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Date Content
30/04/2021 Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, 06/09/2010, 12, Authorised
30/04/2021 Periodic safety update single assessment: Fosphenytoin: List of nationally authorised medicinal products - PSUSA/00001476/202008
30/04/2021 Periodic safety update single assessment: Fosphenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001476/202008
30/04/2021 Periodic safety update single assessment: Cisatracurium: List of nationally authorised medicinal products - PSUSA/00000777/202007
30/04/2021 Periodic safety update single assessment: Cisatracurium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000777/202007
30/04/2021 Academia
30/04/2021 Other: Academia collaboration matrix action plan 2021-2023
30/04/2021 Third European Medicines Agency - EuropaBio bilateral meeting , Virtual meeting, from 05/05/2021 to 05/05/2021
30/04/2021 Other: Prof. Guido Rasi - Assessment outcome of occupational activities after leaving the service (April 2021)
30/04/2021 Periodic safety update single assessment: Betula verrucosa: List of nationally authorised medicinal products - PSUSA/00010815/202007
30/04/2021 Orphan designation: L-cystine bis(N-methylpiperazide) for the: Treatment of cystinuria, 27/06/2018, Positive
30/04/2021 Human medicines European public assessment report (EPAR): Shingrix, Recombinant varicella zoster virus glycoprotein E, Herpes Zoster, 21/03/2018, Additional monitoring, 6, Authorised
30/04/2021 Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation, Neoplasms, 26/03/2021, Generic, Authorised
30/04/2021 Periodic safety update single assessment: Mifepristone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002060/202005
30/04/2021 Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharma, rivastigmine, Alzheimer Disease, Dementia, Parkinson Disease, 11/12/2009, 10, Authorised
30/04/2021 Periodic safety update single assessment: Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/202005
30/04/2021 Periodic safety update single assessment: Trimetazidine: List of nationally authorised medicinal products - PSUSA/00003043/202008
30/04/2021 Periodic safety update single assessment: Metronidazole / neomycin / nystatin: List of nationally authorised medicinal products - PSUSA/00010508/202009
30/04/2021 Periodic safety update single assessment: Bromazepam: List of nationally authorised medicinal products - PSUSA/00000435/202008
30/04/2021 Periodic safety update single assessment: Dexibuprofen: List of nationally authorised medicinal products - PSUSA/00000996/202008
30/04/2021 Periodic safety update single assessment: Dimetindene / phenylephrine: List of nationally authorised medicinal products - PSUSA/00001102/202007
30/04/2021 Orphan designation: Mexiletine hydrochloride for the: Treatment of non-dystrophic myotonia, 07/06/2013, Positive
30/04/2021 Periodic safety update single assessment: Epinephrine: List of nationally authorised medicinal products - PSUSA/00001232/202007
30/04/2021 Periodic safety update single assessment: Ascorbic acid/paracetamol/phenylephrine hydrochloride: List of nationally authorised medicinal products - PSUSA/00000255/202006
30/04/2021 Dasatinib product-specific bioequivalence guidance
30/04/2021 Minutes: CHMP ORGAM minutes for the meeting on 3 November 2020
29/04/2021 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias, Hypercholesterolemia, 17/07/2015, 18, Authorised
29/04/2021 Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 07/06/2010, Biosimilar, 23, Authorised
29/04/2021 Veterinary medicines European public assessment report (EPAR): Dexdomitor, dexmedetomidine hydrochloride, 30/08/2002, 20, Authorised
29/04/2021 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 April 2021
29/04/2021 News and press releases: EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
29/04/2021 Human medicines European public assessment report (EPAR): Nemdatine, memantine, Alzheimer Disease, 22/04/2013, 22/02/2013, Generic, 10, Authorised
29/04/2021 Herbal medicinal product: Allii sativi bulbus, Allii sativi bulbus, F: Assessment finalised
29/04/2021 Orphan designation: lonapegsomatropin for the: Treatment of growth hormone deficiency, 17/10/2019, Positive
29/04/2021 Human medicines European public assessment report (EPAR): Victoza, liraglutide, Diabetes Mellitus, Type 2, 30/06/2009, 22, Authorised
29/04/2021 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 16/12/2016, Generic, 8, Authorised
29/04/2021 Human medicines European public assessment report (EPAR): Vipdomet, alogliptin benzoate, metformin hydrochloride, Diabetes Mellitus, Type 2, 18/09/2013, 8, Authorised
29/04/2021 Regulatory and procedural guideline: IRIS guide for parallel distribution applicants
29/04/2021 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 5, Authorised
29/04/2021 Human medicines European public assessment report (EPAR): Lysodren, Mitotane, Adrenal Cortex Neoplasms, 28/04/2004, 16, Authorised
28/04/2021 Template or form: Mutual-recognition decentralised referral product information template (English) version 4.2
28/04/2021 Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary, 12/04/2006, Biosimilar, 18, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Glycogen Storage Disease Type II, 28/03/2006, 18, Authorised
28/04/2021 Periodic safety update single assessment: Solifenacin: List of nationally authorised medicinal products - PSUSA/00002769/202006
28/04/2021 Orphan designation: 1,2:5,6-Dianhydrogalactitol for the: Treatment of glioma, 24/01/2013, Positive
28/04/2021 Human medicines European public assessment report (EPAR): HyQvia, Human normal immunoglobulin, Immunologic Deficiency Syndromes, 16/05/2013, Additional monitoring, 16, Authorised
28/04/2021 Orphan designation: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles for the: Treatment of ornithine transcarbamylase deficiency, 27/06/2018, Withdrawn
28/04/2021 Human medicines European public assessment report (EPAR): Comtan, entacapone, Parkinson Disease, 22/09/1998, 25, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Diabetes Mellitus, 08/02/2018, Additional monitoring, 5, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 41, Authorised
28/04/2021 Maximum Residue Limits - Report: Bupivacaine (porcine species): Summary report - Committee for Veterinary Medicinal Products
28/04/2021 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, Additional monitoring, 10, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders, Epilepsy, 10/04/2014, 22, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia, Cancer, 22/08/2002, 36, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Incresync, alogliptin, pioglitazone, Diabetes Mellitus, Type 2, 19/09/2013, 10, Authorised
28/04/2021 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections, Skin Diseases, Bacterial, Soft Tissue Infections, 24/04/2006, 32, Authorised
26/04/2021 Referrals document: Use of Vaxzevria to prevent COVID-19 - Article-5(3) procedure: Assessment report
26/04/2021 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, 2, Authorised
26/04/2021 Human medicines European public assessment report (EPAR): Rivastigmine Actavis, rivastigmine hydrogen tartrate, Dementia, Alzheimer Disease, Parkinson Disease, 16/06/2011, Generic, 14, Authorised
26/04/2021 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome, Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, 2, Authorised
26/04/2021 Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen, human thrombin, Hemostasis, Surgical, 10/11/2017, Additional monitoring, 4, Authorised
26/04/2021 Template or form: Mutual-recognition, decentralised and referral product-information template version 4.2
26/04/2021 Veterinary medicines European public assessment report (EPAR): Nobilis IB Primo QX, live avian infectious bronchitis virus, strain D388, 04/09/2014, 5, Authorised
26/04/2021 News and press releases: EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26/04/2021 Monitoring of COVID-19 medicines
26/04/2021 Agenda: Agenda - PDCO agenda of the 20-23 April 2021 meeting
26/04/2021 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer, 18/12/2007, Biosimilar, 28, Authorised
26/04/2021 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 16, Authorised
26/04/2021 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 14, Authorised
26/04/2021 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 41, Authorised
26/04/2021 Veterinary medicines European public assessment report (EPAR): Nobilis IB 4-91, live attenuated avian infectious bronchitis virus variant strain 4-91, 09/06/1998, 15, Authorised
26/04/2021 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, 9, Authorised
26/04/2021 Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia, Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021
26/04/2021 Human medicines European public assessment report (EPAR): Odomzo, sonidegib diphosphate, Carcinoma, Basal Cell, 14/08/2015, 10, Authorised
26/04/2021 Annex to CHMP highlights: Annex to Vaxzevria Art.5.3 - Visual risk contextualisation
26/04/2021 Orphan designation: Cannabidiol for the: Treatment of tuberous sclerosis, 17/01/2018, Positive
26/04/2021 Orphan designation: Diclofenamide for the: Treatment of periodic paralysis, 17/02/2016, Positive
26/04/2021 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, Colorectal Neoplasms, 19/09/2018, Additional monitoring, 6, Authorised
26/04/2021 Herbal medicinal product: Cinnamomi corticis aetheroleum , Cinnamomi corticis aetheroleum, F: Assessment finalised
26/04/2021 Other: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMBASE
26/04/2021 Scientific guideline: Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics
26/04/2021 Summary of opinion: Maviret, glecaprevir, pibrentasvir, 22/04/2021, Positive
26/04/2021 Report: Applications for new human medicines under evaluation by the CHMP: April 2021
26/04/2021 Minutes: Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - December 2020
26/04/2021 Submission deadlines for orphan designations
26/04/2021 Regulatory and procedural guideline: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2020-2021
23/04/2021 Referrals document: Interim Opinion of the Committee for Medicinal products for Human Use pursuant to Article 5(3) of Regulation (EC) No 726/2004 for Vaxzevria
23/04/2021 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 12, Authorised
23/04/2021 Guidance on good manufacturing practice and good distribution practice: Questions and answers
23/04/2021 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 23/03/2015, 16, Authorised
23/04/2021 Other: Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs
23/04/2021 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosilate, Stroke, Venous Thromboembolism, 19/06/2015, 14, Authorised
23/04/2021 News and press releases: AstraZeneca’s COVID-19 vaccine: benefits and risks in context
23/04/2021 Human medicines European public assessment report (EPAR): Mavenclad, Cladribine, Multiple Sclerosis, 22/08/2017, 4, Authorised
23/04/2021 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 13, Authorised
23/04/2021 News and press releases: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna
23/04/2021 EMA press briefing to update on analysis of data on Vaxzevria, the COVID-19 vaccine from AstraZeneca , Virtual meeting, from 23/04/2021 to 23/04/2021
23/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 22 April 2021
23/04/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
23/04/2021 Summary of opinion: Abiraterone Krka , abiraterone acetate, 22/04/2021, Positive
23/04/2021 Summary of opinion: Koselugo, selumetinib, 22/04/2021, Positive
23/04/2021 News and press releases: New treatment for rare autoimmune disease of nerve cells
23/04/2021 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 7, Authorised
23/04/2021 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 9, Authorised
23/04/2021 News and press releases: EMA working on COVID-19 during closure on 27 April 2021
23/04/2021 Periodic safety update single assessment: Iopromide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001773/202006
23/04/2021 Periodic safety update single assessment: Iopromide: List of nationally authorised medicinal products - PSUSA/00001773/202006
23/04/2021 Periodic safety update single assessment: Iohexol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001768/202006
23/04/2021 Periodic safety update single assessment: Iohexol: List of nationally authorised medicinal products - PSUSA/00001768/202006
23/04/2021 Periodic safety update single assessment: Tamoxifen: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002846/202004
23/04/2021 Periodic safety update single assessment: Tamoxifen: List of nationally authorised medicinal products - PSUSA/00002846/202004
23/04/2021 Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 19/05/2006, 20, Authorised
22/04/2021 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, Additional monitoring, 6, Authorised
22/04/2021 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, Generic, 8, Authorised
22/04/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: April 2021
22/04/2021 Medicines for use outside the European Union
22/04/2021 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 9, Authorised
22/04/2021 Overview of comments: Overview of comments received on 'Public guidance - Parallel application for EU-M4all (Article 58) opinion and Centralised Marketing Authorisation procedure' (EMA/104275/2021)
22/04/2021 Other: Submission deadlines for paediatric applications 2021-2024
22/04/2021 Regulatory and procedural guideline: Public guidance - Parallel application for EU-M4all (Article 58) opinion and Centralised Marketing Authorisation procedure
22/04/2021 Human medicines European public assessment report (EPAR): Movymia, teriparatide, Osteoporosis, 11/01/2017, Additional monitoring, Biosimilar, 8, Authorised
22/04/2021 Human medicines European public assessment report (EPAR): Cinryze, C1 inhibitor (human), Angioedemas, Hereditary, 15/06/2011, Additional monitoring, 20, Authorised
22/04/2021 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, Additional monitoring, 18, Authorised
22/04/2021 Orphan designation: (3'R,4'S,5'R)-N-[(3R,6S)-6-carbamoyltetrahydro-2H-pyran-3-yl]-6''-chloro-4'-(2-chloro-3-fluoropyridin-4-yl)-4,4-dimethyl-2''-oxo-1'',2''-dihydrodispiro[cyclohexane-1,2'-pyrrolidine-3',3''-indole]-5'-carboxamide mono(4-methylbenzenesulfonate) monohydrate for the: Treatment of soft tissue sarcoma, 20/03/2017, Positive
22/04/2021 Orphan designation: Eicosapentaenoic acid for the: Treatment of familial adenomatous polyposis (FAP), 08/10/2009, Positive
22/04/2021 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 42, Authorised
22/04/2021 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 43, Authorised
21/04/2021 News and press releases: Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21/04/2021 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 14, Authorised
21/04/2021 Template or form: Application form for European Medicines Agency certificates of medicinal products
21/04/2021 Periodic safety update single assessment: Gadoxetic acid disodium: List of nationally authorised medicinal products - PSUSA/00001509/202004
21/04/2021 Periodic safety update single assessment: Epirubicin: List of nationally authorised medicinal products - PSUSA/00001234/202006
21/04/2021 Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/202005
21/04/2021 Human medicines European public assessment report (EPAR): Evkeeza, Evinacumab, Hypercholesterolemia, 17/06/2021, Additional monitoring, Exceptional circumstances, Authorised
21/04/2021 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, 1, Authorised
21/04/2021 Periodic safety update single assessment: Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202008
21/04/2021 Periodic safety update single assessment: Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202008
21/04/2021 Periodic safety update single assessment: Gadoteridol: List of nationally authorised medicinal products - PSUSA/00001507/202004
21/04/2021 Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 14, Authorised
21/04/2021 Periodic safety update single assessment: Gadobenic acid: List of nationally authorised medicinal products - PSUSA/00001500/202004
21/04/2021 Periodic safety update single assessment: Fluorescein (systemic use): List of nationally authorised medicinal products - PSUSA/00009153/202004
21/04/2021 Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 46, Authorised
21/04/2021 Periodic safety update single assessment: Gadoteric acid (IV and intravascular formulations): List of nationally authorised medicinal products - PSUSA/00001506/202004
21/04/2021 Periodic safety update single assessment: Porfimer: List of nationally authorised medicinal products - PSUSA/00010332/202004
21/04/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,Dermatophagoides farinae, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/146/2011
20/04/2021 Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, Additional monitoring, Authorised
20/04/2021 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 February 2021
20/04/2021 News and press releases: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
20/04/2021 Periodic safety update single assessment: Dalteparin sodium: List of nationally authorised medicinal products - PSUSA/00000922/202008
20/04/2021 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 21, Authorised
20/04/2021 Human medicines European public assessment report (EPAR): Vfend, voriconazole, Candidiasis, Mycoses, Aspergillosis, 19/03/2002, 48, Authorised
20/04/2021 Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021 , Virtual meeting, from 20/04/2021 to 20/04/2021
20/04/2021 Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 6, Authorised
19/04/2021 Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, Orphan, Additional monitoring, Conditional approval, 2, Authorised
19/04/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 52
19/04/2021 Renewal and annual re-assessment of marketing authorisation
19/04/2021 Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007
19/04/2021 Periodic safety update single assessment: Hexoprenaline sulfate: List of nationally authorised medicinal products - PSUSA/00003170/202008
19/04/2021 Other: Stakeholder engagement highlights 2020
19/04/2021 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits : Imidacloprid
19/04/2021 Maximum Residue Limits - Report: Imidacloprid (fin fish): Summary report - Committee for Veterinary Medicinal Products
19/04/2021 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 8, Authorised
19/04/2021 Human medicines European public assessment report (EPAR): MenQuadfi, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 18/11/2020, Additional monitoring, 1, Authorised
19/04/2021 Other: Timetable: Informed consent and multiple application
19/04/2021 Report: Medicinal products for human use: monthly figures - March 2021
19/04/2021 Agenda: Agenda - CHMP agenda of the 19-22 April 2021 meeting
16/04/2021 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 19, Authorised
16/04/2021 Press briefing on PRAC conclusions on signal of thromboembolic events with COVID-19 Vaccine Janssen , Virtual meeting, from 20/04/2021 to 20/04/2021
16/04/2021 Withdrawn application: Tibsovo, ivosidenib, Date of withdrawal: 13/10/2020, Initial authorisation
16/04/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
16/04/2021 Overview of comments: Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure): List of nationally authorised medicinal products - PSUSA/00010582/202009
16/04/2021 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 24, Authorised
16/04/2021 Changing the labelling and package leaflet (Article 61(3) notifications)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 14 April 2021
16/04/2021 Herbal medicinal product: Hyperici herba, Hyperici herba, P: Draft published
16/04/2021 Worksharing: questions and answers
16/04/2021 Grouping of variations: questions and answers
16/04/2021 Herbal - HMPC opinion on a European Union herbal monograph: Second draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1
16/04/2021 Extensions of marketing authorisations: questions and answers
16/04/2021 Type-IB variations: questions and answers
16/04/2021 Type-IA variations: questions and answers
16/04/2021 Post-authorisation safety studies (PASS)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021
16/04/2021 Herbal medicinal product: Trigonellae foenugraeci semen, Trigonellae foenugraeci semen, F: Assessment finalised
16/04/2021 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Trigonella foenum-graecum L., semen - Revision 1
16/04/2021 Herbal - HMPC assessment report: Draft Assessment report on Trigonella foenum-graecum L., semen - Revision 1
15/04/2021 Veterinary medicines European public assessment report (EPAR): Prevexxion RN+HVT+IBD, Live recombinant Marek’s disease virus, serotype 1, strain RN1250; Live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69, 20/07/2020, Authorised
15/04/2021 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 16, Authorised
15/04/2021 Regulatory and procedural guideline: IRIS guide to registration
15/04/2021 Periodic safety update single assessment: Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008
15/04/2021 COVID-19 vaccines: Article 5(3) reviews
15/04/2021 Periodic safety update single assessment: Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007
15/04/2021 Periodic safety update single assessment: Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007
15/04/2021 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 22, Authorised
15/04/2021 Human medicines European public assessment report (EPAR): Oyavas, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 26/03/2021, Additional monitoring, Biosimilar, Authorised
15/04/2021 Orphan designation: Somapacitan for the: Treatment of growth hormone deficiency, 24/08/2018, Positive
15/04/2021 Human medicines European public assessment report (EPAR): Sogroya, Somapacitan, Growth, 31/03/2021, Orphan, Authorised
15/04/2021 News and press releases: EMA starts review of VIR-7831 for treating patients with COVID-19
15/04/2021 Periodic safety update single assessment: Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006
15/04/2021 Periodic safety update single assessment: Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006
15/04/2021 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 19, Authorised
15/04/2021 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, 13, Authorised
15/04/2021 Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe, Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021
15/04/2021 Periodic safety update single assessment: Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/202008
15/04/2021 Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive
15/04/2021 Paediatric investigation plans
15/04/2021 Other: Common Commentary - EMA/FDA: Common issues requested for discussion by the respective agency (EMA/PDCO and FDA) concerning paediatric oncology development plans (Paediatric Investigation Plans [PIPs] and initial Pediatric Study Plans [iPSPs])
14/04/2021 European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 , Virtual meeting, from 25/03/2021 to 25/03/2021
14/04/2021 Agenda: Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (2021)
14/04/2021 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, 26, Authorised
14/04/2021 Referrals document: Letter from Commissioner Kyriakides asking EMA to follow up on Vaxzevria opinion after Council discussion
14/04/2021 News and press releases: AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
14/04/2021 Periodic safety update single assessment: Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/202008
14/04/2021 Human medicines European public assessment report (EPAR): PecFent, fentanyl, Pain, Cancer, 31/08/2010, 20, Authorised
14/04/2021 News and press releases: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
14/04/2021 News and press releases: IT systems intermittently unavailable from 16 to 18 April 2021
14/04/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2021
14/04/2021 Periodic safety update single assessment: Pefloxacin: List of nationally authorised medicinal products - PSUSA/00002322/202008
14/04/2021 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 23, Authorised
14/04/2021 Human medicines European public assessment report (EPAR): BroPair Spiromax, salmeterol xinafoate, fluticasone propionate, Asthma, 26/03/2021, Authorised
14/04/2021 Overview of comments: Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’
14/04/2021 Agenda: Agenda - CAT agenda of the 14-16 April 2021 meeting
14/04/2021 Agenda: Programme and registration form - Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System
14/04/2021 Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU , Virtual meeting, 13:00 - 15:15 (CET), from 26/03/2021 to 26/03/2021
14/04/2021 Agenda: Agenda - Technical workshop on real-world metadata for regulatory purposes
14/04/2021 Newsletter: Human medicines highlights - April 2021
13/04/2021 Human medicines European public assessment report (EPAR): Seffalair Spiromax, fluticasone propionate, salmeterol xinafoate, Asthma, 26/03/2021, Authorised
13/04/2021 Human medicines European public assessment report (EPAR): Rukobia, fostemsavir trometamol, HIV Infections, 04/02/2021, Additional monitoring, 1, Authorised
13/04/2021 Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, 3, Authorised
13/04/2021 Template or form: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based data collection form
13/04/2021 Other: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based sales and and animal population data collection protocol
13/04/2021 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
13/04/2021 PRAC recommendation on signal: Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (Other viral vaccines)
13/04/2021 Agenda: Agenda - COMP agenda of the 13-15 April 2021 meeting
13/04/2021 Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia, Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021
13/04/2021 Agenda: Agenda - CVMP agenda of the 13-15 April 2021 meeting
13/04/2021 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, 4, Authorised
13/04/2021 Human medicines European public assessment report (EPAR): Beromun, tasonermin, Sarcoma, 12/04/1999, 14, Authorised
13/04/2021 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 42, Authorised
12/04/2021 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 21, Authorised
12/04/2021 Work programme: Nitrosamine Implementation Oversight Group Terms of Reference
12/04/2021 Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry , from 31/03/2021 to 31/03/2021
12/04/2021 Nitrosamine Implementation Oversight Group (NIOG) - Kick-off meeting , from 10/03/2021 to 10/03/2021
12/04/2021 Orphan designation: Ribavirin for the: Treatment of Lassa fever, 21/02/2018, Positive
12/04/2021 Orphan designation: Ribavirin for the: Treatment of Crimean-Congo haemorrhagic fever, 21/03/2018, Positive
12/04/2021 Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, Additional monitoring, 3, Authorised
12/04/2021 Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization, 31/03/2009, 17, Authorised
12/04/2021 Veterinary medicines European public assessment report (EPAR): Leucofeligen FeLV/RCP, purified p45 feline leukaemia virus envelope antigen, live feline calicivirus (strain F9), live feline viral rhinotracheitis virus (strain F2), live feline panleucopenia virus, 24/06/2009, 8, Authorised
09/04/2021 Compliance: Overview