|
22/12/2022 |
Quarterly system demo - Q4 2022
, Online, 09:00 - 12:00 Amsterdam time (CET), from 21/12/2022 to 21/12/2022 |
|
22/12/2022 |
Other: Questions and answers - Quarterly system demo - Q4 2022
|
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, 25/07/2008, 21, Authorised |
|
22/12/2022 |
Newsletter: CTIS newsflash - 12 December 2022
|
|
22/12/2022 |
Newsletter: CTIS newsflash - 5 December 2022
|
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Posaconazole AHCL, posaconazole, Mycoses, 25/07/2019,  , 5, Authorised |
|
22/12/2022 |
Other: European Medicines Agency's data protection notice concerning the Veterinary Info Day meeting on 16-17 February 2023
|
|
22/12/2022 |
Orphan designation: Pegylated adrenomedullin
for the: Treatment of acute respiratory distress syndrome (ARDS), 27/07/2020, Positive |
|
22/12/2022 |
Orphan designation: Human allogeneic bone-marrow-derived osteoblastic-like cells
for the: Treatment of non-traumatic osteonecrosis, 05/08/2013, Positive |
|
22/12/2022 |
Orphan designation: Human allogeneic bone-marrow-derived osteoblastic cells
for the: Treatment of osteogenesis imperfecta, 10/08/2015, Positive |
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Cystic Fibrosis; Respiratory Tract Infections, 25/03/2015,  , 15, Authorised |
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Mycapssa, Octreotide acetate, Acromegaly, 02/12/2022,  , Authorised |
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 17, Authorised |
|
22/12/2022 |
Opinion on medicine for use outside EU: Fexinidazole Winthrop, fexinidazole, Trypanosomiasis, African, 15/11/2018, Positive opinion |
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia; Iron Overload, 28/08/2006, , 51, Authorised |
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Esperoct, Turoctocog alfa pegol, Hemophilia A, 20/06/2019, , 4, Authorised |
|
22/12/2022 |
Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 9, Authorised |
|
22/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Rivogenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0378/2019 |
|
22/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0388/2021 |
|
22/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Pradigastat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0120/2014 |
|
22/12/2022 |
Agenda: Agenda - Human variations electronic application form (eAF) Q&A clinics – session 6
|
|
22/12/2022 |
Human variations electronic application form (eAF) Q&A clinics – session 7
, Online, 11:30 - 12:00 Amsterdam time (CET), from 24/01/2023 to 24/01/2023 |
|
21/12/2022 |
Ninth Nitrosamine Implementation Oversight Group (NIOG) meeting
, Online, from 21/11/2022 to 21/11/2022 |
|
21/12/2022 |
Human medicines European public assessment report (EPAR): Zaltrap, aflibercept, Colorectal Neoplasms, 01/02/2013, 13, Authorised |
|
21/12/2022 |
Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty; Venous Thromboembolism, 18/05/2011, 31, Authorised |
|
21/12/2022 |
Human medicines European public assessment report (EPAR): Exforge HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 15/10/2009, 23, Authorised |
|
21/12/2022 |
Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 November 2022, edition 8)
|
|
21/12/2022 |
Human medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases, 18/08/2021, , ,  , 5, Authorised |
|
21/12/2022 |
Minutes: Minutes of the CAT meeting 3-4 November 2022
|
|
21/12/2022 |
News and press releases: End-of-year message from EMA’s Executive Director |
|
21/12/2022 |
Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 December 2022
|
|
21/12/2022 |
Newsletter: Clinical Trials Highlights - December 2022
|
|
20/12/2022 |
Newsletter: Medicinal products for human use: monthly figures - November 2022
|
|
20/12/2022 |
Human medicines European public assessment report (EPAR): Dafiro HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 03/11/2009, 25, Authorised |
|
20/12/2022 |
Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 23, Authorised |
|
20/12/2022 |
Periodic safety update single assessment: Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202204
|
|
20/12/2022 |
Periodic safety update single assessment: Oxycodone : List of nationally authorised medicinal products - PSUSA/00002254/202204
|
|
20/12/2022 |
Orphan designation: regorafenib
for the: Treatment of glioma, 28/06/2019, Withdrawn |
|
20/12/2022 |
Orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express human alpha-L-iduronidase
for the: Treatment of mucopolysaccharidosis type I, 15/10/2021, Withdrawn |
|
20/12/2022 |
Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia; Bipolar Disorder, 03/12/2009, , 14, Authorised |
|
20/12/2022 |
Human medicines European public assessment report (EPAR): Olanzapine Glenmark, olanzapine, Schizophrenia; Bipolar Disorder, 03/12/2009, , 15, Authorised |
|
20/12/2022 |
Human medicines European public assessment report (EPAR): Fasturtec, rasburicase, Hyperuricemia, 23/02/2001, 29, Authorised |
|
20/12/2022 |
First European Medicines Agency - Vaccines Europe meeting
, European Medicines Agency, Amsterdam, The Netherlands, from 28/11/2022 to 28/11/2022 |
|
20/12/2022 |
News and press releases: EMA business hours over holiday period |
|
19/12/2022 |
Orphan designation: bevacizumab
for the: Treatment of hereditary haemorrhagic telangiectasia, 16/12/2014, Positive |
|
19/12/2022 |
Other: Release notes - production release version 1.6.13 December 2022 - Veterinary Medicinal Products Regulation: Union Product Database
|
|
19/12/2022 |
Human medicines European public assessment report (EPAR): Bemfola, follitropin alfa, Anovulation, 26/03/2014,  , 10, Authorised |
|
19/12/2022 |
Accelerating Clinical Trials in the EU (ACT EU) |
|
19/12/2022 |
News and press releases: Facilitating Decentralised Clinical Trials in the EU |
|
19/12/2022 |
Other: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation
|
|
19/12/2022 |
Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Endometrial Neoplasms, 21/04/2021, , , 6, Authorised |
|
19/12/2022 |
Human medicines European public assessment report (EPAR): Simbrinza, brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle, 18/07/2014, 10, Authorised |
|
19/12/2022 |
Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, , 7, Authorised |
|
19/12/2022 |
Human medicines European public assessment report (EPAR): Axumin, Fluciclovine (18F), Prostatic Neoplasms; Radionuclide Imaging, 21/05/2017, 16, Authorised |
|
19/12/2022 |
Human medicines European public assessment report (EPAR): Shingrix, Recombinant varicella zoster virus glycoprotein E, Herpes Zoster, 21/03/2018, 9, Authorised |
|
19/12/2022 |
Patients' and Consumers' Working Party |
|
19/12/2022 |
Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline |
|
19/12/2022 |
Scientific guideline: Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products
|
|
16/12/2022 |
Other: Letter of Support of model-based clinical trial simulation platform (CTSP) for Duchenne Muscular Dystrophy
|
|
16/12/2022 |
News and press releases: EMA Management Board: highlights of December 2022 meeting |
|
16/12/2022 |
Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline |
|
16/12/2022 |
Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid, 08/09/2003, 89, Authorised |
|
16/12/2022 |
Referral: Synchron
, Article 31 referrals, European Commission final decision, 19/05/2022, 28/11/2022, 16/12/2022 |
|
16/12/2022 |
Work programme: Work plan for the CVMP Novel Therapies & Technologies Working Party (NTWP) 2023
|
|
16/12/2022 |
Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Environmental Risk Assessment Working Party (ERAWP) 2023
|
|
16/12/2022 |
Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Efficacy Working Party (EWP-V) 2023
|
|
16/12/2022 |
Environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs |
|
16/12/2022 |
Scientific guideline: Reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs
|
|
16/12/2022 |
News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022 |
|
16/12/2022 |
Summary of opinion: Fintepla, fenfluramine, 15/12/2022, Positive |
|
16/12/2022 |
Summary of opinion: Kerendia, finerenone, 15/12/2022, Positive |
|
16/12/2022 |
Summary of opinion: Omblastys, iodine (131I) omburtamab, 15/12/2022, Negative |
|
16/12/2022 |
News and press releases: First gene therapy to treat haemophilia B |
|
16/12/2022 |
Summary of opinion: Adcirca (previously Tadalafil Lilly), tadalafil, 16/12/2022, Positive |
|
16/12/2022 |
Summary of opinion: Dimethyl fumarate Accord, dimethyl fumarate, 15/12/2022, Positive |
|
16/12/2022 |
Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel)
for the: Treatment of diffuse large B-cell lymphoma, 16/12/2014, Positive |
|
16/12/2022 |
Human medicines European public assessment report (EPAR): Emadine, emedastine difumarate, Conjunctivitis, Allergic, 27/01/1999, 26, Authorised |
|
16/12/2022 |
Human medicines European public assessment report (EPAR): Ammonaps, Sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease; Citrullinemia; Carbamoyl-Phosphate Synthase I Deficiency Disease, 07/12/1999, 21, Authorised |
|
16/12/2022 |
Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Scientific Advice Working Party (SAWP-V) for 2023
|
|
16/12/2022 |
Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Antimicrobials Working Party (AWP) 2023
|
|
16/12/2022 |
Human medicines European public assessment report (EPAR): Refixia, Nonacog beta pegol, Hemophilia B, 02/06/2017, , 3, Authorised |
|
16/12/2022 |
Work programme: CVMP work plan 2023
|
|
16/12/2022 |
Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product-specific bioequivalence guidance |
|
16/12/2022 |
Scientific guideline: Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance
|
|
16/12/2022 |
Scientific guideline: Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance
|
|
16/12/2022 |
Agenda: Agenda - Quarterly system demo - Q4 2022
|
|
16/12/2022 |
Work programme: Work plan for the Committee for Medicinal Products for Veterinary Use (CVMP) Pharmacovigilance Working Party (PhVWP-V) 2023
|
|
16/12/2022 |
Q&A: Good clinical practice (GCP) |
|
16/12/2022 |
Clinical pharmacology and pharmacokinetics: questions and answers |
|
16/12/2022 |
Other: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022
|
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 25, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2, 23/03/2018, 9, Authorised |
|
15/12/2022 |
Other: Science advice on medicines for Human use in the EU medicines regulatory network
|
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial, 19/01/2006, 37, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin (as acetate), Candidiasis; Aspergillosis, 23/10/2001, 30, Authorised |
|
15/12/2022 |
Third Industry Standing Group (ISG) meeting
, Online, from 22/11/2022 to 22/11/2022 |
|
15/12/2022 |
Minutes: Meeting summary - Third Industry Standing Group (ISG) meeting
|
|
15/12/2022 |
EPAR - Scientific conclusion: Alymsys-H-C-PSUSA-00000403-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
|
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 29, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Mucopolysaccharidosis II, 08/01/2007, ,  , 25, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Advate, octocog alfa, Hemophilia A, 02/03/2004, 31, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL), nyxthracis, Anthrax, 18/11/2020, , , , 3, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 45, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Abevmy, bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, 21/04/2021, , , 5, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Aerius, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 49, Authorised |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 51, Authorised |
|
15/12/2022 |
Orphan designation: pentosan polysulfate sodium
for the: Treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), 21/08/2020, Positive |
|
15/12/2022 |
Orphan designation: pentosan polysulfate sodium
for the: Treatment of mucopolysaccharidosis type I, 19/11/2014, Positive |
|
15/12/2022 |
Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, 13, Authorised |
|
15/12/2022 |
Opinion on medicine for use outside EU: Aluvia, lopinavir, ritonavir, HIV Infections, 21/09/2006, Positive opinion |
|
15/12/2022 |
Herbal medicinal product: Rosmarini folium, Rosmarini folium, F: Assessment finalised
|
|
15/12/2022 |
Agenda: Agenda for the 118th meeting of the Management Board: 14-15 December 2022
|
|
15/12/2022 |
Other: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual
|
|
15/12/2022 |
Human medicines European public assessment report (EPAR): IntronA, interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma, 09/03/2000, 34, Withdrawn |
|
15/12/2022 |
Herbal – European Union list entry: Draft European Union list entry on Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus - Revision 1
|
|
15/12/2022 |
Herbal – European Union list entry: Draft European Union list entry on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus - Revision 1
|
|
15/12/2022 |
Herbal medicinal product: Foeniculi amari fructus, Foeniculi amari fructus, F: Assessment finalised
|
|
15/12/2022 |
Herbal medicinal product: Foeniculi dulcis fructus, Foeniculi dulcis fructus, F: Assessment finalised
|
|
14/12/2022 |
Referral: Nomegestrol and chlormadinone
, nomegestrol, chlormadinone, Article 31 referrals, European Commission final decision, 01/09/2022, 28/11/2022, 14/12/2022 |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer, 18/12/2007, , 30, Authorised |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, , , 14, Authorised |
|
14/12/2022 |
Orphan designation: Concizumab
for the: Treatment of haemophilia B, 12/10/2017, Withdrawn |
|
14/12/2022 |
Orphan designation: Humanised monoclonal IgG4 antibody against tissue-factor-pathway inhibitor (concizumab)
for the: Treatment of haemophilia A, 10/10/2012, Withdrawn |
|
14/12/2022 |
Newsletter: Big Data highlights - Issue 4
|
|
14/12/2022 |
Orphan designation: Alisporivir
for the: Treatment of collagen VI-related myopathies, 16/03/2022, Positive |
|
14/12/2022 |
Agenda: Agenda - Human Variations eAF Form training session
|
|
14/12/2022 |
Template or form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance
|
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Sunosi, solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive, 16/01/2020, , 7, Authorised |
|
14/12/2022 |
Agenda: Agenda - Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
|
|
14/12/2022 |
Orphan designation: besilesomab
for the: Treatment in haematopoietic stem cell transplantation, 17/10/2019, Positive |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Adtralza, Tralokinumab, Dermatitis, Atopic, 17/06/2021, , 2, Authorised |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, , , 11, Authorised |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial, 19/02/2015, 15, Authorised |
|
14/12/2022 |
Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride)
for the: Treatment of Alagille syndrome, 18/12/2013, Positive |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome, 30/06/2013, , 20, Authorised |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Repaglinide Krka, repaglinide, Diabetes Mellitus, Type 2, 03/11/2009, , 8, Authorised |
|
14/12/2022 |
Human medicines European public assessment report (EPAR): Enyglid, repaglinide, Diabetes Mellitus, Type 2, 13/10/2009, , 9, Authorised |
|
14/12/2022 |
Referral: Veterinary medicinal products containing toltrazuril to be administered orally to chickens
, toltrazuril, Article 35, European Commission final decision, 14/07/2022, 09/11/2022 |
|
13/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, PM: decision on the application for modification of an agreed PIP, P/0418/2019 |
|
13/12/2022 |
Other: European Medicines Agency’s privacy statement for the operation of the Security Access Control System
|
|
13/12/2022 |
Other: Record of data processing activity relating to Security Access Control System (public)
|
|
13/12/2022 |
Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, 15, Authorised |
|
13/12/2022 |
Clinical Trials Information System (CTIS): Walk-in clinic - January 2023
, Online, 16:00 - 17:00 Amsterdam time (CET), from 18/01/2023 to 18/01/2023 |
|
13/12/2022 |
Clinical Trials Information System (CTIS): Walk-in clinic - February 2023
, Online, 15:00 - 16:00 Amsterdam time (CET), from 16/02/2023 to 16/02/2023 |
|
13/12/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 10/07/2023 to 14/07/2023 |
|
13/12/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 19/06/2023 to 23/06/2023 |
|
13/12/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 22/05/2023 to 26/05/2023 |
|
13/12/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 17/04/2023 to 21/04/2023 |
|
13/12/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 13/03/2023 to 17/03/2023 |
|
13/12/2022 |
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
, Online, from 30/01/2023 to 03/02/2023 |
|
13/12/2022 |
Work programme: Central Nervous System Working Party (CNSWP) work plan 2022-2024
|
|
13/12/2022 |
Agenda: Programme - Clinical Trials Information System (CTIS) sponsor end user training programme (Feb, May, June 2023)
|
|
13/12/2022 |
EPAR - Public assessment report: Zokinvy : EPAR - Public assessment report
|
|
13/12/2022 |
Clinical Trials Information System (CTIS) sponsor end user training programme - February 2023
, Online, 09:00 - 13:00 Amsterdam time (CET), from 07/02/2023 to 10/02/2023 |
|
13/12/2022 |
Clinical Trials Information System (CTIS) sponsor end user training programme - May 2023
, Online, 14:00 - 18:00 Amsterdam time (CEST), from 02/05/2023 to 05/05/2023 |
|
13/12/2022 |
Clinical Trials Information System (CTIS) sponsor end user training programme - June 2023
, Online, 14:00 - 18:00 Amsterdam time (CEST), from 27/06/2023 to 30/06/2023 |
|
13/12/2022 |
Withdrawn application: Hervelous, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation |
|
13/12/2022 |
Withdrawn application: Tuznue, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation |
|
13/12/2022 |
Second European Medicines Agency and Affordable Medicines Europe bilateral meeting
, Online, 10:00 - 11:00 Amsterdam time (CET), from 16/11/2022 to 16/11/2022 |
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13/12/2022 |
Other: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training: frequently asked questions
|
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13/12/2022 |
Presentation: Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Session 1.0: Introduction
|
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13/12/2022 |
Human medicines European public assessment report (EPAR): Cyramza, Ramucirumab, Stomach Neoplasms, 19/12/2014, 15, Authorised |
|
13/12/2022 |
Human medicines European public assessment report (EPAR): Ruxience, rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus, 01/04/2020, , , 10, Authorised |
|
13/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,Dermatophagoides farinae, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0101/2019 |
|
13/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0084/2019 |
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13/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): birch pollen,alder pollen, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0086/2019 |
|
13/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Testosterone, PM: decision on the application for modification of an agreed PIP, P/0508/2020 |
|
13/12/2022 |
Other: Mandate, objectives and rules of procedure for the CHMP Biologics Working Party (BWP)
|
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13/12/2022 |
Regulatory and procedural guideline: IRIS guide for parallel distribution applicants
|
|
13/12/2022 |
Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 25, Authorised |
|
13/12/2022 |
Human medicines European public assessment report (EPAR): Scintimun, besilesomab, Osteomyelitis; Radionuclide Imaging, 11/01/2010, 6, Authorised |
|
13/12/2022 |
Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 4, Authorised |
|
13/12/2022 |
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February 2023
, Online, 09:00 - 13:00 Amsterdam time (CET), from 13/02/2023 to 15/02/2023 |
|
13/12/2022 |
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - July 2023
, Online, 09:00 - 13:00 Amsterdam time (CET), from 03/07/2023 to 05/07/2023 |
|
13/12/2022 |
Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan anhydrous free-base, Pancreatic Neoplasms, 14/10/2016, , 11, Authorised |
|
13/12/2022 |
Work programme: Haematology Working Party (HWP) work plan 2022-2024
|
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13/12/2022 |
Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, ,  , , 10, Authorised |
|
13/12/2022 |
Newsletter: Human medicines highlights - December 2022
|
|
13/12/2022 |
Orphan designation: Parsaclisib
for the: Treatment of marginal zone lymphoma, 25/07/2019, Withdrawn |
|
12/12/2022 |
Human medicines European public assessment report (EPAR): Teriparatide Sun, teriparatide, Osteoporosis; Osteoporosis, Postmenopausal, 18/11/2022, Authorised |
|
12/12/2022 |
ICH M12 on drug interaction studies - Scientific guideline |
|
12/12/2022 |
Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors, 17/09/2017, , 15, Authorised |
|
12/12/2022 |
Regulatory and procedural guideline: Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA
|
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12/12/2022 |
Antimicrobial resistance |
|
12/12/2022 |
Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Psoriasis; Arthritis, Rheumatoid, 02/02/2000, 70, Authorised |
|
12/12/2022 |
Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing, 18/05/2018, , 10, Authorised |
|
12/12/2022 |
Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 17, Authorised |
|
12/12/2022 |
Periodic safety update single assessment: Estradiol / norethisterone - List of nationally authorised medicinal products - PSUSA/00001278/202203
|
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12/12/2022 |
Human medicines European public assessment report (EPAR): Dimethyl fumarate Mylan, dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting, 13/05/2022, , 3, Authorised |
|
12/12/2022 |
Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - February 2023
, Online, 09:00 - 13:00 Amsterdam time (CET) , from 16/02/2023 to 17/02/2023 |
|
12/12/2022 |
Agenda: Agenda of the CHMP meeting 12-15 December 2022
|
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09/12/2022 |
Mpox (monkeypox) |
|
09/12/2022 |
Periodic safety update single assessment: Carvedilol / ivabradine : List of nationally authorised medicinal products - PSUSA/00010883/202204
|
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09/12/2022 |
Periodic safety update single assessment: Amlodipine / candesartan : List of nationally authorised medicinal products - PSUSA/00010191/202204
|
|
09/12/2022 |
Periodic safety update single assessment: Sulprostone : List of nationally authorised medicinal products - PSUSA/00002828/202204
|
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09/12/2022 |
Agenda: Agenda of the PRAC meeting 28 November - 1 December 2022
|
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09/12/2022 |
Summary of opinion: Simparica Trio, sarolaner, moxidectin, pyrantel embonate, 08/12/2022, Positive |
|
09/12/2022 |
Summary of opinion: Nexgard Spectra, afoxolaner, milbemycin oxime, 08/12/2022, Positive |
|
09/12/2022 |
Summary of opinion: NexGard, afoxolaner, 08/12/2022, Positive |
|
09/12/2022 |
Other: Joint audit programme for EEA GMP inspectorates JAP: Audit notification template
|
|
09/12/2022 |
Summary of opinion: Brucellin Aquilon, 08/12/2022, Positive |
|
09/12/2022 |
Summary of opinion: Credelio Plus, lotilaner / milbemycin oxime, 08/12/2022, Positive |
|
09/12/2022 |
News and press releases: ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2 |
|
09/12/2022 |
Periodic safety update single assessment: Amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil : List of nationally authorised medicinal products - PSUSA/00002210/202204
|
|
09/12/2022 |
Orphan designation: Tremelimumab
for the: Treatment of hepatocellular carcinoma, 09/12/2020, Withdrawn |
|
09/12/2022 |
Periodic safety update single assessment: Ethinylestradiol / levonorgestrel : List of nationally authorised medicinal products - PSUSA/00001309/202204
|
|
09/12/2022 |
Periodic safety update single assessment: Amlodipine / olmesartan : List of nationally authorised medicinal products - PSUSA/00002208/202204
|
|
09/12/2022 |
Human medicines European public assessment report (EPAR): Moventig, naloxegol oxalate, Constipation; Opioid-Related Disorders, 07/12/2014, 15, Authorised |
|
09/12/2022 |
Other: Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation
|
|
09/12/2022 |
Periodic safety update single assessment: Certoparin : List of nationally authorised medicinal products - PSUSA/00000625/202204
|
|
08/12/2022 |
Other: Letter of support for TREAT-NMD Core Dataset for Spinal Muscular Atrophy (SMA)
|
|
08/12/2022 |
Periodic safety update single assessment: Carvedilol - List of nationally authorised medicinal products - PSUSA/00000575/202204
|
|
08/12/2022 |
Periodic safety update single assessment: Candesartan, candesartan / hydrochlorothiazide - List of nationally authorised medicinal products - PSUSA/00000527/202204
|
|
08/12/2022 |
Other: Possible use of the medicinal product TPOXX for the treatment of monkeypox
|
|
08/12/2022 |
Work programme: Oncology Working Party (ONCWP) work plan 2022-2024
|
|
08/12/2022 |
EPAR - Assessment report - Variation: Comirnaty-H-C-005735-II-0129 : EPAR - Assessment report - Variation
|
|
08/12/2022 |
Periodic safety update single assessment: Epoprostenol : List of nationally authorised medicinal products - PSUSA/00001242/202203
|
|
08/12/2022 |
Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 21-23 November 2022
|
|
08/12/2022 |
Agenda: Agenda - Human variations electronic application forms Q&A clinics – session 5
|
|
08/12/2022 |
Orphan designation: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt
for the: Treatment of idiopathic pulmonary fibrosis, 14/07/2016, Positive |
|
08/12/2022 |
News and press releases: ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies |
|
08/12/2022 |
Human medicines European public assessment report (EPAR): Lutetium (177Lu) chloride Billev (previously Illuzyce), lutetium (177Lu) chloride, Radionuclide Imaging, 15/09/2022, 1, Authorised |
|
08/12/2022 |
COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 8 December 2022
|
|
08/12/2022 |
Other: Timetable: Companion diagnostic follow-up consultation - ATMP
|
|
08/12/2022 |
Other: Timetable: Companion diagnostic follow-up consultation
|
|
08/12/2022 |
Human medicines European public assessment report (EPAR): Velphoro, Sucroferric oxyhydroxide, Hyperphosphatemia; Renal Dialysis, 26/08/2014, 9, Authorised |
|
08/12/2022 |
Other: Decision of the Executive Director on rules governing the secondment of national experts to the EMA
|
|
07/12/2022 |
Other: Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedure
|
|
07/12/2022 |
Human medicines European public assessment report (EPAR): Aerinaze, desloratadine, pseudophedrine sulfate, Rhinitis, Allergic, Seasonal, 30/07/2007, 22, Authorised |
|
07/12/2022 |
Human medicines European public assessment report (EPAR): Sycrest, asenapine (as maleate) , Bipolar Disorder, 01/09/2010, 21, Authorised |
|
07/12/2022 |
Human medicines European public assessment report (EPAR): Tookad, padeliporfin di-potassium, Prostatic Neoplasms, 10/11/2017, , 6, Authorised |
|
07/12/2022 |
PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting
|
|
07/12/2022 |
Regulatory and procedural guideline: EudraVigilance registration manual
|
|
07/12/2022 |
Other: List of NCA’s participating in the Simultaneous National Scientific Advice (SNSA) pilot phase 2
|
|
07/12/2022 |
Orphan designation: mitapivat sulfate
for the: Treatment of pyruvate kinase deficiency, 22/04/2020, Positive |
|
06/12/2022 |
Human medicines European public assessment report (EPAR): Jorveza, Budesonide, Esophageal Diseases, 08/01/2018, , , 6, Authorised |
|
06/12/2022 |
News and press releases: ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination |
|
06/12/2022 |
Agenda: Agenda - Human variations electronic application forms Q&A clinics – session 4
|
|
06/12/2022 |
Human medicines European public assessment report (EPAR): Plenadren, hydrocortisone, Adrenal Insufficiency, 03/11/2011, 13, Authorised |
|
06/12/2022 |
Human variations eAF Form (DADI) training session
, Online, 10:00 - 11:30 Amsterdam time (CET), from 08/11/2022 to 08/11/2022 |
|
06/12/2022 |
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system
, Online, from 01/03/2023 to 03/03/2023 |
|
06/12/2022 |
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system
, Online, from 05/06/2023 to 07/06/2023 |
|
06/12/2022 |
Human Variations eAF (DADI) go-live Q&A session
, Online, 14:00 - 15:00 Amsterdam time (CEST), from 27/10/2022 to 27/10/2022 |
|
06/12/2022 |
Human medicines European public assessment report (EPAR): Zytiga, abiraterone acetate, Prostatic Neoplasms, 05/09/2011, , 26, Authorised |
|
06/12/2022 |
Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell, 19/07/2006, , 32, Authorised |
|
06/12/2022 |
ACT EU multi-stakeholder meeting on decentralised clinical trials
, Online, 09:30 - 13:30 Amsterdam time (CEST); European Medicines Agency, Amsterdam, the Netherlands, from 04/10/2022 to 04/10/2022 |
|
06/12/2022 |
Agenda: Agenda of the CVMP meeting 6-8 December 2022
|
|
06/12/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): ritonavir,atazanavir sulfate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0396/2019 |
|
06/12/2022 |
Periodic safety update single assessment: Sertraline : List of nationally authorised medicinal products - PSUSA/00002696/202203
|
|
06/12/2022 |
Periodic safety update single assessment: Nefopam : List of nationally authorised medicinal products - PSUSA/00002131/202203
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