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Date Content
19/07/2019 Human medicines European public assessment report (EPAR): Renvela, sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 09/06/2009, 19, Authorised (updated)
19/07/2019 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 14, Authorised (updated)
19/07/2019 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 29, Authorised (updated)
19/07/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019
19/07/2019 Summary of opinion: Nexgard Spectra, afoxolaner / milbemycin oxime, 19/07/2019, Positive
19/07/2019 Summary of opinion: NexGard, afoxolaner, 19/07/2019, Positive
19/07/2019 Summary of opinion: Nexgard Spectra, afoxolaner / milbemycin oxime, 18/07/2019, Positive
19/07/2019 Summary of opinion: Broadline, eprinomectin, fipronil, praziquantel, (S)-methoprene, 18/07/2019, Positive
19/07/2019 Summary of opinion: Simparica Trio, 18/07/2019, Positive
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 (updated)
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 (updated)
19/07/2019 Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Schizophrenia, Bipolar Disorder, 25/06/2015, Generic, 6, Authorised (updated)
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 (updated)
19/07/2019 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia, Bipolar Disorder, 04/06/2004, 44, Authorised (updated)
19/07/2019 Other: Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
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 European Medicines Agency and European Union payer community meeting , Zorginstituut Nederland, Diemen, The Netherlands, from 18/06/2019 to 18/06/2019 (updated)
19/07/2019 Human medicines European public assessment report (EPAR): Prolia, denosumab, Bone Resorption, Osteoporosis, Postmenopausal, 26/05/2010, 21, Authorised (updated)
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 Human medicines European public assessment report (EPAR): Ucedane, carglumic acid, Hyperammonemia, Amino Acid Metabolism, Inborn Errors, 23/06/2017, Generic, 4, Authorised (updated)
18/07/2019 Scientific publications (updated)
18/07/2019 Orphan designation: Palovarotene for the: Treatment of fibrodysplasia ossificans progressiva, 19/11/2014, Positive (updated)
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 Other: List of eligible industry stakeholder organisations (updated)
18/07/2019 Human medicines European public assessment report (EPAR): Neuraceq, florbetaben (18F), Radionuclide Imaging, Alzheimer Disease, 20/02/2014, 15, Authorised (updated)
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
18/07/2019 Other: Article 57 product data (updated)
17/07/2019 Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 5, Authorised (updated)
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 (updated)
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 (updated)
17/07/2019 Leaflet: Public engagement highlights of 2018
17/07/2019 Periodic safety update reports (PSURs) (updated)
17/07/2019 Other: Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports (updated)
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 (updated)
17/07/2019 Procurement (updated)
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 (updated)
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 (updated)
17/07/2019 Human medicines European public assessment report (EPAR): Maviret, glecaprevir / pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Additional monitoring, 6, Authorised (updated)
17/07/2019 Orphan designation: diazoxide choline for the: Treatment of Prader-Willi syndrome, 12/10/2017, Positive (updated)
17/07/2019 Human medicines European public assessment report (EPAR): Eurartesim, piperaquine tetraphosphate / artenimol, Malaria, 27/10/2011, Additional monitoring, 10, Authorised (updated)
17/07/2019 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 5, Authorised (updated)
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 (updated)
17/07/2019 Referral: Lemtrada ,  alemtuzumab , Article 20 procedures, Under evaluation, 29/04/2019, 17/07/2019 (updated)
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 (updated)
16/07/2019 Orphan designation: Recombinant chimeric monoclonal antibody against CD20 for the: Treatment of chronic lymphocytic leukaemia, 26/11/2009, Positive (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, 29, Authorised (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Mycamine, micafungin, Candidiasis, 25/04/2008, 13, Authorised (updated)
16/07/2019 Veterinary medicines European public assessment report (EPAR): Nexgard Spectra, afoxolaner, milbemycin oxime, 14/01/2015, 4, Authorised (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Memantine Mylan, memantine hydrochloride, Alzheimer Disease, 21/04/2013, Generic, 5, Authorised (updated)
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 (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014, Generic, 8, Authorised (updated)
16/07/2019 Eligible healthcare professionals' organisations (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Volibris, ambrisentan, Hypertension, Pulmonary, 20/04/2008, 20, Authorised (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Jorveza, budesonide, Esophageal Diseases, 08/01/2018, Orphan, 1, Authorised (updated)
16/07/2019 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 9, Authorised (updated)
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 (updated)
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 (updated)
12/07/2019 Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/2007, Generic, 16, Authorised (updated)
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 (updated)
12/07/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 16/12/2016, Generic, 3, Authorised (updated)
12/07/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 7, Authorised (updated)
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of citrullinaemia type 2, 10/06/2010, Positive (updated)
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of hyperargininaemia, 10/06/2010, Positive (updated)
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrom, 10/06/2010, Positive (updated)
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of argininosuccinic aciduria, 10/06/2010, Positive (updated)
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of citrullinaemia type 1, 10/06/2010, Positive (updated)
12/07/2019 Orphan designation: Levoglutamide for the: Treatment of sickle cell disease, 04/07/2012, Positive (updated)
12/07/2019 Orphan designation: Glyceryl tri-(4-phenylbutyrate) for the: Treatment of ornithine carbamoyltransferase deficiency, 10/06/2010, Positive (updated)
12/07/2019 Human medicines European public assessment report (EPAR): Valdoxan, Agomelatine, Depressive Disorder, Major, 19/02/2009, 20, Authorised (updated)
12/07/2019 Referrals document: Fosfomycin Article-31 referral - Timetable for the procedure (updated)
12/07/2019 Referral: Fosfomycin-containing medicinal products , fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol , Article 31 referrals, Under evaluation, 13/12/2018, 12/07/2019 (updated)
12/07/2019 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
12/07/2019 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid, 08/09/2003, 73, Authorised (updated)
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 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet, Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 12/07/2019 (updated)
12/07/2019 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Under evaluation
12/07/2019 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Procedure started
12/07/2019 Human medicines European public assessment report (EPAR): MabThera, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 45, Authorised (updated)
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 (updated)
12/07/2019 News and press releases: PRAC recommends new measures to avoid dosing errors with methotrexate
12/07/2019 Mutual recognition agreements (MRA) (updated)
12/07/2019 News and press releases: EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
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 (updated)
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 (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma), clopidogrel besilate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 16/10/2009, Generic, 16, Authorised (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Triumeq, abacavir sulfate, dolutegravir sodium, lamivudine, HIV Infections, 31/08/2014, Patient safety, 13, Authorised (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Cetrotide, cetrorelix, Ovulation, Ovulation Induction, 12/04/1999, 25, Authorised (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, Additional monitoring, 7, Authorised (updated)
11/07/2019 Veterinary medicines European public assessment report (EPAR): Osurnia, terbinafine / florfenicol, betamethasone acetate, 31/07/2014, Patient safety, 7, Authorised (updated)
11/07/2019 Orphan designation: Muramyl tripeptide phosphatidyl ethanolamine for the: Treatment of osteosarcoma, 21/06/2004, Expired (updated)
11/07/2019 Orphan designation: Caffeine citrate for the: Treatment of primary apnoea of premature newborns, 18/02/2003, Expired (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis, Keratitis, 06/07/2018, Orphan, 2, Authorised (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya), clopidogrel hydrochloride, 20/09/2009, Generic, 9, Authorised (updated)
11/07/2019 Human medicines European public assessment report (EPAR): Foclivia, influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 18/10/2009, Exceptional circumstances, 7, Authorised (updated)
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 (updated)
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): Fiasp, insulin aspart, Diabetes Mellitus, 09/01/2017, Patient safety, Additional monitoring, 3, Authorised (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 33, Authorised (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Aflunov, influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks, 28/11/2010, 9, Authorised (updated)
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 (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Authorised
10/07/2019 Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 25, Authorised (updated)
10/07/2019 Orphan designation: Iodine (131I) iobenguane for the: Treatment of neuroblastoma, 31/01/2008, Positive (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders, Autistic Disorder, 20/09/2018, 3, Authorised (updated)
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 (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Evista, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 05/08/1998, 22, Authorised (updated)
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 (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, Additional monitoring, 5, Authorised (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 5, Authorised (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Pemetrexed medac, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 26/11/2015, Generic, 4, Authorised (updated)
10/07/2019 Orphan designation: Ciclosporin (inhalation use) for the: Prevention of graft rejection after lung transplantation, 29/07/2004, Positive (updated)
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 (updated)
10/07/2019 Orphan designation: Ciclosporin (inhalation use) for the: Treatment of bronchiolitis obliterans syndrome, 24/05/2017, Positive (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Crohn Disease, Arthritis, Psoriatic, Colitis, Ulcerative, 13/08/1999, 54, Authorised (updated)
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 (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/06/2015, Additional monitoring, 9, Authorised (updated)
10/07/2019 Other: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) (updated)
10/07/2019 Advice on impacts of using antimicrobials in animals (updated)
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 (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Advate, octocog alfa, Hemophilia A, 02/03/2004, 24, Authorised (updated)
10/07/2019 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection, Bacterial Infections, 20/09/2018, Additional monitoring, 1, Authorised (updated)
09/07/2019 Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 15, Authorised (updated)
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 (updated)
09/07/2019 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection, Kidney Transplantation, 17/06/2011, 11, Authorised (updated)
09/07/2019 Human medicines European public assessment report (EPAR): Capecitabine Teva, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 10, Authorised (updated)
09/07/2019 Human medicines European public assessment report (EPAR): Zyllt, clopidogrel hydrogen sulphate, Peripheral Vascular Diseases, Stroke, Acute Coronary Syndrome, Myocardial Infarction, 28/09/2009, Generic, 11, Authorised (updated)
09/07/2019 Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration, Macular Edema, Diabetes Complications, 21/11/2012, 17, Authorised (updated)
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 (updated)
09/07/2019 Orphan designation: Carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (miridesap) for the: Treatment of AL amyloidosis, 29/07/2014, Withdrawn (updated)
09/07/2019 Orphan designation: Cyclocreatine for the: Treatment of creatine deficiency syndromes, 27/06/2016, Withdrawn (updated)
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 (updated)
09/07/2019 Orphan designation: Doxorubicine polyisohexylcyanoacrylate nanoparticles for the: Treatment of hepatocellular carcinoma, 21/10/2004, Withdrawn (updated)
09/07/2019 Human medicines European public assessment report (EPAR): Zarzio, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 06/02/2009, Biosimilar, 16, Authorised (updated)
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 (updated)
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 (updated)
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 (updated)
09/07/2019 Orphan designation: Ulocuplumab for the: Treatment of acute myeloid leukaemia, 12/02/2015, Positive (updated)
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 (updated)
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 (updated)
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 (updated)
08/07/2019 Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 8, Authorised (updated)
08/07/2019 Human medicines European public assessment report (EPAR): Terrosa, teriparatide, Osteoporosis, 04/01/2017, Additional monitoring, Biosimilar, 3, Authorised (updated)
08/07/2019 Plasma-master-file certifications (updated)
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 (updated)
08/07/2019 Removing an orphan designation (updated)
08/07/2019 Other: Post-orphan medicinal product designation procedures - guidance to submit an application via IRIS online portal (updated)
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 (updated)
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 Other: List of signals discussed at PRAC since September 2012
08/07/2019 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, Authorised
05/07/2019 Newsletter: Human medicines highlights - July 2019
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 (updated)
05/07/2019 Referral: Xeljanz , tofacitinib , Article 20 procedures, Under evaluation, 05/07/2019 (updated)
05/07/2019 Orphan designation: Heat-killed Mycobacterium vaccae (whole cell) for the: Treatment of tuberculosis, 20/09/2010, Positive (updated)
05/07/2019 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 17, Authorised (updated)
05/07/2019 Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, Orphan, Additional monitoring, Exceptional circumstances, 16, Authorised (updated)
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 (updated)
05/07/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2019
05/07/2019 Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization, Meningitis, Meningococcal, 15/03/2010, 17/12/2009, 27, Authorised (updated)
04/07/2019 Business hours and holidays (updated)
04/07/2019 Human medicines European public assessment report (EPAR): Edurant, rilpivirine hydrochloride, HIV Infections, 28/11/2011, 16, Authorised (updated)
04/07/2019 Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Osteoporosis, Postmenopausal, 17/04/2009, 12, Authorised (updated)
04/07/2019 News and press releases: EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case with Canary Wharf Group
04/07/2019 Periodic safety update single assessment: Diclofenac (topical formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010342/201809
04/07/2019 Periodic safety update single assessment: Diclofenac (topical formulations): List of nationally authorised medicinal products - PSUSA/00010342/201809
04/07/2019 Work programme: Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use (updated)
04/07/2019 Regulatory and procedural guideline: Good practice guidance for communication to the public on medicines’ availability issues
04/07/2019 News and press releases: Medicine shortages: EU network takes steps to improve reporting and communication
04/07/2019 Regulatory and procedural guideline: Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA)
04/07/2019 Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis, 15/06/2017, Additional monitoring, Biosimilar, 3, Authorised (updated)
04/07/2019 Recruitment: European Medicines Agency's privacy statement for selection and recruitment
04/07/2019 Periodic safety update single assessment: Permethrin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002355/201808
03/07/2019 EudraVigilance training and support (updated)
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Berlin , Berlin, Germany, from 23/09/2019 to 25/09/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam , Amsterdam, The Netherlands, from 16/09/2019 to 18/09/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - London , London, United Kingdom, from 14/10/2019 to 16/10/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Vienna , Vienna, Austria, from 02/10/2019 to 04/10/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam , Amsterdam, The Netherlands, from 21/10/2019 to 23/10/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Madrid , Madrid, Spain, from 09/10/2019 to 11/10/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - San Marino , San Marino, from 06/11/2019 to 08/11/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Lisbon , Lisbon, Portugal, from 18/11/2019 to 20/11/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam , Amsterdam, The Netherlands, from 09/12/2019 to 11/12/2019
03/07/2019 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Basel , Basel, Switzerland, from 04/12/2019 to 06/12/2019
03/07/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 June 2019
03/07/2019 Other: Joint letter by the European Commission, EMA and HMA to stakeholders regarding the requirements to provide results for authorised clinical trials in EudraCT
03/07/2019 Clinical trials in human medicines (updated)
03/07/2019 News and press releases: Call for all sponsors to publish clinical trial results in EU database
03/07/2019 Minutes: Minutes of the PRAC meeting 12-15 March 2019
03/07/2019 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
03/07/2019 Pharmacovigilance Risk Assessment Committee (PRAC): 12-15 March 2019 , European Medicines Agency, from 12/03/2019 to 15/03/2019 (updated)
03/07/2019 Extended EudraVigilance medicinal product dictionary (XEVMPD) training (updated)
03/07/2019 eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam) , BCN Amsterdam Arena, Atlas Arena Complex, Amsterdam, The Netherlands, from 19/09/2019 to 20/09/2019
03/07/2019 eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (London) , Tuition House, London, UK, from 17/10/2019 to 18/10/2019
03/07/2019 eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Lisbon) , INFARMED, Lisbon, Portugal, from 21/11/2019 to 22/11/2019
03/07/2019 Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Epilepsy, 29/09/2000, 44, Authorised (updated)
02/07/2019 Human medicines European public assessment report (EPAR): Sixmo, Buprenorphine hydrochloride, Opioid-Related Disorders, 19/06/2019, Additional monitoring, Authorised
02/07/2019 Human medicines European public assessment report (EPAR): ATryn, Antithrombin alfa, Antithrombin III Deficiency, 28/07/2006, Additional monitoring, Exceptional circumstances, 16, Withdrawn (updated)
02/07/2019 Human medicines European public assessment report (EPAR): Airexar Spiromax, salmeterol, fluticasone propionate, Pulmonary Disease, Chronic Obstructive, Asthma, 18/08/2016, 2, Withdrawn (updated)
02/07/2019 Public Statement: Public statement on Airexar Spiromax: Withdrawal of the marketing authorisation in the European Union
02/07/2019 Human medicines European public assessment report (EPAR): Evra, norelgestromin, ethinyl estradiol, Contraception, 21/08/2002, 20, Authorised (updated)
02/07/2019 Veterinary medicines European public assessment report (EPAR): Credelio, lotilaner, 23/04/2017, 3, Authorised (updated)
02/07/2019 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 2, Authorised (updated)
02/07/2019 Human medicines European public assessment report (EPAR): Vivanza, vardenafil, Erectile Dysfunction, 04/03/2003, 25, Authorised (updated)
02/07/2019 Human medicines European public assessment report (EPAR): Champix, varenicline, Tobacco Use Cessation, 25/09/2006, 34, Authorised (updated)
02/07/2019 Scientific guideline: Draft qualification opinion of Multiple sclerosis clinical outcome assessment (MSCOA) (updated)
01/07/2019 Investigation of medicinal products in the term and preterm neonate (updated)