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30/11/2022 Human medicines European public assessment report (EPAR): Mysildecard, sildenafil citrate, Hypertension, Pulmonary, 15/09/2016, Generic, 7, Authorised
30/11/2022 Other: How to access an EMA Microsoft Team as guest user
30/11/2022 Human medicines European public assessment report (EPAR): Kevzara, sarilumab, Arthritis, Rheumatoid, 23/06/2017, Additional monitoring, 9, Authorised
30/11/2022 Human medicines European public assessment report (EPAR): VidPrevtyn Beta, SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection, 10/11/2022, Additional monitoring, Authorised
30/11/2022 Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene (betibeglogene autotemcel) for the: Treatment of beta thalassaemia intermedia and major, 24/01/2013, Withdrawn
30/11/2022 Human medicines European public assessment report (EPAR): Zynteglo, Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia, 29/05/2019, Patient safety, Accelerated assessment, Additional monitoring, Conditional approval, 5, Withdrawn
30/11/2022 Other: Interested parties to the HMPC
30/11/2022 Periodic safety update single assessment: Levothyroxine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001860/202201
30/11/2022 Human medicines European public assessment report (EPAR): Tyverb, lapatinib, Breast Neoplasms, 10/06/2008, 34, Authorised
30/11/2022 17th industry stakeholder platform - operation of European Union (EU) pharmacovigilance , Online, 09:00 - 12:30 Amsterdam time (CET), from 07/11/2022 to 07/11/2022
30/11/2022 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 26, Authorised
30/11/2022 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 11, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Zeposia, ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting; Colitis, Ulcerative, 20/05/2020, Additional monitoring, 4, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Vyepti, eptinezumab, Migraine Disorders, 24/01/2022, 2, Authorised
29/11/2022 Other: Elbasvir - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
29/11/2022 Other: Letter of support for Neurofilament light in childhood neurological diseases
29/11/2022 Other: Letter of support for a Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studies in Parkinson’s Disease
29/11/2022 Periodic safety update single assessment: Levothyroxine : List of nationally authorised medicinal products - PSUSA/00001860/202201
29/11/2022 Pharmacovigilance inspections for veterinary medicines
29/11/2022 Pharmacovigilance inspection procedures: human
29/11/2022 Human medicines European public assessment report (EPAR): Rozlytrek, Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung, 31/07/2020, Additional monitoring, Conditional approval, 5, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Lumykras, sotorasib, Carcinoma, Non-Small-Cell Lung, 06/01/2022, Additional monitoring, Conditional approval, 1, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 60, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Cevenfacta, Eptacog beta (activated), Hemophilia A; Hemophilia B, 15/07/2022, Additional monitoring, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Ximluci, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications, 09/11/2022, Additional monitoring, Biosimilar, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Recarbrio, imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections, 13/02/2020, Additional monitoring, 5, Authorised
29/11/2022 Orphan designation: Linerixibat for the: Treatment of primary biliary cholangitis, 12/11/2021, Positive
29/11/2022 Organisation Management System (OMS) Trouble Shooting Session for CTIS users - October 2022 , Online, 14:00 - 15:00 Amsterdam time (CEST), from 19/10/2022 to 19/10/2022
29/11/2022 Other: Expected publication dates of PRAC recommendations on safety signals
29/11/2022 Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesilate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, Accelerated assessment, 17, Authorised
29/11/2022 Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections, 13/12/2021, Additional monitoring, 3, Authorised
28/11/2022 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 30, Authorised
28/11/2022 European Medicines Agency - Parenteral Drug Association (PDA) bilateral meeting , European Medicines Agency, Amsterdam, the Netherlands, from 05/10/2022 to 05/10/2022
28/11/2022 Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities , European Medicines Agency, Amsterdam, The Netherlands, from 17/10/2022 to 20/10/2022
28/11/2022 Other: Records of data processing activity (public) regarding the processing of personal data in the Clinical Trials Information System (CTIS)
28/11/2022 Second bi-annual Big Data Steering Group and industry stakeholders meeting , Online, 13:00 - 15:00 Amsterdam time (CET), from 03/11/2022 to 03/11/2022
28/11/2022 Regulatory and procedural guideline: ICH guideline Q3C (R8) on impurities: guideline for residual solvents - Step 5
28/11/2022 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, 27, Authorised
28/11/2022 EMA and EATRIS webinar on support for academic and non-profit ATMP developers , Online, from 01/12/2022 to 01/12/2022
25/11/2022 Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, 25/11/2009, 18, Authorised
25/11/2022 Human medicines European public assessment report (EPAR): Tasmar, tolcapone, Parkinson Disease, 27/08/1997, 24, Authorised
25/11/2022 Human medicines European public assessment report (EPAR): Melatonin Neurim, melatonin, Sleep Initiation and Maintenance Disorders, 07/11/2022, Authorised
25/11/2022 Periodic safety update single assessment: Dorzolamide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003168/202202
25/11/2022 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 24, Authorised
25/11/2022 Human medicines European public assessment report (EPAR): Sorafenib Accord , Sorafenib tosilate, Carcinoma, Hepatocellular; Carcinoma, Renal Cell, 09/11/2022, Generic, Authorised
24/11/2022 Human medicines European public assessment report (EPAR): Rebetol, Ribavirin, Hepatitis C, Chronic, 06/05/1999, 39, Authorised
24/11/2022 Human medicines European public assessment report (EPAR): Temybric Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 12/06/2019, Additional monitoring, 4, Withdrawn
24/11/2022 Training and resources for patients and consumers
24/11/2022 Orphan designation: Maribavir for the: Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity, 07/06/2013, Positive
24/11/2022 Orphan designation: Maribavir for the: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity, 18/12/2007, Positive
24/11/2022 Withdrawn application: Exkivity, mobocertinib, Date of withdrawal: 20/07/2022, Initial authorisation
24/11/2022 Periodic safety update single assessment: Mesterolone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010551/202201
24/11/2022 Periodic safety update single assessment: Mesterolone : List of nationally authorised medicinal products - PSUSA/00010551/202201
24/11/2022 Periodic safety update single assessment: Gabapentin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001499/202202
24/11/2022 Periodic safety update single assessment: Gabapentin : List of nationally authorised medicinal products - PSUSA/00001499/202202
24/11/2022 Reflection paper on the application of Regulation (EU) 2019/6 for certain categories of variations
24/11/2022 Scientific guideline: Draft reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations
23/11/2022 Human medicines European public assessment report (EPAR): Javlor, vinflunine, Carcinoma, Transitional Cell; Urologic Neoplasms, 21/09/2009, 10, Authorised
23/11/2022 Human medicines European public assessment report (EPAR): Vumerity, Diroximel fumarate (BIIB098), Multiple Sclerosis, Relapsing-Remitting, 15/11/2021, 3, Authorised
23/11/2022 Periodic safety update single assessment: Frovatriptan : List of nationally authorised medicinal products - PSUSA/00001484/202203
23/11/2022 EPAR - Assessment report - Variation: Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-84-G : EPAR - Assessment Report - Variation
23/11/2022 News and press releases: DARWIN EU® welcomes first data partners
23/11/2022 Data Analysis and Real World Interrogation Network (DARWIN EU)
23/11/2022 Other: European Medicines Agency’s data protection notice for validation of proof of establishment when natural persons apply for orphan designation or a transfer of an orphan designation
23/11/2022 Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0390/2018
23/11/2022 Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, HIV Infections, 17/12/2020, Additional monitoring, 7, Authorised
23/11/2022 Human medicines European public assessment report (EPAR): Fuzeon, enfuvirtide, HIV Infections, 27/05/2003, 23, Authorised
23/11/2022 Withdrawn application: Abylqis, arachis hypogaea extract, Date of withdrawal: 17/12/2021, Initial authorisation
22/11/2022 Template or form: Application form to request a simultaneous national scientific advice (SNSA)
22/11/2022 Other: Guidance for applicants on simultaneous national scientific advice (SNSA) briefing book format and content
22/11/2022 Other: Guidance for applicants on simultaneous national scientific advice (SNSA) phase 2 pilot (from October 2022) – Optimised process
22/11/2022 Human medicines European public assessment report (EPAR): Ibandronic Acid Teva, ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal, 17/09/2010, Generic, 12, Authorised
22/11/2022 Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 October 2022, edition 7)
22/11/2022 Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (onvansertib) for the: Treatment of acute myeloid leukaemia, 24/08/2018, Withdrawn
22/11/2022 Other: List of critical medicines for COVID-19 public health emergency (PHE) under Regulation (EU) 2022/123
22/11/2022 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia; Bipolar Disorder, 12/12/2007, Generic, 29, Authorised
22/11/2022 Minutes: CHMP PROM minutes for the meeting on 5 September 2022
22/11/2022 Minutes: CHMP PROM agenda for the meeting on 5 September 2022
22/11/2022 Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride for the: Treatment of Kabuki syndrome, 19/11/2018, Withdrawn
22/11/2022 Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 3
22/11/2022 Template or form: Annex 1 - Report template for the review of a European Union herbal monograph
22/11/2022 Orphan designation: Hexasodium phytate for the: Treatment of calciphylaxis, 17/07/2012, Positive
22/11/2022 Human medicines European public assessment report (EPAR): Vyvgart, Efgartigimod alfa, Myasthenia Gravis, 10/08/2022, Orphan, Additional monitoring, 2, Authorised
22/11/2022 Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome , terlipressin, Article 31 referrals, CMDh final position, 10/11/2022, 22/11/2022
22/11/2022 Human medicines European public assessment report (EPAR): Anoro Ellipta (previously Anoro), umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 18, Authorised
22/11/2022 Periodic safety update single assessment: Carboplatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/202201
22/11/2022 Periodic safety update single assessment: Carboplatin : List of nationally authorised medicinal products - PSUSA/00000559/202201
22/11/2022 Human medicines European public assessment report (EPAR): Riluzole Zentiva, Riluzole, Amyotrophic Lateral Sclerosis, 07/05/2012, 13, Authorised
22/11/2022 Other: Veterinary Scientific Advice procedure - submission deadlines 2023
22/11/2022 Human medicines European public assessment report (EPAR): Rilutek, Riluzole, Amyotrophic Lateral Sclerosis, 10/06/1996, 31, Authorised
22/11/2022 Network Portfolio
22/11/2022 Orphan designation: Recombinant chimeric monoclonal antibody against CD20 (ublituximab) for the: Treatment of chronic lymphocytic leukaemia, 26/11/2009, Positive
21/11/2022 Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/03/2017, Additional monitoring, 11, Authorised
21/11/2022 News and press releases: New Quality Innovation Expert Group (QIG) supports medicine innovation
21/11/2022 Other: European Medicines Agency’s data protection notice for recording of telephone calls to the EMA official telephone number received at the EMA switchboard
21/11/2022 Report: Annual Report of the Good Clinical Practice Inspectors' Working Group 2021
21/11/2022 Minutes: PDCO minutes of the 11-14 October 2022 meeting
21/11/2022 Guidance for medicine developers and other stakeholders on COVID-19
21/11/2022 Good manufacturing practice
21/11/2022 Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive, 08/05/2014, Additional monitoring, 17, Authorised
21/11/2022 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction, 24/02/2009, 24, Authorised
21/11/2022 Human medicines European public assessment report (EPAR): Ertapenem SUN, ertapenem sodium, Bacterial Infections, 15/07/2022, Generic, Authorised
21/11/2022 News and press releases: Best practices to fight antimicrobial resistance
21/11/2022 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting
21/11/2022 Procurement: EMA/2022/18/ST – Ex-ante publicity of a negotiated procedure - Courier services
21/11/2022 Human medicines European public assessment report (EPAR): Zepatier, elbasvir, grazoprevir, Hepatitis C, Chronic, 22/07/2016, 13, Authorised
21/11/2022 Orphan designation: 6alpha-ethyl-chenodeoxycholic acid for the: Treatment of primary biliary cirrhosis, 27/07/2010, Positive
21/11/2022 Herbal medicinal product: Eschscholziae herba, Eschscholziae herba, F: Assessment finalised
21/11/2022 Herbal medicinal product: Species digestivae and stomachicae, Combination: Species digestivae, F: Assessment finalised
18/11/2022 Other: CHMP rules of procedure
18/11/2022 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, 28, Authorised
18/11/2022 Antimicrobial resistance in veterinary medicine
18/11/2022 Orphan designation: Adeno-associated virus serotype rh10 containing the human GALC gene for the: Treatment of Krabbe disease, 15/10/2021, Positive
18/11/2022 Orphan designation: Cyclic pyranopterin monophosphate (fosdenopterin) for the: Treatment of molybdenum-cofactor deficiency type A, 20/09/2010, Positive
18/11/2022 Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab) for the: Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive
18/11/2022 Development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy - Scientific guideline
18/11/2022 Agenda: Agenda - Ninth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
18/11/2022 Scientific guideline: Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy
18/11/2022 Human medicines European public assessment report (EPAR): Janumet, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 18/02/2009, 29, Authorised
18/11/2022 Orphan designation: poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase) for the: Treatment of hyperargininaemia, 14/07/2016, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of citrullinaemia type 2, 10/06/2010, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrom, 10/06/2010, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of hyperargininaemia, 10/06/2010, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of argininosuccinic aciduria, 10/06/2010, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of citrullinaemia type 1, 10/06/2010, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of ornithine carbamoyltransferase deficiency, 10/06/2010, Positive
18/11/2022 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of carbamoyl-phosphate synthase-1 deficiency, 03/02/2010, Positive
18/11/2022 Other: Incident management plan for medicines for veterinary use
18/11/2022 Periodic safety update single assessment: Mesalazine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001990/202202
18/11/2022 Periodic safety update single assessment: Mesalazine : List of nationally authorised medicinal products - PSUSA/00001990/202202
18/11/2022 News and press releases: European Antibiotic Awareness Day 2022: Preventing antimicrobial resistance together
18/11/2022 Leaflet: Antimicrobial resistance - Infocards
18/11/2022 Other: Timetable: Annual renewal application of conditional marketing authorisation
18/11/2022 Scientific guideline: Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances
18/11/2022 Procurement: Ex ante publicity of a negotiated procedure: EMA/2022/15/CO - On demand supply of books (print and digital)
18/11/2022 Multistakeholder workshop on EMA’s extended mandate , Online, from 01/04/2022 to 01/04/2022
18/11/2022 Report: Report - Multistakeholder workshop on EMA’s extended mandate
18/11/2022 Human medicines European public assessment report (EPAR): Neuraceq, florbetaben (18F), Radionuclide Imaging; Alzheimer Disease, 20/02/2014, 19, Authorised
18/11/2022 Criteria to be considered for the evaluation of new active substance (NAS) status of biological substances
18/11/2022 Report: Cyprus - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Netherlands - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 News and press releases: Sales of antibiotics for animal use have almost halved between 2011-2021
18/11/2022 Leaflet: Responsible use of antibiotics protects animals and people - 2011-2021 Sales of antibiotics for veterinary use are down - Infographic
18/11/2022 Report: Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Norway - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Denmark - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Poland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Estonia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Portugal - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Finland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Romania - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: France - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Slovakia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Germany - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Slovenia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Greece - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Spain - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Hungary - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Sweden - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Iceland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Switzerland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Ireland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: United Kingdom - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Italy - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Austria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Latvia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Belgium - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Lithuania - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Bulgaria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Luxembourg - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Croatia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 Report: Malta - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
18/11/2022 EMA regular press briefing on public health emergencies , Online, 14:00 - 14:30 Amsterdam time (CET), from 24/11/2022 to 24/11/2022
18/11/2022 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration
18/11/2022 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms
18/11/2022 Other: Record of data processing activity relating to the filemaker security database for staff vehicles/bicycles and lost/found property (public)
17/11/2022 Herbal medicinal product: Epilobii herba, Epilobii herba, F: Assessment finalised
17/11/2022 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 08:30 - 10:30 Amsterdam time (CEST), from 05/10/2022 to 05/10/2022
17/11/2022 Human medicines European public assessment report (EPAR): Evotaz, cobicistat, atazanavir, HIV Infections, 13/07/2015, 13, Authorised
17/11/2022 Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Hemophilia A, 08/01/2018, Additional monitoring, 8, Authorised
17/11/2022 Orphan designation: Govorestat for the: Treatment of galactosaemia, 21/06/2022, Positive
17/11/2022 Opinion/decision on a Paediatric investigation plan (PIP): Linear single strand of deoxyribonucleic acid (encoding human retinitis pigmentosa GTPase regulator [RPGR]) packaged in a recombinant adeno-associated virus protein capsid of serotype 5 (AAV5-hRKp.RPGR), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0125/2021
17/11/2022 Human medicines European public assessment report (EPAR): Lamivudine Teva, lamivudine, Hepatitis B, Chronic, 23/10/2009, Generic, 13, Authorised
17/11/2022 Other: Quality Review of Documents (QRD) working group plenary meeting dates
17/11/2022 Human medicines European public assessment report (EPAR): Ovitrelle, choriogonadotropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female, 02/02/2001, 22, Authorised
17/11/2022 Other: Release notes - production release version 1.6.12 November 2022 - Veterinary Medicinal Products Regulation: Union Product Database
17/11/2022 Regulatory and procedural guideline: Committee for Advanced Therapies (CAT) rules of procedure
17/11/2022 Periodic safety update single assessment: Ketoprofen (topical use only) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009205/202201
17/11/2022 Periodic safety update single assessment: Ketoprofen (topical use only) : List of nationally authorised medicinal products - PSUSA/00009205/202201
16/11/2022 Periodic safety update single assessment: Dorzolamide : List of nationally authorised medicinal products - PSUSA/00003168/202202
16/11/2022 Human medicines European public assessment report (EPAR): NeuroBloc, botulinum toxin type B, Torticollis, 22/01/2001, 33, Authorised
16/11/2022 Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Diabetes Mellitus, 08/02/2018, Additional monitoring, 9, Authorised
16/11/2022 Human medicines European public assessment report (EPAR): Evusheld, tixagevimab, cilgavimab, COVID-19 virus infection, 25/03/2022, Additional monitoring, 1, Authorised
16/11/2022 Withdrawn application: Sevsury, surufatinib, Date of withdrawal: 01/08/2022, Initial authorisation
16/11/2022 Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Gaucher Disease, 17/11/1997, 30, Authorised
16/11/2022 Regulatory and procedural guideline: Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems
16/11/2022 Other: Dates of 2023 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests
16/11/2022 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 7-10 November 2022
15/11/2022 Minutes: Minutes of the CAT meeting 5-7 October 2022
15/11/2022 Advanced therapy classification
15/11/2022 Human medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Glycogen Storage Disease Type II, 28/03/2006, 22, Authorised
15/11/2022 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel (as hydrogen sulfate), Myocardial Infarction; Acute Coronary Syndrome; Peripheral Vascular Diseases; Stroke, 18/02/2015, Generic, 14, Authorised
15/11/2022 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 18, Authorised
15/11/2022 Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, 15/05/2009, 18, Authorised
15/11/2022 Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Graft Rejection, 23/04/2007, 25, Authorised
15/11/2022 Template or form: Step 2 - Nitrosamine detected response template
14/11/2022 Human medicines European public assessment report (EPAR): Iasibon, ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms, 21/01/2011, Generic, 11, Authorised
14/11/2022 Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 10, Authorised
14/11/2022 Human medicines European public assessment report (EPAR): Teriflunomide Accord, Teriflunomide, Multiple Sclerosis, Relapsing-Remitting, 09/11/2022, Generic, Authorised
14/11/2022 Human medicines European public assessment report (EPAR): Adasuve, loxapine, Schizophrenia; Bipolar Disorder, 20/02/2013, 14, Authorised
14/11/2022 Template or form: QRD veterinary product-information annotated template (English) version 9.0 highlighted
14/11/2022 Template or form: QRD veterinary product-information template version 9.0
14/11/2022 Template or form: QRD veterinary product-information highlighted template version 9.0
14/11/2022 Template or form: QRD veterinary product-information annotated template (English) version 9.0
14/11/2022 Quarterly system demo - Q3 2022 , Online, 09:00 - 12:30 Amsterdam time (CEST), from 28/09/2022 to 28/09/2022
14/11/2022 Quarterly system demo - Q2 2022 , Online, 09:00 - 11:00 Amsterdam time (CEST), from 28/06/2022 to 28/06/2022
14/11/2022 Quarterly system demo - Q1 2022 , Online, 09:00 - 11:00 Amsterdam time (CET), from 15/03/2022 to 15/03/2022
14/11/2022 Other: Questions and answers - Quarterly system demo - Q3 2022
14/11/2022 Human medicines European public assessment report (EPAR): Halaven, Eribulin, Breast Neoplasms; Liposarcoma, 17/03/2011, 29, Authorised
14/11/2022 Human medicines European public assessment report (EPAR): Exparel liposomal, bupivacaine, Acute Pain, 16/11/2020, 1, Authorised
14/11/2022 Second Industry Standing Group (ISG) meeting , Online, from 26/09/2022 to 26/09/2022
14/11/2022 Newsletter: Human medicines highlights - November 2022
14/11/2022 Other: Example files - production release version 1.6.12 November 2022 - Veterinary Medicinal Products Regulation: Union Product Database
14/11/2022 Other: Declaration of interests: Paul Damien Lynn
14/11/2022 Other: Declaration of interests: Caroline Pothet
14/11/2022 Other: Declaration of interests: Virginia Rojo Guerra
14/11/2022 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, Accelerated assessment, 33, Authorised
11/11/2022 Orphan designation: gefinitib for the: Treatment of Fanconi anaemia type A, 26/10/2018, Positive
11/11/2022 Orphan designation: Metformin for the: Treatment of progressive myoclonic epilepsy type 2 (Lafora disease), 12/12/2016, Positive
11/11/2022 Orphan designation: Temsirolimus for the: Treatment of adrenoleukodystrophy, 30/05/2016, Positive
11/11/2022 Orphan designation: Ubiquinol for the: Treatment of primary coenzyme Q10 deficiency syndrome, 20/09/2016, Positive
11/11/2022 Orphan designation: Haematopoietic stem cells modified with a lentiviral vector containing the CD18 gene for the: Treatment of leukocyte adhesion deficiency type I, 20/09/2016, Positive
11/11/2022 Orphan designation: Lentiviral vector containing the human liver and erythroid pyruvate kinase (PKLR) gene for the: Treatment of pyruvate kinase deficiency, 22/08/2014, Positive
11/11/2022 Orphan designation: Lentiviral vector carrying the Fanconi anaemia-A (FANCA) gene for the: Treatment of Fanconi anaemia type A, 17/12/2010, Positive
11/11/2022 Orphan designation: afatinib for the: Treatment of Fanconi anaemia, 14/12/2018, Positive
11/11/2022 Orphan designation: dimethyl fumarate for the: Treatment of adrenoleukodystrophy, 09/01/2020, Positive
11/11/2022 Orphan designation: Autologous skin equivalent graft composed of keratinocytes and fibroblasts genetically corrected by CRISPR/Cas9-mediated excision of mutation-carrying COL7A1 exon 80 for the: Treatment of epidermolysis bullosa, 28/02/2020, Positive
11/11/2022 Orphan designation: Adeno-associated virus of serotype rh10 encoding Human MLC1 under the control of GFAP promoter for the: Treatment of megalencephalic leukoencephalopathy with subcortical cysts, 15/10/2021, Positive
11/11/2022 Orphan designation: Autologous CD34+ enriched cells transduced with a self-inactivating lentiviral vector containing the codon-optimized RPS19 gene for the: Treatment of Diamond-Blackfan anaemia, 12/11/2021, Positive
11/11/2022 Orphan designation: Fingolimod for the: Treatment of adrenoleukodystrophy, 12/11/2021, Positive
11/11/2022 Orphan designation: Autologous CD34+ cells edited with CRISPR/Cas9 and transduced with an adeno-associated virus vector serotype 6 containing the codon-optimized version of PKLR gene for the: Treatment of pyruvate kinase deficiency, 24/02/2022, Positive
11/11/2022 Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Anemia; Cancer; Kidney Failure, Chronic, 08/06/2001, 45, Authorised
11/11/2022 Human medicines European public assessment report (EPAR): Somavert, Pegvisomant, Acromegaly, 12/11/2002, 27, Authorised
11/11/2022 Summary of opinion: Neoleish, bacterial DNA plasmid containing LACK gene from Leishmania infantum, 10/11/2022, Positive
11/11/2022 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022
11/11/2022 Human medicines European public assessment report (EPAR): Exforge, valsartan, amlodipine (as amlodipine besilate), Hypertension, 16/01/2007, 31, Authorised
11/11/2022 Human medicines European public assessment report (EPAR): Emgality, Galcanezumab, Migraine Disorders, 14/11/2018, Additional monitoring, 9, Authorised
11/11/2022 Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Gaucher Disease, 18/02/2019, Generic, 4, Authorised
11/11/2022 Human medicines European public assessment report (EPAR): Dafiro, amlodipine, valsartan, Hypertension, 15/01/2007, 30, Authorised
11/11/2022 Human medicines European public assessment report (EPAR): Copalia, valsartan, amlodipine (as amlodipine besilate), Hypertension, 15/01/2007, 29, Authorised