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26/04/2021 Article 5(3) opinions (updated)
26/04/2021 Referrals document: Use of Vaxzevria to prevent COVID-19 - Article-5(3) procedure: Assessment report
26/04/2021 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, 2, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Rivastigmine Actavis, rivastigmine hydrogen tartrate, Dementia, Alzheimer Disease, Parkinson Disease, 16/06/2011, Generic, 14, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Maviret, glecaprevir, pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 12, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome, Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, 2, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen, human thrombin, Hemostasis, Surgical, 10/11/2017, Additional monitoring, 4, Authorised (updated)
26/04/2021 Template or form: Mutual-recognition, decentralised and referral product-information template version 4.2 (updated)
26/04/2021 Veterinary medicines European public assessment report (EPAR): Nobilis IB Primo QX, live avian infectious bronchitis virus, strain D388, 04/09/2014, 5, Authorised (updated)
26/04/2021 COVID-19: latest updates (updated)
26/04/2021 News and press releases: EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26/04/2021 Monitoring of COVID-19 medicines (updated)
26/04/2021 Agenda: Agenda - PDCO agenda of the 20-23 April 2021 meeting
26/04/2021 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer, 18/12/2007, Biosimilar, 28, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 16, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, Accelerated assessment, 30, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 14, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 41, Authorised (updated)
26/04/2021 Veterinary medicines European public assessment report (EPAR): Nobilis IB 4-91, live attenuated avian infectious bronchitis virus variant strain 4-91, 09/06/1998, 15, Authorised (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 9, Authorised (updated)
26/04/2021 Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia, Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021
26/04/2021 Human medicines European public assessment report (EPAR): Odomzo, sonidegib diphosphate, Carcinoma, Basal Cell, 14/08/2015, 10, Authorised (updated)
26/04/2021 Orphan designation: Cannabidiol for the: Treatment of tuberous sclerosis, 17/01/2018, Positive (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, 6, Authorised (updated)
26/04/2021 Orphan designation: Diclofenamide for the: Treatment of periodic paralysis, 17/02/2016, Positive (updated)
26/04/2021 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, Colorectal Neoplasms, 19/09/2018, Additional monitoring, 6, Authorised (updated)
26/04/2021 Herbal medicinal product: Cinnamomi corticis aetheroleum , Cinnamomi corticis aetheroleum, F: Assessment finalised (updated)
26/04/2021 Other: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMBASE (updated)
26/04/2021 Summary of product characteristics for anthelmintics (updated)
26/04/2021 Scientific guideline: Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics
26/04/2021 Summary of opinion: Maviret, glecaprevir, pibrentasvir, 22/04/2021, Positive
26/04/2021 Report: Applications for new human medicines under evaluation by the CHMP: April 2021
26/04/2021 Health technology assessment bodies (updated)
26/04/2021 Minutes: Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - December 2020
26/04/2021 Submission deadlines for orphan designations (updated)
26/04/2021 Regulatory and procedural guideline: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2020-2021 (updated)
23/04/2021 Referrals document: Interim Opinion of the Committee for Medicinal products for Human Use pursuant to Article 5(3) of Regulation (EC) No 726/2004 for Vaxzevria
23/04/2021 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 12, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Fabry Disease, 03/08/2001, 30, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 23/03/2015, 16, Authorised (updated)
23/04/2021 Guidance on good manufacturing practice and good distribution practice: Questions and answers (updated)
23/04/2021 Other: Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs
23/04/2021 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosilate, Stroke, Venous Thromboembolism, 19/06/2015, 14, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Retsevmo, Selpercatinib, Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms, 11/02/2021, Additional monitoring, Conditional approval, Authorised
23/04/2021 Human medicines European public assessment report (EPAR): Zejula, Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 12, Authorised (updated)
23/04/2021 Annex to CHMP highlights: Annex to Vaxzevria Art.5.3 - Visual risk contextualisation
23/04/2021 News and press releases: AstraZeneca’s COVID-19 vaccine: benefits and risks in context
23/04/2021 Human medicines European public assessment report (EPAR): Mavenclad, Cladribine, Multiple Sclerosis, 22/08/2017, 4, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 13, Authorised (updated)
23/04/2021 News and press releases: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna
23/04/2021 EMA press briefing to update on analysis of data on Vaxzevria, the COVID-19 vaccine from AstraZeneca , Virtual meeting, from 23/04/2021 to 23/04/2021
23/04/2021 Human medicines European public assessment report (EPAR): COVID-19 Vaccine Janssen, adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection, 11/03/2021, Additional monitoring, Conditional approval, 1, Authorised (updated)
23/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 22 April 2021
23/04/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
23/04/2021 Summary of opinion: Yervoy, ipilimumab, 22/04/2021, Positive
23/04/2021 Summary of opinion: Enspryng, satralizumab, 22/04/2021, Positive
23/04/2021 Summary of opinion: Adtralza, tralokinumab, 22/04/2021, Positive
23/04/2021 Summary of opinion: Jayempi, azathioprine, 22/04/2021, Positive
23/04/2021 Summary of opinion: Evkeeza, evinacumab, 22/04/2021, Positive
23/04/2021 Summary of opinion: Tagrisso, osimertinib, 22/04/2021, Positive
23/04/2021 Summary of opinion: DuoResp Spiromax, budesonide, formoterol, 22/04/2021, Positive
23/04/2021 Summary of opinion: Abiraterone Krka , abiraterone acetate, 22/04/2021, Positive
23/04/2021 Summary of opinion: Celsunax, ioflupane (123I), 22/04/2021, Positive
23/04/2021 Summary of opinion: Aubagio, teriflunomide, 22/04/2021, Positive
23/04/2021 Summary of opinion: Venclyxto, venetoclax, 22/04/2021, Positive
23/04/2021 Referral: Ifosfamide solutions , ifosfamide, Ifosfamide Eg,Ifo-Cell,Ifo-Cell N,Ifo-Cell N 2000, Article 31 referrals, CMDh position, 21/04/2021, 23/04/2021 (updated)
23/04/2021 Summary of opinion: Nulojix, belatacept, 22/04/2021, Positive
23/04/2021 Summary of opinion: BiResp Spiromax, budesonide, formoterol, 22/04/2021, Positive
23/04/2021 Summary of opinion: Onureg, azacitidine, 22/04/2021, Positive
23/04/2021 Summary of opinion: Opdivo, nivolumab, 22/04/2021, Positive
23/04/2021 Summary of opinion: Koselugo, selumetinib, 22/04/2021, Positive
23/04/2021 News and press releases: New treatment for rare autoimmune disease of nerve cells
23/04/2021 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 7, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 40, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 9, Authorised (updated)
23/04/2021 News and press releases: EMA working on COVID-19 during closure on 27 April 2021
23/04/2021 Periodic safety update single assessment: Iopromide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001773/202006
23/04/2021 Periodic safety update single assessment: Iopromide: List of nationally authorised medicinal products - PSUSA/00001773/202006
23/04/2021 Periodic safety update single assessment: Iohexol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001768/202006
23/04/2021 Periodic safety update single assessment: Iohexol: List of nationally authorised medicinal products - PSUSA/00001768/202006
23/04/2021 Human medicines European public assessment report (EPAR): Xyrem, sodium oxybate, Cataplexy, Narcolepsy, 13/10/2005, 31, Authorised (updated)
23/04/2021 Periodic safety update single assessment: Tamoxifen: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002846/202004
23/04/2021 Periodic safety update single assessment: Tamoxifen: List of nationally authorised medicinal products - PSUSA/00002846/202004
23/04/2021 Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 19/05/2006, 20, Authorised (updated)
23/04/2021 Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune), reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human, 20/05/2016, Additional monitoring, Conditional approval, 7, Authorised (updated)
23/04/2021 Other: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2021 (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, Additional monitoring, 6, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, Generic, 8, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, 22, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, 9, Authorised (updated)
22/04/2021 Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for the: Treatment of distal renal tubular acidosis, 20/06/2017, Positive (updated)
22/04/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2021
22/04/2021 Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0392/2018 (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 14, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine, tenofovir disoproxil phosphate, HIV Infections, 09/11/2016, Generic, 5, Authorised (updated)
22/04/2021 Medicines for use outside the European Union (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 9, Authorised (updated)
22/04/2021 Overview of comments: Overview of comments received on 'Public guidance - Parallel application for EU-M4all (Article 58) opinion and Centralised Marketing Authorisation procedure' (EMA/104275/2021)
22/04/2021 Other: Submission deadlines for paediatric applications 2021-2024 (updated)
22/04/2021 Regulatory and procedural guideline: Public guidance - Parallel application for EU-M4all (Article 58) opinion and Centralised Marketing Authorisation procedure
22/04/2021 Human medicines European public assessment report (EPAR): Movymia, teriparatide, Osteoporosis, 11/01/2017, Additional monitoring, Biosimilar, 8, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, Accelerated assessment, 38, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Cinryze, C1 inhibitor (human), Angioedemas, Hereditary, 15/06/2011, Additional monitoring, 20, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis, 13/01/2016, Biosimilar, 14, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, Additional monitoring, 18, Authorised (updated)
22/04/2021 Orphan designation: (3'R,4'S,5'R)-N-[(3R,6S)-6-carbamoyltetrahydro-2H-pyran-3-yl]-6''-chloro-4'-(2-chloro-3-fluoropyridin-4-yl)-4,4-dimethyl-2''-oxo-1'',2''-dihydrodispiro[cyclohexane-1,2'-pyrrolidine-3',3''-indole]-5'-carboxamide mono(4-methylbenzenesulfonate) monohydrate for the: Treatment of soft tissue sarcoma, 20/03/2017, Positive (updated)
22/04/2021 Orphan designation: Eicosapentaenoic acid for the: Treatment of familial adenomatous polyposis (FAP), 08/10/2009, Positive (updated)
22/04/2021 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 42, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 43, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 39, Authorised (updated)
22/04/2021 Human medicines European public assessment report (EPAR): Ribavirin Teva, Ribavirin, Hepatitis C, Chronic, 31/03/2009, Generic, 15, Authorised (updated)
21/04/2021 News and press releases: Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21/04/2021 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 14, Authorised (updated)
21/04/2021 Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, Additional monitoring, 3, Authorised (updated)
21/04/2021 Veterinary Big Data stakeholder forum , Virtual event, from 01/06/2021 to 02/06/2021 (updated)
21/04/2021 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib (s)-malate, Carcinoma, Renal Cell, 09/09/2016, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
21/04/2021 Template or form: Application form for European Medicines Agency certificates of medicinal products (updated)
21/04/2021 Periodic safety update single assessment: Gadoxetic acid disodium: List of nationally authorised medicinal products - PSUSA/00001509/202004
21/04/2021 Periodic safety update single assessment: Epirubicin: List of nationally authorised medicinal products - PSUSA/00001234/202006
21/04/2021 Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/202005
21/04/2021 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, 1, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202008
21/04/2021 Periodic safety update single assessment: Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202008
21/04/2021 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms, 19/06/2015, 36, Authorised (updated)
21/04/2021 Human medicines European public assessment report (EPAR): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human, 12/12/2018, Additional monitoring, 7, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Gadoteridol: List of nationally authorised medicinal products - PSUSA/00001507/202004
21/04/2021 Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 14, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Gadobenic acid: List of nationally authorised medicinal products - PSUSA/00001500/202004
21/04/2021 Periodic safety update single assessment: Fluorescein (systemic use): List of nationally authorised medicinal products - PSUSA/00009153/202004
21/04/2021 Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 46, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Gadoteric acid (IV and intravascular formulations): List of nationally authorised medicinal products - PSUSA/00001506/202004
21/04/2021 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 39, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Porfimer: List of nationally authorised medicinal products - PSUSA/00010332/202004
21/04/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,Dermatophagoides farinae, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/146/2011 (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Comirnaty, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection, 21/12/2020, Additional monitoring, Conditional approval, 5, Authorised (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, Additional monitoring, Authorised
20/04/2021 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 February 2021
20/04/2021 News and press releases: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
20/04/2021 Periodic safety update single assessment: Dalteparin sodium: List of nationally authorised medicinal products - PSUSA/00000922/202008
20/04/2021 Agenda: Agenda - Veterinary Big Data Stakeholder Forum
20/04/2021 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 21, Authorised (updated)
20/04/2021 Extraordinary Management Board meeting on CTIS audit , European Medicines Agency, Amsterdam, the Netherlands, from 21/04/2021 to 21/04/2021
20/04/2021 Human medicines European public assessment report (EPAR): Vfend, voriconazole, Candidiasis, Mycoses, Aspergillosis, 19/03/2002, 48, Authorised (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, Additional monitoring, 14, Authorised (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Exforge, valsartan, amlodipine (as amlodipine besilate), Hypertension, 16/01/2007, 27, Authorised (updated)
20/04/2021 Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021 , Virtual meeting, from 20/04/2021 to 20/04/2021
20/04/2021 Veterinary medicines European public assessment report (EPAR): NexGard Combo, eprinomectin, esafoxolaner, praziquantel, 06/01/2021, Authorised
20/04/2021 Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 6, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, Orphan, Additional monitoring, Conditional approval, 2, Authorised (updated)
19/04/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 52
19/04/2021 Renewal and annual re-assessment of marketing authorisation (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesilate, Melanoma, 26/08/2013, 24, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 20, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 21, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 39, Authorised (updated)
19/04/2021 Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007
19/04/2021 Human medicines European public assessment report (EPAR): Equidacent, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, 24/09/2020, Additional monitoring, Biosimilar, 2, Authorised (updated)
19/04/2021 Periodic safety update single assessment: Hexoprenaline sulfate: List of nationally authorised medicinal products - PSUSA/00003170/202008
19/04/2021 Other: Stakeholder engagement highlights 2020
19/04/2021 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits : Imidacloprid
19/04/2021 Maximum Residue Limits - Report: Imidacloprid (fin fish): Summary report - Committee for Veterinary Medicinal Products
19/04/2021 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 8, Authorised (updated)
19/04/2021 Scientific recommendations on classification of advanced therapy medicinal products (updated)
19/04/2021 Other: Scientific recommendations on classification of advanced therapy medicinal products
19/04/2021 Human medicines European public assessment report (EPAR): MenQuadfi, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 18/11/2020, Additional monitoring, 1, Authorised (updated)
19/04/2021 Other: Timetable: Informed consent and multiple application (updated)
19/04/2021 Report: Medicinal products for human use: monthly figures - March 2021
19/04/2021 Agenda: Agenda - CHMP agenda of the 19-22 April 2021 meeting
16/04/2021 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 19, Authorised (updated)
16/04/2021 Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, Additional monitoring, 15, Authorised (updated)
16/04/2021 Press briefing on PRAC conclusions on signal of thromboembolic events with COVID-19 Vaccine Janssen , Virtual meeting, from 20/04/2021 to 20/04/2021
16/04/2021 Veterinary medicines European public assessment report (EPAR): Prevexxion RN, Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250, 20/07/2020, Authorised
16/04/2021 Supply shortage: Shortage of Vfend (voriconazole) supply shortage
16/04/2021 Human medicines European public assessment report (EPAR): Kesimpta, ofatumumab, Multiple Sclerosis, Relapsing-Remitting, 26/03/2021, Additional monitoring, Authorised
16/04/2021 EPAR - Product Information: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Product information (updated)
16/04/2021 Withdrawn application: Tibsovo, ivosidenib, Date of withdrawal: 13/10/2020, Initial authorisation (updated)
16/04/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
16/04/2021 Overview of comments: Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure): List of nationally authorised medicinal products - PSUSA/00010582/202009
16/04/2021 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 24, Authorised (updated)
16/04/2021 Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, Additional monitoring, Conditional approval, 5, Authorised (updated)
16/04/2021 Pre-authorisation guidance (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
16/04/2021 Changing the labelling and package leaflet (Article 61(3) notifications) (updated)
16/04/2021 Transfer of marketing authorisation: questions and answers (updated)
16/04/2021 Periodic safety update reports (PSURs) (updated)
16/04/2021 Post-authorisation measures: questions and answers (updated)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021
16/04/2021 COVID-19 vaccines: authorised (updated)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 14 April 2021
16/04/2021 Herbal medicinal product: Hyperici herba, Hyperici herba, P: Draft published (updated)
16/04/2021 Worksharing: questions and answers (updated)
16/04/2021 Grouping of variations: questions and answers (updated)
16/04/2021 Extensions of marketing authorisations: questions and answers (updated)
16/04/2021 Type-II variations: questions and answers (updated)
16/04/2021 Type-IB variations: questions and answers (updated)
16/04/2021 Type-IA variations: questions and answers (updated)
16/04/2021 Post-authorisation safety studies (PASS) (updated)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021
16/04/2021 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Trigonella foenum-graecum L., semen - Revision 1
16/04/2021 Herbal medicinal product: Trigonellae foenugraeci semen, Trigonellae foenugraeci semen, F: Assessment finalised (updated)
16/04/2021 Herbal - HMPC assessment report: Draft Assessment report on Trigonella foenum-graecum L., semen - Revision 1
15/04/2021 Veterinary medicines European public assessment report (EPAR): Prevexxion RN+HVT+IBD, Live recombinant Marek’s disease virus, serotype 1, strain RN1250; Live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69, 20/07/2020, Authorised
15/04/2021 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 16, Authorised (updated)
15/04/2021 Regulatory and procedural guideline: IRIS guide to registration (updated)
15/04/2021 Periodic safety update single assessment: Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008
15/04/2021 COVID-19 vaccines: Article 5(3) reviews (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Zometa, zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone, 20/03/2001, 35, Authorised (updated)
15/04/2021 Periodic safety update single assessment: Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007
15/04/2021 Periodic safety update single assessment: Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007
15/04/2021 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 22, Authorised (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Oyavas, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 26/03/2021, Additional monitoring, Biosimilar, Authorised
15/04/2021 Orphan designation: Somapacitan for the: Treatment of growth hormone deficiency, 24/08/2018, Positive (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Sogroya, Somapacitan, Growth, 31/03/2021, Orphan, Authorised
15/04/2021 News and press releases: EMA starts review of VIR-7831 for treating patients with COVID-19
15/04/2021 Periodic safety update single assessment: Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006
15/04/2021 Periodic safety update single assessment: Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006
15/04/2021 Joint HMA/EMA workshop on artificial intelligence in medicines regulation , Virtual event, from 19/04/2021 to 20/04/2021 (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 19, Authorised (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, 13, Authorised (updated)
15/04/2021 Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe, Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021
15/04/2021 Periodic safety update single assessment: Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/202008
15/04/2021 Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive
15/04/2021 Paediatric investigation plans (updated)
15/04/2021 Other: Common Commentary - EMA/FDA: Common issues requested for discussion by the respective agency (EMA/PDCO and FDA) concerning paediatric oncology development plans (Paediatric Investigation Plans [PIPs] and initial Pediatric Study Plans [iPSPs])
14/04/2021 European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 , Virtual meeting, from 25/03/2021 to 25/03/2021 (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Vazkepa, Icosapent ethyl, Dyslipidemias, 26/03/2021, Authorised
14/04/2021 Agenda: Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (2021) (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, 26, Authorised (updated)
14/04/2021 Referrals document: Letter from Commissioner Kyriakides asking EMA to follow up on Vaxzevria opinion after Council discussion
14/04/2021 News and press releases: AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
14/04/2021 COVID-19 vaccines (updated)
14/04/2021 Other: Article 57 product data (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 28, Authorised (updated)
14/04/2021 Periodic safety update single assessment: Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/202008
14/04/2021 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms, Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, 3, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): PecFent, fentanyl, Pain, Cancer, 31/08/2010, 20, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 9, Authorised (updated)
14/04/2021 News and press releases: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
14/04/2021 Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, Additional monitoring, 5, Authorised (updated)
14/04/2021 News and press releases: IT systems intermittently unavailable from 16 to 18 April 2021
14/04/2021 Veterinary medicines European public assessment report (EPAR): Enteroporc Coli, Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6, 06/01/2021, Authorised
14/04/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2021
14/04/2021 Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets (updated)
14/04/2021 Periodic safety update single assessment: Pefloxacin: List of nationally authorised medicinal products - PSUSA/00002322/202008
14/04/2021 Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 13/02/2020, Generic, 1, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 23, Authorised (updated)
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