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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): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 47, Authorised (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 Agenda: Agenda - Multi-stakeholder webinar to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations (new)
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 Abiraterone product-specific bioequivalence guidance (updated)
23/11/2020 Scientific guideline: Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1 (new)
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 Treatments and vaccines for COVID-19 (updated)
20/11/2020 COVID-19: latest updates (updated)
20/11/2020 Human medicines European public assessment report (EPAR): Veklury, remdesivir, Coronavirus Infections, 03/07/2020, Additional monitoring, Conditional approval, 1, 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 Guidance for medicine developers and other stakeholders on COVID-19 (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 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: 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: 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)
17/11/2020 Referral: Ulipristal acetate 5mg medicinal products , Ulipristal acetate , Article 31 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 12/11/2020, 17/11/2020 (updated)
17/11/2020 Referrals document: Ulipristal acetate 5mg medicinal products Article-31 referral - Amendments to the relevant sections of the product information (Annex III) (updated)
17/11/2020 Scientific guideline: Draft 2 - Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (updated)
16/11/2020 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 11, Authorised (updated)
16/11/2020 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, Additional monitoring, 11, Authorised (updated)
16/11/2020 Referral: Picato , ingenol mebutate , Article 20 procedures, European Commission final decision, 30/04/2020, 06/07/2020, 16/11/2020 (updated)
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, 1, Authorised (updated)
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 (updated)
16/11/2020 Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hydrochloride, Soft Tissue Infections, Skin Diseases, Bacterial, 19/02/2015, 11, Authorised (updated)
16/11/2020 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, Accelerated assessment, 37, Authorised (updated)
16/11/2020 Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid, 02/02/2000, 62, Authorised (updated)
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 (updated)
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 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, Polycythemia Vera, 23/08/2012, 21, Authorised (updated)
16/11/2020 Paediatric Committee (PDCO): 10-13 November 2020 , Virtual meeting, from 10/11/2020 to 13/11/2020 (updated)
16/11/2020 Committee for Herbal Medicinal Products (HMPC): 16-18 November 2020 , Virtual meeting, from 16/11/2020 to 18/11/2020 (updated)
16/11/2020 Agenda: Agenda - HMPC agenda of the 16-18 November 2020 meeting (new)
16/11/2020 Regulatory and procedural guideline: IRIS guide for parallel distribution applicants (updated)
16/11/2020 Agenda: Agenda - PDCO agenda of the 10-13 November 2020 meeting (new)
16/11/2020 Frequently asked questions about parallel distribution (updated)
16/11/2020 PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update , Virtual meeting, from 16/11/2020 to 16/11/2020 (updated)
16/11/2020 Agenda: Agenda - PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update (updated)
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 (updated)
16/11/2020 Scientific guideline: Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6 (new)
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 (new)
16/11/2020 EMA’s governance during COVID-19 pandemic (updated)
16/11/2020 Executive Director (updated)
16/11/2020 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
13/11/2020 Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, HIV Infections, 16/01/2014, 21, Authorised (updated)
13/11/2020 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 34, Authorised (updated)
13/11/2020 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, 3, Authorised (updated)
13/11/2020 Standard Operating Procedure - SOP: Standard operating procedure for orphan medicinal product designation and amendment of an existing orphan medicinal product designation (updated)
13/11/2020 Paediatric investigation plans: questions and answers (updated)
13/11/2020 Report: Applications for new human medicines under evaluation by the CHMP: November 2020 (new)
13/11/2020 Other: Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae (updated)
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 (new)
13/11/2020 Other: Pharmacovigilance plan of the EU Regulatory Network for COVID-19 vaccines (new)
13/11/2020 Other: Consideration on core requirements for RMPs of COVID-19 vaccines (new)
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 (updated)
13/11/2020 Risk management plans (updated)
13/11/2020 Summary of opinion: Tivicay, dolutegravir, 12/11/2020, Positive
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: Elzonris, tagraxofusp, 23/07/2020, Positive (updated)
13/11/2020 Summary of opinion: Gamifant, 23/07/2020, Negative (updated)
13/11/2020 Summary of opinion: Xarelto, rivaroxaban, 12/11/2020, Positive
13/11/2020 Summary of opinion: Phesgo, 12/11/2020, Positive
13/11/2020 Summary of opinion: Kyprolis, carfilzomib, 12/11/2020, Positive
13/11/2020 Withdrawn application: Puldysa, idebenone, Date of withdrawal: 28/10/2020, Initial authorisation