What's new

RSS
Date Content
14/10/2019 Veterinary medicines European public assessment report (EPAR): Simparica Trio, moxidectin, sarolaner, pyrantel embonate, 17/09/2019, Authorised
14/10/2019 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 37, Authorised (updated)
14/10/2019 Template or form: Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME) (updated)
14/10/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 17-20 September 2019
14/10/2019 Orphan designation: Sodium benzoate, Sodium phenylacetate for the: Treatment of hyperargininaemia, 28/06/2019, Positive
14/10/2019 Minutes: Minutes of the CHMP meeting 22-25 July 2019
14/10/2019 Human medicines European public assessment report (EPAR): Nuceiva, botulinum toxin type a, Skin Aging, 27/09/2019, Additional monitoring, Authorised
14/10/2019 Committee for Medicinal Products for Human Use (CHMP): 22-25 July 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 22/07/2019 to 25/07/2019 (updated)
14/10/2019 Orphan designation: Sodium benzoate, Sodium phenylacetate for the: Treatment of argininosuccinic aciduria, 28/06/2019, Positive
14/10/2019 Agenda: Agenda - CHMP agenda of the 14-17 October 2019 meeting
14/10/2019 Orphan designation: regorafenib for the: Treatment of glioma, 28/06/2019, Positive
14/10/2019 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 2, Authorised (updated)
14/10/2019 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 22/07/2012, Orphan, Accelerated assessment, 19, Authorised (updated)
14/10/2019 Orphan designation: Recombinant human coagulation factor VIII Fc - von Willebrand factor - XTEN fusion protein for the: Treatment of haemophilia A, 28/06/2019, Positive
14/10/2019 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 63, Authorised (updated)
14/10/2019 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 51, Authorised (updated)
14/10/2019 Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s., pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 27/02/2017, Generic, 5, Authorised (updated)
14/10/2019 News and press releases: European Network of Paediatric Research at EMA elects new chair
11/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, Generic, 14, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Truxima, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Wegener Granulomatosis, Leukemia, Lymphocytic, Chronic, B-Cell, Microscopic Polyangiitis, 17/02/2017, Additional monitoring, Biosimilar, 9, Authorised (updated)
11/10/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019
11/10/2019 Maximum Residue Limits - Summary of opinion: Dicyclanil - Summary opinion of the CVMP on the establishment of maximum residue limits
11/10/2019 Summary of opinion: Mirataz, 11/10/2019, Positive
11/10/2019 Summary of opinion: Neptra, 11/10/2019, Positive
11/10/2019 Template or form: Letter of recommendations - Template (updated)
11/10/2019 Human medicines European public assessment report (EPAR): EndolucinBeta, lutetium (177 Lu) chloride, Radionuclide Imaging, 06/07/2016, Additional monitoring, 5, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Desloratadine Actavis, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 13/01/2012, Generic, 12, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Triumeq, abacavir sulfate, dolutegravir sodium, lamivudine, HIV Infections, 31/08/2014, Patient safety, 14, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 21/09/2017, Additional monitoring, 7, Authorised (updated)
11/10/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 2-5 September 2019 PRAC meeting (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Caelyx, doxorubicin hydrochloride, Sarcoma, Kaposi, Multiple Myeloma, Ovarian Neoplasms, Breast Neoplasms, 20/06/1996, 30, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Thyroid Neoplasms, 09/03/2000, 25, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane sulfate, tazobactam sodium, Bacterial Infections, 18/09/2015, Additional monitoring, 9, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors, 17/09/2017, Orphan, Additional monitoring, 6, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 19, Authorised (updated)
11/10/2019 Orphan designation: Dry extract from birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for the: Treatment of epidermolysis bullosa, 23/02/2011, Positive (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 1, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid, 01/10/2009, 36, Authorised (updated)
11/10/2019 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, 19/06/2015, Additional monitoring, 27, Authorised (updated)
11/10/2019 Regulatory and procedural guideline: PRIME eligibility requests: 2020 deadlines for submission and timetable for assessment
11/10/2019 2019 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA) , European Medicines Agency, Amsterdam, The Netherlands, from 14/10/2019 to 14/10/2019
11/10/2019 Template or form: European Medicines Agency active-substance-master-file-number request form (updated)
11/10/2019 Agenda: Agenda - CAT agenda of the 9-11 October 2019 meeting
11/10/2019 Supply shortage: Maci (matrix applied characterised autologous cultured chondrocytes) implant supply shortage (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, Authorised
10/10/2019 Human medicines European public assessment report (EPAR): MabThera, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 47, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam Accord, levetiracetam, Epilepsy, 03/10/2011, Generic, 10, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam Actavis, levetiracetam, Epilepsy, 03/10/2011, Generic, 14, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata, Papillomavirus Infections, Immunization, Uterine Cervical Dysplasia, 09/06/2015, Additional monitoring, 10, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Entacapone Orion, entacapone, Parkinson Disease, 18/08/2011, 8, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 16, Authorised (updated)
10/10/2019 Periodic safety update single assessment: Mesterolone: List of nationally authorised medicinal products - PSUSA/00010551/201901
10/10/2019 Human medicines European public assessment report (EPAR): Giapreza, Angiotensin II acetate, Hypotension, Shock, 23/08/2019, Additional monitoring, Authorised
10/10/2019 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 5, Authorised (updated)
10/10/2019 Periodic safety update single assessment: Interferon gamma: List of nationally authorised medicinal products - PSUSA/00001760/201901
10/10/2019 Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid serotype AAV-rh74 and a codon-optimised expression cassette to drive the expression of a secretable form of human acid alpha-glucosidase for the: Treatment of glycogen storage disease type II (Pompe's disease), 28/06/2019, Positive
10/10/2019 Human medicines European public assessment report (EPAR): Epclusa, Sofosbuvir, velpatasvir, Hepatitis C, Chronic, 06/07/2016, Accelerated assessment, Additional monitoring, 9, Authorised (updated)
10/10/2019 Orphan designation: rasagiline for the: Treatment of Duchenne muscular dystrophy, 28/06/2019, Positive
10/10/2019 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 3, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi), Lusutrombopag, Thrombocytopenia, 18/02/2019, Additional monitoring, 2, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 7, Authorised (updated)
10/10/2019 Periodic safety update single assessment: Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201903
10/10/2019 Human medicines European public assessment report (EPAR): Ventavis, iloprost, Hypertension, Pulmonary, 15/09/2003, Orphan, 27, Authorised (updated)
10/10/2019 Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Hyperammonemia, Amino Acid Metabolism, Inborn Errors, 23/06/2017, Generic, 5, Authorised (updated)
10/10/2019 Periodic safety update single assessment: Trandolapril: List of nationally authorised medicinal products - PSUSA/00003004/201902
10/10/2019 Human medicines European public assessment report (EPAR): Trogarzo, Ibalizumab, HIV Infections, 26/09/2019, Additional monitoring, Authorised
10/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Epilepsy, 07/01/2014, Generic, 12, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Tobi Podhaler, Tobramycin, Cystic Fibrosis, Respiratory Tract Infections, 20/07/2011, Orphan, 15, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 28/06/2017, Orphan, Additional monitoring, 4, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders, Autistic Disorder, 20/09/2018, 4, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia, Bipolar Disorder, 06/10/2008, Generic, 15, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Hyperkalemia, 22/03/2018, Additional monitoring, 3, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Odomzo, sonidegib diphosphate, Carcinoma, Basal Cell, 14/08/2015, Additional monitoring, 7, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Kiovig, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 18/01/2006, 23, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 12, Authorised (updated)
09/10/2019 Periodic safety update single assessment: Dorzolamide / timolol: List of nationally authorised medicinal products - PSUSA/00001166/201902
09/10/2019 Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features , European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019 (updated)
09/10/2019 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 20, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Fexeric, ferric citrate coordination complex, Hyperphosphatemia, Renal Dialysis, 23/09/2015, Additional monitoring, 2, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Pemetrexed Accord, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, Generic, 4, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014, Generic, 10, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection, Kidney Transplantation, 17/06/2011, 12, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Pregabalin Zentiva, pregabalin, Anxiety Disorders, Epilepsy, 17/07/2015, Generic, 7, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal, epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer, 27/08/2007, Biosimilar, 22, Authorised (updated)
09/10/2019 Periodic safety update single assessment: Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/201902
09/10/2019 Human medicines European public assessment report (EPAR): Olazax Disperzi, olanzapine, Schizophrenia, Bipolar Disorder, 10/12/2009, Generic, 10, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi, busulfan, Hematopoietic Stem Cell Transplantation, 22/09/2014, Generic, 6, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 10, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 12, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 30/06/2013, Generic, 15, Authorised (updated)
09/10/2019 Report: Applications for new human medicines under evaluation by the CHMP: October 2019
09/10/2019 Human medicines European public assessment report (EPAR): Mixtard, insulin human, Diabetes Mellitus, 07/10/2002, 18, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Fosavance, alendronic acid, colecalciferol, Osteoporosis, Postmenopausal, 24/08/2005, 22, Authorised (updated)
09/10/2019 Periodic safety update single assessment: Octenidine dihydrochloride 1-propanol 2-propanol: List of nationally authorised medicinal products - PSUSA/00010417/201901
09/10/2019 Periodic safety update single assessment: Ethanol-orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010416/201902
09/10/2019 Human medicines European public assessment report (EPAR): Respreeza, alpha1-proteinase inhibitor (human), Genetic Diseases, Inborn, Lung Diseases, 20/08/2015, Additional monitoring, 6, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis, Mycoses, Coccidioidomycosis, Aspergillosis, 25/10/2005, 24, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Atosiban SUN, atosiban acetate, Premature Birth, 31/07/2013, Generic, 6, Authorised (updated)
09/10/2019 Periodic safety update single assessment: Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201902
09/10/2019 Referral: Lemtrada ,  alemtuzumab , Article 20 procedures, Under evaluation, 29/04/2019, 09/10/2019 (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Zalviso, sufentanil, Pain, Postoperative, 18/09/2015, 4, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, Orphan, 17, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major, 19/06/2015, Generic, 9, Authorised (updated)
09/10/2019 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 17, Authorised (updated)
09/10/2019 European Medicines Agency (EMA) Joint Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) meeting , European Medicines Agency, Amsterdam, the Netherlands, from 25/09/2019 to 25/09/2019 (updated)
09/10/2019 European Medicines Agency (EMA) Healthcare Professionals' Working Party (HCPWP) meeting , European Medicines Agency, Amsterdam, the Netherlands, from 24/09/2019 to 24/09/2019 (updated)
09/10/2019 European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP) , European Medicines Agency, Amsterdam, the Netherlands, from 24/09/2019 to 24/09/2019 (updated)
09/10/2019 Regulatory and procedural guideline: EudraVigilance release notes v.1.20 (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Circadin, melatonin, Sleep Initiation and Maintenance Disorders, 29/06/2007, 30, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Xeristar, duloxetine, Anxiety Disorders, Depressive Disorder, Major, Diabetic Neuropathies, 17/12/2004, 28, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Protaphane, insulin human, Diabetes Mellitus, 07/10/2002, 17, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Dzuveo, sufentanil citrate, Pain, 25/06/2018, 1, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 07/06/2010, Biosimilar, 20, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Imatinib Actavis, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma, 17/04/2013, Generic, 12, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Yentreve, duloxetine hydrochloride, Urinary Incontinence, Stress, 11/08/2004, 25, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Vyxeos, daunorubicin hydrochloride / cytarabine, Leukemia, Myeloid, Acute, 23/08/2018, Orphan, 1, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Duzallo, allopurinol, lesinurad, Gout, 23/08/2018, Additional monitoring, 1, Authorised (updated)
08/10/2019 Veterinary medicines European public assessment report (EPAR): Cytopoint, lokivetmab, 25/04/2017, 4, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Lonsurf, trifluridine, tipiracil hydrochloride, Colorectal Neoplasms, 25/04/2016, Additional monitoring, 4, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, efavirenz, emtricitabine, tenofovir disoproxil, phosphate, HIV Infections, 17/07/2017, Generic, 4, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Savene, dexrazoxane hydrochloride, Extravasation of Diagnostic and Therapeutic Materials, 27/07/2006, 14, Authorised (updated)
08/10/2019 Agenda: Agenda - HMPC agenda of the 23-25 September 2019 meeting
08/10/2019 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, Additional monitoring, 13, Authorised (updated)
08/10/2019 Agenda: Agenda - CVMP agenda of the 8-10 October 2019 meeting
08/10/2019 Minutes: Minutes - PDCO minutes of the 26-29 March 2019 meeting
08/10/2019 Agenda: Agenda - COMP agenda of the 8-10 October 2019 meeting
08/10/2019 Committee for Orphan Medicinal Products (COMP): 8-10 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 08/10/2019 to 10/10/2019 (updated)
08/10/2019 Procurement (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Prevenar 13, pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18C / pneumococcal polysaccharide serotype 19A, pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F / pneumococcal polysaccharide serotype 3 / pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6A, pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 7F / pneumococcal polysaccharide serotype 9V protein, Pneumococcal Infections, Immunization, 09/12/2009, 34, Authorised (updated)
08/10/2019 Procurement: Ex ante publicity of a negotiated procedure : EMA/2019/35/ED – Executive driver services
08/10/2019 Human medicines European public assessment report (EPAR): Granpidam, sildenafil citrate, Hypertension, Pulmonary, 14/11/2016, Generic, 3, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Yervoy, Ipilimumab, Melanoma, 12/07/2011, 28, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Dexdor, dexmedetomidine hydrochloride, Conscious Sedation, 15/09/2011, 10, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 14, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Abseamed, epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer, 27/08/2007, 18/06/2009, Biosimilar, 22, Authorised (updated)
08/10/2019 Health technology assessment bodies (updated)
08/10/2019 Minutes: Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2018
08/10/2019 Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 17, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Sylvant, siltuximab, EUSA Pharma (Netherlands) BV, 22/05/2014, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Diabetes Mellitus, 24/05/2018, Orphan, 3, Authorised (updated)
08/10/2019 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel hydrogen sulphate, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke, 18/02/2015, Generic, 7, Authorised (updated)
07/10/2019 Relocation to Amsterdam (updated)
07/10/2019 United Kingdom's withdrawal from the European Union ('Brexit') (updated)
07/10/2019 Management Board meeting: 3 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 03/10/2019 to 03/10/2019 (updated)
07/10/2019 Other: Summary of transfers of appropriations in budget 2019
07/10/2019 Management Board meeting: 12-13 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 12/06/2019 to 13/06/2019 (updated)
07/10/2019 Other: Outcome of written procedures finalised during the period from 17 May 2019 to 16 September 2019
07/10/2019 Other: Charter of tasks and responsibilities of the accounting officer
07/10/2019 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 4, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Duloxetine Zentiva, duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus, 20/08/2015, Generic, 3, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 26/07/2018, Additional monitoring, Biosimilar, 3, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Multiple Myeloma, 16/03/2016, 6, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Pegasys, peginterferon alfa-2a, Hepatitis C, Chronic, Hepatitis B, Chronic, 20/06/2002, 37, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 23/02/1998, 34, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Sifrol, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 13/10/1997, 32, Authorised (updated)
07/10/2019 Veterinary medicines European public assessment report (EPAR): NexGard, afoxolaner, 10/02/2014, 9, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Moventig, naloxegol oxalate, Constipation, Opioid-Related Disorders, 07/12/2014, Additional monitoring, 10, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization, 31/03/2009, 15, Authorised (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Zoledronic acid Teva, zoledronic acid, Fractures, Bone, Cancer, 16/08/2012, Generic, 11, Authorised (updated)
07/10/2019 Orphan designation: Imidazolyl ethanamide pentandioic acid for the: Treatment of acute radiation syndrome, 28/06/2019, Positive
07/10/2019 Human medicines European public assessment report (EPAR): DepoCyte, cytarabine, Meningeal Neoplasms, 11/07/2001, 15, Withdrawn (updated)
07/10/2019 Human medicines European public assessment report (EPAR): Simulect, basiliximab, Graft Rejection, Kidney Transplantation, 09/10/1998, 23, Authorised (updated)
07/10/2019 Newsletter: Human medicines highlights - October 2019
07/10/2019 Orphan designation: Gaboxadol monohydrate for the: Treatment of Angelman syndrome, 28/06/2019, Positive
07/10/2019 List of medicines under additional monitoring (updated)
07/10/2019 Medicine for use outside EU: List of medicinal products under additional monitoring (updated)
07/10/2019 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
04/10/2019 Human medicines European public assessment report (EPAR): Reyataz, atazanavir sulphate, HIV Infections, 01/03/2004, 49, Authorised (updated)
04/10/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2019
04/10/2019 Minutes: Minutes - PDCO minutes of the 23-26 April 2019 meeting
04/10/2019 Regulatory and procedural guideline: Procedure for orphan medicinal product designation: Guidance for sponsors submitting an application via IRIS secure online portal (updated)
04/10/2019 Clinical Trial Regulation (updated)
04/10/2019 News and press releases: EMA Management Board: highlights of October 2019 meeting
04/10/2019 News and press releases: Four-week limit for use of high-strength estradiol creams
04/10/2019 Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), Para-aminosalicylic acid, Tuberculosis, 07/04/2014, Orphan, 7, Authorised (updated)
04/10/2019 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 04/10/2019 (updated)
04/10/2019 Human medicines European public assessment report (EPAR): Pifeltro, Doravirine, HIV Infections, 22/11/2018, Additional monitoring, 2, Authorised (updated)
04/10/2019 Human medicines European public assessment report (EPAR): Mektovi, binimetinib, Melanoma, 20/09/2018, Additional monitoring, 2, Authorised (updated)
04/10/2019 Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel hydrogen sulphate, Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke, 27/07/2009, Generic, 13, Authorised (updated)
04/10/2019 Orphan designation: Cannabidiol for the: Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive (updated)
04/10/2019 Orphan designation: Cannabidiol for the: Treatment of Dravet syndrome, 15/10/2014, Positive (updated)
04/10/2019 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, Authorised
04/10/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2019
03/10/2019 Training opportunities for non-EU regulators
03/10/2019 Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors , European Medicines Agency, Amsterdam, The Netherlands, from 11/11/2019 to 12/11/2019
03/10/2019 Orphan designation: S[+] apomorphine for the: Treatment of amyotrophic lateral sclerosis, 09/02/2012, Positive (updated)
03/10/2019 Orphan designation: Adeno-associated viral vector serotype 9 containing the human SMN gene for the: Treatment of spinal muscular atrophy, 19/06/2015, Positive (updated)
03/10/2019 Orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene for the: Treatment of X-linked chronic granulomatous disease, 09/02/2012, Positive (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Cetrotide, cetrorelix, Ovulation, Ovulation Induction, 12/04/1999, 26, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 3, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Desloratadine Teva, desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, 24/11/2011, Generic, 13, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, Additional monitoring, 3, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Mucopolysaccharidosis VII, 23/08/2018, Orphan, Additional monitoring, Exceptional circumstances, 2, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Epilepsy, 26/08/2011, Generic, 9, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Ravicti,  glycerol phenylbutyrate, Urea Cycle Disorders, Inborn, 26/11/2015, Orphan, Additional monitoring, 11, Authorised (updated)
03/10/2019 Periodic safety update single assessment: Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801 (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Toviaz, fesoterodine fumarate, Urinary Bladder, Overactive, 20/04/2007, 22, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Cyramza, Ramucirumab, Stomach Neoplasms, 19/12/2014, Additional monitoring, 8, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 16, Authorised (updated)
03/10/2019 Orphan designation: 5'-cEtG-sp-cEt5MeU-sp-cEt5MeU-sp-dT-sp-dA-sp-dT-sp-dT-sp-dA-sp-dT-sp-dA-sp-dG-sp-dG-sp-dG-sp-cEt5MeC-sp-cEt5MeU-sp-cEt5MeU-3' (also known as DYN101) for the: Treatment of centronuclear myopathies, 28/06/2019, Positive
03/10/2019 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 12, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira), voriconazole, Bacterial Infections and Mycoses, Aspergillosis, Candidiasis, 27/05/2015, Generic, 6, Authorised (updated)
03/10/2019 Administration and Corporate Management (updated)
03/10/2019 Other: Organisation chart: Administration and Corporate Management (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva, irbesartan, hydrochlorothiazide, Hypertension, 26/11/2009, Generic, 17, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine, tenofovir disoproxil phosphate, HIV Infections, 09/11/2016, Generic, 3, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Pramipexole Teva, pramipexole dihydrochloride monohydrate, Parkinson Disease, 18/12/2008, Generic, 19, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 21, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Intuniv, guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity, 17/09/2015, Additional monitoring, 6, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Ovaleap, follitropin alfa, Anovulation, 27/09/2013, Biosimilar, 9, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial, 22/03/2017, Generic, 5, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, 25/11/2009, 13, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Kromeya, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, 2, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease, 15/01/2009, 29, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 27/09/2017, Additional monitoring, 5, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/03/2017, Additional monitoring, 6, Authorised (updated)
03/10/2019 Human medicines European public assessment report (EPAR): Rixathon, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, 15/06/2017, Additional monitoring, Biosimilar, 3, Authorised (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, 26/07/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Pemetrexed Krka, pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 22/05/2018, Generic, 1, Authorised (updated)
02/10/2019 Orphan designation: 2-(2-{[2-(1H-benzimidazol-2-yl)ethyl]amino}ethyl)-N-[(3-fluoropyridine-2-yl)methyl]-1,3-oxazole-4-carboxamide trihydrochloride for the: Treatment of beta-thalassaemia intermedia and major, 28/06/2019, Positive
02/10/2019 Minutes: Minutes of the CHMP meeting 24-27 June 2019 (updated)
02/10/2019 Orphan designation: Reldesemtiv for the: Treatment of spinal muscular atrophy, 28/06/2019, Positive
02/10/2019 Classifications as minor-use-minor-species and limited-market (updated)
02/10/2019 Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide hydrochloride for the: Treatment of maternally-inherited diabetes and deafness, 28/06/2019, Positive
02/10/2019 Human medicines European public assessment report (EPAR): Emtriva, emtricitabine, HIV Infections, 24/10/2003, 29, Authorised (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Zoledronic acid Mylan, zoledronic acid, Fractures, Bone, 23/08/2012, Generic, 9, Authorised (updated)
02/10/2019 Orphan designation: Allogeneic anti-Epstein Barr virus cytotoxic T lymphocytes expanded ex vivo for the: Treatment of post-transplant lymphoproliferative disorder, 26/02/2019, Positive
02/10/2019 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 19, Authorised (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Tandemact, pioglitazone, glimepiride, Diabetes Mellitus, Type 2, 08/01/2007, 16, Authorised (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm GmbH, clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke, 28/07/2009, Generic, 12, Authorised (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Diabetes Mellitus, 23/03/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
02/10/2019 Minutes: Minutes of the COMP meeting 18-20 June 2019
02/10/2019 Periodic safety update reports (PSURs) (updated)
02/10/2019 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
02/10/2019 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, Additional monitoring, 13, Authorised (updated)
02/10/2019 Scientific publications (updated)
02/10/2019 News and press releases: How to ensure that novel analytic methods are fit for decision-making
02/10/2019 Periodic safety update single assessment: Ketoprofen (topical use only)
02/10/2019 Human medicines European public assessment report (EPAR): Inflectra, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 09/09/2013, Biosimilar, 23, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Clopidogrel Mylan, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 14, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Pheburane, Sodium phenylbutyrate, Carbamoyl-Phosphate Synthase I Deficiency Disease, 30/07/2013, 7, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections, Skin Diseases, Bacterial, Soft Tissue Infections, 24/04/2006, 29, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Lumark, lutetium (177 Lu) chloride, Radionuclide Imaging, 18/06/2015, Additional monitoring, 7, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Rasagiline ratiopharm, rasagiline, Parkinson Disease, 12/01/2015, 6, Authorised (updated)
01/10/2019 PIP decision: P/0090/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for ivacaftor / tezacaftor/ potassium (benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl)cyclopropyl]ethoxy}-1Hpyrazol- 1-yl)-2-[ (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Viekirax, Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic, 14/01/2015, Accelerated assessment, Additional monitoring, 18, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Ritemvia, rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis, 13/07/2017, Additional monitoring, Biosimilar, 7, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, Generic, 3, Authorised (updated)
01/10/2019 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Accelerated assessment, Additional monitoring, 1, Authorised (updated)