
24/04/2023 Minutes: Minutes of the CHMP meeting 20-23 February 2023
24/04/2023 Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Arthritis, Rheumatoid, 16/12/2019, Patient safety, Additional monitoring, 14, Authorised
24/04/2023 News and press releases: European Immunization Week 2023: Statement by Executive Director Emer Cooke - Routine vaccination matters! Every dose counts to stay protected
24/04/2023 Newsletter: CTIS newsflash - 21 April 2023
24/04/2023 Minutes: Minutes of the PRAC meeting 28 November - 1 December 2022
24/04/2023 Agenda: Agenda of the PDCO meeting 24-26 April 2023
24/04/2023 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
24/04/2023 Agenda: Agenda of the CHMP meeting 24-26 April 2023
24/04/2023 Other: EMA reply in follow up to the COVI exchange of views on 27 March 2023
24/04/2023 Other: Safety Working Party recommendations on the duration of contraception following the end of treatment with a genotoxic drug
24/04/2023 Regulatory science strategy
21/04/2023 Minutes: Minutes of the COMP meeting 14-16 February 2023
21/04/2023 Human medicines European public assessment report (EPAR): Rivaroxaban Mylan, rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation, 12/11/2021, Generic, 2, Authorised
21/04/2023 Human medicines European public assessment report (EPAR): Epclusa, Sofosbuvir, velpatasvir, Hepatitis C, Chronic, 06/07/2016, Accelerated assessment, 20, Authorised
21/04/2023 Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V., lamivudine, HIV Infections, 10/12/2009, Generic, 19, Authorised
21/04/2023 Summary of opinion: Proteq West Nile, West Nile fever vaccine (live recombinant), 20/04/2023, Positive
21/04/2023 Summary of opinion: Gumbohatch, avian infectious bursal disease vaccine (live), 20/04/2023, Positive
21/04/2023 Summary of opinion: Melovem, meloxicam, 20/04/2023, Positive
21/04/2023 Maximum Residue Limits - Summary of opinion: Rafoxanide (Bovine and ovine milk) - Summary opinion of the CVMP on the establishment of maximum residue limits
21/04/2023 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
21/04/2023 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 22, Authorised
21/04/2023 Human medicines European public assessment report (EPAR): Regkirona, Regdanvimab, COVID-19 virus infection, 12/11/2021, Additional monitoring, 7, Authorised
21/04/2023 Veterinary limited markets
21/04/2023 Withdrawn application: Raltegravir Viatris, raltegravir potassium, Date of withdrawal: 22/02/2023, Initial authorisation
21/04/2023 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 44, Authorised
21/04/2023 Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
21/04/2023 News and press releases: Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
21/04/2023 Scientific guideline: Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
21/04/2023 Direct healthcare professional communication (DHPC): SIMULECT (basiliximab): Do not use WFI ampoules co-packed with vials of sterile freeze-dried powder of Simulect 10mg and 20mg, Active substance: basiliximab, DHPC type: Quality defect, Last updated: 21/04/2023
21/04/2023 Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia, 10/06/2015, 21, Authorised
21/04/2023 Human medicines European public assessment report (EPAR): Eptifibatide Accord, eptifibatide, Myocardial Infarction, 11/01/2016, Generic, 6, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Triumeq, dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections, 31/08/2014, 31, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Lunsumio, mosunetuzumab, Lymphoma, Follicular, 03/06/2022, Orphan, Additional monitoring, Conditional approval, 1, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib phosphate, Vitiligo, 19/04/2023, Authorised
20/04/2023 Other: Release notes - production release version 1.6.22 April 2023 - Veterinary Medicinal Products Regulation: Union Product Database
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir, PM: decision on the application for modification of an agreed PIP, P/0102/2022
20/04/2023 Human medicines European public assessment report (EPAR): Fintepla, Fenfluramine hydrochloride, Epilepsies, Myoclonic, 18/12/2020, Orphan, Additional monitoring, 5, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 14, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 9, Authorised
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tarlatamab, W: decision granting a waiver in all age groups for all conditions or indications, P/0090/2022
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nemtabrutinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0059/2022
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nifurtimox, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0081/2022
20/04/2023 Human medicines European public assessment report (EPAR): INOmax, Nitric oxide, Hypertension, Pulmonary; Respiratory Insufficiency, 01/08/2001, 23, Authorised
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Sunvozertinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0058/2022
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ceralasertib, W: decision granting a waiver in all age groups for all conditions or indications, P/0064/2022
20/04/2023 Human medicines European public assessment report (EPAR): Zoledronic acid Mylan, zoledronic acid, Fractures, Bone, 23/08/2012, Generic, 14, Authorised
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Avexitide (acetate), W: decision granting a waiver in all age groups for all conditions or indications, P/0057/2022
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Flebogamma DIF (previously Flebogammadif), Human normal immunoglobulin, W: decision granting a waiver in all age groups for all conditions or indications, P/0094/2022
20/04/2023 Human medicines European public assessment report (EPAR): Cholib, fenofibrate, simvastatin, Dyslipidemias, 26/08/2013, 15, Authorised
20/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin,2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977), W: decision granting a waiver in all age groups for all conditions or indications, P/0063/2022
20/04/2023 Clinical Trials Information System: training and support
20/04/2023 Other: European Union Member State Public Holidays Recorded in CTIS
20/04/2023 Template or form: Template for sections A to E for the scientific part of the application for orphan designation
20/04/2023 Regulatory and procedural guideline: Amended Biologics Working Party (BWP) Ad hoc Influenza Working Group - EU recommendations for the seasonal influenza vaccine composition for the season 2023/2024
20/04/2023 ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b - Scientific guideline
20/04/2023 Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Gout, 21/04/2008, 23, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 27, Authorised
20/04/2023 Human medicines European public assessment report (EPAR): Simulect, basiliximab, Graft Rejection; Kidney Transplantation, 09/10/1998, 27, Authorised
19/04/2023 Exemptions to labelling and package-leaflet obligations
19/04/2023 Regulatory and procedural guideline: 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
19/04/2023 Human medicines European public assessment report (EPAR): Entecavir Mylan, entecavir monohydrate, Hepatitis B, 18/09/2017, Generic, 6, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Mirikizumab, PM: decision on the application for modification of an agreed PIP, P/0088/2022
19/04/2023 Human medicines European public assessment report (EPAR): Pravafenix, fenofibrate, Pravastatin, Dyslipidemias, 14/04/2011, 7, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, Vosoritide, PM: decision on the application for modification of an agreed PIP, P/0051/2022
19/04/2023 Human medicines European public assessment report (EPAR): Pluvicto, lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant, 09/12/2022, Additional monitoring, 2, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Glutamine, PM: decision on the application for modification of an agreed PIP, P/0068/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adrenaline (epinephrine), PM: decision on the application for modification of an agreed PIP, P/0054/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Palynziq, Pegvaliase, PM: decision on the application for modification of an agreed PIP, P/0089/2022
19/04/2023 Human medicines European public assessment report (EPAR): Mirvaso, brimonidine tartrate, Skin Diseases, 20/02/2014, 13, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Hemgenix, Etranacogene dezaparvovec, PM: decision on the application for modification of an agreed PIP, P/0104/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adtralza, Tralokinumab, PM: decision on the application for modification of an agreed PIP, P/0096/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine, PM: decision on the application for modification of an agreed PIP, P/0053/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rukobia, fostemsavir (tromethamine), PM: decision on the application for modification of an agreed PIP, P/0067/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Efanesoctocog alfa, PM: decision on the application for modification of an agreed PIP, P/0095/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, Guselkumab, PM: decision on the application for modification of an agreed PIP, P/0065/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bempegaldesleukin, PM: decision on the application for modification of an agreed PIP, P/0099/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Supemtek, Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype),Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype),Recombinant Influenza Hemagglutinin-strain B (Victoria lineage),Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4), PM: decision on the application for modification of an agreed PIP, P/0100/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Delgocitinib, PM: decision on the application for modification of an agreed PIP, P/0098/2022
19/04/2023 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 28, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta, PM: decision on the application for modification of an agreed PIP, P/0093/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Isoflurane, PM: decision on the application for modification of an agreed PIP, P/0086/2022
19/04/2023 Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Asthma, 19/09/2022, Additional monitoring, 3, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ridinilazole (hydrate), PM: decision on the application for modification of an agreed PIP, P/0087/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Eptinezumab, PM: decision on the application for modification of an agreed PIP, P/0091/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,Ethinyl estradiol, PM: decision on the application for modification of an agreed PIP, P/0092/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex vivo expanded autologous human corneal epithelium cells containing stem cells, PM: decision on the application for modification of an agreed PIP, P/0066/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Modified allergen extract of birch pollen, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0075/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab, PM: decision on the application for modification of an agreed PIP, P/0074/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tapotoclax, PM: decision on the application for modification of an agreed PIP, P/0123/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lisdexamfetamine dimesilate, PM: decision on the application for modification of an agreed PIP, P/0097/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta, Ofatumumab, PM: decision on the application for modification of an agreed PIP, P/0121/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Phospholipid esters from herring roe (HRO350), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0072/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, Palbociclib, PM: decision on the application for modification of an agreed PIP, P/0117/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant, PM: decision on the application for modification of an agreed PIP, P/0116/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): L-carnitine,glucose,calcium chloride dihydrate,magnesium chloride hexahydrate,sodium lactate,sodium chloride, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0060/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Leriglitazone, PM: decision on the application for modification of an agreed PIP, P/0115/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate, PM: decision on the application for modification of an agreed PIP, P/0073/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, Axicabtagene ciloleucel, PM: decision on the application for modification of an agreed PIP, P/0114/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cosibelimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0061/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Edurant, Rilpivirine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0101/2022
19/04/2023 Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party , EMA and online, 10:00 - 17:00 Amsterdam time (CEST), from 18/04/2023 to 18/04/2023
19/04/2023 Presentation: Presentation - Human Variations eAF training session
19/04/2023 Agenda: Agenda of the CAT meeting 19-21 April 2023
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab, PM: decision on the application for modification of an agreed PIP, P/0142/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0131/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zamtocabtagene autoleucel, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0069/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ralmitaront, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0056/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zinplava, Bezlotoxumab, PM: decision on the application for modification of an agreed PIP, P/0135/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, Eluxadoline, PM: decision on the application for modification of an agreed PIP, P/0128/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Parsabiv, Etelcalcetide, PM: decision on the application for modification of an agreed PIP, P/0133/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine (SCB- 2019), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0070/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001), PM: decision on the application for modification of an agreed PIP, P/0132/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): MIJ821, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0082/2022
19/04/2023 Veterinary Medicines
19/04/2023 Other: Organisation chart: Veterinary Medicines
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin, PM: decision on the application for modification of an agreed PIP, P/0134/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human IgG4 monoclonal antibody against BCMA and CD3 (ABBV-383), W: decision granting a waiver in all age groups for all conditions or indications, P/0108/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Spravato, Esketamine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0136/2022
19/04/2023 Availability of medicines during COVID-19 pandemic
19/04/2023 Periodic safety update single assessment: Fluvastatin : List of nationally authorised medicinal products - PSUSA/00001457/202208
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab, PM: decision on the application for modification of an agreed PIP, P/0129/2022
19/04/2023 Human medicines European public assessment report (EPAR): Ceplene, Histamine dihydrochloride, Leukemia, Myeloid, Acute, 07/10/2008, Additional monitoring, Exceptional circumstances, 12, Authorised
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Indapamide,Telmisartan, W: decision granting a waiver in all age groups for all conditions or indications, P/0111/2022
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0126/2022
19/04/2023 Report: Report on divergent opinion between EFSA and EMA on bisphenol-A
19/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, Ponatinib, PM: decision on the application for modification of an agreed PIP, P/0122/2022
18/04/2023 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 11, Authorised
18/04/2023 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, Accelerated assessment, 34, Authorised
18/04/2023 Other: Member States involved in the European Medicines Agency-European Union Member states-Food and Drug Administration initiative on inspections for generic applications
18/04/2023 Minutes: PDCO minutes of the 21-24 February 2023 meeting
18/04/2023 Fourth EMA and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting , Online, from 18/04/2023 to 18/04/2023
18/04/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:00 - 12:00 Amsterdam time (CEST), from 20/04/2023 to 20/04/2023
18/04/2023 Agenda: Agenda of the CVMP meeting 18-20 April 2023
18/04/2023 Minutes: Minutes of the CAT meeting 15-16 February 2023
18/04/2023 Minutes: Minutes of the CAT meeting 18-19 January 2023
18/04/2023 Human medicines European public assessment report (EPAR): Emtriva, emtricitabine, HIV Infections, 24/10/2003, 33, Authorised
18/04/2023 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis, 26/07/2018, Biosimilar, 12, Authorised
18/04/2023 Human medicines European public assessment report (EPAR): Byfavo, remimazolam besilate, Conscious Sedation, 26/03/2021, Additional monitoring, 5, Authorised
18/04/2023 Periodic safety update single assessment: Fluoxetine - List of nationally authorised medicinal products - PSUSA/00001442/202209
17/04/2023 Periodic safety update single assessment: Paricalcitol - List of nationally authorised medicinal products - PSUSA/00002316/202208
17/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Mayzent, Siponimod (hemifumarate), PM: decision on the application for modification of an agreed PIP, P/0119/2022
17/04/2023 Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid,Ticagrelor, W: decision granting a waiver in all age groups for all conditions or indications, P/0113/2022