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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European public assessment report (EPAR): Iblias, octocog alfa, Hemophilia A, 18/02/2016, Additional monitoring, 4, Withdrawn (updated)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medicines European public assessment report (EPAR): Nonafact, human coagulation factor IX, Hemophilia B, 03/07/2001, 9, Withdrawn (updated)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18/02/2020 Orphan designation: Milatuzumab for the: Treatment of chronic lymphocytic leukaemia, 19/01/2009, Withdrawn (updated)
18/02/2020 Orphan designation: Milatuzumab for the: Treatment of multiple myeloma, 19/01/2009, Withdrawn (updated)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 Human medicines European public assessment report (EPAR): Lifmior, etanercept, Arthritis, Psoriatic, Spondylitis, Ankylosing, Psoriasis, 13/02/2017, Additional monitoring, 8, Withdrawn (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 Report: Applications for new human medicines under evaluation by the CHMP: February 2020 (new)
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)
03/02/2020 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 46, Authorised (updated)
03/02/2020 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 22/07/2012, Orphan, Accelerated assessment, 21, Authorised (updated)
03/02/2020 News and press releases: EU flags are up in EMA’s new building in Amsterdam
03/02/2020 Orphan designation: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine for the: Treatment of maple syrup urine disease, 26/10/2018, Positive (updated)
03/02/2020 Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7) for the: Treatment of epidermolysis bullosa, 20/06/2017, Positive (updated)
03/02/2020 Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7) for the: Treatment of Duchenne muscular dystrophy, 19/02/2014, Positive (updated)
03/02/2020 Veterinary medicines European public assessment report (EPAR): Apoquel, oclacitinib maleate, 12/09/2013, 6, Authorised (updated)
03/02/2020 Human medicines European public assessment report (EPAR): Fertavid, follitropin beta, Infertility, Hypogonadism, 19/03/2009, 12, Authorised (updated)
03/02/2020 Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, 23/08/2018, Orphan, Additional monitoring, 4, Authorised (updated)
03/02/2020 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 27/09/2017, Additional monitoring, 7, Authorised (updated)
03/02/2020 Recruitment: European Medicines Agency's privacy statement for selection and recruitment (updated)
03/02/2020 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 14, Authorised (updated)
03/02/2020 Classifications as minor-use-minor-species and limited-market (updated)
03/02/2020 Funding (updated)
03/02/2020 Financial management and budgetary reporting (updated)
03/02/2020 Veterinary medicines European public assessment report (EPAR): Circovac, inactivated porcine circovirus type 2 (PCV2), 21/06/2007, 10, Authorised (updated)
03/02/2020 Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen, human thrombin, Hemostasis, Surgical, 10/11/2017, Additional monitoring, 2, Authorised (updated)
03/02/2020 Herbal medicinal product: Taraxaci folium, Taraxaci folium, F: Assessment finalised (updated)
03/02/2020 Administration and Corporate Management (updated)
03/02/2020 Other: Organisation chart: Administration and Corporate Management (updated)
01/02/2020 Pharmacovigilance fees: questions and answers (updated)