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31/08/2021 Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic, 02/09/1999, 37, Authorised (updated)
31/08/2021 Human medicines European public assessment report (EPAR): Reagila, cariprazine hydrochloride, Schizophrenia, 13/07/2017, Additional monitoring, 3, Authorised (updated)
31/08/2021 Human medicines European public assessment report (EPAR): Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka), lenalidomide hydrochloride monohydrate, Multiple Myeloma; Lymphoma, Follicular, 11/02/2021, Generic, 1, Authorised (updated)
31/08/2021 Human medicines European public assessment report (EPAR): Fingolimod Mylan, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 18/08/2021, Generic, Authorised
31/08/2021 Human medicines European public assessment report (EPAR): Mvabea, Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola, 01/07/2020, Additional monitoring, Exceptional circumstances, 1, Authorised (updated)
31/08/2021 Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 25/06/2020, Generic, 1, Authorised (updated)
31/08/2021 Veterinary medicines European public assessment report (EPAR): Ypozane, osaterone acetate, 11/01/2007, 4, Authorised (updated)
31/08/2021 Human medicines European public assessment report (EPAR): Idefirix, Imlifidase, Desensitization, Immunologic; Kidney Transplantation, 25/08/2020, Orphan, Additional monitoring, Conditional approval, 1, Authorised (updated)
30/08/2021 Agenda: Agenda - PRAC draft agenda of meeting 30 August - 2 September 2021
30/08/2021 Human medicines European public assessment report (EPAR): Adakveo, Crizanlizumab, Anemia, Sickle Cell, 28/10/2020, Orphan, Additional monitoring, Conditional approval, 2, Authorised (updated)
30/08/2021 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 28, Authorised (updated)
30/08/2021 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , Virtual meeting, from 21/09/2021 to 22/09/2021
30/08/2021 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis, 25/10/2005, 29, Authorised (updated)
27/08/2021 Minutes: Minutes - PDCO minutes of the 18-21 May 2021 meeting
27/08/2021 Human medicines European public assessment report (EPAR): BroPair Spiromax, salmeterol xinafoate, fluticasone propionate, Asthma, 26/03/2021, 1, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 12, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 20, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Adcetris, Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease, 25/10/2012, Orphan, Additional monitoring, Conditional approval, 29, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 13, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 10, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Mircera, Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic, 20/07/2007, 26, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Atazanavir Mylan, atazanavir (as sulfate), HIV Infections, 22/08/2016, Generic, 10, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Abevmy, bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, 21/04/2021, Additional monitoring, Biosimilar, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, Additional monitoring, 14, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, Orphan, 23, Authorised (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 17, Authorised (updated)
27/08/2021 Work programme: Workplan 2021-2023 - HMA / EMA joint Big Data Steering Group
27/08/2021 Other: Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA (updated)
27/08/2021 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 18, Authorised (updated)
26/08/2021 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting
26/08/2021 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting
26/08/2021 Periodic safety update single assessment: Benazepril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000313/202011
26/08/2021 Periodic safety update single assessment: Benazepril : List of nationally authorised medicinal products - PSUSA/00000313/202011
26/08/2021 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, 8, Authorised
26/08/2021 Orphan designation: Heterologous human adult liver-derived stem cells for the: Treatment of carbamoyl-phosphate synthase-1 deficiency, 05/03/2012, Positive
26/08/2021 Orphan designation: Heterologous human adult liver-derived stem cells for the: Treatment of ornithine transcarbamylase deficiency, 27/09/2011, Positive
26/08/2021 Orphan designation: Heterologous human adult liver-derived stem cells for the: Treatment of acute liver failure, 26/04/2012, Positive
26/08/2021 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 6, Authorised
26/08/2021 Human medicines European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop), leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic, 08/01/2010, 17, Authorised
26/08/2021 Orphan designation: Chimeric monoclonal antibody against GD2 for the: Treatment of neuroblastoma, 08/11/2012, Positive
26/08/2021 Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) for the: Treatment of Castleman's disease, 30/11/2007, Positive
26/08/2021 Veterinary medicines European public assessment report (EPAR): Sedadex, dexmedetomidine hydrochloride, 12/08/2016, 4, Authorised
26/08/2021 Human medicines European public assessment report (EPAR): Abiraterone Mylan, abiraterone acetate, Prostatic Neoplasms, 20/08/2021, Generic, Authorised
25/08/2021 Orphan designation: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for the: Treatment of gastrointestinal stromal tumours, 12/10/2017, Positive
25/08/2021 Orphan designation: 2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type, 16/12/2019, Positive
25/08/2021 Human medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Multiple Myeloma, 18/08/2021, Orphan, Additional monitoring, Conditional approval, Authorised
25/08/2021 Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (idecabtagene vicleucel) for the: Treatment of multiple myeloma, 20/04/2017, Positive
25/08/2021 Periodic safety update single assessment: Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001696/202011
25/08/2021 Periodic safety update single assessment: Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: List of nationally authorised medicinal products - PSUSA/00001696/202011
25/08/2021 Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand), oxybutynin, Urinary Incontinence, Urge, 15/06/2004, 19, Authorised
25/08/2021 EPAR - Assessment report - Variation: Zavicefta-H-C-4027-II-0019 : EPAR - Assessment Report - Variation
25/08/2021 Human medicines European public assessment report (EPAR): Eucreas, vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 14/11/2007, 20, Authorised
24/08/2021 Human medicines European public assessment report (EPAR): Evrenzo, Roxadustat, Anemia; Kidney Failure, Chronic, 18/08/2021, Authorised
24/08/2021 Handling competing interests
24/08/2021 Other: Mr Noel Wathion - Assessment outcome of occupational activities after leaving the service
24/08/2021 COVID-19 vaccines: authorised
24/08/2021 News and press releases: Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
24/08/2021 EPAR - Assessment report - Variation: Comirnaty-H-C-5735-II-0030 : EPAR - Assessment report - Variation
24/08/2021 Human medicines European public assessment report (EPAR): Bimzelx, Bimekizumab, Psoriasis, 20/08/2021, Additional monitoring, Authorised
23/08/2021 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations
23/08/2021 Human medicines European public assessment report (EPAR): Seffalair Spiromax, fluticasone propionate, salmeterol xinafoate, Asthma, 26/03/2021, Authorised
23/08/2021 Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), Pretomanid, Tuberculosis, Multidrug-Resistant, 31/07/2020, Orphan, Additional monitoring, Conditional approval, 4, Authorised
23/08/2021 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms
23/08/2021 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances
23/08/2021 Human medicines European public assessment report (EPAR): Pifeltro, Doravirine, HIV Infections, 22/11/2018, Additional monitoring, 4, Authorised
23/08/2021 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes
23/08/2021 Human medicines European public assessment report (EPAR): Aptivus, tipranavir, HIV Infections, 25/10/2005, 40, Authorised
23/08/2021 Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 21/03/2017, Additional monitoring, Biosimilar, 9, Authorised
23/08/2021 Veterinary medicines European public assessment report (EPAR): Nobivac DP Plus, Live attenuated canine distemper virus strain Onderstepoort: 105.1 – 106.5 TCID50, Live recombinant canine parvovirus strain 630a: 105.1 – 106.7 TCID50, 09/12/2020, Authorised
23/08/2021 Work programme: PRAC work plan 2021
20/08/2021 Other: Scientific recommendations on classification of advanced therapy medicinal products
20/08/2021 Human medicines European public assessment report (EPAR): Evista, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 05/08/1998, 27, Authorised
20/08/2021 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome; Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, 3, Authorised
20/08/2021 Veterinary medicines European public assessment report (EPAR): Meloxoral, meloxicam, 19/11/2010, Generic, 8, Authorised
20/08/2021 Human medicines European public assessment report (EPAR): Actos, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 13/10/2000, 28, Authorised
20/08/2021 Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Carcinoma, Non-Small-Cell Lung, 23/10/2012, 30, Authorised
20/08/2021 Human medicines European public assessment report (EPAR): Caspofungin Accord, caspofungin acetate, Candidiasis; Aspergillosis, 11/02/2016, Generic, 6, Withdrawn
20/08/2021 EPAR - All authorised presentations: Evista : EPAR - All Authorised presentations
19/08/2021 Orphan designation: Murine anti-CD22 antibody variable region fused to truncated Pseudomonas exotoxin 38 ( Moxetumomab pasudotox) for the: Treatment of hairy cell leukaemia, 05/12/2008, Withdrawn
19/08/2021 Data Standardisation Strategy stakeholder workshop , Virtual meeting, from 18/05/2021 to 18/05/2021
19/08/2021 Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, Generic, 18, Authorised
19/08/2021 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection; Bacterial Infections, 20/09/2018, Additional monitoring, 4, Authorised
19/08/2021 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms; Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, 5, Authorised
19/08/2021 Human medicines European public assessment report (EPAR): Adtralza, Tralokinumab, 17/06/2021, Additional monitoring, Authorised
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Sotrovimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0240/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Molnupiravir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0345/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Casirivimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0347/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Imdevimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0348/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222), PM: decision on the application for modification of an agreed PIP, P/0266/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir, W: decision granting a waiver in all age groups for all conditions or indications, P/0338/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0333/2021
19/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin, W: decision granting a waiver in all age groups for all conditions or indications, P/0444/2020
19/08/2021 Veterinary medicines European public assessment report (EPAR): Porcilis Pesti, Classical Swine Fever Virus (CSFV) -E2 subunit antigen, 09/06/2000, 12, Withdrawn
19/08/2021 Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 7, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain; Cancer, 04/04/2008, 24, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, 24, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 14, Authorised
18/08/2021 Veterinary medicines European public assessment report (EPAR): Cerenia, maropitant citrate, 28/09/2006, 21, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, Additional monitoring, 11, Authorised
18/08/2021 Veterinary medicines European public assessment report (EPAR): Vectra Felis, pyriproxyfen, dinotefuran, 06/06/2014, 4, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Additional monitoring, 5, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms; Sarcoma, 17/09/2007, 27, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging; Alzheimer Disease, 22/08/2014, 12, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, 27/06/2006, 36, Authorised
18/08/2021 Human medicines European public assessment report (EPAR): Tarceva, erlotinib, Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms, 19/09/2005, 30, Authorised
18/08/2021 Other: General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice
17/08/2021 Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, Orphan, Additional monitoring, Conditional approval, 3, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 40, Authorised
17/08/2021 Minutes: CHMP ORGAM minutes for the meeting on 18 January 2021
17/08/2021 Agenda: CHMP ORGAM agenda for the meeting on 18 January 2021
17/08/2021 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2021
17/08/2021 Minutes: CHMP ORGAM minutes for the meeting on 30 November 2020
17/08/2021 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 27/03/2013, Additional monitoring, Conditional approval, 21, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Pheburane, Sodium phenylbutyrate, Carbamoyl-Phosphate Synthase I Deficiency Disease, 30/07/2013, 9, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 22, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic; Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 18, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, Accelerated assessment, 40, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Ervebo, recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola, 11/11/2019, Additional monitoring, 5, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Tobi Podhaler, Tobramycin, Cystic Fibrosis; Respiratory Tract Infections, 20/07/2011, Orphan, 18, Authorised
17/08/2021 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 12, Authorised
17/08/2021 Veterinary medicines European public assessment report (EPAR): Galliprant, grapiprant, 09/01/2018, 5, Authorised
17/08/2021 Template or form: Simplified salary calculator - Contract Agents
17/08/2021 Template or form: Simplified salary calculator - Temporary Agents
17/08/2021 Human medicines European public assessment report (EPAR): Delstrigo, Doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 6, Authorised
17/08/2021 Other: Records of data processing activity for personal data of staff or external experts processed in a procurement procedure
17/08/2021 Human medicines European public assessment report (EPAR): Tegsedi, inotersen sodium, Amyloidosis, 06/07/2018, Orphan, Accelerated assessment, Additional monitoring, 8, Authorised
17/08/2021 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
17/08/2021 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
16/08/2021 Minutes: CHMP ORGAM minutes for the meeting on 3 November 2020
16/08/2021 Agenda: CHMP ORGAM agenda for the meeting on 3 November 2020
16/08/2021 Minutes: CHMP ORGAM minutes for the meeting on 5 October 2020
16/08/2021 Human medicines European public assessment report (EPAR): Ritemvia, rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis, 13/07/2017, Additional monitoring, Biosimilar, 8, Withdrawn
16/08/2021 News and press releases: EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
16/08/2021 COVID-19 treatments: under evaluation
16/08/2021 News and press releases: Artificial intelligence in medicine regulation
16/08/2021 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 6, Authorised
16/08/2021 Herbal medicinal product: Verbenae citriodorae folium, Verbenae citriodorae folium, F: Assessment finalised
16/08/2021 Standard Operating Procedure - SOP: Standard operating procedure for conducting checks for conflicts of interest of the European Medicines Agency employees assigned duties relating to medicinal products for human or veterinary use
16/08/2021 Agenda: Agenda - CHMP agenda of the 16-19 August 2021 meeting: written procedure
16/08/2021 Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
13/08/2021 Human medicines European public assessment report (EPAR): Rekovelle, follitropin delta, Anovulation, 12/12/2016, Additional monitoring, 4, Authorised
13/08/2021 Human medicines European public assessment report (EPAR): Sutent, sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors, 19/07/2006, 39, Authorised
13/08/2021 Human medicines European public assessment report (EPAR): Cholib, fenofibrate, simvastatin, Dyslipidemias, 26/08/2013, 13, Authorised
13/08/2021 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular, 09/09/2016, Accelerated assessment, 12, Authorised
13/08/2021 Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, 11, Authorised
13/08/2021 Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS , Virtual meeting, 14:00-16:30 (CEST), from 29/07/2021 to 29/07/2021
11/08/2021 Human medicines European public assessment report (EPAR): Lumoxiti, Moxetumomab pasudotox, Leukemia, Hairy Cell, 08/02/2021, Additional monitoring, Withdrawn
11/08/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 11 August 2021
11/08/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 August 2021
11/08/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 August 2021
11/08/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 11 August 2021
11/08/2021 Report: Medicinal products for human use: monthly figures - July 2021
11/08/2021 Minutes: Minutes of the CHMP meeting 21-24 June 2021
11/08/2021 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 24, Authorised
11/08/2021 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid, 01/10/2009, 40, Authorised
11/08/2021 Product-information requirements
10/08/2021 Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, 8, Authorised
10/08/2021 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, 12, Authorised
10/08/2021 Orphan designation: Adenovirus-associated viral vector serotype 5 containing the human RPGR gene for the: Treatment of retinitis pigmentosa, 29/08/2016, Positive
10/08/2021 Orphan designation: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene for the: Treatment of achromatopsia, 31/07/2018, Positive
10/08/2021 Veterinary medicines European public assessment report (EPAR): Prevomax, maropitant, 19/06/2017, 5, Authorised
10/08/2021 Human medicines European public assessment report (EPAR): Ifirmacombi, irbesartan, hydrochlorothiazide, Hypertension, 04/03/2011, Generic, 13, Authorised
10/08/2021 Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Anxiety Disorders; Neuralgia; Epilepsy, 19/06/2015, Generic, 8, Authorised
10/08/2021 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer, 27/05/2015, 11, Authorised
10/08/2021 Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms, 26/03/2021, Generic, 1, Authorised
09/08/2021 Other: European Medicines Agency’s Privacy Statement: Small and Medium Enterprises (SME) Office activities
09/08/2021 Report: Applications for new human medicines under evaluation by the CHMP: August 2021
06/08/2021 Orphan designation: imatinib for the: Treatment of acute respiratory distress syndrome (ARDS), 19/11/2014, Positive
06/08/2021 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
06/08/2021 Other: Production API and registration process - production release version 01.03 July 2021 - Veterinary Medicinal Products Regulation: Union Product Database
06/08/2021 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 7, Authorised
06/08/2021 Newsletter: Clinical Trials Information System (CTIS) highlights - August 2021
06/08/2021 Orphan designation: Adeno-associated viral vector containing the human factor IX gene for the: Treatment of haemophilia B, 11/01/2012, Positive
06/08/2021 News and press releases: Interoperability of track and trace systems: key to public health protection
06/08/2021 International Coalition of Medicines Regulatory Authorities (ICMRA)
05/08/2021 Regulatory and procedural guideline: Procedural guidance for variant strain(s) update to vaccines intended for protection against human coronavirus
05/08/2021 Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Multiple Myeloma, 20/07/2015, Generic, 10, Authorised
05/08/2021 Regulatory and procedural guideline: Dissemination guidelines for training materials: CTIS training programme
05/08/2021 Agenda: Agenda - PRAC draft agenda of meeting 5 August 2021
05/08/2021 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms, 02/08/2009, 26, Authorised
05/08/2021 Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, 13, Authorised
05/08/2021 Orphan designation: Omaveloxolone for the: Adjunctive treatment in haematopoietic cell transplantation, 27/06/2018, Positive
05/08/2021 Newsletter: Human medicines highlights - August 2021
04/08/2021 Human medicines European public assessment report (EPAR): Azacitidine Celgene, azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute, 02/08/2019, 2, Withdrawn
04/08/2021 Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Hidradenitis Suppurativa; Psoriasis; Crohn Disease; Uveitis; Arthritis, Rheumatoid; Arthritis; Colitis, Ulcerative; Spondylitis, Ankylosing; Arthritis, Psoriatic, 24/08/2017, Additional monitoring, Biosimilar, 15, Authorised
04/08/2021 Report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2021
04/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): (2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0415/2020
04/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Doravirine,Islatravir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0395/2020
04/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tiragolumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0412/2020
04/08/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tiragolumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0409/2020
04/08/2021 News and press releases: ECDC and EMA update on COVID-19
04/08/2021 Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 5, Authorised
04/08/2021 Orphan designation: adeno-associated virus serotype 2/6 encoding human alpha-galactosidase A cDNA for the: Treatment of Fabry disease, 09/01/2020, Positive
04/08/2021 Veterinary medicines European public assessment report (EPAR): Credelio Plus, lotilaner, milbemycin oxime, 14/04/2021, Authorised
04/08/2021 Orphan designation: poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase) for the: Treatment of hyperargininaemia, 14/07/2016, Positive
04/08/2021 Human medicines European public assessment report (EPAR): Opatanol, olopatadine hydrochloride, Conjunctivitis, Allergic, 16/05/2002, 21, Authorised
04/08/2021 Plasma master file certificates
03/08/2021 Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration; Macular Edema; Diabetes Complications, 21/11/2012, 22, Authorised
03/08/2021 Orphan designation: Daratumumab for the: Treatment of AL amyloidosis, 25/05/2018, Positive
03/08/2021 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 20/05/2016, Orphan, Accelerated assessment, Additional monitoring, 16, Authorised
03/08/2021 EMA’s governance during COVID-19 pandemic
03/08/2021 Other: Records of data processing activity (public) for the Union Product Database
03/08/2021 Human medicines European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka), irbesartan hydrochloride, Hypertension, 01/12/2008, Generic, 14, Authorised
03/08/2021 EPAR - Paediatric investigation plan compliance statement: Polystyrene sulfonate - List of nationally authorised medicinal products - PSUSA-00002472-202010
03/08/2021 Periodic safety update single assessment: Polystyrene sulfonate - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002472-202010
03/08/2021 Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Epilepsy, 26/03/2021, Additional monitoring, 2, Authorised
03/08/2021 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 11, Authorised
03/08/2021 Human medicines European public assessment report (EPAR): Nyvepria, pegfilgrastim, Neutropenia, 18/11/2020, Additional monitoring, Biosimilar, 3, Authorised
03/08/2021 Other: National contact points for standalone signal notifications
03/08/2021 Signal management
03/08/2021 Human medicines European public assessment report (EPAR): Gilenya, fingolimod hydrochloride , Multiple Sclerosis, 17/03/2011, 29, Authorised
03/08/2021 Human medicines European public assessment report (EPAR): Phesgo, pertuzumab, trastuzumab, Breast Neoplasms, 21/12/2020, Additional monitoring, 1, Authorised
03/08/2021 Periodic safety update single assessment: Perindopril - List of nationally authorised medicinal products - PSUSA-00002354-202010
03/08/2021 Periodic safety update single assessment: Perindopril - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002354-202010
02/08/2021 Human medicines European public assessment report (EPAR): Calquence, Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell, 05/11/2020, Additional monitoring, 1, Authorised
02/08/2021 Minutes: Minutes of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting on 29 June 2021
02/08/2021 Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting on 29 June 2021
02/08/2021 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , Virtual meeting, from 29/06/2021 to 29/06/2021
02/08/2021 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals Adopted at the e 5-8 July 2021 PRAC meeting
02/08/2021 Other: Joining a WebEx meeting as a logged-in user: Instructions for EU Regulatory Network Users
02/08/2021 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting
02/08/2021 Other: List of signals discussed at PRAC since September 2012
02/08/2021 Herbal medicinal products: questions and answers
02/08/2021 Regulatory and procedural guideline: Checklist for initial notifications for parallel distribution: guidance for industry
02/08/2021 Other: Regulatory questions and answers on herbal medicinal products
02/08/2021 Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry
02/08/2021 Other: European Medicines Agency’s Privacy Statement for the operation of Video-surveillance (CCTV) system
02/08/2021 Other: Record of data processing activity (public) for video-surveillance (CCTV) system
02/08/2021 Other: Joint audit programme for EEA GMP inspectorates: Procedure
02/08/2021 Summary of opinion: Nouryant, istradefylline, 22/07/2021, Negative
02/08/2021 Summary of opinion: Nexviadyme, Avalglucosidase alfa, 23/07/2021, Positive
02/08/2021 News and press releases: Six-month countdown to go-live for the Clinical Trials Information System (CTIS)