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Sep 2018 (7) Oct 2018 (245) Nov 2018 (332) Dec 2018 (248) Jan 2019 (305) Feb 2019 (363) Mar 2019 (271) Apr 2019 (344) May 2019 (314) Jun 2019 (391) Jul 2019 (361) Aug 2019 (306) Sep 2019 (167)
Date Content
20/09/2019 Human medicines European public assessment report (EPAR): Uptravi, Selexipag, Hypertension, Pulmonary, 12/05/2016, Additional monitoring, 9, Authorised (updated)
20/09/2019 Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, Additional monitoring, 12, Authorised (updated)
20/09/2019 Summary of opinion: Bortezomib Fresenius Kabi, bortezomib, 19/09/2019, Positive
20/09/2019 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 15/09/2008, Biosimilar, 11, Authorised (updated)
20/09/2019 Human medicines European public assessment report (EPAR): Orbactiv, oritavancin diphosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 18/03/2015, Additional monitoring, 7, Authorised (updated)
20/09/2019 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, 2, Authorised (updated)
20/09/2019 Summary of opinion: Taxotere, docetaxel, 19/09/2019, Positive
20/09/2019 Summary of opinion: Lucentis, ranibizumab, 19/09/2019, Positive
20/09/2019 Summary of opinion: Xospata, gilteritinib, 19/09/2019, Positive
20/09/2019 Summary of opinion: Remsima, infliximab, 19/09/2019, Positive
20/09/2019 Summary of opinion: Dupixent, dupilumab, 19/09/2019, Positive
20/09/2019 Summary of opinion: Benlysta, belimumab, 19/09/2019, Positive
20/09/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
20/09/2019 Summary of opinion: Ivozall, clofarabine, 19/09/2019, Positive
20/09/2019 Summary of opinion: Rhokiinsa, netarsudil, 19/09/2019, Positive
20/09/2019 Summary of opinion: Arsenic trioxide Accord, arsenic trioxide, 19/09/2019, Positive
20/09/2019 Summary of opinion: Qtrilmet, metformin hydrochloride / saxagliptin / dapagliflozin, 19/09/2019, Positive
20/09/2019 Referral: Ranitidine-containing medicinal products , ranitidine , Article 31 referrals, Procedure started
20/09/2019 Summary of opinion: Docetaxel Zentiva (previously Docetaxel Winthrop), docetaxel, 19/09/2019, Positive
20/09/2019 Summary of opinion: Senstend, lidocaine / prilocaine, 19/09/2019, Positive
20/09/2019 Summary of opinion: Bavencio, avelumab, 19/09/2019, Positive
20/09/2019 Regulatory and procedural guideline: Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 62 (1) of Regulation (EC) No 726/2004 (updated)
20/09/2019 Referral: Fosfomycin-containing medicinal products , fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol , Article 31 referrals, Under evaluation, 13/12/2018, 20/09/2019 (updated)
20/09/2019 European Medicines Agency (EMA) Joint Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) meeting , European Medicines Agency, Amsterdam, the Netherlands, from 25/09/2019 to 25/09/2019 (updated)
20/09/2019 European Medicines Agency (EMA) Healthcare Professionals' Working Party (HCPWP) meeting , European Medicines Agency, Amsterdam, the Netherlands, from 24/09/2019 to 24/09/2019 (updated)
20/09/2019 Agenda: Agenda - European Medicines Agency (EMA) Joint Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) meeting
20/09/2019 Agenda: Agenda - European Medicines Agency (EMA) Healthcare Professionals' Working Party (HCPWP) meeting
20/09/2019 European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP) , European Medicines Agency, Amsterdam, the Netherlands, from 24/09/2019 to 24/09/2019 (updated)
20/09/2019 Agenda: Agenda - European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP)
19/09/2019 Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody (satralizumab) for the: Treatment of neuromyelitis optica spectrum disorders, 27/06/2016, Positive (updated)
19/09/2019 Template or form: QRD product-information template version 10.1 - highlighted (updated)
19/09/2019 Template or form: QRD product-information template version 10.1 (updated)
19/09/2019 Periodic safety update single assessment: Ketamine : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001804/201812
19/09/2019 Human medicines European public assessment report (EPAR): Leganto, rotigotine, Restless Legs Syndrome, Parkinson Disease, 16/06/2011, 17, Authorised (updated)
19/09/2019 Periodic safety update single assessment: Ketamine : List of nationally authorised medicinal products - PSUSA/00001804/201812
19/09/2019 Veterinary medicines European public assessment report (EPAR): Nobilis IB Primo QX, live avian infectious bronchitis virus, strain D388, 04/09/2014, 3, Authorised (updated)
19/09/2019 Human medicines European public assessment report (EPAR): Neupro, rotigotine, Restless Legs Syndrome, Parkinson Disease, 15/02/2006, 28, Authorised (updated)
19/09/2019 Human medicines European public assessment report (EPAR): Zalviso, sufentanil, Pain, Postoperative, 18/09/2015, 3, Authorised (updated)
19/09/2019 Veterinary medicines European public assessment report (EPAR): Syvazul BTV, Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01, 09/01/2019, 1, Authorised (updated)
19/09/2019 Regulatory and procedural guideline: Qualification opinion on eSource Direct Data Capture (DDC)
19/09/2019 Overview of comments: Overview of comments on the draft qualification opinion on eSource Direct Data Capture (DDC)
19/09/2019 Annual Report: Annex 10 – 2018 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication (updated)
19/09/2019 Veterinary medicines European public assessment report (EPAR): Zulvac 1 Ovis, inactivated bluetongue virus, serotype-1, 05/08/2011, Accelerated assessment, 6, Authorised (updated)
19/09/2019 Human medicines European public assessment report (EPAR): Spinraza, nusinersen sodium, Muscular Atrophy, Spinal, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, 8, Authorised (updated)
19/09/2019 Human medicines European public assessment report (EPAR): Insulatard, insulin human, Diabetes Mellitus, 07/10/2002, 19, Authorised (updated)
18/09/2019 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis, 29/03/2017, 4, Authorised (updated)
18/09/2019 Summary of opinion: Trulicity, dulaglutide, 19/09/2019, Positive
18/09/2019 Human medicines European public assessment report (EPAR): Empliciti, Elotuzumab, Multiple Myeloma, 11/05/2016, Accelerated assessment, Additional monitoring, 4, Authorised (updated)
18/09/2019 Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Retinal Diseases, 13/03/2013, 12, Authorised (updated)
18/09/2019 Veterinary medicines European public assessment report (EPAR): Ingelvac CircoFLEX, porcine circovirus type 2 ORF2 protein, 13/02/2008, 15, Authorised (updated)
18/09/2019 Other: Important medical event terms list version (MedDRA version 22.1) (updated)
18/09/2019 Other: EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list (updated)
18/09/2019 Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 8, Authorised (updated)
18/09/2019 Human medicines European public assessment report (EPAR): Ketoconazole HRA, Ketoconazole, Cushing Syndrome, 18/11/2014, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised (updated)
18/09/2019 Other: Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC (updated)
18/09/2019 Withdrawn application: Coliprotec F4/F18, porcine post-weaning diarrhoea vaccine (live), Date of withdrawal: 27/05/2019, Post-authorisation
18/09/2019 Veterinary medicines European public assessment report (EPAR): Halocur, halofuginone, 29/10/1999, 8, Authorised (updated)
18/09/2019 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
18/09/2019 Periodic safety update single assessment: Iron (parenteral preparations, except for iron dextran): List of nationally authorised medicinal products - PSUSA/00010236/201901
18/09/2019 Other: Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a development medicinal product (updated)
18/09/2019 Other: eXtended EudraVigilance medicinal product dictionary (XEVMPD) data-entry tool user manual (updated)
18/09/2019 EPAR - Procedural steps taken and scientific information after authorisation: Halocur : EPAR - Procedural steps taken and scientific information after authorisation (updated)
18/09/2019 EPAR - Product Information: Halocur : EPAR - Product Information (updated)
17/09/2019 Agenda: Agenda - PDCO agenda of the 17-20 September 2019 meeting
16/09/2019 Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions , /Haemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis/ , Article 31 referrals, European Commission final decision, 27/06/2019, 09/09/2019, 16/09/2019 (updated)
16/09/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 July 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 16/07/2019 to 18/07/2019 (updated)
16/09/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2019
16/09/2019 Agenda: Agenda - Workshop on the use of registries for tumour histology-independent cancer therapies
16/09/2019 Workshop on the use of registries for tumour histology-independent cancer therapies , European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019
16/09/2019 Periodic safety update single assessment: Ciclosporin (systemic use): List of nationally authorised products - PSUSA/00000745/201812
16/09/2019 Periodic safety update single assessment: Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use): List of nationally authorised products - PSUSA/00010569/201812
16/09/2019 Periodic safety update single assessment: Caffeine / ergotamine: List of nationally authorised products - PSUSA/00000485/201811
16/09/2019 Minutes: CHMP ORGAM minutes for the meeting on 15 April 2019 (updated)
16/09/2019 Agenda: Agenda - CHMP agenda of the 16-19 September 2019 meeting
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)