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30/09/2019 Orphan designation: imatinib for the: Treatment of acute respiratory distress syndrome (ARDS), 19/11/2014, Positive
30/09/2019 Agenda: Agenda - PRAC draft agenda of meeting 30 September-3 October 2019
30/09/2019 Human medicines European public assessment report (EPAR): Inbrija, levodopa, Parkinson Disease, 19/09/2019, Authorised
30/09/2019 Orphan designation: Diaspirin cross-linked haemoglobin for the: Treatment of hepatocellular carcinoma, 19/11/2014, Positive
30/09/2019 Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene for the: Treatment of epidermolysis bullosa, 12/10/2017, Positive
30/09/2019 Orphan designation: Diaspirin cross-linked haemoglobin for the: Treatment of oesophageal cancer, 21/03/2016, Positive
30/09/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 2-5 September 2019 PRAC meeting
27/09/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 16-19 September 2019
27/09/2019 Human medicines European public assessment report (EPAR): Tegsedi, inotersen sodium, Amyloidosis, 05/07/2018, Orphan, Accelerated assessment, Additional monitoring, 3, Authorised
27/09/2019 Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, Generic, 4, Authorised
27/09/2019 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, Additional monitoring, 5, Authorised
27/09/2019 Human medicines European public assessment report (EPAR): Pylobactell, 13C-urea, Breath Tests, Helicobacter Infections, 07/05/1998, 10, Authorised
27/09/2019 Human medicines European public assessment report (EPAR): Darunavir Krka d.d., darunavir, HIV Infections, 18/01/2018, Generic, 3, Authorised
27/09/2019 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 16, Authorised
27/09/2019 Periodic safety update single assessment: Bupropion: List of nationally authorised medicinal products - PSUSA/00000461/201812
27/09/2019 Minutes: Minutes of the PRAC meeting 08-11 April 2019
27/09/2019 Committee for Medicinal Products for Human Use (CHMP): 24-27 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 24/06/2019 to 27/06/2019
26/09/2019 News and press releases: Change of name of liposomal medicines at high risk of medication errors
26/09/2019 Template or form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance and trusted deputy
26/09/2019 Regulatory and procedural guideline: Dates of 2020 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
26/09/2019 Human medicines European public assessment report (EPAR): Lymphoseek, tilmanocept, Radionuclide Imaging, 19/11/2014, 5, Authorised
26/09/2019 Article 5(3) opinions
26/09/2019 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Information on nitrosamines for marketing authorisation holders
26/09/2019 News and press releases: EMA advises companies on steps to take to avoid nitrosamines in human medicines
26/09/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d., emtricitabine, tenofovir disoproxil succinate, HIV Infections, 28/04/2017, Generic, 4, Authorised
25/09/2019 News and press releases: Working parties for healthcare professionals and for patients and consumers elect new co-chairs
25/09/2019 Orphan designation: Elafibranor for the: Treatment of primary biliary cholangitis, 25/07/2019, Positive
25/09/2019 Human medicines European public assessment report (EPAR): Foclivia, influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 18/10/2009, Exceptional circumstances, 8, Authorised
24/09/2019 Orphan designation: Recombinant mutated extracellular domain of the human acetylcholine receptor subunit alpha1 for the: Treatment of myasthenia gravis, 25/07/2019, Positive
24/09/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: September 2019
24/09/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: Septmeber 2019
24/09/2019 Orphan designation: Pevonedistat for the: Treatment of acute myeloid leukaemia, 25/07/2019, Positive
24/09/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 August 2019 written procedure
24/09/2019 Orphan designation: Parsaclisib for the: Treatment of marginal zone lymphoma, 25/07/2019, Positive
24/09/2019 Orphan designation: N-((R)-2,3-dihydroxypropoxyl)-3,4-difluro-2-(2-fluoro-4-iodo-phenylamino)-benzamide for the: Treatment of neurofibromatosis type 1, 25/07/2019, Positive
24/09/2019 Orphan designation: Mavorixafor for the: Treatment of WHIM syndrome, 25/07/2019, Positive
24/09/2019 Orphan designation: 7-ethyl-10-hydroxy-camptothecin for the: Treatment of soft tissue sarcoma, 25/07/2019, Positive
24/09/2019 Orphan designation: 2-(hydroxymethyl)-2-(methoxymethyl)-1-azabicyclo[2.2.2]octan-3-one for the: Treatment of myelodysplastic syndromes, 25/07/2019, Positive
24/09/2019 Human medicines European public assessment report (EPAR): Visudyne, verteporfin, Myopia, Degenerative, Macular Degeneration, 27/07/2000, 33, Authorised
23/09/2019 Human medicines European public assessment report (EPAR): Temybric Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 12/06/2019, Additional monitoring, Authorised
23/09/2019 Implementation of the new Veterinary Medicines Regulation
23/09/2019 News and press releases: EMA’s work on new veterinary regulation advances
23/09/2019 Orphan designation: "Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus (bulevirtide) for the: Treatment of hepatitis delta virus infection, 19/06/2015, Positive
23/09/2019 Qualification of novel methodologies for medicine development
23/09/2019 Regulatory and procedural guideline: Advice on implementing measures under Article 60(1) of Regulation (EU) 2019/6 on veterinary medicinal products - Scientific recommendation on the list of variations not requiring assessment
23/09/2019 Report: Advice on implementing measures under Article 57(3) of Regulation (EU) 2019/6 on veterinary medicinal products - Report on specific requirements for the collection of data on antimicrobial medicinal products used in animals
23/09/2019 Regulatory and procedural guideline: Advice to the European Commission on the Union Product Database
23/09/2019 Regulatory and procedural guideline: Advice implementing measures under Article 146(2) of Regulation (EU) 2019/6 on veterinary medicinal products – Scientific recommendation on the revision of Annex II to Regulation (EU) 2019/6 on veterinary medicinal products
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
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
20/09/2019 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, 2, Authorised
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: Remsima, infliximab, 19/09/2019, Positive
20/09/2019 Summary of opinion: Dupixent, dupilumab, 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: 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 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
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
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
19/09/2019 Template or form: QRD product-information template version 10.1 - highlighted
19/09/2019 Template or form: QRD product-information template version 10.1
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
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
19/09/2019 Human medicines European public assessment report (EPAR): Neupro, rotigotine, Restless Legs Syndrome, Parkinson Disease, 15/02/2006, 28, Authorised
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
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
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
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
19/09/2019 Human medicines European public assessment report (EPAR): Insulatard, insulin human, Diabetes Mellitus, 07/10/2002, 19, Authorised
18/09/2019 Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Retinal Diseases, 13/03/2013, 12, Authorised
18/09/2019 Veterinary medicines European public assessment report (EPAR): Ingelvac CircoFLEX, porcine circovirus type 2 ORF2 protein, 13/02/2008, 15, Authorised
18/09/2019 Other: Important medical event terms list version (MedDRA version 22.1)
18/09/2019 Other: EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list
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
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
18/09/2019 Other: Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC
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
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
18/09/2019 Other: eXtended EudraVigilance medicinal product dictionary (XEVMPD) data-entry tool user manual
18/09/2019 EPAR - Procedural steps taken and scientific information after authorisation: Halocur : EPAR - Procedural steps taken and scientific information after authorisation
18/09/2019 EPAR - Product Information: Halocur : EPAR - Product Information
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
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
16/09/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 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
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
13/09/2019 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, 24/02/2009, 17, Authorised
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: 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
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): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, Orphan, Additional monitoring, Exceptional circumstances, 17, Authorised
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
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
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
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
12/09/2019 Human medicines European public assessment report (EPAR): Cinqaero, Reslizumab, Asthma, 15/08/2016, Additional monitoring, 8, Authorised
12/09/2019 Human medicines European public assessment report (EPAR): Stalevo, levodopa, carbidopa, entacapone, Parkinson Disease, 17/10/2003, 25, Authorised
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
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
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
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
10/09/2019 Periodic safety update single assessment: Protirelin: List of nationally authorised medicinal products - PSUSA/00009273/201901
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
10/09/2019 Other: Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division
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
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 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): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 30, Authorised
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
06/09/2019 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, Orphan, 34, Authorised
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
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
05/09/2019 Human medicines European public assessment report (EPAR): Actrapid, human insulin, Diabetes Mellitus, 07/10/2002, 16, Authorised
05/09/2019 Human medicines European public assessment report (EPAR): Actraphane, insulin human, Diabetes Mellitus, 07/10/2002, 18, Authorised
05/09/2019 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 30, Authorised
05/09/2019 Human medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, HIV Infections, 03/01/2017, Generic, 5, Authorised
04/09/2019 Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Head and Neck Neoplasms, Colorectal Neoplasms, 29/06/2004, 27, Authorised
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): Dovato, dolutegravir sodium, lamivudine, HIV Infections, 01/07/2019, Additional monitoring, Authorised
03/09/2019 Paediatric investigation plans: questions and answers
03/09/2019 Human medicines European public assessment report (EPAR): Renvela, sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 09/06/2009, 20, Authorised
03/09/2019 Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis, Hyperphosphatemia, 28/01/2000, 31, Authorised
03/09/2019 Veterinary medicines European public assessment report (EPAR): Econor, valnemulin, 12/03/1999, 21, Authorised
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
02/09/2019 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 20/03/2014, 17, Authorised
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): Mozobil, Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma, 30/07/2009, Orphan, 17, Authorised
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
01/09/2019 Human medicines European public assessment report (EPAR): Olanzapine Glenmark, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 13, Authorised