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Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Wo 2010/075090 A2
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 1 July 2010 (01.07.2010) WO 2010/075090 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 409/14 (2006.01) A61K 31/7028 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 409/12 (2006.01) A61P 11/06 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US2009/068073 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 15 December 2009 (15.12.2009) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (25) Filing Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, (26) Publication Language: English TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/122,478 15 December 2008 (15.12.2008) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant (for all designated States except US): AUS- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, PEX PHARMACEUTICALS, INC. -
Transdermal Drug Delivery Device Including An
(19) TZZ_ZZ¥¥_T (11) EP 1 807 033 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61F 13/02 (2006.01) A61L 15/16 (2006.01) 20.07.2016 Bulletin 2016/29 (86) International application number: (21) Application number: 05815555.7 PCT/US2005/035806 (22) Date of filing: 07.10.2005 (87) International publication number: WO 2006/044206 (27.04.2006 Gazette 2006/17) (54) TRANSDERMAL DRUG DELIVERY DEVICE INCLUDING AN OCCLUSIVE BACKING VORRICHTUNG ZUR TRANSDERMALEN VERABREICHUNG VON ARZNEIMITTELN EINSCHLIESSLICH EINER VERSTOPFUNGSSICHERUNG DISPOSITIF D’ADMINISTRATION TRANSDERMIQUE DE MEDICAMENTS AVEC COUCHE SUPPORT OCCLUSIVE (84) Designated Contracting States: • MANTELLE, Juan AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Miami, FL 33186 (US) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI • NGUYEN, Viet SK TR Miami, FL 33176 (US) (30) Priority: 08.10.2004 US 616861 P (74) Representative: Awapatent AB P.O. Box 5117 (43) Date of publication of application: 200 71 Malmö (SE) 18.07.2007 Bulletin 2007/29 (56) References cited: (73) Proprietor: NOVEN PHARMACEUTICALS, INC. WO-A-02/36103 WO-A-97/23205 Miami, FL 33186 (US) WO-A-2005/046600 WO-A-2006/028863 US-A- 4 994 278 US-A- 4 994 278 (72) Inventors: US-A- 5 246 705 US-A- 5 474 783 • KANIOS, David US-A- 5 474 783 US-A1- 2001 051 180 Miami, FL 33196 (US) US-A1- 2002 128 345 US-A1- 2006 034 905 Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
In February 2013, Glaxosmithkline (GSK) Announced a Commitment To
In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clincal Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered CONFIDENTIAL GM2004/00056/00GM2004/00056/00 SAM40040SAM40040 The GlaxoSmithKline group of companies A twenty-four week, randomised, double-dummy, double-blind, parallel group study to compare the occurrence of exacerbations between SERETIDE DISKUS 50/250µg 1 inhalation bd and formoterol/budesonide Breath-Actuated Dry Powder Inhaler 4.5/160µg 2 inhalations bd in subjects with moderate to severe asthma. Clinical Study Report for Study SAM40040 (Development Phase IV) Document Number: GM2004/00056/00 Compound Number: CCI18781/ GR33343 Investigational Product: SERETIDE Generic Drug Name: salmeterol/fluticasone propionate combination Indication Studied: Asthma Initiation Date: 26 Nov 2001 Completion Date: 13 Jan 2003 Early Termination Date: N/A Date of Report: August 2004 Sponsor Signatory: (and Medical Officer) Vice President European Clinical Respiratory Medicines Development Centre This study was performed in compliance with Good Clinical Practices including the archiving of essential documents. -
Moderní Antihistaminika V Léčbě Alergie – Současné Trendy V Symptomatické Terapii Alergických Onemocnění
100 Hlavní téma Moderní antihistaminika v léčbě alergie – současné trendy v symptomatické terapii alergických onemocnění Jaroslava Braunová, Mojmír Račanský Oddělení alergologie a klinické imunologie FNOL, Ústav imunologie UP Olomouc Alergická onemocnění jsou problémem současné medicíny. Nejde o pouhé projevy sezónní rýmy, s nimiž se do jisté míry setkal snad každý, ale také o závažné stavy, jako je anafylakticky šok a exacerbace bronchiálního astmatu. Nezanedbatelnou kapitolu tvoří problematika různých kožních projevů přecitlivělosti. Vždy však působí postiženému značné nepříjemnosti. Spolu s rostoucí incidencí těchto alergolo- gických diagnóz pochopitelně stoupá i poptávka po jejich účinné léčbě. Za kauzální léčbu považujeme alergenovou imunoterapii (AIT). Ta však není indikována pro všechny pacienty a všechny alergologické diagnózy. Vyžaduje vysokou compliance ze strany nemocného, přesné určení spouštěče alergické reakce u daného pacienta a existenci dostupného standardizovaného alergenu. Symptomatická terapie antihistaminiky představuje jednu ze zásadních možností ovlivnění rozvoje alergické reakce přímo na periferním histaminovém receptoru H1. Klíčová slova: alergie, symptomatická terapie, antihistaminika, alergický zánět. Modern antihistamines in treating allergies: current trends in symptomatic therapy of allergic conditions Allergic diseases are a serious problem in modern medicine. It is not only a question of pollinosis, but also of other allergic diseases such as bronchial asthma, atopic dermatitis, urticaria, angioedema or -
NVA237 / Glycopyrronium Bromide Multinational, Multi-Database Drug
Quantitative Safety & Epidemiology NVA237 / Glycopyrronium bromide Non-interventional Final Study Report NVA237A2401T Multinational, multi-database drug utilization study of inhaled NVA237 in Europe Author Document Status Final Date of final version 28 April 2016 of the study report EU PAS register ENCEPP/SDPP/4845 number Property of Novartis Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis NIS Report Template Version 2.0 August-13-2014 Novartis Confidential Page 2 Non-interventional study report NVA237A/Seebri® Breezhaler®/CNVA237A2401T PASS information Title Multinational, multi-database drug utilization study of inhaled NVA237 in Europe –Final Study Report Version identifier of the Version 1.0 final study report Date of last version of 28 April 2016 the final study report EU PAS register number ENCEPP/SDPP/4845 Active substance Glycopyrronium bromide (R03BB06) Medicinal product Seebri®Breezhaler® / Tovanor®Breezhaler® / Enurev®Breezhaler® Product reference NVA237 Procedure number SeebriBreezhaler: EMEA/H/C/0002430 TovanorBreezhaler: EMEA/H/C/0002690 EnurevBreezhaler: EMEA/H/C0002691 Marketing authorization Novartis Europharm Ltd holder Frimley Business Park Camberley GU16 7SR United Kingdom Joint PASS No Research question and In the context of the NVA237 marketing authorization objectives application, the Committee for Medicinal Products for Human Use (CHMP) recommended conditions for marketing authorization and product information and suggested to conduct a post-authorization -
Obecná Alergologie, Alergie - Pojem
12.02.2017 Obecná alergologie, Alergie - pojem (alergie, „nealergie“, alergeny, léčba neadekvátní reakce imunitního systému typu zánětu alergií a alergické stavy) na jinak neškodnou cizorodou látku (alergen), má s přihlédnutím k dětskému věku objektivní i subjektivní složku: - objektivně jsou známky poškození některých orgánů (sliznice nosu, spojivky, kůže, bronchy, ..) - subjektivně jsou nepříjemně vnímané poruchy funkce takto postižených orgánů Alergik = pacient s klinickými příznaky reakce přecitlivosti navozené imunolog.mechanismy. MUDr.Jiří NEVRLKA Poliklinika Zahradníkova 2/8 BRNO ambulance pro alergologii a klinickou imunologii Alergie pozitivita v testech na alergeny !! Alergie - pojem Alergie - pojem imunopatologické reakce „nepravé alergie a pseudoalergie“ časný typ Reakce I.typu - mediovaná protilátkami IgE, • IgE non dependentní alergie (pozdní typ) - vyjádřena u osob s atopickou reaktivitou Alergolog - reakce nezprostředkovaná IgE, ale Ag-specif.T-lymfocyty - nejčastější typ alergie (alergie v užším smyslu) navazující na IgE mechanismus .. např. potraviny, alergie na lepek - inhalační alergie, alergie hmyzí jed, anafylaxe, (atopická dermatitida).. dominantní mechanismus .. např. kontaktní alergeny, léky, celiakie Reakce II.typu - mediovaná non IgE protilátkami - cytotoxické protilátky, např. transfuzní reakce x blokující protilátky, např. • Zkřížená reaktivita: myastenia gravis x stimulační protilátky, např. Graves-Basedowova choroba - reakce na antigeny strukturálně podobné reálnému alergenu Reakce III.typu – mediovaná -
(12) Patent Application Publication (10) Pub. No.: US 2010/0081713 A1 Sharma Et Al
US 20100081713A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0081713 A1 Sharma et al. (43) Pub. Date: Apr. 1, 2010 (54) COMPOSITIONS AND METHODS FOR (22) Filed: Mar. 18, 2009 TREATINGVIRAL INFECTIONS Related U.S. Application Data (75) Inventors: Geeta Sharma, Singapore (SG); (60) Provisional application No. 61/069,917, filed on Mar. Ralf Altmeyer, Singapore (SG); 19, 2008. Vishal Pendharker, Singapore (SG); Yu Chen, Singapore (SG); Publication Classification Michael Foley, Chestnut Hill, MA (51) Int. Cl. (US) A63L/35 (2006.01) A6II 3L/25 (2006.01) Correspondence Address: A63L/35 (2006.01) Gearhart Law LLC A6II 3/13 (2006.01) 4 Femdale Avenue A6IP3L/2 (2006.01) Chatham, NJ 07928 (US) (52) U.S. Cl. .......... 514/459; 514/529; 514/647: 514/662 (73) Assignee: CombinatoRx, (Singapore) Pte. (57) ABSTRACT Ltd. The present invention provides compositions, methods, and kits for treating or preventing a viral infection (e.g., an infec (21) Appl. No.: 12/406,716 tion caused by an influenza virus). Patent Application Publication Apr. 1, 2010 Sheet 1 of 2 US 2010/0081713 A1 ------ 80 r -0. Vehicle 0.5% HPMC g - - Sertraline-30mg/kg/day - £ 60 “A Sertraline-100mg/kg/day/kg/day i -v. Oseltamivir-30mg/kg/day ...i -0. Oseltamivir-100mg/kg/day -0. (Sertraline 30mg/kg+ . 40 Prednisolone 0.1 mg/Kg) Figure 1 Patent Application Publication Apr. 1, 2010 Sheet 2 of 2 US 2010/0081713 A1 100 468OOO 2 O Wehicle Sentraline 10 mg/kg Sentraline 30mg/kg Setraline 100mg/kg Figure 2 US 2010/008 1713 A1 Apr. -
Marrakesh Agreement Establishing the World Trade Organization
No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX -
CURRICULUM VITAE Name: John E. Koundourellis Address: School Of
CURRICULUM VITAE Name: John E. Koundourellis Address: School of Pharmacy, Department of Pharmaceutical Technology, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece. Tel: +302310997643, Fax: +302310997652 e-mail: [email protected] Job Title: Associate Professor Marital status: Married / two children Education 1973 Pharmacy degree (School of Pharmacy, Aristotelian University of Thessaloniki, Greece) 1978 M. Phil. Degree (School of Pharmacy, University of Bath, Avon, England) 1981 Ph.D (School of Pharmacy, University of Bath, Avon, England) Research Interests: · Development various chromatographic systems for the quantification of drugs and their metabolites in pharmaceutical preparations and in biological fluids · Quantification of drugs by employing zero order and derivative spectra · Characterization of drugs and their polymorphic forms using X-ray diffraction data Infrared and Raman Spectrophotometry Publications: Theses 1. J. E. Kountourellis, Spectrometric and Spectrophotometric Analysis of 2- lmidazolines, M. Phil Thesis, Bath University, September 1978 2. J. E. Kountourellis, Carbon -13 NMR Quantitative and Qualitative Analysis. Ph. D. Thesis, Bath University, September 1981 Papers in Scientific Journals 1. × - Ray Powder Diffraction Data for Nine Medicinal 2 - Imidazolines J.T.R. Owen, J.E. Kountourellis, F.A. Underwood, Journal of the Association of Official Analytical Chemists 64, No 5,1164 - 1173(1981). 2. Studies of carbon -13 n.m.r. spectroscopy in pharmaceutical analysis: the composition of commercial samples of gentamicin sulphate. J.E. Kountourellis, R.T. Parfitt, A.F. Casy Journal of Pharmacy and Pharmacology 35: 279-283 (1983). 3. Mass Spectra and Fragmentation Pathways of two Medicinal Aryl -I midazo-lines under Electron Impact. J.E. Kountourellis, Pharmakeftiko Deltio, Vol X, 47- 54, (1984) 4. -
BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available
BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] BMJ Open Pediatric drug utilization in the Western Pacific region: Australia, Japan, South Korea, Hong Kong and Taiwan Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032426 review only Article Type: Research Date Submitted by the 27-Jun-2019 Author: Complete List of Authors: Brauer, Ruth; University College London, Research Department of Practice and Policy, School of Pharmacy Wong, Ian; University College London, Research Department of Practice and Policy, School of Pharmacy; University of Hong Kong, Centre for Safe Medication Practice and Research, Department