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30/11/2020 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 17, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesilate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 13, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Dovato, dolutegravir sodium, lamivudine, HIV Infections, 01/07/2019, 5, Authorised (updated)
30/11/2020 Veterinary medicines European public assessment report (EPAR): Kexxtone, monensin (as monensin sodium), 28/01/2013, 7, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 11, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, Orphan, Additional monitoring, 6, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 29/05/2006, Additional monitoring, Exceptional circumstances, 29, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis, 13/01/2016, Additional monitoring, Biosimilar, 12, Authorised (updated)
30/11/2020 Scientific publications (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Kevzara, sarilumab, Arthritis, Rheumatoid, 23/06/2017, Additional monitoring, 4, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Cholestagel, colesevelam (as hydrochloride), Hypercholesterolemia, 09/03/2004, 22, Authorised (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, 11, Authorised (updated)
30/11/2020 Orphan designation: Recombinant adeno-associated viral vector serotype 5 encoding Staphylococcus aureus Cas9 endonuclease and two guide RNAs complementary to two regions of intron 26 of the CEP290 gene for the: Treatment of Leber's congenital amaurosis, 16/10/2017, Positive (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 7, Authorised (updated)
30/11/2020 Orphan designation: Recombinant human bone morphogenetic protein 4 for the: Treatment of glioma, 15/10/2014, Positive (updated)
30/11/2020 Human medicines European public assessment report (EPAR): Veklury, remdesivir, Coronavirus Infections, 03/07/2020, Additional monitoring, Conditional approval, 2, Authorised (updated)
30/11/2020 Periodic safety update single assessment: Lamivudine / tenofovir disoproxil: List of nationally authorised medicinal products - PSUSA/00010751/202003 (new)
30/11/2020 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 48, Authorised (updated)
30/11/2020 Veterinary medicines European public assessment report (EPAR): Purevax RC, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), 23/02/2005, 14, Authorised (updated)
30/11/2020 Workshop on support for orphan medicines development , Virtual event, from 30/11/2020 to 30/11/2020 (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Prevenar 13, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections, Immunization, 09/12/2009, 39, Authorised (updated)
27/11/2020 Guidance for medicine developers and other stakeholders on COVID-19 (updated)
27/11/2020 Product information: Reference documents and guidelines (updated)
27/11/2020 Product-information requirements (updated)
27/11/2020 Other: Questions and answers on labelling flexibilities for COVID19 vaccines (new)
27/11/2020 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, 8, Authorised (updated)
27/11/2020 Herbal medicinal product: Juniperi aetheroleum, Juniperi aetheroleum, F: Assessment finalised (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 6, Authorised (updated)
27/11/2020 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
27/11/2020 News and press releases: Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
27/11/2020 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, 19, Authorised (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Pemetrexed Krka, pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 22/05/2018, Generic, 3, Authorised (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, HIV Infections, 16/01/2014, 22, Authorised (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans, Protein C Deficiency, 15/07/2001, 15, Authorised (updated)
27/11/2020 Maximum Residue Limits - Report: Isoeugenol (fin fish): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 15/01/2015, 17, Authorised (updated)
27/11/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
27/11/2020 Orphan designation: Obiltoxaximab for the: Treatment of anthrax, 24/08/2018, Positive (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Obiltoxaximab SFL, Obiltoxaximab, Anthrax, 18/11/2020, Orphan, Additional monitoring, Exceptional circumstances, Authorised
27/11/2020 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 23/03/2015, 13, Authorised (updated)
27/11/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP, , attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 15, Authorised (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 7, Authorised (updated)
27/11/2020 Orphan designation: Picropodophyllin for the: Treatment of glioma, 23/08/2017, Positive (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma), clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 16/10/2009, Generic, 19, Authorised (updated)
27/11/2020 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders, Epilepsy, 10/04/2014, 21, Authorised (updated)
27/11/2020 Agenda: Agenda - Multi-stakeholder webinar to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations (updated)
27/11/2020 Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations , Virtual event, from 27/11/2020 to 27/11/2020 (updated)
27/11/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), 22/02/2005, 15, Authorised (updated)
27/11/2020 Certification of medicinal products (updated)
27/11/2020 Other: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2020 (new)
27/11/2020 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
27/11/2020 Procurement (updated)
27/11/2020 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, Authorised
27/11/2020 Procurement: Market survey: Data Access to an electronic health care record database from the United Kingdom (new)
27/11/2020 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 26, Authorised (updated)
27/11/2020 EMA roundtable with stakeholders on the 15-year anniversary of the SME Regulation , Virtual meeting, from 27/11/2020 to 27/11/2020 (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer, 18/12/2007, Biosimilar, 27, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): NovoThirteen, catridecacog, Blood Coagulation Disorders, Inherited, 03/09/2012, 6, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Zeffix, lamivudine, Hepatitis B, Chronic, 29/07/1999, 25, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, Additional monitoring, Exceptional circumstances, 20, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, 14/02/1996, 34, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Zavesca, miglustat, Gaucher Disease, Niemann-Pick Diseases, 20/11/2002, 16/06/2009, 32, Authorised (updated)
26/11/2020 Veterinary medicines European public assessment report (EPAR): Chanhold, selamectin, 17/04/2019, 1, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Velphoro, Sucroferric oxyhydroxide, Hyperphosphatemia, Renal Dialysis, 26/08/2014, 8, Authorised (updated)
26/11/2020 Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 11/11/2012, 18, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, 2, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014, Additional monitoring, 12, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, 14, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Viagra, sildenafil, Erectile Dysfunction, 13/09/1998, 36, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Granpidam, sildenafil citrate, Hypertension, Pulmonary, 14/11/2016, Generic, 4, Authorised (updated)
26/11/2020 Periodic safety update single assessment: Clobetasol: List of nationally authorised medicinal products - PSUSA/00000799/202002 (new)
26/11/2020 Human medicines European public assessment report (EPAR): Nepexto, etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis, 20/05/2020, Additional monitoring, Biosimilar, 2, Authorised (updated)
26/11/2020 Periodic safety update single assessment: Clobetasol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000799/202002 (new)
26/11/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 5, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Suliqua, insulin glargine, lixisenatide, Diabetes Mellitus, Type 2, 11/01/2017, Additional monitoring, 7, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Epilepsy, 14/12/2011, Generic, 13, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Retinal Diseases, 13/03/2013, 14, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms, Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, 1, Authorised (updated)
26/11/2020 Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/79/2009 (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Zirabev, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 14/02/2019, Additional monitoring, Biosimilar, 6, Authorised (updated)
26/11/2020 Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 7, Authorised (updated)
25/11/2020 Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva, lamivudine, zidovudine, HIV Infections, 28/02/2011, Generic, 11, Authorised (updated)
25/11/2020 Human medicines European public assessment report (EPAR): Silapo, epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic, 18/12/2007, Biosimilar, 17, Authorised (updated)
25/11/2020 Human medicines European public assessment report (EPAR): Phelinun, melphalan hydrochloride, Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Neuroblastoma, Ovarian Neoplasms, Hematopoietic Stem Cell Transplantation, 16/11/2020, Authorised
25/11/2020 Human medicines European public assessment report (EPAR): Abraxane, paclitaxel, Breast Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, 11/01/2008, 27, Authorised (updated)
25/11/2020 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, 19/06/2015, 33, Authorised (updated)
25/11/2020 Human medicines European public assessment report (EPAR): Supemtek, Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human, 16/11/2020, Additional monitoring, Authorised
25/11/2020 Opinion/decision on a Paediatric investigation plan (PIP): Molidustat (sodium), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0273/2014 (updated)
25/11/2020 Opinion/decision on a Paediatric investigation plan (PIP): fremanezumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0386/2017 (updated)
25/11/2020 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (lumasiran) for the: Treatment of primary hyperoxaluria, 21/03/2016, Positive (updated)
25/11/2020 Human medicines European public assessment report (EPAR): Oxlumo, Lumasiran sodium, Hyperoxaluria, Primary, 19/11/2020, Orphan, Additional monitoring, Authorised
25/11/2020 Orphan designation: Dextran sulfate low molecular weight for the: Treatment of amyotrophic lateral sclerosis, 21/08/2020, Positive
25/11/2020 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 14, Authorised (updated)
25/11/2020 Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for the: Treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, 21/08/2020, Positive
25/11/2020 Orphan designation: Copper histidinate for the: Treatment of Menkes disease, 21/08/2020, Positive
25/11/2020 Orphan designation: Adeno-associated viral vector serotype 3B encoding shortened human ATP7B for the: Treatment of Wilson's disease, 21/08/2020, Positive
25/11/2020 Orphan designation: 6-((3S,4S)-4-methyl-1-(pyrimidin-2-yl-methyl)pyrrolidin-3-yl)-3-tetrahydropyran-4-yl-7H-imidazo(1,5-a)pyrazin-8-one for the: Treatment of sickle cell disease, 21/08/2020, Positive
25/11/2020 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 55, Authorised (updated)
25/11/2020 Agenda: Agenda and registration form - EMA EudraVigilance information day on 2 December 2020 (updated)
25/11/2020 Orphan designation: Trehalose for the: Treatment of mucopolysaccharidosis type III (Sanfilippo syndrome), 21/08/2020, Positive
25/11/2020 Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile for the: Treatment of von Hippel-Lindau disease, 21/08/2020, Positive
25/11/2020 Orphan designation: Venglustat for the: Treatment of GM2 gangliosidosis, 21/08/2020, Positive
25/11/2020 Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta for the: Treatment of Gaucher disease, 21/08/2020, Positive
25/11/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
25/11/2020 List of medicines under additional monitoring (updated)
25/11/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
25/11/2020 Orphan designation: Autologous T cells transduced with lentiviral vector containing a tandem chimeric antigen receptor directed against CD20 and CD19 for the: Treatment of diffuse large B-cell lymphoma, 21/08/2020, Positive
25/11/2020 Orphan designation: Human frataxin fused to TAT cell-penetrating peptide for the: Treatment of Friedreich’s ataxia, 21/08/2020, Positive
25/11/2020 Orphan designation: Infigratinib for the: Treatment of cholangiocarcinoma, 21/08/2020, Positive
25/11/2020 Orphan designation: Allogeneic T-cell precursors, mobilised peripheral blood-derived, ex vivo cultured for the: Treatment in haematopoietic stem cell transplantation, 21/08/2020, Positive
25/11/2020 Orphan designation: Protein-based delivery vector carrying a DNA payload encoding an RNA-guided nuclease that targets stx genes of Shiga toxin-producing Escherichia coli for the: Prevention of haemolytic uraemic syndrome, 21/08/2020, Positive
25/11/2020 Orphan designation: pentosan polysulfate sodium for the: Treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), 21/08/2020, Positive
25/11/2020 Orphan designation: Humanised IgG1 monoclonal antibody against human eotaxin-2 for the: Treatment of primary sclerosing cholangitis, 21/08/2020, Positive
25/11/2020 Orphan designation: 2-(2-(18F)fluoropyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine for the: Diagnosis of progressive supranuclear palsy, 21/08/2020, Positive
25/11/2020 Orphan designation: Allogeneic hepatoblastoma cells encapsulated in alginate, ex vivo expanded for the: Treatment of acute liver failure, 21/08/2020, Positive
25/11/2020 Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for the: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 21/08/2020, Positive
25/11/2020 Orphan designation: Adeno-associated virus serotype 2/8 vector containing the human PDE6A gene for the: Treatment of retinitis pigmentosa, 21/08/2020, Positive
25/11/2020 Orphan designation: Bis-(3-deoxy-3-(4-(3-fluorophenyl)-1H-1,2,3-triazol-1-yl)-beta-D-galactopyranosyl) sulfane for the: Treatment of idiopathic pulmonary fibrosis, 21/08/2020, Positive
25/11/2020 Business hours and holidays (updated)
24/11/2020 Other: Records of data processing activity for contact details of journalist and other media professionals (public) (new)
24/11/2020 Other: European Medicines Agency's privacy statement for media professionals (new)
24/11/2020 Orphan designation: Hydroxychloroquine for the: Treatment of antiphospholipid syndrome, 12/01/2017, Positive (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Mvabea, Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola, 01/07/2020, Additional monitoring, Exceptional circumstances, Authorised (updated)
24/11/2020 Orphan designation: Allogeneic umbilical cord tissue-derived mesenchymal stromal cells ex vivo expanded for the: Prevention of bronchopulmonary dysplasia, 21/08/2020, Positive
24/11/2020 Human medicines European public assessment report (EPAR): Lamzede, velmanase alfa, alpha-Mannosidosis, 23/03/2018, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Emselex, darifenacin hydrobromide, Urinary Incontinence, Urge, Urinary Bladder, Overactive, 22/10/2004, 23, Authorised (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 17, Authorised (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 5, Authorised (updated)
24/11/2020 Committee for Orphan Medicinal Products (COMP) (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Rivaroxaban Accord, rivaroxaban, Acute Coronary Syndrome, Coronary Artery Disease, Peripheral Arterial Disease, Venous Thromboembolism, Stroke, Atrial Fibrillation, Pulmonary Embolism, 16/11/2020, Generic, Authorised
24/11/2020 Orphan designation: synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker (zilucoplan) for the: Treatment of paroxysmal nocturnal haemoglobinuria, 14/10/2016, Positive (updated)
24/11/2020 Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) for the: Treatment of sickle cell disease, 09/08/2012, Positive (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Adakveo, Crizanlizumab, Anemia, Sickle Cell, 28/10/2020, Orphan, Additional monitoring, Authorised
24/11/2020 Human medicines European public assessment report (EPAR): Insuman, insulin human, Diabetes Mellitus, 21/02/1997, 30, Authorised (updated)
24/11/2020 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, 1, Authorised (updated)
24/11/2020 Veterinary medicines European public assessment report (EPAR): Zulvac 8 Bovis, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02, 15/01/2010, 7, Withdrawn (updated)
24/11/2020 News and press releases: Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations
23/11/2020 Human medicines European public assessment report (EPAR): Zaltrap, aflibercept, Colorectal Neoplasms, 01/02/2013, 9, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, Additional monitoring, 23, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Diabetes Mellitus, 27/09/2004, 30, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Nyvepria, pegfilgrastim, Neutropenia, 18/11/2020, Additional monitoring, Biosimilar, Authorised
23/11/2020 Human medicines European public assessment report (EPAR): Docetaxel Teva, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 26/01/2010, Generic, 18, Authorised (updated)
23/11/2020 Overview of comments: Draft 1 - Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance' (new)
23/11/2020 Lapatinib product-specific bioequivalence guidance (updated)
23/11/2020 Palbociclib product-specific bioequivalence guidance (updated)
23/11/2020 Scientific guideline: Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1 (new)
23/11/2020 Agenda: Agenda - PRAC draft agenda of meeting 23-26 November 2020 (new)
23/11/2020 Human medicines European public assessment report (EPAR): Skyrizi, Risankizumab, Psoriasis, 26/04/2019, Additional monitoring, 4, Authorised (updated)
23/11/2020 News and press releases: Workshop on regulatory support for development of orphan medicines
23/11/2020 Scientific guideline: Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1 (new)
23/11/2020 Abiraterone product-specific bioequivalence guidance (updated)
23/11/2020 Overview of comments: Overview of comments received on 'Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance' - Revision 1 (new)
23/11/2020 Human medicines European public assessment report (EPAR): Insulatard, insulin human, Diabetes Mellitus, 07/10/2002, 20, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, Orphan, Additional monitoring, Exceptional circumstances, 17, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Yellox, bromfenac sodium sesquihydrate, Pain, Postoperative, Ophthalmologic Surgical Procedures, 18/05/2011, 10, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan, hydrochlorothiazide, Essential Hypertension, 13/03/2013, Generic, 11, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): Ribavirin Teva, Ribavirin, Hepatitis C, Chronic, 31/03/2009, Generic, 14, Authorised (updated)
23/11/2020 Human medicines European public assessment report (EPAR): NovoRapid, insulin aspart, Diabetes Mellitus, 07/09/1999, 31, Authorised (updated)
23/11/2020 Public Statement: Public statement on Ribavirin Mylan: Withdrawal of the marketing authorisation in the European Union (new)
23/11/2020 Human medicines European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers), Ribavirin, Hepatitis C, Chronic, 10/06/2010, Generic, 10, Withdrawn (updated)
23/11/2020 PRAC recommendations on safety signals (updated)
23/11/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC (new)
23/11/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (new)
23/11/2020 Other: List of signals discussed at PRAC since September 2012 (updated)
23/11/2020 Veterinary medicines European public assessment report (EPAR): ProteqFlu, Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus, 06/03/2003, 14, Authorised (updated)
20/11/2020 News and press releases: Update on remdesivir - EMA will evaluate new data from Solidarity trial
20/11/2020 Human medicines European public assessment report (EPAR): Yervoy, Ipilimumab, Melanoma, 12/07/2011, 34, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic, 24/08/2017, Additional monitoring, Biosimilar, 13, Authorised (updated)
20/11/2020 News and press releases: HMA/EMA statement on approval of vaccines
20/11/2020 Human medicines European public assessment report (EPAR): Busilvex, busulfan, Hematopoietic Stem Cell Transplantation, 09/07/2003, 17, Authorised (updated)
20/11/2020 Veterinary medicines European public assessment report (EPAR): Aivlosin, tylvalosin, 09/09/2004, 31, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid monohydrate, Fractures, Bone, Cancer, 03/08/2012, Generic, 13, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 48, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Azacitidine betapharm, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 24/03/2020, Generic, 1, Authorised
20/11/2020 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 20/05/2016, Orphan, Accelerated assessment, Additional monitoring, 14, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 17, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Drug-Related Side Effects and Adverse Reactions, 26/04/2019, Additional monitoring, Conditional approval, 6, Authorised (updated)
20/11/2020 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 9-12 November 2020 (new)
20/11/2020 Report: List of products granted eligibility to PRIME (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 4, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir, ritonavir, HIV Infections, 14/01/2016, Generic, 10, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Myalepta, Metreleptin, Lipodystrophy, Familial Partial, 29/07/2018, Orphan, Additional monitoring, Exceptional circumstances, 4, Authorised (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Zavicefta, avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial, Soft Tissue Infections, Pneumonia, Urinary Tract Infections, Gram-Negative Bacterial Infections, 23/06/2016, Additional monitoring, 10, Authorised (updated)
20/11/2020 News and press releases: Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) - deadline extended (updated)
20/11/2020 Pharmacovigilance Risk Assessment Committee (PRAC) (updated)
20/11/2020 Other: Letter of support for the VABS-II Adaptive Behavior Composite (VABS-II-ABC) score as measure of adaptive social functioning in people with Autism Spectrum Disorders (ASD) without intellectual disability (new)
20/11/2020 Other: Letter of support for N170 ERP as a prognostic biomarker for adaptive social functioning and its potential to stratify study populations in people with Autism spectrum disorders (ASD) without intellectual disability (new)
19/11/2020 Template or form: Day 80 assessment report - Clinical template with guidance rev.02.20 (updated)
19/11/2020 Report: Medicinal products for human use: monthly figures - October 2020 (new)
19/11/2020 Minutes: Minutes of the PRAC meeting 11-14 May 2020 (new)
19/11/2020 Veterinary medicines European public assessment report (EPAR): Activyl Tick Plus, indoxacarb, permethrin, 09/01/2012, 8, Authorised (updated)
19/11/2020 Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Lymphoma, B-Cell, 16/01/2020, Orphan, Additional monitoring, Conditional approval, 1, Authorised (updated)
19/11/2020 Orphan designation: Retinol palmitate for the: Prevention of bronchopulmonary dysplasia, 27/07/2020, Positive
19/11/2020 Human medicines European public assessment report (EPAR): Spedra, avanafil, Erectile Dysfunction, 21/06/2013, 26/04/2013, 12, Authorised (updated)
19/11/2020 Orphan designation: Tinostamustine for the: Treatment of T-cell prolymphocytic leukaemia, 27/07/2020, Positive
19/11/2020 Orphan designation: Imetelstat sodium for the: Treatment of myelodysplastic syndromes, 27/07/2020, Positive
19/11/2020 Orphan designation: Maralixibat chloride for the: Treatment of biliary atresia, 27/07/2020, Positive
19/11/2020 Orphan designation: Benzyl benzoate, beta-caryophyllene, cineole, cinnamaldehyde, cinnamyl acetate, linalool, trans-2-methoxycinnamaldehyde for the: Treatment of eumycetoma, 18/06/2020, Negative
19/11/2020 Orphan designation: melatonin for the: Treatment of intracerebral haemorrhage, 06/07/2020, Negative
19/11/2020 Orphan designation: Adeno-associated viral vector expressing acid alpha-glucosidase gene for the: Treatment of glycogen storage disease type II (Pompe's disease), 27/07/2020, Positive
19/11/2020 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
19/11/2020 Orphan designation: Triheptanoin for the: Treatment of carnitine-acylcarnitine translocase deficiency, 27/07/2020, Positive
19/11/2020 Orphan designation: Pegylated adrenomedullin for the: Treatment of acute respiratory distress syndrome (ARDS), 27/07/2020, Positive
19/11/2020 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 30, Authorised (updated)
19/11/2020 Human medicines European public assessment report (EPAR): Gilenya, fingolimod hydrochloride , Multiple Sclerosis, 17/03/2011, Patient safety, Additional monitoring, 26, Authorised (updated)
19/11/2020 News and press releases: EMA organises public meeting on COVID-19 vaccines
19/11/2020 COVID-19 vaccines: key facts (updated)
19/11/2020 Transparency: exceptional measures for COVID-19 medicines (updated)
19/11/2020 COVID-19 vaccines: development, evaluation, approval and monitoring (updated)
19/11/2020 Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU , Virtual meeting, from 11/12/2020 to 11/12/2020
19/11/2020 Other: EMA considerations on COVID-19 vaccine approval (new)
19/11/2020 EMA considerations on COVID-19 vaccine approval
19/11/2020 Multidisciplinary: vaccines (updated)
19/11/2020 Orphan designation: Fasudil hydrochloride for the: Treatment of non-traumatic subarachnoid haemorrhage, 27/07/2020, Positive
19/11/2020 Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for the: Treatment of achondroplasia, 27/07/2020, Positive
19/11/2020 Orphan designation: Hemopexin for the: Treatment of sickle cell disease, 27/07/2020, Positive
19/11/2020 Hexaxim H-W-2495 (updated)
19/11/2020 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 29, Authorised (updated)
19/11/2020 Other: Quality Review of Documents (QRD) working group plenary meeting dates (updated)
18/11/2020 Medical devices (updated)
18/11/2020 Pharmacovigilance Inspectors Working Group (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 18, Authorised (updated)
18/11/2020 Other: List of acronyms and abbreviations used in CVMP agenda and minutes (updated)
18/11/2020 Regulatory and procedural guideline: Remote pharmacovigilance inspections of MAHs during a crisis situation - Points to consider (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Inflectra, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 26, Authorised (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major, 19/06/2015, Generic, 13, Authorised (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Arikayce liposomal, Amikacin sulfate, Respiratory Tract Infections, 27/10/2020, Orphan, Authorised
18/11/2020 Human medicines European public assessment report (EPAR): Hexyon, diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 22, Authorised (updated)
18/11/2020 15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance , from 30/10/2020 to 30/10/2020 (updated)
18/11/2020 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 23, Authorised (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 39, Authorised (updated)
18/11/2020 Other: Declaration of interest: Irene Rager (updated)
18/11/2020 Other: Declaration of interests: Emer Cooke (new)
18/11/2020 Other: Declaration of interests: Angela-Christina Schmidt (new)
18/11/2020 Veterinary medicines European public assessment report (EPAR): ProteqFlu-Te, Clostridium tetani toxoid / Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus, 06/03/2003, 15, Authorised (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Bortezomib Sun, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 9, Authorised (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Accelerated assessment, 15, Authorised (updated)
18/11/2020 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, 6, Authorised (updated)
18/11/2020 News and press releases: EMA marks European Antibiotic Awareness Day
18/11/2020 Antimicrobial resistance (updated)
18/11/2020 Leaflet: Responsible use of antibiotics: what’s your role? - Infocards (updated)
18/11/2020 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, 24/02/2009, 22, Authorised (updated)
17/11/2020 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 29, Authorised (updated)
17/11/2020 Veterinary medicines European public assessment report (EPAR): Vectra 3D, dinotefuran, pyriproxyfen, permethrin, 04/12/2013, 5, Authorised (updated)
17/11/2020 Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/12/2009, 11, Authorised (updated)
17/11/2020 Human medicines European public assessment report (EPAR): Evicel, human fibrinogen, human thrombin, Hemostasis, Surgical, 05/10/2008, 16, Authorised (updated)
17/11/2020 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 13, Authorised (updated)
17/11/2020 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 12, Authorised (updated)