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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
30/11/2020 Human medicines European public assessment report (EPAR): Dovato, dolutegravir sodium, lamivudine, HIV Infections, 01/07/2019, 5, Authorised
30/11/2020 Veterinary medicines European public assessment report (EPAR): Kexxtone, monensin (as monensin sodium), 28/01/2013, 7, Authorised
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
30/11/2020 Human medicines European public assessment report (EPAR): Cholestagel, colesevelam (as hydrochloride), Hypercholesterolemia, 09/03/2004, 22, Authorised
30/11/2020 Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, 11, Authorised
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
30/11/2020 Human medicines European public assessment report (EPAR): Scenesse, afamelanotide, Protoporphyria, Erythropoietic, 22/12/2014, Orphan, Additional monitoring, Exceptional circumstances, 7, Authorised
30/11/2020 Orphan designation: Recombinant human bone morphogenetic protein 4 for the: Treatment of glioma, 15/10/2014, Positive
30/11/2020 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 48, Authorised
30/11/2020 Periodic safety update single assessment: Lamivudine / tenofovir disoproxil: List of nationally authorised medicinal products - PSUSA/00010751/202003
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
27/11/2020 Guidance for medicine developers and other stakeholders on COVID-19
27/11/2020 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, 8, Authorised
27/11/2020 Herbal medicinal product: Juniperi aetheroleum, Juniperi aetheroleum, F: Assessment finalised
27/11/2020 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 6, Authorised
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
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
27/11/2020 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans, Protein C Deficiency, 15/07/2001, 15, Authorised
27/11/2020 Maximum Residue Limits - Report: Isoeugenol (fin fish): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use
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
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
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
27/11/2020 Orphan designation: Picropodophyllin for the: Treatment of glioma, 23/08/2017, Positive
27/11/2020 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders, Epilepsy, 10/04/2014, 21, Authorised
27/11/2020 Agenda: Agenda - Multi-stakeholder webinar to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations
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
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
27/11/2020 Certification of medicinal products
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
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
26/11/2020 Human medicines European public assessment report (EPAR): NovoThirteen, catridecacog, Blood Coagulation Disorders, Inherited, 03/09/2012, 6, Authorised
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
26/11/2020 Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, 14/02/1996, 34, Authorised
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
26/11/2020 Veterinary medicines European public assessment report (EPAR): Chanhold, selamectin, 17/04/2019, 1, Authorised
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
26/11/2020 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, 2, Authorised
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
26/11/2020 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, 14, Authorised
26/11/2020 Human medicines European public assessment report (EPAR): Viagra, sildenafil, Erectile Dysfunction, 13/09/1998, 36, Authorised
26/11/2020 Human medicines European public assessment report (EPAR): Granpidam, sildenafil citrate, Hypertension, Pulmonary, 14/11/2016, Generic, 4, Authorised
26/11/2020 Periodic safety update single assessment: Clobetasol: List of nationally authorised medicinal products - PSUSA/00000799/202002
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
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
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
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
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
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
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
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
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
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
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
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
25/11/2020 Agenda: Agenda and registration form - EMA EudraVigilance information day on 2 December 2020
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 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
24/11/2020 Other: Records of data processing activity for contact details of journalist and other media professionals (public)
24/11/2020 Other: European Medicines Agency's privacy statement for media professionals
24/11/2020 Orphan designation: Hydroxychloroquine for the: Treatment of antiphospholipid syndrome, 12/01/2017, Positive
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
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
24/11/2020 Human medicines European public assessment report (EPAR): Emselex, darifenacin hydrobromide, Urinary Incontinence, Urge, Urinary Bladder, Overactive, 22/10/2004, 23, Authorised
24/11/2020 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 17, Authorised
24/11/2020 Committee for Orphan Medicinal Products (COMP)
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
24/11/2020 Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) for the: Treatment of sickle cell disease, 09/08/2012, Positive
24/11/2020 Human medicines European public assessment report (EPAR): Adakveo, Crizanlizumab, Anemia, Sickle Cell, 28/10/2020, Orphan, Additional monitoring, Conditional approval, Authorised
24/11/2020 Human medicines European public assessment report (EPAR): Insuman, insulin human, Diabetes Mellitus, 21/02/1997, 30, Authorised
24/11/2020 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, 1, Authorised
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
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
23/11/2020 Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Diabetes Mellitus, 27/09/2004, 30, Authorised
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
23/11/2020 Overview of comments: Draft 1 - Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance'
23/11/2020 Lapatinib product-specific bioequivalence guidance
23/11/2020 Palbociclib product-specific bioequivalence guidance
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
23/11/2020 Agenda: Agenda - PRAC draft agenda of meeting 23-26 November 2020
23/11/2020 Human medicines European public assessment report (EPAR): Skyrizi, Risankizumab, Psoriasis, 26/04/2019, Additional monitoring, 4, Authorised
23/11/2020 News and press releases: Workshop on regulatory support for development of orphan medicines
23/11/2020 Scientific guideline: Abiraterone acetate tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1
23/11/2020 Abiraterone acetate product-specific bioequivalence guidance
23/11/2020 Overview of comments: Overview of comments received on 'Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance' - Revision 1
23/11/2020 Human medicines European public assessment report (EPAR): Insulatard, insulin human, Diabetes Mellitus, 07/10/2002, 20, Authorised
23/11/2020 Human medicines European public assessment report (EPAR): Yellox, bromfenac sodium sesquihydrate, Pain, Postoperative, Ophthalmologic Surgical Procedures, 18/05/2011, 10, Authorised
23/11/2020 Human medicines European public assessment report (EPAR): Ribavirin Teva, Ribavirin, Hepatitis C, Chronic, 31/03/2009, Generic, 14, Authorised
23/11/2020 Human medicines European public assessment report (EPAR): NovoRapid, insulin aspart, Diabetes Mellitus, 07/09/1999, 31, Authorised
23/11/2020 Public Statement: Public statement on Ribavirin Mylan: Withdrawal of the marketing authorisation in the European Union
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
23/11/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC
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
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): 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
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
20/11/2020 Veterinary medicines European public assessment report (EPAR): Aivlosin, tylvalosin, 09/09/2004, 31, Authorised
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
20/11/2020 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 48, Authorised
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 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 9-12 November 2020
20/11/2020 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 4, Authorised
20/11/2020 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir, ritonavir, HIV Infections, 14/01/2016, Generic, 10, Authorised
20/11/2020 News and press releases: Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) - deadline extended
20/11/2020 Pharmacovigilance Risk Assessment Committee (PRAC)
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
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
19/11/2020 Template or form: Day 80 assessment report - Clinical template with guidance rev.02.20
19/11/2020 Report: Medicinal products for human use: monthly figures - October 2020
19/11/2020 Minutes: Minutes of the PRAC meeting 11-14 May 2020
19/11/2020 Veterinary medicines European public assessment report (EPAR): Activyl Tick Plus, indoxacarb, permethrin, 09/01/2012, 8, Authorised
19/11/2020 Human medicines European public assessment report (EPAR): Spedra, avanafil, Erectile Dysfunction, 21/06/2013, 26/04/2013, 12, Authorised
19/11/2020 Orphan designation: Retinol palmitate for the: Prevention of bronchopulmonary dysplasia, 27/07/2020, Positive
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: 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 News and press releases: EMA organises public meeting on COVID-19 vaccines
19/11/2020 Other: EMA considerations on COVID-19 vaccine approval
19/11/2020 EMA considerations on COVID-19 vaccine approval
19/11/2020 Multidisciplinary: vaccines
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 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 29, Authorised
19/11/2020 Other: Quality Review of Documents (QRD) working group plenary meeting dates
18/11/2020 Pharmacovigilance Inspectors Working Group
18/11/2020 Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 18, Authorised
18/11/2020 Other: List of acronyms and abbreviations used in CVMP agenda and minutes
18/11/2020 Regulatory and procedural guideline: Remote pharmacovigilance inspections of MAHs during a crisis situation - Points to consider
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
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
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 15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance , from 30/10/2020 to 30/10/2020
18/11/2020 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 23, Authorised
18/11/2020 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 39, Authorised
18/11/2020 Other: Declaration of interest: Irene Rager
18/11/2020 Other: Declaration of interests: Emer Cooke
18/11/2020 Other: Declaration of interests: Angela-Christina Schmidt
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
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
18/11/2020 News and press releases: EMA marks European Antibiotic Awareness Day
18/11/2020 Antimicrobial resistance
18/11/2020 Leaflet: Responsible use of antibiotics: what’s your role? - Infocards
18/11/2020 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, 24/02/2009, 22, Authorised
17/11/2020 Veterinary medicines European public assessment report (EPAR): Vectra 3D, dinotefuran, pyriproxyfen, permethrin, 04/12/2013, 5, Authorised
17/11/2020 Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/12/2009, 11, Authorised
17/11/2020 Human medicines European public assessment report (EPAR): Evicel, human fibrinogen, human thrombin, Hemostasis, Surgical, 05/10/2008, 16, Authorised
17/11/2020 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 13, Authorised
17/11/2020 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 12, Authorised
17/11/2020 Referrals document: Ulipristal acetate 5mg medicinal products Article-31 referral - Amendments to the relevant sections of the product information (Annex III)
17/11/2020 Scientific guideline: Draft 2 - Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance
16/11/2020 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, Additional monitoring, 11, Authorised
16/11/2020 Referral: Picato , ingenol mebutate , Article 20 procedures, European Commission final decision, 30/04/2020, 06/07/2020, 16/11/2020
16/11/2020 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, 1, Authorised
16/11/2020 Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 28/06/2017, Orphan, Additional monitoring, 7, Authorised
16/11/2020 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, Accelerated assessment, 37, Authorised
16/11/2020 Human medicines European public assessment report (EPAR): Memantine LEK, memantine hydrochloride, Alzheimer Disease, 21/04/2013, 21/02/2013, Generic, 5, Authorised
16/11/2020 News and press releases: EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
16/11/2020 Committee for Herbal Medicinal Products (HMPC): 16-18 November 2020 , Virtual meeting, from 16/11/2020 to 18/11/2020
16/11/2020 Agenda: Agenda - HMPC agenda of the 16-18 November 2020 meeting
16/11/2020 Regulatory and procedural guideline: IRIS guide for parallel distribution applicants
16/11/2020 Frequently asked questions about parallel distribution
16/11/2020 Agenda: Agenda - PDCO agenda of the 10-13 November 2020 meeting
16/11/2020 Agenda: Agenda - PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update
16/11/2020 News and press releases: Emer Cooke takes office as head of EMA
16/11/2020 Evaluation of anticancer medicinal products in man
16/11/2020 Scientific guideline: Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6
16/11/2020 Other: Appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products - Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8
16/11/2020 Executive Director
13/11/2020 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 34, Authorised
13/11/2020 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, 3, Authorised
13/11/2020 Standard Operating Procedure - SOP: Standard operating procedure for orphan medicinal product designation and amendment of an existing orphan medicinal product designation
13/11/2020 Paediatric investigation plans: questions and answers
13/11/2020 Report: Applications for new human medicines under evaluation by the CHMP: November 2020
13/11/2020 Other: Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae
13/11/2020 Other: Letter from the chairs of EMA's Management Board to Guido Rasi at the end of his term as EMA's Executive Director
13/11/2020 Other: Pharmacovigilance plan of the EU Regulatory Network for COVID-19 vaccines
13/11/2020 Other: Consideration on core requirements for RMPs of COVID-19 vaccines
13/11/2020 News and press releases: EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
13/11/2020 Pharmacovigilance: Overview
13/11/2020 Risk management plans
13/11/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020
13/11/2020 Summary of opinion: Gamifant, 23/07/2020, Negative
13/11/2020 Withdrawn application: Roctavian, Valoctocogene roxaparvovec, Date of withdrawal: 04/11/2020, Initial authorisation
13/11/2020 Withdrawn application: Tibsovo, ivosidenib, Date of withdrawal: 13/10/2020, Initial authorisation
13/11/2020 News and press releases: Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
13/11/2020 News and press releases: Message from EMA’s outgoing Executive Director, Guido Rasi
13/11/2020 News and press releases: Ulipristal acetate for uterine fibroids: EMA recommends restricting use
13/11/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 9-12 November 2020
13/11/2020 Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Prostatic Neoplasms, Castration-Resistant, 27/03/2020, Additional monitoring, 2, Authorised
13/11/2020 Human medicines European public assessment report (EPAR): Forsteo, teriparatide, Osteoporosis, Osteoporosis, Postmenopausal, 10/06/2003, 22, Authorised
13/11/2020 Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Breast Neoplasms, 31/08/2018, Additional monitoring, 6, Authorised
13/11/2020 Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 6, Authorised
13/11/2020 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 7, Authorised
13/11/2020 Regulatory and procedural guideline: Guidance on paediatric submissions
12/11/2020 Veterinary medicines European public assessment report (EPAR): Frontpro (previously known as Afoxolaner Merial), afoxolaner, 20/05/2019, 3, Authorised
12/11/2020 Human medicines European public assessment report (EPAR): Cholib, fenofibrate, simvastatin, Dyslipidemias, 26/08/2013, 12, Authorised
12/11/2020 Human medicines European public assessment report (EPAR): Repaglinide Krka, repaglinide, Diabetes Mellitus, Type 2, 03/11/2009, Generic, 6, Authorised
12/11/2020 Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 28, Authorised
12/11/2020 Report: Report - Workshop on benefit-risk of medicines used during pregnancy and breastfeeding
12/11/2020 Workshop on benefit-risk of medicines used during pregnancy and breastfeeding , Virtual meeting, from 22/09/2020 to 22/09/2020
12/11/2020 Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Diabetes Mellitus, 23/03/2018, Additional monitoring, Biosimilar, 5, Authorised
12/11/2020 Referral: Betamox LA 150 mg/ml suspension for injection and associated names, and generics products thereof , Amoxicillin trihydrate , Article 35, European Commission final decision, 16/07/2020, 12/10/2020
12/11/2020 Direct healthcare professional communication (DHPC): Tecfidera (dimethyl fumarate): Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia , Active substance: dimethyl fumarate, DHPC type: Type II variation, Last updated: 12/11/2020
12/11/2020 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, Additional monitoring, 9, Authorised
12/11/2020 Human medicines European public assessment report (EPAR): Veltassa, patiromer sorbitex calcium, Hyperkalemia, 19/07/2017, Additional monitoring, 2, Authorised
12/11/2020 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Crohn Disease, Arthritis, Psoriatic, Colitis, Ulcerative, 13/08/1999, 56, Authorised
12/11/2020 Human medicines European public assessment report (EPAR): NovoMix, insulin aspart, Diabetes Mellitus, 01/08/2000, 28, Authorised
12/11/2020 Minutes: Minutes of the CVMP meeting of 6-7 October 2020
12/11/2020 Committee for Orphan Medicinal Products (COMP): 8-10 September 2020 , Virtual meeting, from 08/09/2020 to 10/09/2020
12/11/2020 Minutes: Minutes of the COMP meeting 8-10 September 2020
12/11/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: November 2020
12/11/2020 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
12/11/2020 Regulatory and procedural guideline: Draft concept paper on the reporting of antimicrobial sales and use in animals at the EU level
11/11/2020 Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa) for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome), 21/03/2012, Positive