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Endothelin System and Therapeutic Application of Endothelin Receptor
xperim ACCESS Freely available online & E en OPEN l ta a l ic P in h l a C r m f o a c l a o n l o r g u y o J Journal of ISSN: 2161-1459 Clinical & Experimental Pharmacology Research Article Endothelin System and Therapeutic Application of Endothelin Receptor Antagonists Abebe Basazn Mekuria, Zemene Demelash Kifle*, Mohammedbrhan Abdelwuhab Department of Pharmacology, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia ABSTRACT Endothelin is a 21 amino acid molecule endogenous potent vasoconstrictor peptide. Endothelin is synthesized in vascular endothelial and smooth muscle cells, as well as in neural, renal, pulmonic, and inflammatory cells. It acts through a seven transmembrane endothelin receptor A (ETA) and endothelin receptor B (ETB) receptors belongs to G protein-coupled rhodopsin-type receptor superfamily. This peptide involved in pathogenesis of cardiovascular disorder like (heart failure, arterial hypertension, myocardial infraction and atherosclerosis), renal failure, pulmonary arterial hypertension and it also involved in pathogenesis of cancer. Potentially endothelin receptor antagonist helps the treatment of the above disorder. Currently, there are a lot of trails both per-clinical and clinical on endothelin antagonist for various cardiovascular, pulmonary and cancer disorder. Some are approved by FAD for the treatment. These agents are including both selective and non-selective endothelin receptor antagonist (ETA/B). Currently, Bosentan, Ambrisentan, and Macitentan approved -
Homozygous Familial Hypercholesterolemia - Juxtapid® (Lomitapide Capsules)
Cigna National Formulary Coverage Policy Prior Authorization Homozygous Familial Hypercholesterolemia - Juxtapid® (lomitapide capsules) Table of Contents Product Identifer(s) National Formulary Medical Necessity ................ 1 52036 Conditions Not Covered....................................... 3 Background .......................................................... 3 References .......................................................... 4 Revision History ................................................... 4 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. -
THELIN, INN-Sitaxentan Sodium
European Medicines Agency Evaluation of Medicines for Human Use London, 17 December 2009 Doc. Ref EMA/831836/2009 ASSESSMENT REPORT FOR Thelin International non-proprietary name/Common name: sitaxentan sodium EMEA/H/C/000679/II/0018 Variation Assessment Report as adopted by theauthorised CHMP with all information of a commercially confidential nature deleted longer no product Medicinal 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: [email protected] http://www.ema.europa.eu European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged. I. SCIENTIFIC DISCUSSION 1.1. Introduction Thelin contains sitaxentan sodium, which is an endothelin receptor antagonist, with higher selectivity for the ETA receptor than the ETB receptor subtype. Endothelin-1 (ET-1) is a potent vascular paracrine and autocrine peptide in the lung, and can also promote fibrosis, cell proliferation, cardiac hypertrophy and remodeling, and is pro-inflammatory. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension (PAH), as well as other cardiovascular disorders and connective tissue diseases, including scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension, and atherosclerosis, suggesting a pathogenic role of ET- 1 in these diseases. In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases. Additionally, PAH is also characterised by reduced nitric oxide activity. ET-1 actions are mediated through endothelin A receptors (ETA), present on smooth muscle cells, and endothelin B receptors (ETB), present on endothelial cells. -
Corrigendum Doi:10.1093/Eurheartj/Ehr046
Corrigendum doi:10.1093/eurheartj/ehr046 ............................................................................................................................................................................. Corrigendum to: ‘Guidelines for the diagnosis and treatment of pulmonary hypertension’ [European Heart Journal (2009) 30, 2493–2537]. The Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Authors/Task Force Members: Nazzareno Galie` (Chairperson) (Italy); Marius M. Hoeper (Germany); Marc Humbert (France); Adam Torbicki (Poland); Jean-Luc Vachiery (France); Joan Albert Barbera (Spain); Maurice Beghetti (Switzerland); Paul Corris (UK); Sean Gaine (Ireland); J. Simon Gibbs (UK); Miguel Angel Gomez-Sanchez (Spain); Guillaume Jondeau (France); Walter Klepetko (Austria) Christian Opitz (Germany); Andrew Peacock (UK); Lewis Rubin (USA); Michael Zellweger (Switzerland); Gerald Simonneau (France). Withdrawal of sitaxentan in the treatment of pulmonary arterial hypertension The 2009 ESC Practice Clinical Guidelines for the diagnosis and treatment of pulmonary hypertension included the endothelin receptor antag- onist sitaxentan in an algorithm of evidence-based treatment for pulmonary arterial hypertension. Sitaxentan was recommended with a Class I/Level A grade of evidence in WHO functional class III patients and Class IIa/Level C grade of evidence -
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). -
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. -
Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object. -
(12) United States Patent (10) Patent No.: US 9,044,466 B2 Cohen Et Al
USOO9044466B2 (12) United States Patent (10) Patent No.: US 9,044,466 B2 Cohen et al. (45) Date of Patent: *Jun. 2, 2015 (54) ORAL COMPOSITIONS COMPRISINGA 2800/882 (2013.01); A61O II/00 (2013.01); ZINC COMPOUND AND AN A61K 45/06 (2013.01); A61 K47/02 (2013.01); ANT-MICROBAL AGENT (Continued) (58) Field of Classification Search (75) Inventors: Marvin Cohen, St. Louis, MO (US); CPC ...... A61K 8/27; A61 K33/30; A61K 31/4425 Susanne Cohen, St. Louis, MO (US); USPC ............................................................ 424/49 Robert G. Flynn, Dupo, IL (US) See application file for complete search history. (73) Assignee: THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF (56) References Cited NEW YORK, Albany, NY (US) U.S. PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this 4,226,851 A 10/1980 Sompayrac patent is extended or adjusted under 35 4,692,262 A 9, 1987 Brown et al. U.S.C. 154(b) by 0 days. (Continued) This patent is Subject to a terminal dis claimer. FOREIGN PATENT DOCUMENTS CN 101780016 A T 2010 (21) Appl. No.: 13/204,595 WO WO-OOf 51559 A1 9, 2000 (22) Filed: Aug. 5, 2011 (Continued) OTHER PUBLICATIONS (65) Prior Publication Data International Preliminary Report on Patentability for International US 2012/003428O A1 Feb. 9, 2012 Application No. PCT/US2011/046831 dated Feb. 21, 2013. Related U.S. Application Data (Continued) (60) Provisional application No. 61/371,695, filed on Aug. Primary Examiner – Rachael E. Bredefeld 7, 2010, provisional application No. 61/371,696, filed (74) Attorney, Agent, or Firm — Harness, Dickey & Pierce, on Aug. -
Low Acyl Gellan Gum for Inclusion on the National List of Substances Allowed in Organic Production and Handling (7 CFR 205.605 (B)
Petition for Evaluation of Low Acyl Gellan Gum for Inclusion on the National List of Substances Allowed in Organic Production and Handling (7 CFR 205.605 (b) Submitted by: CP Kelco U.S., Inc. 3100 Cumberland Blvd., Suite 600 Atlanta, GA 30339 Date: 08 August 2019 CP Kelco U.S., Inc. 08 August 2019 National Organic List Petiion Low Acyl Gellan Gum Table of Contents Item A.1 — Section of National List ........................................................................................................... 4 Item A.2 — OFPA Category - Crop and Livestock Materials .................................................................... 4 Item A.3 — Inert Ingredients ....................................................................................................................... 4 1. Substance Name ................................................................................................................................... 5 2. Petitioner and Manufacturer Information ............................................................................................. 5 2.1. Corporate Headquarters ................................................................................................................5 2.2. Manufacturing/Processing Facility ...............................................................................................5 2.3. Contact for USDA Correspondence .............................................................................................5 3. Intended or Current Use .......................................................................................................................5 -
Malta Medicines List April 08
Defined Daily Doses Pharmacological Dispensing Active Ingredients Trade Name Dosage strength Dosage form ATC Code Comments (WHO) Classification Class Glucobay 50 50mg Alpha Glucosidase Inhibitor - Blood Acarbose Tablet 300mg A10BF01 PoM Glucose Lowering Glucobay 100 100mg Medicine Rantudil® Forte 60mg Capsule hard Anti-inflammatory and Acemetacine 0.12g anti rheumatic, non M01AB11 PoM steroidal Rantudil® Retard 90mg Slow release capsule Carbonic Anhydrase Inhibitor - Acetazolamide Diamox 250mg Tablet 750mg S01EC01 PoM Antiglaucoma Preparation Parasympatho- Powder and solvent for solution for mimetic - Acetylcholine Chloride Miovisin® 10mg/ml Refer to PIL S01EB09 PoM eye irrigation Antiglaucoma Preparation Acetylcysteine 200mg/ml Concentrate for solution for Acetylcysteine 200mg/ml Refer to PIL Antidote PoM Injection injection V03AB23 Zovirax™ Suspension 200mg/5ml Oral suspension Aciclovir Medovir 200 200mg Tablet Virucid 200 Zovirax® 200mg Dispersible film-coated tablets 4g Antiviral J05AB01 PoM Zovirax® 800mg Aciclovir Medovir 800 800mg Tablet Aciclovir Virucid 800 Virucid 400 400mg Tablet Aciclovir Merck 250mg Powder for solution for inj Immunovir® Zovirax® Cream PoM PoM Numark Cold Sore Cream 5% w/w (5g/100g)Cream Refer to PIL Antiviral D06BB03 Vitasorb Cold Sore OTC Cream Medovir PoM Neotigason® 10mg Acitretin Capsule 35mg Retinoid - Antipsoriatic D05BB02 PoM Neotigason® 25mg Acrivastine Benadryl® Allergy Relief 8mg Capsule 24mg Antihistamine R06AX18 OTC Carbomix 81.3%w/w Granules for oral suspension Antidiarrhoeal and Activated Charcoal -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark
A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas Working Paper Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark ZEW Discussion Papers, No. 10-062 Provided in Cooperation with: ZEW - Leibniz Centre for European Economic Research Suggested Citation: Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas (2010) : Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark, ZEW Discussion Papers, No. 10-062, Zentrum für Europäische Wirtschaftsforschung (ZEW), Mannheim This Version is available at: http://hdl.handle.net/10419/41440 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu Dis cus si on Paper No. 10-062 Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark Ulrich Kaiser, Susan J.