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29/01/2021 News and press releases: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29/01/2021 COVID-19 treatments: authorised
29/01/2021 Withdrawn application: Dexamethasone Taw, dexamethasone phosphate, Date of withdrawal: 20/01/2021, Initial authorisation
29/01/2021 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 27/03/2013, Additional monitoring, Conditional approval, 20, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Lacosamide UCB, lacosamide, Epilepsies, Partial, 26/08/2019, 1, Authorised
29/01/2021 Press briefing on EU recommendation for COVID-19 Vaccine AstraZeneca , Virtual meeting, from 29/01/2021 to 29/01/2021
29/01/2021 Veterinary medicines European public assessment report (EPAR): Sevohale (previously known as Sevocalm), sevoflurane, 21/06/2016, Generic, 4, Authorised
29/01/2021 Provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines
29/01/2021 Scientific guideline: Draft concept paper on the provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines
29/01/2021 Data requirements for multi-strain dossiers for Inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot-and-mouth disease (FMD)
29/01/2021 Scientific guideline: Draft concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD)
29/01/2021 Scientific guideline: Draft concept paper for the development of a guideline on data requirements for vaccine platform technology master files (PTMF)
29/01/2021 Data requirements for vaccine platform technology master files (PTMF)
29/01/2021 Scientific guideline: Draft concept paper for the development of a guideline on data requirements for vaccine antigen master files (VAMF)
29/01/2021 Data requirements for for vaccine antigen master files (VAMF)
29/01/2021 Scientific guideline: Draft concept paper for the development of a guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances
29/01/2021 Data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances
29/01/2021 Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, Orphan, Additional monitoring, 11, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 5, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Halimatoz, adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 8, Withdrawn
29/01/2021 Human medicines European public assessment report (EPAR): Imatinib Teva, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma, 07/01/2013, Generic, 15, Authorised
29/01/2021 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, 81, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Entecavir Accord, Entecavir, Hepatitis B, Chronic, 25/09/2017, Generic, 3, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Multiple Myeloma, 25/08/2020, Orphan, Additional monitoring, Conditional approval, 1, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Yttriga, yttrium (90Y) chloride, Radionuclide Imaging, 19/01/2006, 10, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Potactasol, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 06/01/2011, Generic, 8, Authorised
29/01/2021 Brexit-related guidance for companies
29/01/2021 ICH Q3D Elemental impurities
29/01/2021 Overview of comments: Overview of comments received on ICH guideline Q3D(R2) on elemental impurities (EMA/CHMP/ICH/353369/2013)
29/01/2021 Agenda: CHMP ORGAM minutes for the meeting on 15 June 2020
29/01/2021 Template or form: Confidentiality undertaking for observers
29/01/2021 News and press releases: First COVID-19 vaccine safety update published
29/01/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: January 2021
29/01/2021 Data Monitoring Committees issues
28/01/2021 Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Epilepsy, 07/01/2014, Generic, 16, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 13, Authorised
28/01/2021 Orphan designation: Clofazimine for the: Treatment of nontuberculous mycobacterial lung disease, 21/08/2019, Positive
28/01/2021 Human medicines European public assessment report (EPAR): Nilemdo, Bempedoic acid, Hypercholesterolemia, Dyslipidemias, 01/04/2020, Additional monitoring, 3, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Aerinaze, desloratadine, pseudophedrine sulfate, Rhinitis, Allergic, Seasonal, 30/07/2007, 18, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib citrate, Arthritis, Rheumatoid, 21/03/2017, 25/04/2013, Patient safety, Additional monitoring, 16, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck, 17/07/2015, Additional monitoring, 31, Authorised
28/01/2021 Veterinary medicines European public assessment report (EPAR): Advocate, imidacloprid, moxidectin, 02/04/2003, 22, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Zynteglo, Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia, 29/05/2019, Orphan, Accelerated assessment, Additional monitoring, Conditional approval, 3, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 5, Authorised
28/01/2021 News and press releases: Clarification of Comirnaty dosage interval
28/01/2021 Veterinary medicines European public assessment report (EPAR): Nobilis IB Primo QX, live avian infectious bronchitis virus, strain D388, 04/09/2014, 4, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Opioid-Related Disorders, Constipation, 01/07/2008, 17, Authorised
28/01/2021 Newsletter: Veterinary Medicines Regulation highlights - Issue 3
28/01/2021 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, 2, Authorised
28/01/2021 Herbal medicinal product: Caryophylii floris aetheroleum, Caryophylii floris aetheroleum, F: Assessment finalised
28/01/2021 Human medicines European public assessment report (EPAR): Doptelet, avatrombopag maleate, Thrombocytopenia, 20/06/2019, Additional monitoring, 3, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency, 26/05/2016, Orphan, Additional monitoring, 5, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Multiple Myeloma, 19/11/2015, Orphan, Accelerated assessment, 18, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma, telmisartan, Hypertension, 03/10/2011, Generic, 9, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 8, Authorised
28/01/2021
28/01/2021 Periodic safety update single assessment: Diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed): List of nationally authorised medicinal products - PSUSA/00001128/202005
28/01/2021 Periodic safety update single assessment: ciprofloxacin hydrochloride / dexamethasone acetate (ear drops, suspension): List of nationally authorised medicinal products - PSUSA/00010012/202004
28/01/2021 Regulatory and procedural guideline: Dossier requirements for nationally authorised porducts (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device
28/01/2021 Agenda: CHMP ORGAM agenda for the meeting on 15 June 2020
28/01/2021 Other: Information Technology Directors Group - List of nominated members (alphabetically by country)
27/01/2021 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 6, Authorised
27/01/2021 Periodic safety update single assessment: Clarithromycin: List of nationally authorised medicinal products - PSUSA/00000788/202004
27/01/2021 Periodic safety update single assessment: Clarithromycin: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000788/202004
27/01/2021 Periodic safety update single assessment: Piroxicam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002438/202004
27/01/2021 Periodic safety update single assessment: Piroxicam: List of nationally authorised medicinal products - PSUSA/00002438/202004
27/01/2021 Human medicines European public assessment report (EPAR): Ibandronic Acid Teva, ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, Osteoporosis, Postmenopausal, 17/09/2010, Generic, 10, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Zubsolv, Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 10/11/2017, 5, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 27, Authorised
27/01/2021 Direct healthcare professional communication (DHPC): Shortage of Nucala (mepolizumab) Pre-Filled Pen (EU/1/15/1043/003, EU/1/15/1043/004), Active substance: Mepolizumab, DHPC type: Medicine shortage, Last updated: 27/01/2021
27/01/2021 Human medicines European public assessment report (EPAR): Coagadex, Human coagulation factor X, Factor X Deficiency, 16/03/2016, Orphan, Accelerated assessment, Additional monitoring, 6, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis, 29/03/2017, 7, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan, acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome, Myocardial Infarction, 09/01/2020, Generic, 2, Authorised
27/01/2021 Implementation of the new Veterinary Medicines Regulation
27/01/2021 Overview of comments: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 - Overview of comments
27/01/2021 Human medicines European public assessment report (EPAR): Zostavax, varicella-zoster virus (live, attenuated), Herpes Zoster, Immunization, 19/05/2006, 29, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, Additional monitoring, 5, Authorised
27/01/2021 Committee for Medicinal Products for Human Use (CHMP): 25-28 May 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 25/05/2020 to 28/05/2020
27/01/2021 Minutes: CHMP ORGAM minutes for the meeting on 18 May 2020
27/01/2021 Human medicines European public assessment report (EPAR): Lojuxta, Lomitapide, Hypercholesterolemia, 31/07/2013, Additional monitoring, Exceptional circumstances, 13, Authorised
27/01/2021 Paediatric Committee (PDCO): 26-29 January 2021 , Virtual meeting, from 26/01/2021 to 29/01/2021
27/01/2021 Agenda: Agenda - PDCO agenda of the 26-29 January 2021 meeting
27/01/2021 Agenda: CHMP ORGAM agenda for the meeting on 18 May 2020
27/01/2021 Agenda: CHMP ORGAM agenda for the meeting on 20 April 2020
27/01/2021 Minutes: CHMP ORGAM minutes for the meeting on 20 April 2020
27/01/2021 Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan, hydrochlorothiazide, Essential Hypertension, 13/03/2013, Generic, 12, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid, colecalciferol, Osteoporosis, Postmenopausal, 16/10/2009, 15, Authorised
27/01/2021 Report: Meeting summary - PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update
27/01/2021 Minutes: CHMP ORGAM minutes for the meeting on 16 March 2020
27/01/2021 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, Additional monitoring, 4, Authorised
26/01/2021 Funding
26/01/2021 Agenda: Agenda - CHMP agenda of the 25-29 January 2021 meeting
26/01/2021 Other: Assent / Informed consent guidance for paediatric clinical trials with medicinal products in Europe
26/01/2021 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 20/05/2016, Orphan, Accelerated assessment, Additional monitoring, 15, Authorised
26/01/2021 Human medicines European public assessment report (EPAR): Invanz, ertapenem sodium, Community-Acquired Infections, Streptococcal Infections, Staphylococcal Infections, Gram-Negative Bacterial Infections, Surgical Wound Infection, Pneumonia, Bacterial, 18/04/2002, 23, Authorised
26/01/2021 Veterinary medicines European public assessment report (EPAR): Onsior, robenacoxib, 16/12/2008, 14, Authorised
26/01/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information
25/01/2021 Periodic safety update single assessment: Nicergoline: List of nationally authorised medicinal products - PSUSA/00002150/202005
25/01/2021 Periodic safety update single assessment: Chlorpromazine: List of nationally authorised medicinal products - PSUSA/00000715/202005
25/01/2021 Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections, 04/02/2002, 55, Authorised
25/01/2021 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Accelerated assessment, Additional monitoring, 4, Authorised
25/01/2021 Human medicines European public assessment report (EPAR): Ocaliva, Obeticholic acid, Liver Cirrhosis, Biliary, 12/12/2016, Orphan, Additional monitoring, Conditional approval, 8, Authorised
25/01/2021 Orphan designation: Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19) for the: Treatment of mantle cell lymphoma, 13/11/2019, Positive
25/01/2021 Human medicines European public assessment report (EPAR): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell, 14/12/2020, Orphan, Additional monitoring, Conditional approval, Authorised
25/01/2021 News and press releases: Cyberattack on EMA - update 6
25/01/2021 Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for the: Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive
25/01/2021 Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, 07/01/2021, Orphan, Additional monitoring, Exceptional circumstances, Authorised
25/01/2021 Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 3, Authorised
25/01/2021 Template or form: Innovation Task Force (ITF) briefing meeting request form
25/01/2021 Report: Medicinal products for human use: monthly figures - December 2020
25/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm GmbH, clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke, 28/07/2009, Generic, 12, Withdrawn
25/01/2021 Other: European Medicines Agency’s privacy statement for user research for the design of the Union Product Database
25/01/2021 Other: Records of data processing activity for user research for the design of the Union Product Database
25/01/2021 Other: Timetable accelerated assessment request for initial marketing authorisation applications
25/01/2021 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Accelerated assessment, 17, Authorised
25/01/2021 Paediatric Committee (PDCO): 10-13 November 2020 , Virtual meeting, from 10/11/2020 to 13/11/2020
25/01/2021 Work programme: CVMP work plan 2021
25/01/2021 Minutes: Minutes - PDCO minutes of the 10-13 November 2020 meeting
25/01/2021 Periodic safety update single assessment: Ketobemidone: List of nationally authorised medicinal products - PSUSA/0001807/202005
25/01/2021 Orphan designation: Oxytocin for the: Treatment of Prader-Willi syndrome, 29/07/2014, Positive
25/01/2021 Veterinary medicines European public assessment report (EPAR): Velactis, cabergoline, 09/12/2015, 1, Withdrawn
25/01/2021 Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, 10, Authorised
25/01/2021 Report: European Medicines Agency budget for 2021
25/01/2021 Veterinary medicines European public assessment report (EPAR): Profender, emodepside, praziquantel, 27/07/2005, 19, Authorised
22/01/2021 Human medicines European public assessment report (EPAR): Ocrevus, ocrelizumab, Multiple Sclerosis, 08/01/2018, Additional monitoring, 9, Authorised
22/01/2021 Report: Summary report - EU big data stakeholder virtual forum
22/01/2021 EU big data stakeholder virtual forum , Virtual meeting, from 15/12/2020 to 15/12/2020
22/01/2021 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 8-11 December 2020
22/01/2021 Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane sulfate, tazobactam sodium, Bacterial Infections, 18/09/2015, 13, Authorised
22/01/2021 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 27/09/2017, Additional monitoring, 9, Authorised
22/01/2021 Periodic safety update single assessment: Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004
22/01/2021 Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 23/11/2015, Orphan, Additional monitoring, 11, Authorised
22/01/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021
22/01/2021 Periodic safety update single assessment: Deoxycholic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/202004
22/01/2021 Periodic safety update single assessment: Deoxycholic acid: List of nationally authorised medicinal products - PSUSA/00010525/202004
22/01/2021 Human medicines European public assessment report (EPAR): Xofluza, Baloxavir marboxil, Influenza, Human, 07/01/2021, Additional monitoring, Authorised
22/01/2021 Pharmaceutical industry
22/01/2021 Report: European Medicines Agency’s interaction with industry stakeholders - Biennial report 2018-19
22/01/2021 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 23/07/2012, Orphan, Accelerated assessment, 27, Authorised
22/01/2021 Human medicines European public assessment report (EPAR): ViraferonPeg, peginterferon alfa-2b, Hepatitis C, Chronic, 28/05/2000, 36, Withdrawn
22/01/2021 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202005
22/01/2021 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, Additional monitoring, 5, Authorised
22/01/2021 Periodic safety update single assessment: Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202005
22/01/2021 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 7, Authorised
22/01/2021 Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 38, Authorised
21/01/2021 Periodic safety update single assessment: Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/202005
21/01/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database
21/01/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API)
21/01/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information
21/01/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products
21/01/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications
21/01/2021 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 9, Authorised
21/01/2021 Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepine acetate, Epilepsy, 21/04/2009, 27, Authorised
21/01/2021 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 18, Authorised
21/01/2021 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 12, Authorised
21/01/2021 Agenda: Agenda - Fourth EMA-Medicines for Europe bilateral meeting
21/01/2021 European Medicines Agency and Medicines for Europe fourth bilateral meeting , Virtual meeting, from 26/01/2021 to 26/01/2021
21/01/2021 Other: Policy 78: EMA environmental policy
21/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Brazikumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0397/2017
21/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0321/2018
21/01/2021 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, 17, Authorised
21/01/2021 Periodic safety update single assessment: Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/202006
21/01/2021 Periodic safety update single assessment: Dexpanthenol xylometazoline: List of nationally authorised medicinal products - PSUSA/00010030/202005
21/01/2021 Periodic safety update single assessment: Peppermint oil: List of nationally authorised medicinal products - PSUSA/00010436/202005
21/01/2021 Human medicines European public assessment report (EPAR): Roclanda, Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle, Ocular Hypertension, 07/01/2021, Additional monitoring, Authorised
21/01/2021 Fifth industry stakeholder platform on research and development support , Virtual meeting, from 16/11/2020 to 16/11/2020
21/01/2021 Report: Human medicines highlights 2020
21/01/2021 News and press releases: Human medicines: highlights of 2020
21/01/2021 News and press releases: Veterinary medicines: highlights of 2020
21/01/2021 Report: Veterinary medicines highlights 2020
21/01/2021 Periodic safety update single assessment: Gadoteric acid (intra articular formulation): List of nationally authorised medicinal products - PSUSA/00001505/202004
20/01/2021 News and press releases: Extra dose from vials of Comirnaty COVID-19 vaccine
20/01/2021 Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 16, Authorised
20/01/2021 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202005
20/01/2021 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202005
20/01/2021 Other: Timetable: Annual renewal application of conditional marketing authorisation
20/01/2021 Other: Timetable: Annual renewal application of conditional marketing authorisation - ATMP
20/01/2021 Other: Timetable: Marketing authorisation renewal application - ATMP
20/01/2021 Other: Timetable: Annual reassessment - ATMP
20/01/2021 Other: Timetable: Marketing authorisation renewal application
20/01/2021 Other: Timetable: Annual reassessment
20/01/2021 Periodic safety update single assessment: Ticlopidine: List of nationally authorised medicinal products - PSUSA/00002952/202005
20/01/2021 Leaflet: Inforcard for patients: Reporting suspected side effects of medicines in patients with COVID-19
20/01/2021 Public-health advice during COVID-19 pandemic
20/01/2021 Periodic safety update single assessment: valsartan, hydrochlorothiazide / valsartan: List of nationally authorised medicinal products - PSUSA/00010396/202004
20/01/2021 Periodic safety update single assessment: Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/202005
20/01/2021 EPAR - Risk-management-plan summary: COVID-19 Vaccine Moderna: EPAR - Risk-management-plan
19/01/2021 Periodic safety update single assessment: Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/202005
19/01/2021 Periodic safety update single assessment: Gadopentetic acid: List of nationally authorised medicinal products - PSUSA/00001504/202004
19/01/2021 Human medicines European public assessment report (EPAR): Ryzodeg, insulin aspart, insulin degludec, Diabetes Mellitus, 21/01/2013, 12, Authorised
19/01/2021 Periodic safety update single assessment: Amfepramone: List of nationally authorised medicinal products - PSUSA/00000138/202006
19/01/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 51
19/01/2021 Human medicines European public assessment report (EPAR): Roteas, edoxaban tosilate, Stroke, Venous Thromboembolism, 19/04/2017, Additional monitoring, 8, Authorised
19/01/2021 Agenda: Agenda - CAT agenda of the 20-22 January 2021 meeting
19/01/2021 Agenda: Agenda - CVMP agenda of the 19-21 January 2021 meeting
19/01/2021 News and press releases: Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
19/01/2021 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, Patient safety, 32, Authorised
19/01/2021 Eligible patients and consumers organisations
18/01/2021 Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Gaucher Disease, 17/11/1997, 25, Authorised
18/01/2021 Human medicines European public assessment report (EPAR): Qutavina, teriparatide, Osteoporosis, 27/08/2020, Biosimilar, Withdrawn
18/01/2021 Human medicines European public assessment report (EPAR): Ovitrelle, choriogonadotropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female, 02/02/2001, 20, Authorised
18/01/2021 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 14, Authorised
18/01/2021 Periodic safety update single assessment: Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004
18/01/2021 Human medicines European public assessment report (EPAR): Yervoy, Ipilimumab, Melanoma, 12/07/2011, 35, Authorised
18/01/2021 Agenda: Agenda - COMP agenda of the 19-21 January 2021 meeting
18/01/2021 Withdrawn application: Puldysa, idebenone, Date of withdrawal: 28/10/2020, Initial authorisation
18/01/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2020
18/01/2021 Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines , Virtual meeting, from 03/12/2020 to 03/12/2020
18/01/2021 Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2020 , Virtual meeting, from 03/11/2020 to 05/11/2020
18/01/2021 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 12, Authorised
18/01/2021 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 13, Authorised
18/01/2021 Other: Organisation chart: Information Management
18/01/2021 Periodic safety update single assessment: Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025
18/01/2021 Periodic safety update single assessment: Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025
18/01/2021 Periodic safety update single assessment: Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005
18/01/2021 Periodic safety update single assessment: Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004
18/01/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004
18/01/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004
18/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 12, Authorised
18/01/2021 Periodic safety update single assessment: Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004
18/01/2021 Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Multiple Myeloma, 14/11/2019, Generic, 3, Authorised
18/01/2021 Periodic safety update single assessment: Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004
16/01/2021 Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Retinal Diseases, 13/03/2013, 15, Authorised
15/01/2021 Other: CHMP meeting dates 2019, 2020 and 2021
15/01/2021 Human medicines European public assessment report (EPAR): Tyverb, lapatinib, Breast Neoplasms, 10/06/2008, 31, Authorised
15/01/2021 Transparency: exceptional measures for COVID-19 medicines
15/01/2021 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005
15/01/2021 Regulatory and procedural guideline: IRIS guide for applicants
15/01/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: September 2020
15/01/2021 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 31, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Diabetes Mellitus, 20/01/2013, 14, Authorised
15/01/2021 News and press releases: Cyberattack on EMA - update 5
15/01/2021 Agenda: Agenda - HMPC agenda of the 11-13 January 2021 meeting
15/01/2021 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
15/01/2021 Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 16, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi, busulfan, Hematopoietic Stem Cell Transplantation, 22/09/2014, Generic, 8, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): INOmax, Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency, 01/08/2001, 22, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): Grepid, clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 27/07/2009, Generic, 21, Authorised
15/01/2021 Minutes: Minutes of the CHMP meeting 14-17 September 2020
15/01/2021 Orphan designation: dimethyl fumarate for the: Adjunctive treatment in haematopoietic cell transplantation, 21/03/2018, Positive
15/01/2021 Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesilate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 14, Authorised
15/01/2021 Other: Questions and answers on signal management
15/01/2021 Template or form: Application form for the involvement of healthcare professionals’ organisations in the activities of the European Medicines Agency
14/01/2021 Human medicines European public assessment report (EPAR): Sebivo, telbivudine, Hepatitis B, Chronic, 24/04/2007, 20, Withdrawn
14/01/2021 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia, Cancer, 22/08/2002, 35, Authorised
14/01/2021 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 12, Authorised
14/01/2021 Coronavirus disease (COVID-19)
14/01/2021 Treatments and vaccines for COVID-19
14/01/2021 COVID-19 treatments
14/01/2021 National competent authorities (human)