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31/05/2018 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 39, Authorised
31/05/2018 Human medicines European public assessment report (EPAR): Silodyx, silodosin, Prostatic Hyperplasia, 29/01/2010, 12, Authorised
31/05/2018 Committee meeting report: Monthly report on application procedures guidelines and related documents for veterinary medicines: April 2018
31/05/2018 Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 April 2018 , European Medicines Agency, London, UK, from 17/04/2018 to 19/04/2018
31/05/2018 Minutes: Minutes of the CHMP meeting 19-22 March 2018
31/05/2018 Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018 , European Medicines Agency, London, UK, from 19/03/2018 to 22/03/2018
31/05/2018 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 17, Authorised
30/05/2018 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA (also known as patisiran) for the: Treatment of transthyretin-mediated amyloidosis, 06/04/2017, Positive
30/05/2018 Orphan designation: Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA for the: Treatment of Huntington's disease, 19/03/2015, Positive
30/05/2018 Orphan designation: Recombinant chimeric monoclonal antibody against CD20 for the: Treatment of chronic lymphocytic leukaemia, 26/11/2009, Positive
30/05/2018 Orphan designation: Octreotide chloride (lipid depot solution) for the: Treatment of acromegaly, 12/06/2009, Positive
30/05/2018 Minutes: Minutes of the CVMP meeting of 17-19 April 2018
30/05/2018 Report: Supporting medicines for children in the European Union
30/05/2018 Report: How to better apply the paediatric legislation to boost development of medicines for children - Report on a multi-stakeholder workshop held at EMA on Tuesday 20 March 2018
30/05/2018 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 1, Authorised
29/05/2018 Orphan designation: nilotinib for the: Treatment of chronic myeloid leukaemia, 22/05/2006, Positive
29/05/2018 Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
29/05/2018 Withdrawn application: Fulphila, pegfilgrastim, Date of withdrawal: 03/08/2017, Initial authorisation
29/05/2018 Orphan designation: Tobramycin (inhalation powder) for the: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 17/03/2003, Positive
29/05/2018 Orphan designation: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class (atinumab) for the: Treatment of spinal cord injury, 19/01/2009, Positive
29/05/2018 Orphan designation: pasireotide for the: Treatment of Cushing's disease, 08/10/2009, Positive
29/05/2018 Orphan designation: pasireotide for the: Treatment of acromegaly, 08/10/2009, Positive
29/05/2018 Orphan designation: Panobinostat for the: Treatment of multiple myeloma, 08/11/2012, Positive
29/05/2018 Orphan designation: Osilodrostat for the: Treatment of Cushing's syndrome, 15/10/2014, Positive
29/05/2018 Orphan designation: Midostaurin for the: Treatment of mastocytosis, 04/08/2010, Positive
29/05/2018 Orphan designation: Midostaurin for the: Treatment of acute myeloid leukaemia, 29/07/2004, Positive
29/05/2018 Orphan designation: Humanised monoclonal antibody against P-selectin for the: Treatment of sickle-cell disease, 09/08/2012, Positive
29/05/2018 Orphan designation: Human monoclonal antibody against human interleukin 13 for the: Treatment of eosinophilic oesophagitis, 13/11/2013, Positive
29/05/2018 News and press releases: Construction of new EMA building in Amsterdam on track
29/05/2018 Orphan designation: everolimus for the: Treatment of tuberous sclerosis, 04/08/2010, Positive
29/05/2018 Human medicines European public assessment report (EPAR): Sebivo, telbivudine, Hepatitis B, Chronic, 24/04/2007, 20, Authorised
29/05/2018 Orphan designation: Venetoclax for the: Treatment of mantle cell lymphoma, 12/12/2017, Positive
29/05/2018 Orphan designation: Rovalpituzumab tesirine for the: Treatment of small cell lung cancer, 30/05/2016, Positive
29/05/2018 Orphan designation: Venetoclax for the: Treatment of diffuse large B-cell lymphoma, 14/10/2016, Positive
29/05/2018 Orphan designation: Venetoclax for the: Treatment of multiple myeloma, 14/10/2016, Positive
29/05/2018 Orphan designation: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F(depatuxizumab mafodotin for the: Treatment of glioma, 29/07/2014, Positive
29/05/2018 Orphan designation: Humanised recombinant IgG4 anti-human tau antibody for the: Treatment of progressive supranuclear palsy, 28/04/2016, Positive
29/05/2018 Orphan designation: Mazindol for the: Treatment of narcolepsy, 12/02/2015, Withdrawn
29/05/2018 Orphan designation: Yttrium (90Y) edotreotide for the: Treatment of gastro-entero-pancreatic neuroendocrine tumors, 04/12/2008, Withdrawn
29/05/2018 Orphan designation: 2-[4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)-phenoxymethyl]-quinoline succinic acid for the: Treatment of Huntington's disease, 14/07/2016, Withdrawn
28/05/2018 Agenda: Agenda - PDCO agenda of the 29 May-01 June 2018 meeting
28/05/2018 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018
28/05/2018 Class waivers
28/05/2018 Other: European Medicines Agency decision CW-0001-2015 of 23 July 2015 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council
28/05/2018 Human medicines European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis), pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, 5, Authorised
28/05/2018 Minutes: Minutes of the HMPC 29-30 January 2018 meeting
28/05/2018 Minutes: Minutes of the COMP meeting of 13-15 March 2018
28/05/2018 Other: Referentials Management Services (RMS) operating model
28/05/2018 Orphan designation: Olaparib for the: Treatment of ovarian cancer, 06/12/2007, Withdrawn
28/05/2018 Agenda: Agenda - CHMP agenda of the 28-31 May 2018 meeting
28/05/2018 Human medicines European public assessment report (EPAR): Votrient, pazopanib, Carcinoma, Renal Cell, 14/06/2010, 20, Authorised
25/05/2018 Human medicines European public assessment report (EPAR): SonoVue, sulphur hexafluoride, Ultrasonography, Echocardiography, 26/03/2001, 16, Authorised
25/05/2018 Committee for Advanced Therapies (CAT): 23-25 May 2018 , European Medicines Agency, London, UK, from 23/05/2018 to 25/05/2018
25/05/2018 Agenda: Agenda - CAT agenda of the 23-25 May 2018 meeting
25/05/2018 Orphan designation: Treprostinil sodium for the: Treatment of chronic thromboembolic pulmonary hypertension, 08/02/2013, Positive
24/05/2018 Periodic safety update single assessment: Dornase alpha: List of nationally authorised medicinal products - PSUSA/00001164/201709
24/05/2018 Periodic safety update single assessment: Tretinoin (topical formulations): List of nationally authorised medicinal products - PSUSA/00003016/201708
24/05/2018 Periodic safety update single assessment: Lysine acetylsalicylate: List of nationally authorised medicinal products - PSUSA/00001921/201709
24/05/2018 Periodic safety update single assessment: Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201710
24/05/2018 News and press releases: Development of antibiotics for children - towards a global approach
24/05/2018 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, Additional monitoring, 16, Authorised
24/05/2018 Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure , European Medicines Agency, London, UK, from 20/04/2018 to 20/04/2018
24/05/2018 Report: Report - Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure
24/05/2018 Medicines for use outside the European Union
24/05/2018 Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union
24/05/2018 Human medicines European public assessment report (EPAR): Rydapt, Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis, 18/09/2017, Orphan, Additional monitoring, 2, Authorised
23/05/2018 Periodic safety update single assessment: Metronidazole / neomycin / nystatin: List of nationally authorised medicinal products - PSUSA/00010508/201709
23/05/2018 Periodic safety update single assessment: Modafinil: List of nationally authorised medicinal products - PSUSA/00010242/201708
23/05/2018 Periodic safety update single assessment: Fluoxetine: List of nationally authorised medicinal products - PSUSA/00001442/201709
23/05/2018 Periodic safety update single assessment: Vigabatrin: List of nationally authorised medicinal products - PSUSA/00003112/201709
23/05/2018 Periodic safety update single assessment: Bromazepam: List of nationally authorised medicinal products - PSUSA/00000435/201708
23/05/2018 Periodic safety update single assessment: Etidronate: List of nationally authorised medicinal products - PSUSA/00001320/201709
23/05/2018 Periodic safety update single assessment: Minocycline: List of nationally authorised medicinal products - PSUSA/00002065/201708
23/05/2018 Periodic safety update single assessment: Treosulfan: List of nationally authorised medicinal products - PSUSA/00009319/201708
23/05/2018 Standard Operating Procedure - SOP: Standard operating procedure for Paediatric investigation plan or a waiver from start of procedure to clock-stop or PDCO opinion
23/05/2018 Orphan designation: Modified mRNA encoding the UGT1A1 protein for the: Treatment of Crigler-Najjar syndrome, 27/06/2016, Positive
23/05/2018 Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
23/05/2018 Periodic safety update single assessment: Fenoterol (respiratory indications): List of nationally authorised medicinal products - PSUSA/00001366/201709
23/05/2018 Orphan designation: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid  for the: Treatment of acute myeloid leukaemia, 22/08/2014, Positive
23/05/2018 Periodic safety update single assessment: Sodium oxybate (intravenous use): List of nationally authorised medicinal products - PSUSA/00010613/201710
23/05/2018 Human medicines European public assessment report (EPAR): Desloratadine Teva, desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, 24/11/2011, Generic, 12, Authorised
23/05/2018 Periodic safety update single assessment: Losartan: List of nationally authorised medicinal products - PSUSA/00001912/201709
23/05/2018 Periodic safety update single assessment: Human von willebrand factor: List of nationally authorised medicinal products - PSUSA/00001642/201709
23/05/2018 Human medicines European public assessment report (EPAR): Celsentri, maraviroc, HIV Infections, 18/09/2007, 22, Authorised
23/05/2018 Human medicines European public assessment report (EPAR): Segluromet, ertugliflozin l-pyroglutamic acid / metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 1, Authorised
23/05/2018 Periodic safety update single assessment: Desflurane: List of nationally authorised medicinal products - PSUSA/00000958/201709
23/05/2018 Agenda: Agenda - CVMP agenda of the 23-25 May 2018 meeting
23/05/2018 Work programme: Work plan for the Pharmacovigilance Inspectors Working Group for 2018
23/05/2018 Periodic safety update single assessment: Dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)
23/05/2018 Human medicines European public assessment report (EPAR): Olysio, simeprevir, Hepatitis C, Chronic, 14/05/2014, Additional monitoring, 13, Withdrawn
22/05/2018 News and press releases: Working together for people with rare and complex diseases
22/05/2018 Periodic safety update single assessment: Piperacillin / tazobactam: List of nationally authorised medicinal products - PSUSA/00002425/201709
22/05/2018 Periodic safety update single assessment: Ropivacaine: List of nationally authorised medicinal products - PSUSA/00002662/201709
22/05/2018 Periodic safety update single assessment: Dexibuprofen: List of nationally authorised medicinal products - PSUSA/00000996/201708
22/05/2018 Agenda: Agenda - COMP agenda of the 22-24 May 2018 meeting
22/05/2018 Report: Appendix 2: Agenda and participants - CAR-T cell therapy registries workshop
22/05/2018 Report: Report - CAR-T cell therapy registries workshop
22/05/2018 Report: Appendix 1: Proposed data elements relating to efficacy and to safety - CAR-T cell therapy registries workshop
22/05/2018 Human medicines European public assessment report (EPAR): Hexyon, Diphtheria toxoid, filamentous haemagglutinin, hepatitis B surface antigen, pertussis toxoid, tetanus toxoid, Haemophilus influenzae type b polysaccharide, polyribosylribitol phosphate conjugated to tetanus protein, type 1 (mahoney), type 2 (mef-1), type 3 (saukett), Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 18, Authorised
18/05/2018 Human medicines European public assessment report (EPAR): Simulect, basiliximab, Graft Rejection, Kidney Transplantation, 09/10/1998, 22, Authorised
18/05/2018 Agenda: Agenda - Third industry stakeholder platform on research and development support
18/05/2018 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018
18/05/2018 News and press releases: PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
18/05/2018 News and press releases: EMA review of Zinbryta confirms medicine's risks outweigh its benefits
18/05/2018 News and press releases: New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir
18/05/2018 Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox, 31/07/2013, Additional monitoring, Exceptional circumstances, 13, Authorised
18/05/2018 Periodic safety update single assessment: Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709
18/05/2018 Periodic safety update single assessment: Midazolam (all pharmaceutical forms and indications apart from oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures): List of nationally authorised medicinal products - PSUSA/00002057/...
18/05/2018 Periodic safety update single assessment: Idebenone (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00001721/201709
18/05/2018 News and press releases: European Medicines Agency closed 21 May 2018
18/05/2018 Human medicines European public assessment report (EPAR): Edarbi, Azilsartan medoxomil, Hypertension, 07/12/2011, Additional monitoring, 7, Authorised
17/05/2018 European Medicines Agency veterinary medicines innovation day , European Medicines Agency, London, UK, from 19/04/2018 to 19/04/2018
17/05/2018 Veterinary medicines European public assessment report (EPAR): BTVPUR AlSap 1, bluetongue-virus serotype-1 antigen, 17/12/2010, 4, Withdrawn
17/05/2018 Veterinary medicines European public assessment report (EPAR): Dexdomitor, dexmedetomidine hydrochloride, 30/08/2002, 18, Authorised
17/05/2018 Human medicines European public assessment report (EPAR): Clopidogrel Mylan, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 11, Authorised
17/05/2018 Orphan designation: genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII for the: Treatment of epidermolysis bullosa, 16/04/2018, Positive
17/05/2018 Orphan designation: adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1 for the: Treatment of amyotrophic lateral sclerosis, 16/04/2018, Positive
17/05/2018 Orphan designation: Burosumab for the: Treatment of phosphaturic mesenchymal tumour, 16/04/2018, Positive
17/05/2018 Orphan designation: polatuzumab vedotin for the: Treatment of diffuse large B-cell lymphoma, 16/04/2018, Positive
17/05/2018 Orphan designation: autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo for the: Treatment of ovarian cancer, 16/04/2018, Positive
17/05/2018 Orphan designation: Efgartigimod alfa for the: Treatment of myasthenia gravis, 21/03/2018, Positive
17/05/2018 Orphan designation: Recombinant modified ricin toxin A-chain subunit for the: Prevention of ricin poisoning, 21/03/2018, Positive
17/05/2018 Orphan designation: Docosahexaenoic acid ethyl ester for the: Treatment of sickle cell disease, 21/03/2018, Positive
17/05/2018 Orphan designation: Tazemetostat for the: Treatment of malignant mesothelioma, 21/03/2018, Positive
17/05/2018 Orphan designation: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA for the: Treatment of haemophilia B, 21/03/2018, Positive
16/05/2018 Veterinary medicines European public assessment report (EPAR): BTVPUR Alsap 8, bluetongue virus serotype 8 antigen, 17/03/2009, 5, Withdrawn
16/05/2018 Paediatric Committee (PDCO): 20-23 March 2018 , European Medicines Agency, London, UK, from 20/03/2018 to 23/03/2018
16/05/2018 Minutes: Minutes - PDCO minutes of the 20-23 March 2018 meeting
16/05/2018 Minutes: Minutes - PDCO minutes of the 20-23 February 2018 meeting
16/05/2018 Work programme: Committee for Medicinal Products for Human Use (CHMP): Work Plan 2018
16/05/2018 Scientific guideline: Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q3D (R1) on elemental impurities - Step 2b - Revision 1
16/05/2018 Scientific guideline: ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - questions and answers - Step 5
16/05/2018 Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 11, Authorised
16/05/2018 Human medicines European public assessment report (EPAR): Urorec, silodosin, Prostatic Hyperplasia, 29/01/2010, 14, Authorised
16/05/2018 Public Statement: Public statement on Vibativ: Withdrawal of the marketing authorisation in the European Union
16/05/2018 Human medicines European public assessment report (EPAR): Vibativ, telavancin, Pneumonia, Bacterial, Cross Infection, 02/09/2011, Additional monitoring, 10, Withdrawn
15/05/2018 Report: Medicinal products for human use: monthly figures - April 2018
15/05/2018 Orphan designation: Recombinant human acid alpha-glucosidase for the: Treatment of glycogen storage disease type II (Pompe's disease), 21/03/2018, Positive
15/05/2018 Orphan designation: Ribavirin for the: Treatment of Lassa fever, 21/02/2018, Positive
15/05/2018 Human medicines European public assessment report (EPAR): Zyllt, clopidogrel hydrogen sulphate, Peripheral Vascular Diseases, Stroke, Acute Coronary Syndrome, Myocardial Infarction, 28/09/2009, Generic, 10, Authorised
15/05/2018 Orphan designation: Ribavirin for the: Treatment of Crimean-Congo haemorrhagic fever, 21/03/2018, Positive
15/05/2018 Minutes: Minutes of the COMP meeting of 13-15 February 2018
15/05/2018 Orphan designation: Tazemetostat for the: Treatment of follicular lymphoma, 21/03/2018, Positive
15/05/2018 Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, Additional monitoring, 16, Authorised
15/05/2018 Orphan designation: dimethyl fumarate for the: Treatment of Friedreich's ataxia, 21/03/2018, Positive
15/05/2018 Recruitment: Careers at European Medicines Agency (EMA) - External guidance with the general conditions for recruitment and employment at the EMA
15/05/2018 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 23, Authorised
15/05/2018 Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 8, Authorised
15/05/2018 Human medicines European public assessment report (EPAR): Pregabalin Sandoz GmbH, pregabalin, Anxiety Disorders, Epilepsy, 19/06/2015, Generic, 4, Authorised
14/05/2018 Periodic safety update single assessment: Diclofenac / misoprostol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001040/201707
14/05/2018 Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018 , European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018
14/05/2018 Agenda: Agenda - PRAC draft agenda of meeting 14-17 May 2018
14/05/2018 Report: Applications for new human medicines under evaluation by the CHMP: May 2018
14/05/2018 Orphan designation: Gemfibrozil for the: Treatment of neuronal ceroid lipofuscinosis, 21/03/2018, Positive
14/05/2018 Newsletter: News bulletin for small and medium-sized enterprises - Issue 43
14/05/2018 Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing, 23/06/2017, Additional monitoring, Biosimilar, 3, Authorised
14/05/2018 Human medicines European public assessment report (EPAR): Rivastigmine Actavis, rivastigmine hydrogen tartrate, Dementia, Alzheimer Disease, Parkinson Disease, 16/06/2011, Generic, 13, Authorised
14/05/2018 Human medicines European public assessment report (EPAR): Vivanza, vardenafil, Erectile Dysfunction, 04/03/2003, 24, Authorised
14/05/2018 Human medicines European public assessment report (EPAR): Leflunomide Winthrop, leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic, 08/01/2010, 14, Authorised
14/05/2018 Human medicines European public assessment report (EPAR): Imatinib medac, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, 25/09/2013, Generic, 5, Authorised
14/05/2018 Human medicines European public assessment report (EPAR): Prandin, repaglinide, Diabetes Mellitus, Type 2, 29/01/2001, 16, Authorised
14/05/2018 Periodic safety update single assessment: Methylaminolevulinate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002019/201706
14/05/2018 Periodic safety update single assessment: Methylaminolevulinate: List of nationally authorised medicinal products - PSUSA/00002019/201706
14/05/2018 Regulatory and procedural guideline: EudraVigilance user manual for marketing authorisation holders
14/05/2018 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 1, Authorised
12/05/2018 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 12, Authorised
08/05/2018 Minutes: Minutes of the PRAC meeting 5-8 March 2018
08/05/2018 Human medicines European public assessment report (EPAR): Leganto, rotigotine, Restless Legs Syndrome, Parkinson Disease, 16/06/2011, 16, Authorised
08/05/2018 Template or form: PRIME eligibility request: applicant’s justification
08/05/2018 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm GmbH, clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke, 28/07/2009, Generic, 10, Authorised
08/05/2018 Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 33, Authorised
08/05/2018 Newsletter: Human medicines highlights - May 2018
08/05/2018 Orphan designation: Tazemetostat for the: Treatment of diffuse large B-cell lymphoma, 21/03/2018, Positive
08/05/2018 Orphan designation: Ivosidenib for the: Treatment of biliary tract cancer, 21/03/2018, Positive
08/05/2018 Orphan designation: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide for the: Treatment of C3 glomerulopathy, 21/03/2018, Positive
08/05/2018 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 April 2018
08/05/2018 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, 6, Authorised
07/05/2018 Periodic safety update single assessment: Clarithromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000788/201704
07/05/2018 Periodic safety update single assessment: Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/201707
07/05/2018 News and press releases: Two years of PRIME
07/05/2018 Other: European Medicines Agency guidance on interactions in the context of PRIME
07/05/2018 Report: PRIME: a two-year overview
07/05/2018 Regulatory and procedural guideline: Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME)
07/05/2018 Human medicines European public assessment report (EPAR): Ruconest, Recombinant human C1-inhibitor, Angioedemas, Hereditary, 28/10/2010, 9, Authorised
07/05/2018 Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic, 02/09/1999, 34, Authorised
07/05/2018 Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, Orphan, 11, Authorised
07/05/2018 Thirteenth industry stakeholder platform - operation of EU pharmacovigilance , European Medicines Agency, London, UK, from 20/03/2018 to 20/03/2018
07/05/2018 Report: Highlights from the 13th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 20 March 2018
07/05/2018 Regulatory and procedural guideline: User guide on how to generate PDF versions of the product information - human
07/05/2018 User safety of topically administered products
07/05/2018 Scientific guideline: Guideline on user safety of topically administered veterinary medicinal products
07/05/2018 Overview of comments: Overview of comments received on 'Guideline on user safety of topically administered veterinary medicinal products'
07/05/2018 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 April 2018 PRAC
07/05/2018 Orphan designation: Bosutinib for the: Treatment of chronic myeloid leukaemia, 04/08/2010, Withdrawn
07/05/2018 News and press releases: European Medicines Agency closed 9-11 May 2018
07/05/2018 Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 19, Authorised
07/05/2018 Veterinary medicines European public assessment report (EPAR): Startvac, Escherichia coli J5 inactivated / Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex, 11/02/2009, 3, Authorised
04/05/2018 Human medicines European public assessment report (EPAR): Atriance, nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, 22/08/2007, Orphan, Additional monitoring, Exceptional circumstances, 19, Authorised
04/05/2018 Human medicines European public assessment report (EPAR): Biopoin, epoetin theta, Kidney Failure, Chronic, Anemia, Cancer, 23/10/2009, 13, Authorised
04/05/2018 Type-IA variations: questions and answers
04/05/2018 Transfer of marketing authorisation: questions and answers
04/05/2018 Human medicines European public assessment report (EPAR): Kogenate Bayer, octocog alfa, Hemophilia A, 04/08/2000, 30, Authorised
03/05/2018 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Fluazuron
03/05/2018 Maximum Residue Limits - Divergent opinion: Divergent position on a CVMP opinion on the establishment of maximum residue limits: For extension of fluazuron for fin fish (automatic extrapolation to milk)
03/05/2018 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Solvent naphtha, light aromatic
03/05/2018 Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate for the: Treatment of mucopolysaccharidosis type I, 22/09/2016, Positive
03/05/2018 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
03/05/2018 Orphan designation: Recombinant human interleukin-12 for the: Treatment of acute radiation syndrome, 29/08/2016, Positive
03/05/2018 Orphan designation: Tadekinig alfa for the: Treatment of haemophagocytic lymphohistiocytosis, 14/10/2016, Positive
03/05/2018 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
03/05/2018 Orphan designation: 4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one for the: Treatment of pancreatic cancer, 12/10/2017, Positive
03/05/2018 Orphan designation: 2'-O-(2-Methoxyethyl) phosphorothioate antisense oligonucleotide targeting the growth hormone receptor for the: Treatment of acromegaly, 27/06/2016, Positive
03/05/2018 Orphan designation: (1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione for the: Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy's disease), 28/04/2016, Positive
03/05/2018 Orphan designation: live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O for the: Treatment of osteosarcoma, 14/12/2015, Positive
03/05/2018 Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work
03/05/2018 Agenda: CHMP ORGAM agenda for the meeting on 16 April 2018
03/05/2018 Haemophilia registries workshop , European Medicines Agency, London, UK, from 08/06/2018 to 08/06/2018
03/05/2018 Agenda: Agenda – Haemophilia registries workshop
03/05/2018 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 April 2018
03/05/2018 Reporting a quality defect to EMA
03/05/2018 Quality defects and recalls
03/05/2018 Template or form: Defective product report form
03/05/2018 Regulatory and procedural guideline: How to use the defective product report to notify a quality defect to European Medicines Agency
03/05/2018 Veterinary medicines European public assessment report (EPAR): Ecoporc Shiga, genetically modified recombinant Shiga-toxin-2e antigen, 10/04/2013, 3, Authorised
02/05/2018 Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products , European Medicines Agency, London, UK, from 23/03/2018 to 23/03/2018
02/05/2018 Minutes: Minutes - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products
02/05/2018 Other: PSURs for centrally authorised veterinary medicinal products: procedure on PSUR submission and evaluation for non-marketed products
02/05/2018 News and press releases: EMA 2017 annual report published
02/05/2018 Annual reports and work programmes
02/05/2018 Presentation: Presentation - Registry initiative - April 2018
02/05/2018 Periodic safety update single assessment: Candesartan, candesartan / hydrochlorothiazide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000527/201704
02/05/2018 Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges , European Medicines Agency, London, UK, from 04/05/2018 to 04/05/2018
02/05/2018 Agenda: Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges
02/05/2018 Annual Report: Annexes - 2017 annual report of the European Medicines Agency
02/05/2018 Regulatory and procedural guideline: Qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects
02/05/2018 Regulatory and procedural guideline: Overview of comments on 'Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects'
02/05/2018 Annual Report: Annex 10 – 2017 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
02/05/2018 Committee for Advanced Therapies (CAT): 15-16 February 2018 , European Medicines Agency, London, UK, from 15/02/2018 to 16/02/2018
02/05/2018 Minutes: Minutes of the CAT meeting 15-16 February 2018
02/05/2018 Human medicines European public assessment report (EPAR): Trydonis, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 26/04/2018, Authorised
02/05/2018 Maximum Residue Limits - Report: Fluazuron (All ruminants, except bovine and ovine, and fin fish): European public maximum-residue-limit assessment report (EPMAR) - CVMP
02/05/2018 Maximum Residue Limits - Report: Solvent naphtha, light aromatic (All food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
02/05/2018 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 22/02/2005, 9, Authorised
02/05/2018 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains) / attenuated Chlamydophila felis (905 strain) / attenuated feline panleucopenia virus (PLI IV), 22/02/2005, 11, Authorised
02/05/2018 Periodic safety update single assessment: Ezetimibe / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010271/201707
02/05/2018 Veterinary medicines European public assessment report (EPAR): Purevax RCP FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 9, Authorised
02/05/2018 Human medicines European public assessment report (EPAR): Spedra, avanafil, Erectile Dysfunction, 21/06/2013, 26/04/2013, 11, Authorised
02/05/2018 Public Statement: Public statement on Zinbryta: Withdrawal of the marketing authorisation in the European Union