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30/09/2020 Human medicines European public assessment report (EPAR): Repaglinide Accord, repaglinide, Diabetes Mellitus, Type 2, 22/12/2011, Generic, 6, Authorised
30/09/2020 Article 5(3) opinions
30/09/2020 Other: Dexamethasone - COVID19 - Article-5(3) procedure: Assessment report
30/09/2020 Human medicines European public assessment report (EPAR): Zinplava, bezlotoxumab, Enterocolitis, Pseudomembranous, 18/01/2017, Additional monitoring, 5, Authorised
30/09/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 17 September 2020
30/09/2020 Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, 20/11/2018, 4, Authorised
29/09/2020 Human medicines European public assessment report (EPAR): Lumark, lutetium (177Lu) chloride, Radionuclide Imaging, 18/06/2015, 9, Authorised
29/09/2020 Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma, Glioblastoma, 26/01/1999, 33, Authorised
29/09/2020 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 18, Authorised
29/09/2020 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, 2, Authorised
29/09/2020 Orphan designation: DNA plasmid encoding a recombinant fusion protein consisting of the extracellular domain of human TNFα p55 receptor linked to the human IgG1 Fc domain for the: Treatment of non-infectious uveitis, 17/02/2016, Positive
29/09/2020 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis, Mycoses, Coccidioidomycosis, Aspergillosis, 25/10/2005, 27, Authorised
29/09/2020 Human medicines European public assessment report (EPAR): Integrilin, eptifibatide, Angina, Unstable, Myocardial Infarction, 01/07/1999, 24, Authorised
29/09/2020 Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, 17/02/2009, 16, Authorised
29/09/2020 Agenda: Agenda - Workshop on the General Data Protection Regulation (GDPR) and secondary use of data for medicines and public health purposes
29/09/2020 Veterinary medicines European public assessment report (EPAR): UpCard, Torasemide anhydrous, 31/07/2015, 2, Authorised
29/09/2020 Agenda: Agenda - PRAC draft agenda of meeting 28 September - 1 October 2020
29/09/2020 Report: Medicinal products for human use: monthly figures - August 2020
29/09/2020 Minutes: Minutes of the CAT meeting 15-17 July 2020
29/09/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2020
28/09/2020 Withdrawn application: Sondelbay, teriparatide, Date of withdrawal: 19/06/2020, Initial authorisation
28/09/2020 Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, Additional monitoring, 15, Authorised
28/09/2020 Human medicines European public assessment report (EPAR): Celsentri, maraviroc, HIV Infections, 18/09/2007, 26, Authorised
28/09/2020 Human medicines European public assessment report (EPAR): Shingrix, Recombinant varicella zoster virus glycoprotein E, Herpes Zoster, 21/03/2018, Additional monitoring, 5, Authorised
28/09/2020 Orphans: Regulatory and procedural guidance and forms
28/09/2020 Other: Quick interactive guide to IRIS registration process
28/09/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC meeting
28/09/2020 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC
28/09/2020 Human medicines European public assessment report (EPAR): Jyseleca, filgotinib maleate, Arthritis, Rheumatoid, 24/09/2020, Additional monitoring, Authorised
28/09/2020 Other: European Medicines Agency’s privacy statement for the use of Microsoft Teams and SharePoint Online pilot users
28/09/2020 Other: Orientation guide for patient representatives and healthcare professionals - EMA building
28/09/2020 Human medicines European public assessment report (EPAR): Tolucombi, telmisartan, hydrochlorothiazide, Hypertension, 13/03/2013, Generic, 9, Authorised
25/09/2020 Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Multiple Sclerosis, 13/03/1997, 33, Authorised
25/09/2020 Orphan designation: Synthetic glucagon analogue modified to contain 7 amino acid substitutions for the: Treatment of congenital hyperinsulinism, 20/06/2017, Positive
25/09/2020 Other: Important medical event terms list version (MedDRA version 23.1)
25/09/2020 Minutes: Minutes of the CHMP meeting 22-25 June 2020
25/09/2020 Procurement: Ex ante publicity of a negotiated procedure : EMA 2019-37-CO - Exhibition logistics
25/09/2020 Veterinary medicines European public assessment report (EPAR): Clynav, pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins, 26/06/2017, 5, Authorised
25/09/2020 Plasma master file certificates
25/09/2020 Human medicines European public assessment report (EPAR): Cymbalta, duloxetine, Anxiety Disorders, Diabetic Neuropathies, Depressive Disorder, Major, 17/12/2004, 30, Authorised
25/09/2020 Supply shortage: Nulojix (belatacept) supply shortage
24/09/2020 Orphan designation: Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the: treatment of metachromatic leukodystrophy, 26/06/2020, Positive
24/09/2020 Orphan designation: axicabtagene ciloleucel for the: Treatment of marginal zone lymphoma, 26/06/2020, Positive
24/09/2020 Orphan designation: Lys40(NODAGA-68Ga)NH2-exendin-4 for the: Diagnosis of insulinoma, 26/06/2020, Positive
24/09/2020 Template or form: Submission of comments on ‘Guideline on registry-based studies’ (EMA/484811/2020)
24/09/2020 Scientific guideline: Guideline on registry-based studies
24/09/2020 News and press releases: Guideline on registry-based studies - launch of public consultation
24/09/2020 Leaflet: Public engagement highlights of 2019
23/09/2020 Human medicines European public assessment report (EPAR): Humalog, insulin lispro, Diabetes Mellitus, 30/04/1996, 32, Authorised
23/09/2020 Orphan designation: Anti-CD123 IgG1 humanised monoclonal antibody conjugated to N1-(2-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)ethyl)-N6-((S)-1-(((S)-1-((3-((((S)-8-methoxy-6-oxo-11,12,12a,13-tetrahydro-6H-benzo[5,6][1,4]diazepino[1,2-a]indol-9-yl)oxy)methyl)-5-((((S)-8-methoxy-6-oxo-12a,13-dihydro-6Hbenzo[5,6][1,4]diazepino[1,2-a]indol-9-yl)oxy)methyl)phenyl)amino)-1-oxopropan-2-yl)amino)-1-oxopropan-2-yl)adipamide for the: Treatment of blastic plasmacytoid dendritic cell neoplasm, 26/06/2020, Positive
23/09/2020 Orphan designation: (+)-Epicatechin for the: Treatment of Becker muscular dystrophy, 26/06/2020, Positive
23/09/2020 Requesting a minor use / minor species (MUMS) / limited market classification
23/09/2020 Direct healthcare professional communication (DHPC): Nulojix (belatacept): Extension of the temporary restriction in supply up until 4Q 2021 (initiated in March 2017), Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 23/09/2020
23/09/2020 News and press releases: How incidents with medicines are managed in the EU – a ten-year analysis
22/09/2020 Q&A: Extension applications
22/09/2020 Veterinary medicines European public assessment report (EPAR): Suvaxyn Circo+MH RTU, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein, Inactivated Mycoplasma hyopneumoniae, strain P-5722-3, 06/11/2015, 6, Authorised
22/09/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2020
22/09/2020 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia, Iron Overload, 28/08/2006, Additional monitoring, 47, Authorised
22/09/2020 Orphan designation: Ketoconazole for the: Treatment of Cushing's syndrome, 23/04/2012, Positive
22/09/2020 Orphan designation: Nomacopan for the: Treatment of bullous pemphigoid, 26/06/2020, Positive
22/09/2020 Orphan designation: stiripentol for the: Treatment of primary hyperoxaluria, 26/06/2020, Positive
22/09/2020 Orphan designation: Onfekafusp alfa for the: Treatment of glioma, 26/06/2020, Positive
22/09/2020 Human medicines European public assessment report (EPAR): Duloxetine Lilly, duloxetine, Neuralgia, Diabetic Neuropathies, Depressive Disorder, Major, 08/12/2014, 8, Authorised
22/09/2020 Human medicines European public assessment report (EPAR): Tamiflu, oseltamivir, Influenza, Human, 20/06/2002, 39, Authorised
22/09/2020 Human medicines European public assessment report (EPAR): Yentreve, duloxetine hydrochloride, Urinary Incontinence, Stress, 11/08/2004, 27, Authorised
22/09/2020 Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin (as acetate), Candidiasis, Aspergillosis, 23/10/2001, 26, Authorised
21/09/2020 Veterinary medicines European public assessment report (EPAR): Inflacam, meloxicam, 09/12/2011, Generic, 11, Authorised
21/09/2020 Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, 11/01/2008, 20, Authorised
21/09/2020 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 13, Authorised
21/09/2020 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 11, Authorised
21/09/2020 Human medicines European public assessment report (EPAR): Pemetrexed medac, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 26/11/2015, Generic, 6, Authorised
21/09/2020 Q&A: Type II variations
21/09/2020 Periodic safety update single assessment: Beta-alanine: List of nationally authorised medicinal products - PSUSA/00010510/202001
21/09/2020 Minutes: Minutes of the CAT meeting 12-14 August 2020
21/09/2020 Agenda: Agenda - HMPC agenda of the 21-23 September 2020 meeting
21/09/2020 Regulatory and procedural guideline: IRIS guide to registration
21/09/2020 Online training: How to submit Initial and follow-up scientific advice applications (veterinary) using IRIS , Virtual meeting, from 14/10/2020 to 14/10/2020
21/09/2020 Online training: How to submit initial and follow-up scientific advice applications (human) using IRIS , Virtual meeting, from 13/10/2020 to 13/10/2020
21/09/2020 Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira), voriconazole, Bacterial Infections and Mycoses, Aspergillosis, Candidiasis, 27/05/2015, Generic, 8, Authorised
21/09/2020 Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 5, Authorised
18/09/2020 Veterinary medicines European public assessment report (EPAR): Ecoporc Shiga, genetically modified recombinant Shiga-toxin-2e antigen, 10/04/2013, 4, Authorised
18/09/2020 Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec) for the: Treatment of X-linked myotubular myopathy, 10/08/2015, Positive
18/09/2020 Minutes: Minutes of the CVMP meeting of 14-16 July 2020 meeting
18/09/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
18/09/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 14-17 September 2020
18/09/2020 News and press releases: First treatment for rare metabolic disorder alkaptonuria
18/09/2020 News and press releases: New treatment for children with chronic kidney disease
18/09/2020 News and press releases: New oral treatment for moderate to severe atopic dermatitis
18/09/2020 Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside for the: Treatment of anti-MAG neuropathy, 17/07/2017, Positive
18/09/2020 Orphan designation: 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid for the: Treatment of systemic sclerosis, 12/03/2013, Positive
18/09/2020 Orphan designation: Flucytosine for the: Treatment of glioma, 22/02/2018, Positive
18/09/2020 Orphan designation: Vocimagene amiretrorepvec for the: Treatment of glioma, 22/02/2018, Positive
18/09/2020 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, 4, Authorised
18/09/2020 Other: European Medicines Regulatory Network COVID-19 Business Continuity Plan
18/09/2020 Veterinary medicines European public assessment report (EPAR): Respiporc FLUpan H1N1, Inactivated influenza A virus/human strain:A/Jena/VI5258/2009(H1N1)pdm09, 17/05/2017, 5, Authorised
18/09/2020 Human medicines European public assessment report (EPAR): Sildenafil Actavis, sildenafil, Erectile Dysfunction, 10/12/2009, Generic, 13, Authorised
18/09/2020 Other: EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list
17/09/2020 Parallel consultation with regulators and health technology assessment bodies
17/09/2020 Agenda: Agenda - Workshop on benefit-risk of medicines used during pregnancy and breastfeeding
17/09/2020 Human medicines European public assessment report (EPAR): Truvada, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 20/02/2005, 43, Authorised
17/09/2020 Human medicines European public assessment report (EPAR): Ruxience, rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus, 01/04/2020, Additional monitoring, Biosimilar, 2, Authorised
17/09/2020 News and press releases: IT systems unavailable from 18 to 20 September 2020
17/09/2020 Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F for the: Treatment of multiple myeloma, 16/10/2017, Positive
17/09/2020 Veterinary pre-submission Q&A: 1-20
16/09/2020 Human medicines European public assessment report (EPAR): Hizentra, human normal immunoglobulin (SCIg), Immunologic Deficiency Syndromes, 14/04/2011, 20, Authorised
16/09/2020 Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 14/11/2019, Generic, 2, Authorised
16/09/2020 Human medicines European public assessment report (EPAR): Myocet liposomal (previously Myocet), doxorubicin hydrochloride, Breast Neoplasms, 13/07/2000, 22, Authorised
16/09/2020 Human medicines European public assessment report (EPAR): Votubia, everolimus, Tuberous Sclerosis, 02/09/2011, Orphan, 27, Authorised
16/09/2020 Human medicines European public assessment report (EPAR): Tolura, telmisartan, Hypertension, 04/06/2010, Generic, 9, Authorised
16/09/2020 Human medicines European public assessment report (EPAR): Kigabeq, vigabatrin, Spasms, Infantile, Epilepsies, Partial, 20/09/2018, 3, Authorised
16/09/2020 Other: Record of data processing activity for EudraVigilance (public)
16/09/2020 Referral: Budesonide SUN , budesonide , Article 29(4) referrals, European Commission final decision, 25/06/2020, 19/08/2020, 16/09/2020
16/09/2020 Human medicines European public assessment report (EPAR): Visudyne, verteporfin, Myopia, Degenerative, Macular Degeneration, 27/07/2000, 35, Authorised
16/09/2020 Other: European Medicines Agency’s Privacy Statement for EudraVigilance
16/09/2020 Other: European Medicines Agency’s privacy statement for the EMA Account Management system
16/09/2020 Other: Record of data processing activity regarding EMA Account Management System (public)
16/09/2020 Human medicines European public assessment report (EPAR): Azacitidine Mylan, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 27/03/2020, Generic, 1, Authorised
16/09/2020 EMA EudraVigilance information day , Virtual meeting, from 02/12/2020 to 02/12/2020
16/09/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 106 (6) of Regulation (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via rout
16/09/2020 Support for industry on clinical data publication
16/09/2020 Veterinary medicines European public assessment report (EPAR): Poulvac E. coli, Live aroA gene deleted Escherichia coli, type 078, strain EC34195, 15/06/2012, 9, Authorised
16/09/2020 Recommendation on medication errors: Peyona: potential for dosing errors
16/09/2020 Human medicines European public assessment report (EPAR): Desloratadine Teva, desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, 24/11/2011, Generic, 15, Authorised
16/09/2020 Herbal medicinal product: Menthae piperitae aetheroleum, Menthae piperitae aetheroleum, F: Assessment finalised
16/09/2020 Human medicines European public assessment report (EPAR): Pioglitazone Actavis, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 15/03/2012, Generic, 7, Authorised
15/09/2020 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 25-28 February 2020
15/09/2020 Human medicines European public assessment report (EPAR): Reyataz, atazanavir (as sulphate), HIV Infections, 01/03/2004, 50, Authorised
15/09/2020 Orphan designation: humanised monoclonal antibody of the IgG4 kappa isotype targeting CD47 (magrolimab) for the: Treatment of acute myeloid leukaemia, 11/11/2015, Positive
14/09/2020 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, Orphan, 20, Authorised
14/09/2020 Periodic safety update single assessment: Lidocaine / phenazone: List of nationally authorised medicinal products - PSUSA/00002359/202001
14/09/2020 Periodic safety update single assessment: Cyanocobalamin / diclofenac / pyridoxine / thiamine: List of nationally authorised medicinal products - PSUSA/00001041/202001
14/09/2020 Periodic safety update single assessment: Tizanidine: List of nationally authorised medicinal products - PSUSA/00002977/201912
14/09/2020 Periodic safety update single assessment: Amisulpride: List of nationally authorised medicinal products - PSUSA/00000167/202001
14/09/2020 Human medicines European public assessment report (EPAR): RotaTeq, rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization, Rotavirus Infections, 26/06/2006, 29, Authorised
14/09/2020 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 32, Authorised
14/09/2020 Other: Mandate - HMA / EMA joint Big Data Steering Group
14/09/2020 Human medicines European public assessment report (EPAR): Trimbow, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 17/07/2017, 3, Authorised
14/09/2020 News and press releases: Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
14/09/2020 Agenda: Agenda - CHMP agenda of the 14-17 September 2020 meeting
11/09/2020 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 65, Authorised
11/09/2020 Human medicines European public assessment report (EPAR): Leflunomide ratiopharm, leflunomide, Arthritis, Rheumatoid, 28/11/2010, Generic, 14, Authorised
11/09/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-9 September 2020
11/09/2020 Summary of opinion: Librela, 09/09/2020, Positive
11/09/2020 Summary of opinion: OvuGel, 09/09/2020, Positive
11/09/2020 Summary of opinion: Cytopoint, lokivetmab, 09/09/2020, Positive
11/09/2020 Maximum Residue Limits - Summary of opinion: Imidacloprid (Fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits
11/09/2020 Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter, Active substance: Letermovir, Last updated: 11/09/2020
11/09/2020 Other: Records of data processing activity for the use of Microsoft Teams and SharePoint Online pilot users (public)
11/09/2020 Regulatory and procedural guideline: Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions
11/09/2020 Periodic safety update single assessment: Alitretinoin (oral use): List of nationally authorised medicinal products - PSUSA/00010710/202001
11/09/2020 Periodic safety update single assessment: Celiprolol: List of nationally authorised medicinal products - PSUSA/00000617/202001
11/09/2020 Periodic safety update single assessment: Omega-3-acid ethyl esters: List of nationally authorised medicinal products - PSUSA/00010312/202001
11/09/2020 Periodic safety update single assessment: Metamizole sodium / triacetonamine tosilate: List of nationally authorised medicinal products - PSUSA/00001999/202001
11/09/2020 Periodic safety update single assessment: Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet): List of nationally authorised medicinal products - PSUSA/00010465/201912
11/09/2020 Periodic safety update single assessment: Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/202001
11/09/2020 Periodic safety update single assessment: Bacillus clausii multi-antibioresistant spores: List of nationally authorised medicinal products - PSUSA/00000284/201911
11/09/2020 Periodic safety update single assessment: Bacillus clausii multi-antibioresistant spores: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000284/201911
11/09/2020 Periodic safety update single assessment: Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/202002
11/09/2020 Human medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 30/06/2013, Generic, 16, Authorised
10/09/2020 Human medicines European public assessment report (EPAR): Imatinib Actavis, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma, 17/04/2013, Generic, 12, Authorised
10/09/2020 Agenda: Agenda - EMA Clinical Trial Information System (CTIS) webinar: Dynamic demo of sponsor workspace
10/09/2020 Newsletter: News bulletin for small and medium-sized enterprises - Issue 50
10/09/2020 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
10/09/2020 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel)
10/09/2020 Regulatory and procedural guideline: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms
10/09/2020 Agenda: Agenda - CAT agenda of the 9-11 September 2020 meeting
09/09/2020 Orphan designation: Artesunate for the: Treatment of malaria, 28/02/2020, Positive
09/09/2020 Human medicines European public assessment report (EPAR): Vihuma, simoctocog alfa, Hemophilia A, 13/02/2017, Additional monitoring, 4, Authorised
09/09/2020 Human medicines European public assessment report (EPAR): Temomedac, temozolomide, Glioma, Glioblastoma, 25/01/2010, Generic, 14, Authorised
09/09/2020 Veterinary medicines European public assessment report (EPAR): Vectormune FP ILT + AE, live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) and avian encephalomyelitis virus, strain Calnek 1143 (AE), 24/04/2020, 1, Authorised
09/09/2020 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, 5, Authorised
09/09/2020 Periodic safety update single assessment: Sodium benzoate / grindelia tincture / polygala syrup: List of nationally authorised medicinal products - PSUSA/00010543/201912
09/09/2020 Periodic safety update single assessment: Human alpha1-proteinase inhibitor (apart from the centrally authorised product): List of nationally authorised medicinal products - PSUSA/00000108/201912
09/09/2020 Periodic safety update single assessment: Varicella zoster-immunoglobulin: List of nationally authorised medicinal products - PSUSA/00010266/201912
09/09/2020 Veterinary medicines European public assessment report (EPAR): Suvaxyn PRRS MLV, Modified live porcine respiratory and reproductive syndrome virus, 24/08/2017, 4, Authorised
09/09/2020 Minutes: Minutes of the 108th meeting of the Management Board: 11 June 2020
09/09/2020 Report: Applications for new human medicines under evaluation by the CHMP: September 2020
08/09/2020 Agenda: Agenda - CVMP agenda of the 8-10 September 2020 meeting
08/09/2020 Agenda: Agenda - COMP agenda of the 8-10 September 2020 meeting
07/09/2020 Human medicines European public assessment report (EPAR): Trecondi, Treosulfan, Hematopoietic Stem Cell Transplantation, 20/06/2019, Orphan, 2, Authorised
07/09/2020 Periodic safety update single assessment: Iron (parenteral preparations, except for iron dextran): List of nationally authorised medicinal products - PSUSA/00010236/202001
07/09/2020 Periodic safety update single assessment: Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001
07/09/2020 Human medicines European public assessment report (EPAR): Protopic, tacrolimus, Dermatitis, Atopic, 27/02/2002, 24, Authorised
04/09/2020 Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Wet Macular Degeneration, Macular Edema, Myopia, Degenerative, Diabetes Complications, 22/01/2007, 37, Authorised
04/09/2020 Human medicines European public assessment report (EPAR): Cinacalcet Accordpharma, cinacalcet hydrochloride, Hyperparathyroidism, 03/04/2020, Generic, 1, Authorised
04/09/2020 Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, urea (13C), Breath Tests, Helicobacter Infections, 14/08/1997, 17, Authorised
04/09/2020 Veterinary medicines European public assessment report (EPAR): Simparica, sarolaner, 06/11/2015, 7, Authorised
04/09/2020 Extraordinary Management Board meeting: 25 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 25/06/2020 to 25/06/2020
04/09/2020 Minutes: Minutes of the Extraordinary Management Board meeting for the nomination of the Executive Director: 25 June 2020
04/09/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2020
04/09/2020 News and press releases: PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
04/09/2020 Newsletter: Human medicines highlights - September 2020
03/09/2020 Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Hemophilia A, 18/11/2015, 10, Authorised
03/09/2020 Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 35, Authorised
03/09/2020 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 22, Authorised
03/09/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2020 to 18/06/2020
03/09/2020 Minutes: Minutes of the CVMP meeting of 16-18 June 2020
03/09/2020 Agenda: Agenda - PDCO agenda of the 1-4 September 2020 meeting
03/09/2020 Human medicines European public assessment report (EPAR): Ravicti, glycerol phenylbutyrate, Urea Cycle Disorders, Inborn, 26/11/2015, Orphan, Additional monitoring, 12, Authorised
03/09/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 23/11/2020 to 25/11/2020
03/09/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Virtual meeting, from 30/09/2020 to 02/10/2020
03/09/2020 Agenda: Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (September, October, November, December 2020)
02/09/2020 Human medicines European public assessment report (EPAR): Zimbus Breezhaler, glycopyrronium bromide, Indacaterol (acetate), Mometasone furoate, Asthma, 03/07/2020, Authorised
02/09/2020 News and press releases: EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
01/09/2020 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 June 2020
01/09/2020 Report: Medicinal products for human use: monthly figures - July 2020