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PUBLIC ASSESSMENT REPORT Decentralised Procedure Dienogest
PUBLIC ASSESSMENT REPORT Decentralised Procedure Dienogest Aristo 2 mg Tabletten Procedure Number: DE/H/5431/001/DC Active Substance: Dienogest Dosage Form: Tablet Marketing Authorisation Holder in the RMS, Germany: Aristo Pharma GmbH Publication: 18.12.2019 This module reflects the scientific discussion for the approval of Dienogest Aristo 2 mg Tabletten. The procedure was finalised on 10.10.2019. TABLE OF CONTENTS I INTRODUCTION ......................................................................................................................... 4 II EXECUTIVE SUMMARY .......................................................................................................... 4 II.1 PROBLEM STATEMENT............................................................................................................... 4 II.2 ABOUT THE PRODUCT ................................................................................................................ 4 II.3 GENERAL COMMENTS ON THE SUBMITTED DOSSIER ............................................................... 5 II.4 GENERAL COMMENTS ON COMPLIANCE WITH GMP, GLP, GCP AND AGREED ETHICAL PRINCIPLES ........................................................................................................................................... 5 III SCIENTIFIC OVERVIEW AND DISCUSSION .................................................................... 6 III.1 QUALITY ASPECTS .................................................................................................................... 6 III.2 -
Weliki Nowgorod Weliki Nowgorod (Russ
Titelregister zu: • Ergänzungsseite I a zu Seekriege und Seegefechte der Hanse • Ergänzungsseite I b zu Seekriege und Seegefechte der Hanse • Ergänzungsseite I c zu Seekriege und Seegefechte der Hanse • Ergänzungsseite II a zu Seekriege und Seegefechte der Hanse • Ergänzungsseite II b zu Seekriege und Seegefechte der Hanse • Ergänzungsseite II c zu Seekriege und Seegefechte der Hanse • Ergänzungsseite II d zu Seekriege und Seegefechte der Hanse • Ergänzungsseite II e zu Seekriege und Seegefechte der Hanse • Ergänzungsseite II f zu Seekriege und Seegefechte der Hanse Titelregister zu: • Ergänzungsseite III zu Seekriege und Seegefechte der Hanse Nowgorod - Weliki Nowgorod Weliki Nowgorod (russ. Вели" кий Но"вгород) oder auch Nowgorod-Weliki (zu deutsch Groß-Nowgorod, bis 1999 offiziell nur Nowgorod (russ. Но"вгород), früher auch deutsch Navgard/Naugard und altnordisch Hólmgarðr) ist eine Großstadt in Russland mit 214.777 Einwohnern (Stand: 2010) und liegt etwa 180 km südsüdöstlich von Sankt Petersburg am Wolchow nördlich des Ilmensees. Sie ist das Verwaltungszentrum der im Föderationskreis Nordwestrussland liegenden Oblast Nowgorod. Weliki Nowgorod, das im September 2009 sein 1150-jähriges Bestehen feierte, gehört zu den ältesten Städten Russlands. Im Mittelalter war Nowgorod Hauptstadt einer einflussreichen Handelsrepublik und bedeutender Mittler zwischen den Rus und dem Abendland, bevor es Teil des zentralisierten russischen Reichs wurde. Nowgorods architektonisches Erbe ist seit 1992 UNESCO-Weltkulturerbe.[1] Geographie Geographische Lage Nowgorod liegt im Nordwesten des europäischen Teils von Russland und ist 180 Kilometer von St. Petersburg und 524 Kilometer von Moskau entfernt. Von Süden nach Norden durchschneidet der Fluss Wolchow die Stadt. Sie liegt durchschnittlich auf 25 m ü. NN. Das Stadtgebiet hat eine Fläche von 90 Quadratkilometern. -
Sport and Physical Education in Germany
Sport and Physical Education in Germany Sport and physical education represent important components of German national life, from school and community participation, to elite, international level sport. This unique and comprehensive collection brings together material from leading German scholars to examine the role of sport and PE in Germany from a range of historical and contemporary perspectives. Key topics covered include: • Sport and PE in pre-war, post-war and re-unified Germany; • Sport and PE in schools; • Coach education; • Elite sport and sport science; • Women and sport; • Sport and recreation facilities. This book offers an illuminating insight into how sport and PE have helped to shape modern Germany. It is fascinating reading for anyone with an interest in the history and sociology of sport, and those working in German studies. Roland Naul is Professor of Sport Science and Sport Pedagogy, Essen University. He is ICSSPE Regional Director for Western Europe and Vice- President of ISCPES. Ken Hardman is a Reader in Education at the University of Manchester. He is a former president of ISCPES and a Fellow of the UK Physical Education Association. International Society for Comparative Physical Education and Sport Series Series Editor: Ken Hardman University of Manchester Other titles in the series include: Sport and Physical Education in China Edited by James Riordan and Robin Jones Sport and Physical Education in Germany Edited by Roland Naul and Ken Hardman International Society for Comparative Physical Education and Sport London and New York First published 2002 by Routledge 11 New Fetter Lane, London EC4P 4EE Simultaneously published in the USA and Canada by Routledge 29 West 35th Street, New York, NY 10001 Routledge is an imprint of the Taylor & Francis Group This edition published in the Taylor and Francis e-Library, 2005. -
Effects of Dienogest, a Synthetic Steroid, on Experimental Endometriosis in Rats
European Journal of Endocrinology (1998) 138 216–226 ISSN 0804-4643 Effects of dienogest, a synthetic steroid, on experimental endometriosis in rats Yukio Katsuki, Yukiko Takano, Yoshihiro Futamura, Yasunori Shibutani, Daisuke Aoki1, Yasuhiro Udagawa1 and Shiro Nozawa1 Toxicology Laboratory, Mochida Pharmaceutical Co. Ltd, Fujieda, Shizuoka 426, Japan and 1Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo 160, Japan (Correspondence should be addressed to Y Katsuki, Toxicology Laboratory, Mochida Pharmaceutical Co. Ltd, 342 Gensuke Fujieda, Shizuoka 426, Japan) Abstract Objective: Dienogest, a synthetic steroid with progestational activity, is used as a component of oral contraceptives and is currently being evaluated clinically for the treatment of endometriosis. The present study was conducted to confirm the effects of dienogest on experimental endometriosis in rats and to elucidate its mechanism of action. Design: Experimental endometriosis induced by autotransplantation of endometrium in rats. Methods: Endometrial implants, immune system, and bone mineral were investigated after 3 weeks of medication. Results: Dienogest (0.1–1 mg/kg per day, p.o.) reduced the endometrial implant volume to the same extent as danazol (100 mg/kg per day, p.o.). Simultaneously, dienogest ameliorated the endometrial implant-induced alterations of the immune system; i.e. it increased the natural killer activity of peritoneal fluid cells and splenic cells, decreased the number of peritoneal fluid cells, and decreased interleukin-1b production by peritoneal macrophages. In contrast, danazol (100 mg/kg per day, p.o.) and buserelin (30 mg/kg per day, s.c.) had none of these immunologic effects. Additionally, combined administration of dienogest (0.1 mg/kg per day) plus buserelin (0.3 mg/kg per day) suppressed the bone mineral loss induced by buserelin alone, with no reduction of the effect on endometrial implants. -
German Football: History, Culture, Society
1111 2111 German Football 3 4 5111 6 7 8 9 1011 1 2 3111 German Football: History, Culture, Society provides unprecedented analysis 4 of the place of football in post-war and post-reunification Germany, revealing 5 the motives and drives underlying Germany’s successful bid to host the 2006 6 World Cup finals. 7 The contributors explore the significance of football in German sporting 8 and cultural life, showing how football has emerged as a major focus 9 for the expression of a coherent national identity and as evidence of the 20111 restoration of German national pride in the post-World War II period. 1 Major themes include: 2 3 • German football’s desire for success on the international stage 4 • Footballing expressions of local, regional and national identity 5 • The East European legacy 6 • Ethnic dynamics, migrant populations and Europeanization 7 • German football’s commercial economy 8 • Women’s football in Germany 9 • Literary and media perceptions of the German game 30111 1 With contributions from a range of disciplinary perspectives, German 2 Football illuminates key cultural moments – the 1954 victory, the founding 3 of the Bundesliga in 1963, the 1974 World Cup victory as hosts, its third 4 World Cup triumph in Italia ’90, the winning bid for 2006 – from a variety 5 of angles. 6 The result is an innovative, open-minded and critical analysis of football’s 7 burgeoning significance in German cultural life, which will be of import- 8 ance to readers in Sport Studies and German Studies alike and of interest 9 as well to followers of the world game. -
Illegal Manipulation of Your Body
ES.010 Chemistry of Sports Illegal manipulation of your body Schedule of events for today: 1. Update on workout on Thursday – in the pool 4 pm. 2. Drugs in sports 3. Introduction to Wind tunnel testing – preview of next week’s class with Kim Blair. Drugs in Sports • Blood Doping, Artificial • THG Oxygen Carriers and • Human Chorionic Erythropoietin (EPO) Gonadotrophin (HCG) • Human Growth Hormone • Adrenocorticotropic Hormone • Anabolic Steroids (ACTH) • Insulin-like Growth Factor • Beta-2-Agonists (IGF-1) • Hormone Antagonists and • Cocaine Modulators • Caffeine • Diuretics • Narcotics • Gene Doping • Cannabinoids • Amphetamines Why do Athletes Take Drugs? There are a large number of reasons why an athlete may decide to take drugs. A selection are listed here: • Pressure to succeed, either from themselves or coaches/family and sponsors (major reason) • Belief that their competitors are taking drugs • Pressure from governments/national authorities (as occurred in the eastern bloc countries in the 60's and 70's) • Financial rewards for outstanding performance • Lack of access to, or funding for training facilities and additional support (nutrition, psychological support) • Community and media attitudes and expectations of success Reference:http://www.teachpe.com/drugs/drugs.php. Drugs in Sports • Blood Doping and Erythropoietin • THG (EPO) • Human Chorionic Gonadotrophin • Human Growth Hormone (HCG) • Anabolic Steroids • Adrenocorticotropic Hormone • Insulin-like Growth Factor (IGF- (ACTH) 1) • Beta-2-Agonists • Cocaine • Hormone Antagonists -
The United States' and International Response to the Problem
Fordham Intellectual Property, Media and Entertainment Law Journal Volume 12 Volume XII Number 2 Volume XII Book 2 Article 5 2002 The United States’ and International Response to the Problem of Doping in Sports Edward H. Jurith General Counsel, Office of National Drug Control Policy, Executive Office of the President Bill Koenig Lieutenant Commander, USN, Special Assistant, Office of National Drug Control Policy Follow this and additional works at: https://ir.lawnet.fordham.edu/iplj Part of the Entertainment, Arts, and Sports Law Commons, and the Intellectual Property Law Commons Recommended Citation Edward H. Jurith and Bill Koenig, The United States’ and International Response to the Problem of Doping in Sports, 12 Fordham Intell. Prop. Media & Ent. L.J. 461 (2002). Available at: https://ir.lawnet.fordham.edu/iplj/vol12/iss2/5 This Article is brought to you for free and open access by FLASH: The Fordham Law Archive of Scholarship and History. It has been accepted for inclusion in Fordham Intellectual Property, Media and Entertainment Law Journal by an authorized editor of FLASH: The Fordham Law Archive of Scholarship and History. For more information, please contact [email protected]. JURITH.FINAL 2/15/02 2:55 PM ARTICLES The United States’ and International Response to the Problem of Doping in Sports Edward H. Jurith* and Mark W. Beddoes** INTRODUCTION Athletes and sports events play important roles in American society. During times of crisis, sports have rallied the nation’s morale. Americans took tremendous pride when Jesse Owens single- handedly destroyed Hitler’s attempt to prove the supremacy of the German “Aryan” race at the 1936 Olympics. -
Kicking Through the Wall: Football, Division, and Entanglement In
Kicking Through the Wall: Football, Division, and Entanglement in Postwar Berlin By Emmanuel Hogg, BA (Hons), MA A thesis submitted to the Faculty of Graduate and Postdoctoral Affairs in partial fulfillment of the requirements for the degree of Doctor of Philosophy in History Carleton University Ottawa, ON © 2016, Emmanuel Hogg Abstract Seldom is the German capital referred to as a “Fußballstadt” (“football-city”). When Berlin and football are mentioned together, themes of corruption, hooliganism, the Stasi, and scandal dominate. And yet, Berlin holds a rich footballing history that dates back to the late nineteenth and early twentieth centuries and has long played an important role in the lives of Berliners as spaces for sociability. In the postwar period, two divergent states emerged, each with their own competing structures of football. Whereas in the Federal Republic football remained an autonomous but not apolitical space, it was explicitly politicized in East Germany. As an important form of “soft power” during the Cold War, the people’s game reveals the extent to which the Iron Curtain was much more porous and elastic than the imagery of the Berlin Wall suggests. Rather than view football as “war without the fighting”, a microcosm that interprets the German and Cold War past as simplistic, reductive, and dichotomous, this dissertation analyzes the sport’s inherent dynamism that presented Berliners on both sides of the Wall with unique spaces for social interaction. Although both German states tried to use the sport to assert their own interests, this dissertation argues that football simultaneously provided fans with a relatively free space authorities could not effectively control, opening the opportunity for German- German interactions. -
Part 4 April 2021 2014 (Jenapharm, Germany) RH002 Suppliers Submission of the SRA Approved Text
Levonorgestrel 30µg Tablets WHOPAR part 4 April 2021 2014 (Jenapharm, Germany) RH002 Suppliers submission of the SRA approved text Professional datasheet 1. Name of the medicinal product Microlut 30 microgram coated tablets 2. Qualitative and quantitative composition Levonorgestrel One coated tablet contains: 30 µg Levonorgestrel Other constituents with known effect: 33 mg lactose monohydrate and 19.6 mg sucrose (see section 4.4). See section 6.1 for a full list of all the other constituents. 3. Dosage form Coated tablet The tablets are white, biconvex, and round. 4. Clinical particulars 4.1 Indications Contraception for women 4.2 Posology and method of administration Posology One tablet of Microlut daily without tablet-free breaks Method of administration The first tablet is removed from a blister pack well marked with the abbreviated day of the week for the start of tablet-taking. The tablets are taken continually for 35 days in the direction of the arrows, irrespective of whether bleeding occurs. 1 Levonorgestrel 30µg Tablets WHOPAR part 4 April 2021 2014 (Jenapharm, Germany) RH002 Suppliers submission of the SRA approved text The day after the tablets from one blister pack have been used up, the first tablet from a new blister pack is taken. The tablets must be taken at about the same time every day with a sufficient amount of liquid. The interval between two consecutive tablets should be as close as possible to 24 hours. To avoid jeopardizing the contraceptive effect this time must not be exceeded by more than three hours at all events. The maximum reliability of Microlut can only be guaranteed if the time between tablet-taking is kept as close as possible to 24 hours. -
Gynaecological Uses of Dienogest Alone and in Combination with Oestrogens V
Drug Review © 2015 Journal of Medical Drug Reviews. All rights reserved. J Med Drug Rev 2015;5:1 – 31 Gynaecological uses of dienogest alone and in combination with oestrogens V. Bartsch With a comment by Prof. Dr. med. Thomas Römer Index Evangelisches Krankenhaus Köln-Weyertal 1. Introduction 2 SUMMARY 2. Pharmacology of dienogest 2 2.1 Chemistry 2 Dienogest is a hybrid synthetic gestagen which 2.2 Pharmacokinetics 2 shares characteristics with 19-nortestosterone 2.3 Pharmacodynamics 3 and progesterone derivatives, and also has ad- 2.3.1 Endocrinological effects 3 vantageous substance specific pharmacological 2.3.2 Endometrial activity 5 features. These include a high oral bioavailabil- 2.3.3 Other effects 5 ity, strong suppressive effect on the endometri- 3. Ethinyl estradiol and dienogest (Valette®/Maxim®) 6 um, lack of oestrogenic and androgenic effects, 3.1 Use as contraceptive 6 with a significant antiandrogenic efficacy com- 3.1.1 Methodology of the clinical trials 7 ponent. Due to its reliable ovulation inhibiting 3.1.2 Contraceptive efficacy 7 effect, dienogest is a part of oral contraceptives 3.1.3 Safety and tolerability 8 in combination with ethinyl estradiol (Valette®, 3.1.4 Cycle and bleeding control 9 3.1.5 Impact on lab results, coagulation system Maxim®) or is a part in a 4-phasic drug (Qlaira®) and blood pressure 9 with dynamic dosage in combination with estra- 3.1.6 Return of fertility after using Valette® 10 diol valerate (Qlaira®). Due to the specific effi- 3.2 Use in women with acne 10 ® ® cacy profile of dienogest, Valette and Maxim 4. -
The Effects of Anabolic-Androgenic Steroids on Aging in Bodybuilders
Iowa State University Capstones, Theses and Retrospective Theses and Dissertations Dissertations 1-1-2003 The effects of anabolic-androgenic steroids on aging in bodybuilders Barbara Szlendakova Iowa State University Follow this and additional works at: https://lib.dr.iastate.edu/rtd Recommended Citation Szlendakova, Barbara, "The effects of anabolic-androgenic steroids on aging in bodybuilders" (2003). Retrospective Theses and Dissertations. 20055. https://lib.dr.iastate.edu/rtd/20055 This Thesis is brought to you for free and open access by the Iowa State University Capstones, Theses and Dissertations at Iowa State University Digital Repository. It has been accepted for inclusion in Retrospective Theses and Dissertations by an authorized administrator of Iowa State University Digital Repository. For more information, please contact [email protected]. The effects of anabolic-androgenic steroids on aging in bodybuilders by Barbara Szlendakova A thesis submitted to the graduate faculty in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE Major: Genetics Program of Study Committee: Eric Henderson (Maj or Professor) Fredric Janzen Douglas King Iowa State University Ames, Iowa 2003 11 Graduate College Iowa State University This is to certify that the master's thesis of Barbara Szlendakova has met the requirements of Iowa State University Signatures have been redacted for privacy iii TABLE OF CONTENTS ABSTRACT v1 CHAPTER 1. INTRODUCTION 1 Cellular Aging and Telomeres 1 What are anabolic-androgenic steroids 2 Structure of anabolic-androgenic steroids 4 How do steroids work? 5 Modes of anabolic-androgenic steroid use 8 Oral preparations 8 Effectiveness of oral steroids 8 lnjectible preparations 12 Oil-based preparations 12 Water-based preparations 13 Transdermal preparations 15 Anabolic-androgenic steroid use 15 Medical uses of anabolic-androgenic steroids 16 Side effects of steroid abuse 17 CHAPTER 2. -
Regjistri I Barnave Te Regjistruara Ne Shqiperi Perditesuar Deri Me 03.09.2014
REGJISTRI I BARNAVE TE REGJISTRUARA NE SHQIPERI PERDITESUAR DERI ME 03.09.2014 Nr. EMRI TREGTAR FORME/DOZA PRINCIPI AKTIV PAKETIMI Hard capsules x Box x 1 bottle x 42, 1 ALLI ORLISTAT 60mg Box x 1 bottle x 84 Solution for METHOXY POLYETHYLENE Box x 1 pre-filled 2 MIRCERA injection x 30µg / GLYCOL-EPOETIN BETA syringe x 0.3ml 0.3ml Solution for METHOXY POLYETHYLENE Box x 1 pre-filled 3 MIRCERA injection x 120µg / GLYCOL-EPOETIN BETA syringe x 0.3ml 0.3ml Solution for METHOXY POLYETHYLENE Box x 1 pre-filled 4 MIRCERA injection x 360µg / GLYCOL-EPOETIN BETA syringe x 0.6ml 0.6ml Film Coated Tablets SITAGLIPTIN (as SITAGLIPTIN 5 JANUVIA Box x 28 x 25mg PHOSPHATE MONOHYDRATE) Film Coated Tablets SITAGLIPTIN (as SITAGLIPTIN 6 JANUVIA Box x 98 x 50mg PHOSPHATE MONOHYDRATE) Film Coated Tablets SITAGLIPTIN (as SITAGLIPTIN 7 JANUVIA Box x 28 x 100mg PHOSPHATE MONOHYDRATE) Powder for solution DORIPENEM (as DORIPENEM 8 DORIBAX for infusion x Box x 10 vials MONOHYDRATE) 500mg/vial Powder for solution CEFTRIAXONE (as CEFTRIAXONE 9 ROCEPHIN for I.V. injection x DISODIUM x 3.5H O x 2.386g) Box x 1 vial 2g/vial 2 TENOFOVIR DISOPROXIL (eq. to Film coated tablets x Box x 1 plastic bottle 10 VIREAD 300mg TENOFOVIR DISOPROXIL 245mg x 30 FUMARATE or 136mg TENOFOVIR) EMTRICITABINE + TENOFOVIR Film coated tablets x DISOPROXIL (eq. to 300mg Box x 1 plastic bottle 11 TRUVADA (200mg + 245mg) TENOFOVIR DISOPROXIL x 30 FUMARATE or 136mg TENOFOVIR) 12 MEDROL Tablets x 4mg METHYLPREDNISOLONE Box x 30 13 MEDROL Tablets x 16mg METHYLPREDNISOLONE Box x 50; Box x 20 14 MEDROL Tablets x 100mg METHYLPREDNISOLONE Box x 10 Solution for CLINDAMYCIN (as CLINDAMYCIN- Box x 1 ampoule x 15 DALACIN C injection x 2-PHOSPHATE ) 2ml 150mg/ml RUSCOSIDES (corresponding to 0.04g of 50% extract per suppository) + Suppositories x DESONIDE or PREDNACINOLONE CIRKAN A LA (0.02g + 0.0005g + 16 + HEPARIN SODIUM SALT + Box x 12 PREDNACINOLONE 500 UI + 5000 UI + RETINOL or VIT.