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13/09/2019 Periodic safety update single assessment: Bisoprolol / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000420/201811
13/09/2019 Human medicines European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion, levodopa, carbidopa, entacapone, Parkinson Disease, 23/08/2011, 10, Authorised (updated)
13/09/2019 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, 24/02/2009, 17, Authorised (updated)
13/09/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019
13/09/2019 Summary of opinion: Gumbohatch, avian infectious bursal disease vaccine (live), 12/09/2019, Positive
13/09/2019 Summary of opinion: Nobivac Myxo-RHD Plus, myxomatosis and rabbit haemorrhagic viral disease vaccine (live recombinant), 12/09/2019, Positive
13/09/2019 Summary of opinion: Bravecto, fluralaner, 13/09/2019, Positive
13/09/2019 Summary of opinion: Vectra Felis, pyriproxyfen / dinotefuran, 13/09/2019, Positive
13/09/2019 Summary of opinion: Velactis, cabergoline, 13/09/2019, Negative
13/09/2019 Human medicines European public assessment report (EPAR): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used), Influenza, Human, 12/12/2018, Additional monitoring, 3, Authorised (updated)
13/09/2019 Other: Article 57 product data (updated)
13/09/2019 Referral: Xeljanz , tofacitinib , Article 20 procedures, Under evaluation, 13/09/2019 (updated)
13/09/2019 News and press releases: EMA to provide guidance on avoiding nitrosamines in human medicines
13/09/2019 News and press releases: EMA to review ranitidine medicines following detection of NDMA
13/09/2019 Periodic safety update single assessment: Metoclopramide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002036/201811
13/09/2019 Periodic safety update single assessment: Metoclopramide: List of nationally authorised medicinal products - PSUSA/00002036/201811
13/09/2019 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
13/09/2019 Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, Orphan, Additional monitoring, Exceptional circumstances, 17, Authorised (updated)
12/09/2019 Human medicines European public assessment report (EPAR): Lacosamide UCB, lacosamide, Epilepsies, Partial, 26/08/2019, Authorised
12/09/2019 Committee for Advanced Therapies (CAT): 11-13 September 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 11/09/2019 to 13/09/2019 (updated)
12/09/2019 Minutes: Minutes of the CAT meeting 19-21 June 2019
12/09/2019 Agenda: Agenda - CAT agenda of the 11-13 September 2019 meeting
12/09/2019 Enpr-EMA priority activities (updated)
12/09/2019 Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif), Human normal immunoglobulin, Mucocutaneous Lymph Node Syndrome, Guillain-Barre Syndrome, Bone Marrow Transplantation, Purpura, Thrombocytopenic, Idiopathic, Immunologic Deficiency Syndromes, 23/07/2007, 17, Authorised (updated)
12/09/2019 Other: Preparedness of medicines’ clinical trials in paediatrics: Recommendations by the Enpr-EMA working group on trial preparedness
12/09/2019 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, 10, Authorised (updated)
12/09/2019 Human medicines European public assessment report (EPAR): Cinqaero, Reslizumab, Asthma, 15/08/2016, Additional monitoring, 8, Authorised (updated)
12/09/2019 Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease, 15/01/2009, 28, Authorised (updated)
12/09/2019 Human medicines European public assessment report (EPAR): Stalevo, levodopa, carbidopa, entacapone, Parkinson Disease, 17/10/2003, 25, Authorised (updated)
12/09/2019 Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz), levodopa, carbidopa, entacapone, Parkinson Disease, 11/11/2013, 6, Authorised (updated)
11/09/2019 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 21, Authorised (updated)
11/09/2019 Periodic safety update single assessment: Hepatitis A vaccines (inactivated, adsorbed): List of nationally authorised medicinal products - PSUSA/00001596/201901
11/09/2019 Periodic safety update single assessment: Roxithromycin: List of nationally authorised medicinal products - PSUSA/00002669/201812
11/09/2019 Human medicines European public assessment report (EPAR): Gilenya, fingolimod hydrochloride , Multiple Sclerosis, 17/03/2011, Patient safety, Additional monitoring, 23, Authorised (updated)
11/09/2019 Periodic safety update single assessment: Dexketoprofen / tramadol: List of nationally authorised medicinal products - PSUSA/00010468/201901
11/09/2019 Veterinary medicines European public assessment report (EPAR): Advocate, imidacloprid, moxidectin, 02/04/2003, 20, Authorised (updated)
11/09/2019 Periodic safety update single assessment: Carboplatin: List of nationally authorised medicinal products - PSUSA/00000559/201901
11/09/2019 Periodic safety update single assessment: Alitretinoin (oral use): List of nationally authorised medicinal products - PSUSA/00010710/201901
11/09/2019 Periodic safety update single assessment: Pentoxyverine: List of nationally authorised medicinal products - PSUSA/00002345/201812
11/09/2019 Periodic safety update single assessment: Amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application): List of nationally authorised medicinal products - PSUSA/00010187/201901
11/09/2019 Minutes: Minutes of the COMP meeting 21-23 May 2019
11/09/2019 Newsletter: Human medicines highlights - September 2019
11/09/2019 Periodic safety update single assessment: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure): List of nationally authorised products - PSUSA/00010693/201901
11/09/2019 Periodic safety update single assessment: Flunitrazepam: List of nationally authorised medicinal products - PSUSA/00001418/201901
10/09/2019 Veterinary medicines European public assessment report (EPAR): HorStem, equine umbilical cord mesenchymal stem cells, 19/06/2019, Authorised
10/09/2019 Periodic safety update single assessment: Bezafibrate: List of nationally authorised products - PSUSA/00000405/201901
10/09/2019 Periodic safety update single assessment: Biotin: List of nationally authorised medicinal products - PSUSA/00000414/201901
10/09/2019 Periodic safety update single assessment: Niflumic acid: List of nationally authorised products - PSUSA/00002157/201812
10/09/2019 Report: Applications for new human medicines under evaluation by the CHMP: August 2019 (updated)
10/09/2019
10/09/2019 Committee for Orphan Medicinal Products (COMP): 10-12 September 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 10/09/2019 to 12/09/2019 (updated)
10/09/2019 Other: Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
10/09/2019 Agenda: Agenda - CVMP agenda of the 10-12 September 2019 meeting
10/09/2019 Human medicines European public assessment report (EPAR): Mycamine, micafungin, Candidiasis, 25/04/2008, 14, Authorised (updated)
10/09/2019 Report: Medicinal products for human use: monthly figures - August 2019
10/09/2019 Agenda: Agenda - COMP agenda of the 10-12 September 2019 meeting
10/09/2019 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, Additional monitoring, 12, Authorised (updated)
10/09/2019 Periodic safety update single assessment: Benzydamine / cetylpyridine: List of nationally authorised medicinal products - PSUSA/00000378/201901
09/09/2019 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, 9, Authorised (updated)
09/09/2019 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 30, Authorised (updated)
09/09/2019 Periodic safety update single assessment: Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201902
09/09/2019 Human medicines European public assessment report (EPAR): Trydonis, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 26/04/2018, 1, Authorised (updated)
06/09/2019 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, Orphan, 34, Authorised (updated)
06/09/2019 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), beclometasone dipropionate anhydrous, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 1, Authorised (updated)
06/09/2019 Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 15/01/2015, 15, Authorised (updated)
06/09/2019 Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 18/08/2016, 8, Authorised (updated)
06/09/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
06/09/2019 Referral: Picato , ingenol mebutate , Article 20 procedures, Procedure started
05/09/2019 Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Hidradenitis Suppurativa, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Skin Diseases, Papulosquamous, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
05/09/2019 Human medicines European public assessment report (EPAR): Actrapid, human insulin, Diabetes Mellitus, 07/10/2002, 16, Authorised (updated)
05/09/2019 Human medicines European public assessment report (EPAR): Actraphane, insulin human, Diabetes Mellitus, 07/10/2002, 18, Authorised (updated)
05/09/2019 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, 6, Authorised (updated)
05/09/2019 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 30, Authorised (updated)
05/09/2019 Human medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, HIV Infections, 03/01/2017, Generic, 5, Authorised (updated)
04/09/2019 Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Head and Neck Neoplasms, Colorectal Neoplasms, 29/06/2004, 27, Authorised (updated)
04/09/2019 Report: PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 July 2019
04/09/2019 Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Cystitis, Interstitial, 02/06/2017, 6, Authorised (updated)
04/09/2019 Human medicines European public assessment report (EPAR): Dovato, dolutegravir sodium, lamivudine, HIV Infections, 01/07/2019, Additional monitoring, Authorised
04/09/2019 Orphan designation: Eculizumab for the: Treatment of neuromyelitis optica spectrum disorders, 05/08/2013, Positive (updated)
04/09/2019 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, Accelerated assessment, 26, Authorised (updated)
03/09/2019 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, Additional monitoring, 4, Authorised (updated)
03/09/2019 Paediatric investigation plans: questions and answers (updated)
03/09/2019 Human medicines European public assessment report (EPAR): Renvela, sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 09/06/2009, 20, Authorised (updated)
03/09/2019 Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis, Hyperphosphatemia, 28/01/2000, 31, Authorised (updated)
03/09/2019 Veterinary medicines European public assessment report (EPAR): Econor, valnemulin, 12/03/1999, 21, Authorised (updated)
02/09/2019 Agenda: Agenda - PRAC draft agenda of meeting 2-5 September 2019
02/09/2019 Veterinary medicines European public assessment report (EPAR): Rheumocam, meloxicam, 10/01/2008, Generic, 12, Authorised (updated)
02/09/2019 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 20/03/2014, 17, Authorised (updated)
02/09/2019 Periodic safety update single assessment: Tapentadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201811
02/09/2019 Periodic safety update single assessment: Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201811
02/09/2019 Human medicines European public assessment report (EPAR): Pixuvri, pixantrone dimaleate, Lymphoma, Non-Hodgkin, 10/05/2012, Additional monitoring, Conditional approval, 20, Authorised (updated)
02/09/2019 Human medicines European public assessment report (EPAR): Mozobil, Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma, 30/07/2009, Orphan, 17, Authorised (updated)
02/09/2019 Human medicines European public assessment report (EPAR): Lartruvo, Olaratumab, Sarcoma, 09/11/2016, Patient safety, Orphan, Accelerated assessment, Additional monitoring, Conditional approval, 3, Withdrawn (updated)