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31/07/2019 Human medicines European public assessment report (EPAR): Capecitabine Medac, capecitabine, Colorectal Neoplasms, 19/11/2012, Generic, 8, Authorised
31/07/2019 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 12, Authorised
31/07/2019 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 9, Authorised
31/07/2019 Periodic safety update single assessment: Diclofenac (systemic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001048/201809
31/07/2019 Periodic safety update single assessment: Diclofenac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001048/201809
31/07/2019 Medicines under additional monitoring: Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU)
31/07/2019 Medicines under additional monitoring: Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU)
31/07/2019 Veterinary medicines European public assessment report (EPAR): Nasym, live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56, 29/07/2019, Authorised
31/07/2019 Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies , European Medicines Agency, London, UK, from 26/11/2018 to 26/11/2018
31/07/2019 PRIME: priority medicines
31/07/2019 Report: Report: Workshop with stakeholders on support to quality development in early access approaches (i.e. PRIME, Breakthrough Therapies)
31/07/2019 News and press releases: Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published
31/07/2019 EPAR - Public assessment report: Nasym : EPAR - Public Assessment report
31/07/2019 Human medicines European public assessment report (EPAR): Tepadina, thiotepa, Hematopoietic Stem Cell Transplantation, 15/03/2010, Orphan, 12, Authorised
31/07/2019 Committee for Orphan Medicinal Products (COMP): 20-22 January 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 20/01/2020 to 22/01/2020
31/07/2019 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis, 13/01/2016, Additional monitoring, Biosimilar, 9, Authorised
31/07/2019 Other: Committee for Orphan Medicinal Products (COMP) meetings 2019, 2020 and 2021
31/07/2019 Human medicines European public assessment report (EPAR): Pantoloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 16, Authorised
31/07/2019 Committee for Orphan Medicinal Products (COMP): 16-18 July 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 16/07/2019 to 18/07/2019
31/07/2019 Human medicines European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers), Ribavirin, Hepatitis C, Chronic, 10/06/2010, Generic, 10, Authorised
31/07/2019 News and press releases: Names of liposomal medicines to be changed to avoid medication errors
31/07/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: July 2019
31/07/2019 Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Breast Neoplasms, 31/08/2018, Additional monitoring, 2, Authorised
31/07/2019 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 3, Authorised
30/07/2019 Business hours and holidays
30/07/2019 Mosquirix H-W-2300
30/07/2019 Human medicines European public assessment report (EPAR): LysaKare, L-Arginine Hydrochloride / L-Lysine Hydrochloride, Radiation Injuries, 25/07/2019, Authorised
30/07/2019 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 12, Authorised
30/07/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2019
30/07/2019 Periodic safety update single assessment: Letrozole: CMDh scientific conclusions and grounds for variation, amendments to product information and implementation timetable - PSUSA/00001842/201810
30/07/2019 Periodic safety update single assessment: Letrozole: List of nationally authorised medicinal products - PSUSA/00001842/201810
30/07/2019 Human medicines European public assessment report (EPAR): Parsabiv, etelcalcetide hydrochloride, Hyperparathyroidism, Secondary, 11/11/2016, Additional monitoring, 7, Authorised
30/07/2019 Orphan designation: Tamoxifen citrate for the: Treatment of Duchenne muscular dystrophy, 12/10/2017, Positive
30/07/2019 Orphan designation: Metformin and L-citrulline for the: Treatment of Duchenne muscular dystrophy, 17/01/2018, Positive
30/07/2019 Veterinary medicines European public assessment report (EPAR): Suvaxyn PRRS MLV, Modified live porcine respiratory and reproductive syndrome virus, 24/08/2017, 3, Authorised
30/07/2019 Orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene for the: Treatment of mucopolysaccharidosis type I, 17/01/2018, Positive
30/07/2019 Orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 17/01/2018, Positive
30/07/2019 Orphan designation: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII for the: Treatment of haemophilia A, 22/05/2017, Positive
30/07/2019 Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia, Bipolar Disorder, 15/11/2015, Generic, 8, Authorised
30/07/2019 Pre-authorisation guidance
29/07/2019 Aluvia H-W-764
29/07/2019 Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), aripiprazole, Schizophrenia, Bipolar Disorder, 30/06/2015, Generic, 8, Authorised
29/07/2019 Other: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based sales and and animal population data collection protocol
29/07/2019 Template or form: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based data collection form
29/07/2019 Orphan designation: trientine dihydrochloride for the: Treatment of Wilson's disease, 24/10/2003, Withdrawn
29/07/2019 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 2, Authorised
29/07/2019 Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Hepatolenticular Degeneration, 25/07/2019, Authorised
29/07/2019 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, Additional monitoring, 18, Authorised
26/07/2019 Periodic safety update single assessment: Baclofen (oral): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000294/201809
26/07/2019 Periodic safety update single assessment: Baclofen (oral): List of nationally authorised medicinal products - PSUSA/00000294/201809
26/07/2019 Human medicines European public assessment report (EPAR): Ulunar Breezhaler, Glycopyrronium bromide, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 23/04/2014, 12, Authorised
26/07/2019 Human medicines European public assessment report (EPAR): Imatinib Teva, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma, 07/01/2013, Generic, 13, Authorised
26/07/2019 Human medicines European public assessment report (EPAR): Prepandrix, A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks, 14/05/2008, Accelerated assessment, 13, Authorised
26/07/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019
26/07/2019 Summary of opinion: Tecentriq, atezolizumab, 25/07/2019, Positive
26/07/2019 Summary of opinion: Vitrakvi, larotrectinib, 25/07/2019, Positive
26/07/2019 News and press releases: Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy
26/07/2019 Summary of opinion: Keytruda, pembrolizumab, 25/07/2019, Positive
26/07/2019 Summary of opinion: Soliris, eculizumab, 25/07/2019, Positive
26/07/2019 News and press releases: First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
25/07/2019 European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
25/07/2019 Human medicines European public assessment report (EPAR): DaTSCAN, ioflupane (123l), Tomography, Emission-Computed, Single-Photon, Lewy Body Disease, Parkinson Disease, Alzheimer Disease, 27/07/2000, 21, Authorised
25/07/2019 Human medicines European public assessment report (EPAR): Optison, perflutren, Echocardiography, 17/05/1998, 18, Authorised
25/07/2019 Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, Additional monitoring, 7, Authorised
25/07/2019 Human medicines European public assessment report (EPAR): Izba, travoprost, Ocular Hypertension, Glaucoma, Open-Angle, 20/02/2014, 4, Authorised
25/07/2019 Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Hemophilia A, 18/11/2015, Additional monitoring, 8, Authorised
25/07/2019 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia, Iron Overload, 28/08/2006, Orphan, Additional monitoring, 42, Authorised
25/07/2019 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty, Venous Thromboembolism, 18/05/2011, 17, Authorised
25/07/2019 Template or form: Template for registering new active substance on EUTCT
25/07/2019 Other: EMA tracking tool: relocation to Amsterdam - Main milestones
25/07/2019 Other: Policy 26: Records management
25/07/2019 Other: Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information
25/07/2019 Presentation: Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Session 2.4: Operation types, data quality and data ownership
25/07/2019 Other: EudraVigilance eXtended medicinal product dictionary acknowledgment codes
25/07/2019 Other: Chapter 3.I: Technical specifications of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
25/07/2019 Other: Chapter 3.I: Technical specifications of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
24/07/2019 News and press releases: Paediatric Committee elects Koenraad Norga as its new chair
24/07/2019 Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 9, Authorised
24/07/2019 Agenda: Agenda - PDCO agenda of the 23-26 July 2019 meeting
24/07/2019 Newsletter: Human medicines highlights - July 2019
24/07/2019 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Additional monitoring, Biosimilar, 11, Authorised
24/07/2019 Human medicines European public assessment report (EPAR): Cabazitaxel Teva, cabazitaxel, Prostatic Neoplasms, 11/07/2019, Refused
24/07/2019 Human medicines European public assessment report (EPAR): Ciambra, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 02/12/2015, Generic, 3, Authorised
24/07/2019 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 25, Authorised
24/07/2019 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, Additional monitoring, 5, Authorised
23/07/2019 Human medicines European public assessment report (EPAR): Ilumetri, tildrakizumab, Psoriasis, 17/09/2018, Additional monitoring, 2, Authorised
23/07/2019 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 27, Authorised
23/07/2019 Veterinary medicines European public assessment report (EPAR): Draxxin, tulathromycin, 11/11/2003, 21, Authorised
23/07/2019 Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 09/06/2010, 14, Authorised
23/07/2019 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 21, Authorised
23/07/2019 Human medicines European public assessment report (EPAR): Descovy, emtricitabine, tenofovir alafenamide, HIV Infections, 21/04/2016, Additional monitoring, 13, Authorised
23/07/2019 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 2, Authorised
22/07/2019 Human medicines European public assessment report (EPAR): Corlentor, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 25/10/2005, 25, Authorised
22/07/2019 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 18, Authorised
22/07/2019 Human medicines European public assessment report (EPAR): Rapamune, Sirolimus, Graft Rejection, Kidney Transplantation, 13/03/2001, 39, Authorised
22/07/2019 Human medicines European public assessment report (EPAR): NexoBrid, concentrate of proteolytic enzymes enriched in bromelain, Debridement, 18/12/2012, Orphan, Additional monitoring, 9, Authorised
22/07/2019 Agenda: Agenda - CHMP agenda of the 22-25 July 2019 meeting
22/07/2019 Human medicines European public assessment report (EPAR): Trecondi, Treosulfan, Hematopoietic Stem Cell Transplantation, 20/06/2019, Additional monitoring, Authorised
22/07/2019 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, Additional monitoring, 5, Authorised
20/07/2019 Recruitment: Careers at European Medicines Agency (EMA) - Guidance on selection and recruitment
19/07/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019
19/07/2019 Standard Operating Procedure - SOP: Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission
19/07/2019 Referral: Basiron AC and associated names , benzoyl peroxide , Article 13 referrals, European Commission final decision, 28/03/2019, 04/07/2019, 19/07/2019
19/07/2019 Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Schizophrenia, Bipolar Disorder, 25/06/2015, Generic, 6, Authorised
19/07/2019 Human medicines European public assessment report (EPAR): Vaborem, meropenem trihydrate, vaborbactam, Urinary Tract Infections, Bacteremia, Bacterial Infections, Respiratory Tract Infections, Pneumonia, Pneumonia, Ventilator-Associated, 20/11/2018, Additional monitoring, 2, Authorised
19/07/2019 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 44, Authorised
19/07/2019 Other: Information Technology Directors Group - List of nominated members (alphabetically by country)
19/07/2019 Minutes: Minutes of the European Medicines Agency and European Union payer community meeting
19/07/2019 Agenda: Agenda - European Medicines Agency and European Union payer community meeting
19/07/2019 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption, Osteoporosis, Postmenopausal, 26/05/2010, 21, Authorised
19/07/2019 News and press releases: EMA takes note of the European Ombudsman’s decision on pre-submission activities
18/07/2019 Periodic safety update single assessment: Valaciclovir: List of nationally authorised medicinal products - PSUSA/00003086/201812
18/07/2019 Periodic safety update single assessment: Naltrexone: List of nationally authorised medicinal products - PSUSA/00002117/201811
18/07/2019 Agenda: Agenda - CAT agenda of the 17-19 July 2019 meeting
18/07/2019 Periodic safety update single assessment: Etonogestrel: List of nationally authorised medicinal products - PSUSA/00001331/201809
18/07/2019 Periodic safety update single assessment: Milrinone: List of nationally authorised medicinal products - PSUSA/00002064/201810
18/07/2019 Orphan designation: Palovarotene for the: Treatment of fibrodysplasia ossificans progressiva, 19/11/2014, Positive
18/07/2019 Periodic safety update single assessment: Anti-T lymphocyte immunoglobulin for human use, horse: List of nationally authorised medicinal products Maintenance - PSUSA/00010433/201811
18/07/2019 Periodic safety update single assessment: Hydromorphone: List of nationally authorised medicinal products - PSUSA/00001686/201811
18/07/2019 Human medicines European public assessment report (EPAR): Neuraceq, florbetaben (18F), Radionuclide Imaging, Alzheimer Disease, 20/02/2014, 15, Authorised
18/07/2019 Periodic safety update single assessment: Amino acid combinations / glucose / triglyceride combinations / with or without electrolytes / mineral compounds - only for the drug Numeta: List of nationally authorised medicinal products - PSUSA/00010190/201812
17/07/2019 Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 5, Authorised
17/07/2019 Human medicines European public assessment report (EPAR): Xultophy, insulin degludec, liraglutide, Diabetes Mellitus, Type 2, 18/09/2014, Additional monitoring, 12, Authorised
17/07/2019 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 3, Authorised
17/07/2019 Leaflet: Public engagement highlights of 2018
17/07/2019 Other: Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports
17/07/2019 Template or form: Template for a request for amendments of or addition of active substances or combinations of active substances to the European Union reference-date list
17/07/2019 Procurement: Ex ante publicity of a negotiated procedure: EMA/2019/17/SG – Provision of syndicated work area recovery site
17/07/2019 Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile for the: Treatment of medullary thyroid carcinoma, 26/10/2018, Positive
17/07/2019 Report: Medicinal products for human use: monthly figures - June 2019
17/07/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 June 2019
17/07/2019 Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products , capecitabine, fluorouracil, tegafur, flucytosine , Article 31 referrals, Under evaluation, 17/07/2019
17/07/2019 Orphan designation: diazoxide choline for the: Treatment of Prader-Willi syndrome, 12/10/2017, Positive
17/07/2019 Human medicines European public assessment report (EPAR): Eurartesim, piperaquine tetraphosphate / artenimol, Malaria, 27/10/2011, 10, Authorised
17/07/2019 Human medicines European public assessment report (EPAR): Crysvita, Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant, 19/02/2018, Orphan, Additional monitoring, Conditional approval, 1, Authorised
17/07/2019 Periodic safety update single assessment: Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201901
17/07/2019 Periodic safety update single assessment: Sertindole: List of nationally authorised medicinal products - PSUSA00002695201901
17/07/2019 Report: Applications for new human medicines under evaluation by the CHMP: July 2019
16/07/2019 Agenda: Agenda - CVMP agenda of the 16-18 July 2019 meeting
16/07/2019 Periodic safety update single assessment: Cefotaxime : List of nationally authorised medicinal products - PSUSA/00000599/201812
16/07/2019 Periodic safety update single assessment: Yellow fever vaccine (live): List of nationally authorised medicinal products - PSUSA/00003135/201812
16/07/2019 Periodic safety update single assessment: Terazosin: List of nationally authorised medicinal products - PSUSA/00002895/201811
16/07/2019 Human medicines European public assessment report (EPAR): Ristaben, sitagliptin, Diabetes Mellitus, Type 2, 15/03/2010, 19, Authorised
16/07/2019 Orphan designation: Recombinant chimeric monoclonal antibody against CD20 for the: Treatment of chronic lymphocytic leukaemia, 26/11/2009, Positive
16/07/2019 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, 29, Authorised
16/07/2019 Human medicines European public assessment report (EPAR): Memantine Mylan, memantine hydrochloride, Alzheimer Disease, 21/04/2013, Generic, 5, Authorised
16/07/2019 Human medicines European public assessment report (EPAR): Ammonaps, Sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease, Citrullinemia, Carbamoyl-Phosphate Synthase I Deficiency Disease, 07/12/1999, 19, Authorised
16/07/2019 Eligible healthcare professionals' organisations
16/07/2019 Human medicines European public assessment report (EPAR): Volibris, ambrisentan, Hypertension, Pulmonary, 20/04/2008, 20, Authorised
16/07/2019 Human medicines European public assessment report (EPAR): Jorveza, budesonide, Esophageal Diseases, 08/01/2018, Orphan, Accelerated assessment, 1, Authorised
16/07/2019 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 9, Authorised
16/07/2019 Agenda: Agenda - COMP agenda of the 16-18 July 2019 meeting
15/07/2019 Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 34, Authorised
15/07/2019 Periodic safety update single assessment: Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA-00009182-201812
15/07/2019 Periodic safety update single assessment: Indoramin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001740/201809
15/07/2019 Periodic safety update single assessment: Indoramin: List of nationally authorised medicinal products - PSUSA/00001740/201809
15/07/2019 Minutes: Minutes of the CAT meeting 20-22 February 2019
15/07/2019 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201811
15/07/2019 Human medicines European public assessment report (EPAR): Ambrisentan Mylan, ambrisentan, Hypertension, Pulmonary, 20/06/2019, Generic, Authorised
15/07/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2019
12/07/2019 Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, 20/11/2018, 1, Authorised
12/07/2019 Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/2007, Generic, 16, Authorised
12/07/2019 Periodic safety update single assessment: Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201811
12/07/2019 Orphan designation: Recombinant adeno-associated viral vector serotype 5 encoding Staphylococcus aureus Cas9 endonuclease and two guide RNAs complementary to two regions of intron 26 of the CEP290 gene for the: Treatment of Leber's congenital amaurosis, 16/10/2017, Positive
12/07/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 7, Authorised
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of citrullinaemia type 2, 10/06/2010, Positive
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of hyperargininaemia, 10/06/2010, Positive
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrom, 10/06/2010, Positive
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of argininosuccinic aciduria, 10/06/2010, Positive
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of citrullinaemia type 1, 10/06/2010, Positive
12/07/2019 Orphan designation: Levoglutamide for the: Treatment of sickle cell disease, 04/07/2012, Positive
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of ornithine carbamoyltransferase deficiency, 10/06/2010, Positive
12/07/2019 Human medicines European public assessment report (EPAR): Valdoxan, Agomelatine, Depressive Disorder, Major, 19/02/2009, 20, Authorised
12/07/2019 Minutes: Minutes - PDCO minutes of the 29 January - 1 February 2019 meeting
12/07/2019 Report: PRAC statistics: July 2019
12/07/2019 News and press releases: PRAC recommends new measures to avoid dosing errors with methotrexate
12/07/2019 Other: Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 11 July 2019
12/07/2019 News and press releases: EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
12/07/2019 Mutual recognition agreements (MRA)
11/07/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019
11/07/2019 Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 43, Authorised
11/07/2019 Periodic safety update single assessment: Levofloxacin (except for the centrally authorised product): List of nationally authorised medicinal products - PSUSA/00001854/201810
11/07/2019 Periodic safety update single assessment: Levofloxacin (except for the centrally authorised product): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001854/201810
11/07/2019 Human medicines European public assessment report (EPAR): Nplate, romiplostim, Purpura, Thrombocytopenic, Idiopathic, 04/02/2009, 21, Authorised
11/07/2019 Veterinary medicines European public assessment report (EPAR): Osurnia, terbinafine / florfenicol, betamethasone acetate, 31/07/2014, Patient safety, 7, Authorised
11/07/2019 Orphan designation: Muramyl tripeptide phosphatidyl ethanolamine for the: Treatment of osteosarcoma, 21/06/2004, Expired
11/07/2019 Orphan designation: Caffeine citrate for the: Treatment of primary apnoea of premature newborns, 18/02/2003, Expired
11/07/2019 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis, Keratitis, 06/07/2018, Orphan, Accelerated assessment, 2, Authorised
11/07/2019 Orphan designation: Fc- and CDR-modified humanised monoclonal antibody against C5 (ravulizumab) for the: Treatment of paroxysmal nocturnal haemoglobinuria, 30/05/2016, Withdrawn
11/07/2019 EPAR - Assessment report on maintenance of orphan designation - Initial authorisation: Ultomiris : Orphan designation withdrawal assessment report (initial authorisation)
10/07/2019 Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 33, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Ocaliva, Obeticholic acid, Liver Cirrhosis, Biliary, 12/12/2016, Orphan, Additional monitoring, Conditional approval, 5, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 25, Authorised
10/07/2019 Orphan designation: Iodine (131I) iobenguane for the: Treatment of neuroblastoma, 31/01/2008, Positive
10/07/2019 Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 12, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Evista, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 05/08/1998, 22, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, Additional monitoring, 5, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 5, Authorised
10/07/2019 Orphan designation: Ciclosporin (inhalation use) for the: Prevention of graft rejection after lung transplantation, 29/07/2004, Positive
10/07/2019 Orphan designation: N-(3-(4-(3-(diisobutylamino)propyl)piperazin-1-yl)propyl)-1H-benzo[d]imidazol-2-amine disulphate salt for the: Treatment of progressive supranuclear palsy, 12/02/2015, Positive
10/07/2019 Orphan designation: Ciclosporin (inhalation use) for the: Treatment of bronchiolitis obliterans syndrome, 24/05/2017, Positive
10/07/2019 Minutes: Minutes of the CVMP meeting of 21-22 May 2019
10/07/2019 Minutes: Minutes of the CVMP meeting of 15-16 April 2019
10/07/2019 Minutes: Minutes of the CVMP meeting of 19-21 March 2019
10/07/2019 Human medicines European public assessment report (EPAR): Raxone, idebenone, Optic Atrophy, Hereditary, Leber, 08/09/2015, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/06/2015, Additional monitoring, 9, Authorised
10/07/2019 Other: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
10/07/2019 Advice on impacts of using antimicrobials in animals
10/07/2019 Regulatory and procedural guideline: Overview of comments received on 'Answer to the request from the EC for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial vet products
10/07/2019 Regulatory and procedural guideline: Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobial veterinary medicinal products
10/07/2019 Human medicines European public assessment report (EPAR): Memantine Accord, memantine hydrochloride, Alzheimer Disease, 03/12/2013, Generic, 6, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Advate, octocog alfa, Hemophilia A, 02/03/2004, 24, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection, Bacterial Infections, 20/09/2018, Additional monitoring, 1, Authorised
09/07/2019 Veterinary medicines European public assessment report (EPAR): Fevaxyn Pentofel, inactivated feline calicivirus / inactivated feline Chlamydophila felis / inactivated feline leukaemia virus / inactivated feline panleukopenia virus, inactivated feline rhinotracheitis virus, 05/02/1997, 19, Authorised
09/07/2019 Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration, Macular Edema, Diabetes Complications, 21/11/2012, 17, Authorised
09/07/2019 Orphan designation: Recombinant monoclonal antibody to human serum amyloid P component (dezamizumab) for the: Treatment of AL amyloidosis, 29/07/2014, Withdrawn
09/07/2019 Orphan designation: Carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (miridesap) for the: Treatment of AL amyloidosis, 29/07/2014, Withdrawn
09/07/2019 Orphan designation: Cyclocreatine for the: Treatment of creatine deficiency syndromes, 27/06/2016, Withdrawn
09/07/2019 Orphan designation: CD33-directed antibody-drug conjugate consisting of an antibody conjugated to a DNA cross-linking pyrrolobenzodiazepine dimer drug (vadastuximab talirine) for the: Treatment of acute myeloid leukaemia, 10/08/2015, Withdrawn
09/07/2019 Orphan designation: Doxorubicine polyisohexylcyanoacrylate nanoparticles for the: Treatment of hepatocellular carcinoma, 21/10/2004, Withdrawn
09/07/2019 Orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase) for the: Prevention of arteriovenous access dysfunction in haemodialysis patients, 16/01/2014, Withdrawn
09/07/2019 Orphan designation: N-methyl-4-({4-[({3-methyl(methylsulfonyl)aminopyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride (defactinib) for the: Treatment of ovarian cancer, 15/01/2015, Positive
09/07/2019 Orphan designation: N-methyl-4-({4-[({3-methyl(methylsulfonyl)aminopyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride (defactinib) for the: Treatment of malignant mesothelioma, 07/06/2013, Positive
09/07/2019 Orphan designation: Ulocuplumab for the: Treatment of acute myeloid leukaemia, 12/02/2015, Positive
09/07/2019 Human medicines European public assessment report (EPAR): Segluromet, ertugliflozin l-pyroglutamic acid / metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 2, Authorised
08/07/2019 Agenda: Agenda - PRAC draft agenda of meeting 8-11 July 2019
08/07/2019 Human medicines European public assessment report (EPAR): Xromi, hydroxycarbamide, Anemia, Sickle Cell, 01/07/2019, Authorised
08/07/2019 Periodic safety update single assessment: Carmustine (implant): List of nationally authorised medicinal products - PSUSA/00010348/201809
08/07/2019 Periodic safety update single assessment: Carmustine (implant): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010348/201809
08/07/2019 Human medicines European public assessment report (EPAR): Procoralan, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 25/10/2005, 21, Authorised
08/07/2019 Human medicines European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren), clopidogrel hydrogen sulphate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 15, Authorised
08/07/2019 Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 8, Authorised
08/07/2019 Human medicines European public assessment report (EPAR): Terrosa, teriparatide, Osteoporosis, 04/01/2017, Additional monitoring, Biosimilar, 3, Authorised
08/07/2019 Public Statement: Public statement on Rituzena: Withdrawal of the marketing authorisation in the European Union
08/07/2019 Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella), rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, 13/07/2017, Additional monitoring, Biosimilar, 7, Withdrawn
08/07/2019 Removing an orphan designation
08/07/2019 Other: Post-orphan medicinal product designation procedures - guidance to submit an application via IRIS online portal
08/07/2019 News and press releases: Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA)
08/07/2019 Human medicines European public assessment report (EPAR): Miglustat Gen.Orph, miglustat, Gaucher Disease, 09/11/2017, Generic, 4, Authorised
08/07/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 11-14 June 2019 PRAC meeting
08/07/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 June 2019 PRAC
08/07/2019 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, Authorised
05/07/2019 Periodic safety update single assessment: Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/201808
05/07/2019 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, Conditional approval, Authorised
05/07/2019 Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib citrate, Arthritis, Rheumatoid, 21/03/2017, 25/04/2013, Patient safety, Additional monitoring, 7, Authorised
05/07/2019 Orphan designation: Heat-killed Mycobacterium vaccae (whole cell) for the: Treatment of tuberculosis, 20/09/2010, Positive
05/07/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 15-16 April 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 15/04/2019 to 16/04/2019
05/07/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2019
04/07/2019 Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Osteoporosis, Postmenopausal, 17/04/2009, 12, Authorised