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LGM-Pharma-Regulatory-1527671011
Pipeline Products List Specialty Portfolio Updated Q2 2018 Updated Q2 2018 See below list of newly approved API’s, samples are readily available for your R&D requirements: Inhalation Ophthalmic Transdermal Sublingual Abaloparatide Defibrotide Sodium Liraglutide Rituximab Abciximab Deforolimus Lixisenatide Rivastigmine Aclidinium Bromide Azelastine HCl Agomelatine Alprazolam Abemaciclib Delafloxacin Lumacaftor Rivastigmine Hydrogen Tartrate Beclomethasone Dipropionate Azithromycin Amlodipine Aripiprazole Acalabrutinib Denosumab Matuzumab Rizatriptan Benzoate Budesonide Besifloxacin HCl Apomorphine Eletriptan HBr Aclidinium Bromide Desmopressin Acetate Meloxicam Rocuronium Bromide Adalimumab Difluprednate Memantine Hydrochloride Rolapitant Flunisolide Bimatoprost Clonidine Epinephrine Aflibercept Dinoprost Tromethamine Micafungin Romidepsin Fluticasone Furoate Brimonidine Tartrate Dextromethorphan Ergotamine Tartrate Agomelatine Dolasetron Mesylate Mitomycin C Romosozumab Fluticasone Propionate Bromfenac Sodium Diclofenac Levocetrizine DiHCl Albiglutide Donepezil Hydrochloride Mometasone Furoate Rotigotine Formoterol Fumarate Cyclosporine Donepezil Meclizine Alectinib Dorzolamide Hydrochloride Montelukast Sodium Rucaparib Iloprost Dexamethasone Valerate Estradiol Melatonin Alemtuzumab Doxercalciferol Moxifloxacin Hydrochloride Sacubitril Alirocumab Doxorubicin Hydrochloride Mycophenolate Mofetil Salmeterol Xinafoate Indacaterol Maleate Difluprednate Fingolimod Meloxicam Amphotericin B Dulaglutide Naldemedine Secukinumab Levalbuterol Dorzolamide -
Commission Implementing Regulation (EU)
21.3.2013 EN Official Journal of the European Union L 80/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) No 230/2013 of 14 March 2013 on the withdrawal from the market of certain feed additives belonging to the group of flavouring and appetising substances (Text with EEA relevance) THE EUROPEAN COMMISSION, submitted before that deadline for the only animal category for which those feed additives had been auth orised pursuant to Directive 70/524/EEC. Having regard to the Treaty on the Functioning of the European Union, (4) For transparency purposes, feed additives for which no applications for authorisation were submitted within the Having regard to Regulation (EC) No 1831/2003 of the period specified in Article 10(2) of Regulation (EC) No European Parliament and of the Council of 22 September 1831/2003 were listed in a separate part of the 2003 on additives for use in animal nutrition ( 1 ), and in Community Register of Feed Additives. particular Article 10(5) thereof, (5) Those feed additives should therefore be withdrawn from Whereas: the market as far as their use as flavouring and appetising substances is concerned, except for animal species and categories of animal species for which applications for (1) Regulation (EC) No 1831/2003 provides for the auth authorisation have been submitted. This measure does orisation of additives for use in animal nutrition and not interfere with the use of some of the abovemen for the grounds and procedures for granting such auth tioned additives according to other animal species or orisation. Article 10 of that Regulation provides for the categories of animal species or to other functional re-evaluation of additives authorised pursuant to Council groups for which they may be allowed. -
Preliminary Effects of Pagoclone, a Partial GABA Agonist, On
ORIGINAL RESEARCH Preliminary effects of pagoclone, a partial GABAA agonist, on neuropsychological performance 1 Angela F Caveney Abstract: Pagoclone is a novel cyclopyrrolone that acts as a partial GABAA receptor agonist. Bruno Giordani1 Preclinical studies suggest that pagoclone may have clinical utility as an anxiolytic agent, as George M Haig2 well as a reduced incidence of side-effects. The present study was conducted to determine whether pagoclone would affect healthy individuals’ performances on neuropsychological 1Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA; measures as a function of dose within the projected therapeutic range. Twelve healthy adult 2Neurosciences Development, Abbott subjects were randomly assigned to dosage groups in a 3-way crossover study. Participants Laboratories, Abbott Park, IL, USA were administered neuropsychological measures six hours following dosing on Day 1 and Day 6 of administration of the drug. Dose effects were noted on measures of alertness, learning, and memory and movement time. Signifi cant effects were also noted on measures of alertness, learning and memory, information processing and psychomotor speed. Overall, the results of this small, preliminary study do not support a fi nding of behavioral toxicity for these doses of pagoclone. Rather, a pattern was found of transient and mild negative effects on learning and memory scores at the highest dose administered, though these changes were small and no longer evident by the sixth day of use. Keywords: pagoclone, cyclopyrrolone, neuropsychological, memory, generalized anxiety disorder Introduction Behavioral toxicity refers to the extent to which a drug affects an individual’s ability to perform the psychomotor and cognitive tasks of everyday life (Ramaekers 1998). -
Aquagenic Pruritus: First Manifestation of *Corresponding Author Polycythemia Vera Jacek C
DERMATOLOGY ISSN 2473-4799 http://dx.doi.org/10.17140/DRMTOJ-1-102 Open Journal Mini Review Aquagenic Pruritus: First Manifestation of *Corresponding author Polycythemia Vera Jacek C. Szepietowski, MD, PhD Department of Dermatology Venereology and Allergology Wroclaw Medical University Edyta Lelonek, MD; Jacek C. Szepietowski, MD, PhD* Ul. Chalubinskiego 1 50-368 Wroclaw, Poland E-mail: [email protected] Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland Volume 1 : Issue 1 Article Ref. #: 1000DRMTOJ1102 ABSTRACT Article History Aquagenic Pruritus (AP) can be a first symptom of systemic disease; especially strong th Received: January 25 , 2016 correlation with myeloproliferative disorders was described. In Polycythemia Vera (PV) pa- th Accepted: February 18 , 2016 tients its prevalence varies from 31% to 69%. In almost half of the cases AP precedes the th Published: February 19 , 2016 diagnosis of PV and has significant influence on sufferers’ quality of life. Due to the lack of the insight in pathogenesis of AP the treatment is still largely experiential. However, the new Citation JAK1/2 inhibitors showed promising results in management of AP among PV patients. Lelonek E, Szepietowski JC. Aqua- genic pruritus: first manifestation of polycythemia vera. Dermatol Open J. KEYWORDS: Aquagenic pruritus; Polycythemia vera; JAK inhibitors. 2016; 1(1): 3-5. doi: 10.17140/DRM- TOJ-1-102 Aquagenic pruritus (AP) is a skin condition characterized by the development of in- tense itching without observable skin lesions and evoked by contact with water at any tempera- ture. Its prevalence varies from 31% to 69% in Polycythemia vera (PV) patients.1,2,3 It has sig- nificant influence on sufferers’ quality of life and can exert a psychological effect to the extent of abandoning bathing or developing phobia to bathing. -
The Itch New Yorker 2008
The New Yorker June 30, 2008 Annals of Medicine The Itch Its mysterious power may be a clue to a new theory about brains and bodies. by Atul Gawande It was still shocking to M. how much a few wrong turns could change your life. She had graduated from Boston College with a degree in psychology, married at twenty-five, and had two children, a son and a daughter. She and her family settled in a town on Massachusetts’ southern shore. She worked for thirteen years in health care, becoming the director of a residence program for men who’d suffered severe head injuries. But she and her husband began fighting. There were betrayals. By the time she was thirty-two, her marriage had disintegrated. In the divorce, she lost possession of their home, and, amid her financial and psychological struggles, she saw that she was losing her children, too. Within a few years, she was drinking. She began dating someone, and they drank together. After a while, he brought some drugs home, and she tried them. The drugs got harder. Eventually, they were doing heroin, which turned out to be readily available from a street dealer a block away from her apartment. One day, she went to see a doctor because she wasn’t feeling well, and learned that she had contracted H.I.V. from a contaminated needle. She had to leave her job. She lost visiting rights with her children. And she developed complications from the H.I.V., including shingles, which caused painful, blistering sores across her scalp and forehead. -
GABA Receptors
D Reviews • BIOTREND Reviews • BIOTREND Reviews • BIOTREND Reviews • BIOTREND Reviews Review No.7 / 1-2011 GABA receptors Wolfgang Froestl , CNS & Chemistry Expert, AC Immune SA, PSE Building B - EPFL, CH-1015 Lausanne, Phone: +41 21 693 91 43, FAX: +41 21 693 91 20, E-mail: [email protected] GABA Activation of the GABA A receptor leads to an influx of chloride GABA ( -aminobutyric acid; Figure 1) is the most important and ions and to a hyperpolarization of the membrane. 16 subunits with γ most abundant inhibitory neurotransmitter in the mammalian molecular weights between 50 and 65 kD have been identified brain 1,2 , where it was first discovered in 1950 3-5 . It is a small achiral so far, 6 subunits, 3 subunits, 3 subunits, and the , , α β γ δ ε θ molecule with molecular weight of 103 g/mol and high water solu - and subunits 8,9 . π bility. At 25°C one gram of water can dissolve 1.3 grams of GABA. 2 Such a hydrophilic molecule (log P = -2.13, PSA = 63.3 Å ) cannot In the meantime all GABA A receptor binding sites have been eluci - cross the blood brain barrier. It is produced in the brain by decarb- dated in great detail. The GABA site is located at the interface oxylation of L-glutamic acid by the enzyme glutamic acid decarb- between and subunits. Benzodiazepines interact with subunit α β oxylase (GAD, EC 4.1.1.15). It is a neutral amino acid with pK = combinations ( ) ( ) , which is the most abundant combi - 1 α1 2 β2 2 γ2 4.23 and pK = 10.43. -
Test Items for Licensing Examination Krok 1 PHARMACY
MINISTRY OF PUBLIC HEALTH OF UKRAINE Department of human resources policy, education and science Testing Board Student ID Last name Variant ________________ Test items for licensing examination Krok 1 PHARMACY (російськомовний варіант) General Instruction Every one of these numbered questions or unfinished statements in this chapter corresponds to answers or statements endings. Choose the answer (finished statements) that fits best and fill in the circle with the corresponding Latin letter on the answer sheet. Authors of items: Abramov A.V., Aleksandrova K.V., Andronov D.Yu., Bilyk O.V., Blinder O.O., Bobyr V.V., Bobrovska O.A., Bohatyriova O.V., Bodnarchuk O.V., Boieva S.S., Bolokhovska T.O., Bondarenko Yu.I., Bratenko M.K., Buchko O.V., Cherneha H.V., Davydova N.V., Deriuhina L.I., Didenko N.O., Dmytriv A.M., Doroshkevych I.O., Dutka N.M., Dynnyk K.V., Filipova L.O., Havryliuk I.M., Herhel T.M., Hlushkova O.M., Hozhdzinsky S.M., Hrekova T.A., Hrechana O.V., Hruzevsky O.A., Hudyvok Ya.S., Hurmak I.S., Ivanets L.M., Ivanov Ye.I., Kartashova T.V., Kava T.V., Kazakova V.V., Kazmirchuk H.V., Kernychna I.Z., Khlus K.M., Khmelnykova L.I., Klebansky Ye.O., Klopotsky H.A., Klymniuk S.I., Kobylinska L.I., Koldunov V.V., Kolesnyk V.P., Kolesnikova T.O., Komlevoy O.M., Kononenko N.M., Kornijevsky Yu.Y., Kremenska L.V., Krushynska T.Yu., Kryzhanovska A.V., Kryshtal M.V., Kukurychkin Ye.R., Kuznietsova N.L., Kuzmina A.V., Lisnycha A.M., Lychko V.H., Makats Ye.F., Maly V.V., Matvijenko A.H., Menchuk K.M., Minarchenko V.M., Mikheiev A.O., Mishchenko -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
Psychiatric Comorbidities in Non-Psychogenic Chronic Itch, a US
1/4 CLINICAL REPORT Psychiatric Comorbidities in Non-psychogenic Chronic Itch, a US- DV based Study 1 1 1 1 1 2 cta Rachel Shireen GOLPANIAN , Zoe LIPMAN , Kayla FOURZALI , Emilie FOWLER , Leigh NATTKEMPER , Yiong Huak CHAN and Gil YOSIPOVITCH1 1 2 A Department of Dermatology and Cutaneous Surgery, and Itch Center University of Miami Miller School of Medicine, Miami, USA, and Clinical Trials and Epidemiology Research Unit, Singapore Research suggests that itch and psychiatric diseases SIGNIFICANCE are intimately related. In efforts to examine the preva- lence of psychiatric diagnoses in patients with chronic The primary aim of this study was to examine the preva- itch not due to psychogenic causes, we conducted a lence of psychiatric diagnoses in patients with chronic itch retrospective chart review of 502 adult patients diag- that is not due to psychogenic causes. The secondary aim nosed with chronic itch in an outpatient dermatology of this study was to determine whether psychiatric diagno- clinic specializing in itch and assessed these patients ses have any correlation to specific itch characteristics such enereologica for a co-existing psychiatric disease. Psychiatric di- as itch intensity, or if there are any psychiatric-specific di- V sease was identified and recorded based on ICD-10 seases this patient population is more prone to. This infor- codes made at any point in time which were recor- mation will not only allow us to better understand the po- ded in the patient’s electronic medical chart, which tential factors underlying the presentation of chronic itch, includes all medical department visits at the Univer- but also allow us to provide these patients with more holis- ermato- sity of Miami. -
European Guideline Chronic Pruritus Final Version
EDF-Guidelines for Chronic Pruritus In cooperation with the European Academy of Dermatology and Venereology (EADV) and the Union Européenne des Médecins Spécialistes (UEMS) E Weisshaar1, JC Szepietowski2, U Darsow3, L Misery4, J Wallengren5, T Mettang6, U Gieler7, T Lotti8, J Lambert9, P Maisel10, M Streit11, M Greaves12, A Carmichael13, E Tschachler14, J Ring3, S Ständer15 University Hospital Heidelberg, Clinical Social Medicine, Environmental and Occupational Dermatology, Germany1, Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Poland2, Department of Dermatology and Allergy Biederstein, Technical University Munich, Germany3, Department of Dermatology, University Hospital Brest, France4, Department of Dermatology, Lund University, Sweden5, German Clinic for Diagnostics, Nephrology, Wiesbaden, Germany6, Department of Psychosomatic Dermatology, Clinic for Psychosomatic Medicine, University of Giessen, Germany7, Department of Dermatology, University of Florence, Italy8, Department of Dermatology, University of Antwerpen, Belgium9, Department of General Medicine, University Hospital Muenster, Germany10, Department of Dermatology, Kantonsspital Aarau, Switzerland11, Department of Dermatology, St. Thomas Hospital Lambeth, London, UK12, Department of Dermatology, James Cook University Hospital Middlesbrough, UK13, Department of Dermatology, Medical University Vienna, Austria14, Department of Dermatology, Competence Center for Pruritus, University Hospital Muenster, Germany15 Corresponding author: Elke Weisshaar -
G Genito Urinary System and Sex Hormones
WHO/EMP/RHT/TSN/2018.2 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Learning clinical pharmacology with the use of INNs and their stems. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.2). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. -
WO 2015/072852 Al 21 May 2015 (21.05.2015) P O P C T
(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 WO 2015/072852 Al 21 May 2015 (21.05.2015) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 36/84 (2006.01) A61K 31/5513 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/045 (2006.01) A61P 31/22 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 31/522 (2006.01) A61K 45/06 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, PCT/NL20 14/050780 KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (22) International Filing Date: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 13 November 2014 (13.1 1.2014) PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (25) Filing Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 61/903,430 13 November 2013 (13. 11.2013) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, (71) Applicant: RJG DEVELOPMENTS B.V.