News & events

What's new

RSS
Feb 2019 (38) Mar 2019 (220) Apr 2019 (273) May 2019 (232) Jun 2019 (305) Jul 2019 (229) Aug 2019 (198) Sep 2019 (146) Oct 2019 (412) Nov 2019 (404) Dec 2019 (211) Jan 2020 (440) Feb 2020 (271)
Date Content
21/02/2020 Maximum Residue Limits - Summary of opinion: Bupivacaine - Summary opinion of the CVMP on the establishment of maximum residue limits (new)
21/02/2020 Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 23, Authorised (updated)
21/02/2020 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 2020
21/02/2020 Summary of opinion: Clynav, Salmon pancreas disease vaccine (recombinant DNA plasmid), 20/02/2020, Positive
21/02/2020 Summary of opinion: Vectormune FP ILT + AE, fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live), 20/02/2020, Positive
21/02/2020 Summary of opinion: Tulissin, tulathromycin, 20/02/2020, Positive
21/02/2020 Summary of opinion: Tulaven, tulathromycin, 20/02/2020, Positive
21/02/2020 Human medicines European public assessment report (EPAR): Levetiracetam Accord, levetiracetam, Epilepsy, 03/10/2011, Generic, 11, Authorised (updated)
21/02/2020 Human medicines European public assessment report (EPAR): Fycompa, perampanel, Epilepsies, Partial, 23/07/2012, 16, Authorised (updated)
21/02/2020 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 20/03/2014, 18, Authorised (updated)
21/02/2020 Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 13/02/2020, Generic, Authorised
21/02/2020 From data to evidence in medicines regulation , European Medicines Agency, Amsterdam, The Netherlands, from 22/04/2020 to 22/04/2020
21/02/2020 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, 3, Authorised (updated)
21/02/2020 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, 20, Authorised (updated)
21/02/2020 Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, 01/10/2008, 12, Authorised (updated)
21/02/2020 Hexaxim H-W-2495 (updated)
21/02/2020 Human medicines European public assessment report (EPAR): Hexacima, diphtheria toxoid / tetanus toxoid, two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin ) / inactivated poliomyelitis virus types 1,2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein, hepatitis-B surface antigen, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 19, Authorised (updated)
21/02/2020 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia, 19/11/2015, Generic, 5, Authorised (updated)
21/02/2020 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 11, Authorised (updated)
21/02/2020 Periodic safety update single assessment: Clebopride: List of nationally authorised medicinal products - PSUSA/00000789/201906 (new)
21/02/2020 Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, Orphan, Additional monitoring, Exceptional circumstances, 16, Authorised (updated)
20/02/2020 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, 12/01/2005, 53, Authorised (updated)
20/02/2020 Human medicines European public assessment report (EPAR): Lifmior, etanercept, Arthritis, Psoriatic, Spondylitis, Ankylosing, Psoriasis, 13/02/2017, Additional monitoring, 8, Withdrawn (updated)
20/02/2020 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, Additional monitoring, 19, Authorised (updated)
20/02/2020 Direct healthcare professional communication: Risks associated with systemic exposure to estradiol creams (new)
20/02/2020 Good manufacturing practice (updated)
20/02/2020 Human medicines European public assessment report (EPAR): Cialis, tadalafil, Erectile Dysfunction, 12/11/2002, 27, Authorised (updated)
20/02/2020 Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Cystic Fibrosis, Respiratory Tract Infections, 25/03/2015, Additional monitoring, 10, Authorised (updated)
20/02/2020 Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201907 (new)
19/02/2020 Report: Applications for new human medicines under evaluation by the CHMP: February 2020 (updated)
19/02/2020 Committee for Advanced Therapies (CAT): 19-21 February 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 19/02/2020 to 21/02/2020 (updated)
19/02/2020 Agenda: Agenda - CAT agenda of the 19-21 February 2020 meeting (new)
19/02/2020 Pharmacovigilance Risk Assessment Committee (PRAC): 30 September-3 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 30/09/2019 to 03/10/2019 (updated)
19/02/2020 Minutes: Minutes of the PRAC meeting 30 September-03 October 2019 (new)
19/02/2020 Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, Exceptional circumstances, 3, Authorised (updated)
19/02/2020 Human medicines European public assessment report (EPAR): Sirturo, bedaquiline fumarate, Tuberculosis, Multidrug-Resistant, 05/03/2014, Orphan, Additional monitoring, Conditional approval, 16, Authorised (updated)
19/02/2020 Human medicines European public assessment report (EPAR): NeuroBloc, botulinum toxin type B, Torticollis, 22/01/2001, 32, Authorised (updated)
19/02/2020 Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Erectile Dysfunction, 22/03/2017, 2, Authorised (updated)
19/02/2020 Other: European Medicines Agency’s privacy statement for the pre-employment medical examination (new)
19/02/2020 Orphan designation: Combretastatin A1 diphosphate- for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive (updated)
19/02/2020 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary biliary cirrhosis, 22/08/2014, Positive (updated)
19/02/2020 Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine for the: Treatment of fragile X syndrome, 20/04/2017, Positive (updated)
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing the human CNGB3 gene for the: Treatment of achromatopsia caused by mutations in the CNGB3 gene, 08/02/2013, Positive (updated)
19/02/2020 Orphan designation: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol (fosbretabulin tromethamine) for the: Treatment of anaplastic thyroid cancer, 14/04/2004, Positive (updated)
19/02/2020 Orphan designation: Ovine specific immunoglobulin (Fab) fragments raised against Vipera berus veno for the: Treatment of snakebite envenomation, 09/10/2015, Positive (updated)
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene for the: Treatment of congenital alpha-1 antitrypsin deficiency, 20/03/2007, Positive (updated)
19/02/2020 Orphan designation: Fosbretabulin tromethamine for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours, 21/03/2016, Positive (updated)
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing the human retinoschisin gene for the: Treatment of X-linked juvenile retinoschisis, 12/03/2013, Positive (updated)
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene for the: Treatment of achromatopsia caused by mutations in the CNGA3 gene, 09/10/2015, Positive (updated)
19/02/2020 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary sclerosing cholangitis, 14/12/2015, Positive (updated)
19/02/2020 Orphan designation: Fosbretabulin tromethamine for the: Treatment of ovarian cancer, 17/07/2013, Positive (updated)
19/02/2020 Orphan designation: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha) for the: Treatment of glioma, 19/02/2014, Positive (updated)
19/02/2020 Orphan designation: Recombinant adeno-associated viral vector containing the human RPGR gene for the: Treatment of retinitis pigmentosa caused by mutations in the RPGR gene, 30/05/2016, Positive (updated)
19/02/2020 Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020, Generic, Authorised
18/02/2020 Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 30/11/2009, 16, Authorised (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Isturisa, Osilodrostat phosphate, Cushing Syndrome, 09/01/2020, Orphan, Additional monitoring, Authorised
18/02/2020 Veterinary medicines European public assessment report (EPAR): Vectormune ND, cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, 08/09/2015, 5, Authorised (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 15, Authorised (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Iblias, octocog alfa, Hemophilia A, 18/02/2016, Additional monitoring, 4, Withdrawn (updated)
18/02/2020 ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5 (updated)
18/02/2020 Scientific guideline: ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5 - Revision 3 (new)
18/02/2020 ICH E9 statistical principles for clinical trials (updated)
18/02/2020 Scientific guideline: ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials Step 5 (new)
18/02/2020 Agenda: Agenda - CVMP agenda of the 18-20 February 2020 meeting (new)
18/02/2020 Other: EU Innovation Network: E-mail addresses for users (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Nonafact, human coagulation factor IX, Hemophilia B, 03/07/2001, 9, Withdrawn (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Beovu, brolucizumab, Wet Macular Degeneration, 13/02/2020, Additional monitoring, Authorised
18/02/2020 Orphan designation: Milatuzumab for the: Treatment of chronic lymphocytic leukaemia, 19/01/2009, Withdrawn (updated)
18/02/2020 Orphan designation: Milatuzumab for the: Treatment of multiple myeloma, 19/01/2009, Withdrawn (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, Additional monitoring, 6, Authorised (updated)
18/02/2020 Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, Additional monitoring, Authorised (updated)
18/02/2020 Regulatory and procedural guideline: Checklist for sponsors applying for the transfer of orphan medicinal product designation (updated)
17/02/2020 Other: European Commission-DG Health and Food Safety and European Medicines Agency action plan on advanced therapy medicinal products (ATMPs) (updated)
17/02/2020 Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (updated)
17/02/2020 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, 12, Authorised (updated)
17/02/2020 Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation (updated)
17/02/2020 Agenda: Agenda - COMP agenda of the 18-20 February 2020 meeting (new)
17/02/2020 Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, Generic, 15, Authorised (updated)
17/02/2020 Template or form: Mutual-recognition, decentralised and referral product-information template version 4.1 (updated)
17/02/2020 Human medicines European public assessment report (EPAR): Sycrest, asenapine maleate , Bipolar Disorder, 01/09/2010, 16, Authorised (updated)
17/02/2020 Withdrawn application: Opsumit, macitentan, Date of withdrawal: 08/11/2019, Post-authorisation (updated)
17/02/2020 Periodic safety update single assessment: Ganciclovir: List of nationally authorised medicinal products - PSUSA/00001516/201906 (new)
17/02/2020 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 19, Authorised (updated)
17/02/2020 Periodic safety update single assessment: Human plasma proteins with not less than 95% albumin: List of nationally authorised medicinal products - PSUSA/00010605/201907 (new)
17/02/2020 Other: HMPC: overview of assessment work - priority list (updated)
17/02/2020 Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 15, Authorised (updated)
17/02/2020 Other: List of signals discussed at PRAC since September 2012 (updated)
17/02/2020 Periodic safety update single assessment: Octenidine: List of nationally authorised medicinal products - PSUSA/00010748/201907 (new)
14/02/2020 Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, Hidradenitis Suppurativa, 13/02/2020, Biosimilar, Authorised
14/02/2020 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 7, Authorised (updated)
14/02/2020 Other: European Medicines Agency’s privacy statement public and targeted consultations (new)
14/02/2020 Use of herbal medicinal products containing estragole (updated)
14/02/2020 Other: Second draft - Revision 1: Public statement on the use of herbal medicinal products containing estragole (new)
14/02/2020 Overview of comments: Overview of comments received on the draft revised Public statement on the use of herbal medicinal products containing estragole (EMA/HMPC/137212/2005 Rev 1) (new)
14/02/2020 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 14/02/2020 (updated)
14/02/2020 Direct healthcare professional communications
14/02/2020 News and press releases: Restrictions in use of cyproterone due to meningioma risk
14/02/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020
14/02/2020 Human medicines European public assessment report (EPAR): Zalmoxis, Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation, Graft vs Host Disease, 18/08/2016, Conditional approval, 1, Withdrawn (updated)
14/02/2020 Human medicines European public assessment report (EPAR): Zejula, niraparib tosylate monohydrate, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 7, Authorised (updated)
14/02/2020 Periodic safety update single assessment: Rocuronium : List of nationally authorised medicinal products - PSUSA/00002656/201902 (new)
14/02/2020 Periodic safety update single assessment: Rocuronium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002656/201902 (new)
13/02/2020 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib s-malate, Carcinoma, Renal Cell, 09/09/2016, Accelerated assessment, Additional monitoring, 7, Authorised (updated)
13/02/2020 Report: Information Management Strategy 2020-2022 (new)
13/02/2020 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 12, Authorised (updated)
13/02/2020 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 6, Authorised (updated)
13/02/2020 Human medicines European public assessment report (EPAR): Seebri Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 10, Authorised (updated)
13/02/2020 Template or form: Connecting to the Agency ESTRI Gateway using an AS2 compatible product (updated)
13/02/2020 Veterinary medicines European public assessment report (EPAR): Draxxin, tulathromycin, 11/11/2003, 22, Authorised (updated)
13/02/2020 Orphan designation: Replication-incompetent, non-integrating, herpes simplex virus 1 vector expressing the human transglutaminase-1 enzyme for the: Treatment of autosomal recessive congenital ichthyosis, 13/11/2019, Positive
13/02/2020 Orphan designation: Ganaxolone for the: Treatment of CDKL5 deficiency disorder, 13/11/2019, Positive
13/02/2020 Orphan designation: Exendin (9-39) for the: Treatment of congenital hyperinsulinism, 13/11/2019, Positive
13/02/2020 Orphan designation: Chimeric fibril-reactive IgG1k monoclonal antibody 11-1F4 for the: Treatment of AL amyloidosis, 13/11/2019, Positive
13/02/2020 Orphan designation: Camsirubicin for the: Treatment of soft tissue sarcoma, 13/11/2019, Positive
13/02/2020 Orphan designation: Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19) for the: Treatment of mantle cell lymphoma, 13/11/2019, Positive
12/02/2020 Orphan designation: (2S,3R,4R,5S)-2-(hydroxymethyl)-1-pentylpiperidine-3,4,5-triol for the: Treatment of GM2 gangliosidosis, 13/11/2019, Positive
12/02/2020 Orphan designation: 4-((E)-(5-(2-(2-((S)-2-((S)-1-(L-threonyl-L-lysyl)pyrrolidine-2-carboxamido)-5-guanidinopentanamido)acetamido)-2-carboxyethyl)-2-hydroxyphenyl)diazenyl)phenyl (2-(trimethylammonio)ethyl) phosphate for the: Treatment of non-infectious uveitis, 13/11/2019, Positive
12/02/2020 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 3, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, Additional monitoring, 13, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans, Protein C Deficiency, 15/07/2001, 14, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 15, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Temybric Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 12/06/2019, Additional monitoring, 1, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 4, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 16, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 3, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, Biosimilar, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 15, Authorised (updated)
12/02/2020 EudraVigilance Veterinary (updated)
12/02/2020 News and press releases: Public access to suspected side effect reports of veterinary medicines
12/02/2020 Human medicines European public assessment report (EPAR): NutropinAq, somatropin, Turner Syndrome, Dwarfism, Pituitary, 15/02/2001, 17, Authorised (updated)
12/02/2020 Veterinary medicines European public assessment report (EPAR): Inflacam, meloxicam, 09/12/2011, Generic, 10, Authorised (updated)
12/02/2020 Veterinary medicines European public assessment report (EPAR): Rheumocam, meloxicam, 10/01/2008, Generic, 13, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): MabThera, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 48, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Revolade, Eltrombopag, Purpura, Thrombocytopenic, Idiopathic, 11/03/2010, Orphan, 24, Authorised (updated)
12/02/2020 Substances and products data management services (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Zoledronic acid Teva, zoledronic acid, Fractures, Bone, Cancer, 16/08/2012, Generic, 12, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 4, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/03/2017, Additional monitoring, 8, Authorised (updated)
12/02/2020 Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA synthetase for the: Treatment of limb-girdle muscular dystrophy, 27/02/2017, Withdrawn (updated)
12/02/2020 Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase for the: treatment of facioscapulohumeral muscular dystrophy, 12/02/2015, Withdrawn (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, 1, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Glivec, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 07/11/2001, Additional monitoring, 37, Authorised (updated)
12/02/2020 Orphan designation: 2-Hydroxyoleic acid for the: Treatment of glioma, 27/10/2011, Positive (updated)
12/02/2020 Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo for the: Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Withdrawn (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, 24, Authorised (updated)
12/02/2020 Human medicines European public assessment report (EPAR): Votubia, everolimus, Tuberous Sclerosis, 02/09/2011, Orphan, 25, Authorised (updated)
12/02/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2020 (new)
12/02/2020 Scientific publications (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 19, Authorised (updated)
11/02/2020 Human medicines European public assessment report (EPAR): GONAL-f, follitropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female, Hypogonadism, 20/10/1995, 23, Authorised (updated)
11/02/2020 Veterinary medicines European public assessment report (EPAR): Stelfonta, tigilanol tiglate, 15/01/2020, Authorised
11/02/2020 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption, Osteoporosis, Postmenopausal, 26/05/2010, 22, Authorised (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Infertility, Hypogonadism, 02/05/1996, 27, Authorised (updated)
11/02/2020 Plasma master file certificates (updated)
11/02/2020 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, 3, Authorised (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 5, Authorised (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Tavlesse, Fostamatinib disodium, Thrombocytopenia, 09/01/2020, Authorised
11/02/2020 Orphan designation: lenalidomide for the: Treatment of follicular lymphoma, 24/01/2013, Withdrawn (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, Additional monitoring, 18, Authorised (updated)
11/02/2020 Orphan designation: Beraprost sodium for the: Treatment of pulmonary arterial hypertension, 10/07/2008, Withdrawn (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes, 14/06/2007, Additional monitoring, 40, Authorised (updated)
11/02/2020 Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1 (new)
11/02/2020 Regulatory and procedural guideline: Product Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 (new)
11/02/2020 Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 6 (new)
11/02/2020 Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7 (new)
11/02/2020 Regulatory and procedural guideline: Substances, Products, Organisations, Referentials (SPOR): SPOR API v2 Specification (new)
11/02/2020 Regulatory and procedural guideline: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide (new)
11/02/2020 Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, Orphan, Additional monitoring, 14, Authorised (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 26, Authorised (updated)
11/02/2020 Other: Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
11/02/2020 Other: Nominations to the European Union Telematics governance bodies (updated)
11/02/2020 ICH M9 on biopharmaceutics classification system based biowaivers (updated)
11/02/2020 Other: Article 57 product data (updated)
11/02/2020 Report: List of products granted eligibility to PRIME (updated)
11/02/2020 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 27-30 January 2020 (new)
11/02/2020 Human medicines European public assessment report (EPAR): Evotaz, atazanavir sulfate, cobicistat, HIV Infections, 13/07/2015, Additional monitoring, 8, Authorised (updated)
11/02/2020 Withdrawn application: Xyndari, glutamine, Date of withdrawal: 18/09/2019, Initial authorisation (updated)
11/02/2020 Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 18/09/2013, 14, Authorised (updated)
11/02/2020 Rewards and incentives for paediatric medicines (updated)
11/02/2020 Template or form: Dossier administrative validation checklist (updated)
11/02/2020 Work programme: Committee for Medicinal Products for Human Use (CHMP): Work Plan 2020 (new)
10/02/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 13-16 January 2020 PRAC meeting (new)
10/02/2020 Newsletter: Human medicines highlights - February 2020 (new)
10/02/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2019 (new)
10/02/2020 Agenda: Agenda - PRAC draft agenda of meeting 10-13 February 2020 (new)
10/02/2020 Minutes: Minutes - PDCO minutes of the 23-26 July 2019 meeting (new)
10/02/2020 Minutes: Minutes - PDCO minutes of the 17-20 September 2019 meeting (new)
10/02/2020 Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, Additional monitoring, 4, Authorised (updated)
10/02/2020 Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 17, Authorised (updated)
10/02/2020 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Position provided by CMDh, 30/01/2020, 10/02/2020 (updated)
10/02/2020 Regulatory and procedural guideline: Member states contact points for translations review (updated)
10/02/2020 Report: Final programming document 2020-2022 (new)
10/02/2020 Human medicines European public assessment report (EPAR): Humalog, insulin lispro, Diabetes Mellitus, 30/04/1996, 30, Authorised (updated)
10/02/2020 Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, 18/05/2018, Additional monitoring, Biosimilar, 5, Authorised (updated)
07/02/2020 Template or form: Day 80 assessment report - Clinical template with guidance rev.02.20 (updated)
07/02/2020 Other: European Medicines Agency's privacy statement for the organisation of meetings and events (new)
07/02/2020 Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Tyrosinemias, 20/02/2005, Orphan, 17, Authorised (updated)
07/02/2020 Withdrawn application: Idhifa, enasidenib, Date of withdrawal: 06/12/2019, Initial authorisation (updated)
07/02/2020 Application withdrawal assessment report: Withdrawal assessment report for Idhifa (new)
06/02/2020 Pre-authorisation guidance (updated)
06/02/2020 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
06/02/2020 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
06/02/2020 Human medicines European public assessment report (EPAR): Baqsimi, Glucagon, Diabetes Mellitus, 16/12/2019, Authorised
06/02/2020 Human medicines European public assessment report (EPAR): Ulunar Breezhaler, Glycopyrronium bromide, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 23/04/2014, 13, Authorised (updated)
06/02/2020 Human medicines European public assessment report (EPAR): Zavesca, miglustat, Gaucher Disease, Niemann-Pick Diseases, 20/11/2002, 16/06/2009, 30, Authorised (updated)
06/02/2020 Press Release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 2020 (updated)
06/02/2020 Regulatory and procedural guideline: Labelling-exemption requests under Article 63 of Directive 2001/83/EC examined by the Quality Review of Documents group (updated)
05/02/2020 Veterinary medicines European public assessment report (EPAR): Eravac, For active immunisation of rabbits against Rabbit haemorrhagic disease type 2 virus (RHDV2)For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2), 22/09/2016, 4, Authorised (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, 20/11/2018, 2, Authorised (updated)
05/02/2020 Template or form: Template - Orphan designation sponsor’s name and/or address change notification letter (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 12, Authorised (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Diabetes Mellitus, Type 2, 23/08/2011, 15, Authorised (updated)
05/02/2020 Other: About us - European Medicines Agency (EMA) (updated)
05/02/2020 Quality of medicines questions and answers: Part 1 (updated)
05/02/2020 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
05/02/2020 Orphan designation: Bromelain for the: Treatment of pseudomyxoma peritonei, 14/12/2018, Positive (updated)
05/02/2020 Orphan designation: Acetylcysteine for the: Treatment of pseudomyxoma peritonei, 14/12/2018, Positive (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Jivi, Damoctocog alfa pegol, Hemophilia A, 22/11/2018, Additional monitoring, 1, Authorised (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, 23/08/2012, 18, Authorised (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Renvela, sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 09/06/2009, 21, Authorised (updated)
05/02/2020 Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 29/05/2006, Additional monitoring, Exceptional circumstances, 27, Authorised (updated)
05/02/2020 Withdrawn application: Nuzyra, omadacycline, Date of withdrawal: 17/10/2019, Initial authorisation (updated)
05/02/2020 Herbal medicinal product: Combination: Valerianae radix and Lupuli flos, Combination: Valerianae radix and Lupuli flos, F: Assessment finalised (updated)
04/02/2020 Coronavirus disease (COVID-19)
04/02/2020 News and press releases: EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19)
04/02/2020 Human medicines European public assessment report (EPAR): Myocet liposomal (previously Myocet), doxorubicin hydrochloride, Breast Neoplasms, 13/07/2000, 21, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Fexeric, ferric citrate coordination complex, Hyperphosphatemia, Renal Dialysis, 23/09/2015, Additional monitoring, 2, Withdrawn (updated)
04/02/2020 Summary of opinion: Azacitidine Mylan, azacitidine, 30/01/2020, Positive (updated)
04/02/2020 Referral: Lemtrada ,  alemtuzumab , Article 20 procedures, European Commission final decision, 14/11/2019, 16/01/2020, 04/02/2020 (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 29, Authorised (updated)
04/02/2020 Orphan designation: Deferiprone for the: Treatment of neurodegeneration with brain iron accumulation, 27/06/2018, Positive (updated)
04/02/2020 Orphan designation: Deferiprone for the: Treatment of sickle cell disease, 23/02/2011, Positive (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Pylobactell, 13C-urea, Breath Tests, Helicobacter Infections, 07/05/1998, 11, Authorised (updated)
04/02/2020 Other: European authorities working to avoid shortages of medicines due to Brexit – Questions and answers (updated)
04/02/2020 Minutes: Minutes of the CVMP meeting of 3-5 December 2019 (new)
04/02/2020 Minutes: Minutes of the PRAC meeting 2-5 September 2019 (new)
04/02/2020 Report: European Medicines Agency budget for 2020 (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 14, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Zynquista, Sotagliflozin, Diabetes Mellitus, Type 1, 26/04/2019, Additional monitoring, 1, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Breast Neoplasms, 06/05/2019, Generic, 3, Authorised (updated)
04/02/2020 Extended EudraVigilance medicinal product dictionary (XEVMPD) training (updated)
04/02/2020 eXtended EudraVigilance Medicinal Product Dictionary training course (Lisbon) , Lisbon, Portugal, from 14/05/2020 to 15/05/2020
04/02/2020 eXtended EudraVigilance Medicinal Product Dictionary training course (Amsterdam) , European Medicines Agency, Amsterdam, the Netherlands, from 18/06/2020 to 19/06/2020
04/02/2020 eXtended EudraVigilance Medicinal Product Dictionary training course (Munich) , Munich, Germany, from 02/07/2020 to 03/07/2020
04/02/2020 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, Generic, 5, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Glycogen Storage Disease Type II, 28/03/2006, Orphan, 17, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Enurev Breezhaler, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 8, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 18, Authorised (updated)
04/02/2020 Human medicines European public assessment report (EPAR): Xiliarx, vildagliptin, Diabetes Mellitus, Type 2, 19/11/2008, 17, Authorised (updated)
04/02/2020 Orphan designation: Recombinant human monoclonal antibody against hepatitis-B virus (active ingredient lenvervimab) for the: Prevention of hepatitis-B re-infection following liver transplantation, 15/08/2013, Positive (updated)