Antiphlogistika / Antirheumatika Systemisch (ATC-Code: M01*)
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Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
Estonian Statistics on Medicines 2016 1/41
Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole -
(CNAM-TS) Database
Manoj Sharma et al. / Journal of Pharmacy Research 2012,5(9),4893-4896 Research Article Available online through ISSN: 0974-6943 http://jprsolutions.info Use of NSAIDs in France: Analysis from French reimbursement (CNAM-TS) database Manoj Sharma1*, Sinem E. Gulmez2, Régis Lassalle3, Nicholas Moore4 1Research Fellow. INSERM U657 Pharmaco-Epidémiologie, Service de Pharmacologie, Université de Bordeaux, Bordeaux, France. Manager, Global Pharmacovigilance Deptt. Panacea Biotec Ltd. New Delhi,India 2Associate Professor of Pharmacology, M.D., PhD. INSERM CIC-P 0005 Pharmaco-Epidémiologie, Service de Pharmacologie, Université de Bordeaux, Bordeaux, France. 3Statistician and Database Manager, INSERM CIC-P 0005 Pharmaco-Epidémiologie, Service de Pharmacologie, Université de Bordeaux, Bordeaux, France. 4Professor of Clinical Pharmacology, MD, PhD, FRCP(Edin), FISPE. INSERM CIC-P 0005 Pharmaco-Epidémiologie, Service de Pharmacologie, Université de Bordeaux, Bordeaux, France. Received on:07-06-2012; Revised on: 18-07-2012; Accepted on:25-08-2012 ABSTRACT Background: Reimbursement databases provide indirect data regarding drug use or its exposure. In France, approximately 85% of the general population is covered by the national health insurance system (Caisse Nationale d’ Assurance Maladie des Travaileurs Salariés (CNAM-TS), which reimburses prescribed drugs and other medical expenses to salaried persons and families. Since analysis of reimbursement databases ensures that the prescribed drugs have at least been dispensed, even if not used, the present study was conducted to assess the utilization pattern of nimesulide and other NSAIDs in French population from reimbursement database (CNAM-TS). Method: Reimbursement data of NSAIDs (ATC code M01) were extracted from CNAM-TS database for the period 2002-2007. The defined daily doses (DDDs) were calculated from the number and size of packages of each NSAID and the different NSAIDs were ranked on the basis of total defined daily doses prescribed. -
Outcome of Upper Gastro-Intestinal Bleeding and Use of Ibuprofen Versus Article Research Paracetamol
Outcome of upper gastro-intestinal bleeding and use of ibuprofen versus Research article paracetamol • William J. Blot, Thomas Fischer, Gunnar Lauge Nielsen, Søren Friis, Michael Mumma, Loren Lipworth, Raymond DuBois, Joseph K. McLaughlin and Henrik T. Sørensen Introduction Pharm World Sci 2004; 26: 319–323. © 2004 Kluwer Academic Publishers. Printed in the Netherlands. It has been known for over a decade that use of nons- teroidal anti-inflammatory drugs (NSAIDs) can result W.J. Blot, M. Mumma, L. Lipworth, J.K. McLaughlin: in increased risk of upper gastro-intestinal bleeding International Epidemiology Institute, Rockville, Maryland, USA 1-3 R. Dubois: Vanderbilt University Medical Center, Nashville, (UGIB) . Numerous epidemiologic studies have doc- Tennessee, USA umented that rates of UGIB are elevated (about four- T. Fisher, G.L. Nielsen: Department of Clinical Epidemiology, fold on average) among persons taking aspirin and Aarhus and Aalborg University Hospitals, Aalborg, Denmark 1-3 H.T. Sørensen (correspondence, e-mail: [email protected]): non-aspirin NSAIDs . Variation in risk with the dose Department of Clinical Epidemiology, Aarhus; Aalborg and type of medication has been shown, but all forms University Hospitals, Aalborg, and Medical Department V, and doses appear to result in some elevation in risk1–3. Aarhus University Hospital, Aarhus, Denmark T. Fischer: Department of Cardiology, Aalborg University What is less clear is whether NSAID-related UGIB Hospital, Aalborg, Denmark differs in severity from non-NSAID-related UGIB, with G.L.Nielsen: Department of Gastroenterology, Aalborg the few outcome studies producing conflicting University Hospital, Aalborg, Denmark 4–12 S. Friis: Danish Cancer Society, Copenhagen, Denmark results . -
The Nurofen Plus Data Sheet
NEW ZEALAND DATA SHEET NUROFEN PLUS 1. TRADE NAME OF THE MEDICINAL PRODUCT NUROFEN PLUS Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ibuprofen 200.0 mg and codeine phosphate hemihydrate 12.8 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet, film-coated NUROFEN PLUS is a white film coated, biconvex capsule-shaped tablet embossed with the logo ‘N+’ on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications For the temporary relief of strong pain and or inflammation associated with headache (including migraine and tension headache), period pain, dental pain, back pain, neuralgia, rheumatic and arthritic, and muscular pain. 4.2 Posology and Method of Administration Posology: Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken every 4 to 6 times daily as necessary. The maximum daily dose should not exceed 6 tablets in 24 hours. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Excessive use can be harmful. Codeine can cause addiction Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Nurofen Plus - 12 October 2020 Adults, the elderly and children over 12 years; Initial dose, two tablets taken with fluid, then one to two tablets every 4 to 6 hours as necessary. Maximum 6 tablets in a 24 hour period Children aged less than 12 years: Ibuprofen + Codeine combination solid dose strength products should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 & 4.4). -
Non-Steroidal Anti-Inflammatory Drug Use and the Risk of Acute
Drugs - Real World Outcomes (2017) 4:127–137 DOI 10.1007/s40801-017-0113-x ORIGINAL RESEARCH ARTICLE Non-Steroidal Anti-Inflammatory Drug Use and the Risk of Acute Myocardial Infarction in the General German Population: A Nested Case–Control Study 1,2 1 1 Kathrin Tho¨ne • Bianca Kollhorst • Tania Schink Published online: 4 July 2017 Ó The Author(s) 2017. This article is an open access publication Abstract sampling. Multivariable conditional logistic regression was Introduction Use of non-steroidal anti-inflammatory drugs applied to estimate odds ratios (ORs) and 95% confidence (NSAIDs) has been associated with an increased relative intervals (CIs). Duration of NSAID use was calculated by risk of acute myocardial infarction (AMI), but the label the cumulative amount of dispensed defined daily doses warnings refer particularly to patients with cardiovascular (DDDs), and stratified analyses were conducted for risk factors. The magnitude of relative AMI risk for potential effect modifiers. patients with and without cardiovascular risk factors varies Results Overall, 17,236 AMI cases were matched to between studies depending on the drugs and doses studied. 1,714,006 controls. Elevated relative AMI risks were seen Objectives The aim of our study was to estimate popula- for current users of fixed combinations of diclofenac with tion-based relative AMI risks for individual and widely misoprostol (OR 1.76, 95% CI 1.26–2.45), indometacin used NSAIDs, for a cumulative amount of NSAID use, and (1.69, 1.22–2.35), ibuprofen (1.54, 1.43–1.65), etoricoxib for patients with and without a prior history of cardiovas- (1.52, 1.24–1.87), and diclofenac (1.43, 1.34–1.52) com- cular risk factors. -
(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of - Medicines belonging to the ATC group M01 (Antiinflammatory and antirheumatic products) Table of Contents Page INTRODUCTION 6 DISCLAIMER 8 GLOSSARY OF TERMS USED IN THIS DOCUMENT 9 ACTIVE SUBSTANCES Phenylbutazone (ATC: M01AA01) 11 Mofebutazone (ATC: M01AA02) 17 Oxyphenbutazone (ATC: M01AA03) 18 Clofezone (ATC: M01AA05) 19 Kebuzone (ATC: M01AA06) 20 Indometacin (ATC: M01AB01) 21 Sulindac (ATC: M01AB02) 25 Tolmetin (ATC: M01AB03) 30 Zomepirac (ATC: M01AB04) 33 Diclofenac (ATC: M01AB05) 34 Alclofenac (ATC: M01AB06) 39 Bumadizone (ATC: M01AB07) 40 Etodolac (ATC: M01AB08) 41 Lonazolac (ATC: M01AB09) 45 Fentiazac (ATC: M01AB10) 46 Acemetacin (ATC: M01AB11) 48 Difenpiramide (ATC: M01AB12) 53 Oxametacin (ATC: M01AB13) 54 Proglumetacin (ATC: M01AB14) 55 Ketorolac (ATC: M01AB15) 57 Aceclofenac (ATC: M01AB16) 63 Bufexamac (ATC: M01AB17) 67 2 Indometacin, Combinations (ATC: M01AB51) 68 Diclofenac, Combinations (ATC: M01AB55) 69 Piroxicam (ATC: M01AC01) 73 Tenoxicam (ATC: M01AC02) 77 Droxicam (ATC: M01AC04) 82 Lornoxicam (ATC: M01AC05) 83 Meloxicam (ATC: M01AC06) 87 Meloxicam, Combinations (ATC: M01AC56) 91 Ibuprofen (ATC: M01AE01) 92 Naproxen (ATC: M01AE02) 98 Ketoprofen (ATC: M01AE03) 104 Fenoprofen (ATC: M01AE04) 109 Fenbufen (ATC: M01AE05) 112 Benoxaprofen (ATC: M01AE06) 113 Suprofen (ATC: M01AE07) 114 Pirprofen (ATC: M01AE08) 115 Flurbiprofen (ATC: M01AE09) 116 Indoprofen (ATC: M01AE10) 120 Tiaprofenic Acid (ATC: -
Review of Existing Classification Efforts
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 4.1.1 Review of existing classification efforts Due date of deliverable: (15.01.2008) Actual submission date: (07.02.2008) Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UGent Revision 1.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public X PP Restricted to other programme participants (including the Commission 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) Task 4.1 : Review of existing classification efforts Authors: Kristof Pil, Elke Raes, Thomas Van den Neste, An-Sofie Goessaert, Jolien Veramme, Alain Verstraete (Ghent University, Belgium) Partners: - F. Javier Alvarez (work package leader), M. Trinidad Gómez-Talegón, Inmaculada Fierro (University of Valladolid, Spain) - Monica Colas, Juan Carlos Gonzalez-Luque (DGT, Spain) - Han de Gier, Sylvia Hummel, Sholeh Mobaser (University of Groningen, the Netherlands) - Martina Albrecht, Michael Heiβing (Bundesanstalt für Straßenwesen, Germany) - Michel Mallaret, Charles Mercier-Guyon (University of Grenoble, Centre Regional de Pharmacovigilance, France) - Vassilis Papakostopoulos, Villy Portouli, Andriani Mousadakou (Centre for Research and Technology Hellas, Greece) DRUID 6th Framework Programme Deliverable D.4.1.1. Revision 1.0 Review of Existing Classification Efforts Page 2 of 127 Introduction DRUID work package 4 focusses on the classification and labeling of medicinal drugs according to their influence on driving performance. -
Concordance Assessment of Self-Reported Medication Use in the Netherlands Three- Generation Lifelines Cohort Study with the Phar
Journal name: Clinical Epidemiology Article Designation: Original Research Year: 2018 Volume: 10 Clinical Epidemiology Dovepress Running head verso: Sediq et al Running head recto: Concordance study of medication usage in the Lifelines Cohort Study open access to scientific and medical research DOI: http://dx.doi.org/10.2147/CLEP.S163037 Open Access Full Text Article ORIGINAL RESEARCH Concordance assessment of self-reported medication use in the Netherlands three- generation Lifelines Cohort Study with the pharmacy database IADB.nl: The PharmLines Initiative Rahmat Sediq1 Background: While self-reported data are commonly used as a source of medication use for Jurjen van der Schans1 pharmaco-epidemiological studies, such information is prone to forms of bias. Several previ- Aafje Dotinga2 ous studies showed that various factors like age, type of drug and data collection method may Rolinde A Alingh2 influence accuracy. We aimed to assess the concordance of the self-reported medication use that Bob Wilffert1,3 was documented at entry to the Lifelines Cohort Study, a three-generation follow-up study in the Netherlands that started in 2006 and included over 167,000 participants. Jens HJ Bos1 Materials and methods: As part of the PharmLines Initiative, we collected medication data Catharina CM from the Lifelines participants encoded according to the Anatomical Therapeutic Chemical 1 Schuiling-Veninga (ATC) coding scheme and linked the data via Statistics Netherlands to the widely used and rep- 1,4 Eelko Hak resentative pharmacy prescription database of the University of Groningen, IADB.nl. Analyses 1Department of Pharmaco-Therapy, were conducted at second level of ATC coding for all recorded medications as well as a top Epidemiology & Economics, University list of most used medications at drug-specific fifth level. -
COMPARISON of the WHO ATC CLASSIFICATION & Ephmra/Intellus Worldwide ANATOMICAL CLASSIFICATION
COMPARISON OF THE WHO ATC CLASSIFICATION & EphMRA/Intellus Worldwide ANATOMICAL CLASSIFICATION November 2020 Comparison of the WHO ATC Classification and EphMRA / Intellus Worldwide Anatomical Classification The following booklet is designed to improve the understanding of the two classification systems. The development of the two systems had previously taken place separately. EphMRA and WHO are now working together to ensure that there is a convergence of the 2 systems rather than a divergence. In order to better understand the two classification systems, we should pay attention to the way in which substances/products are classified. WHO mainly classifies substances according to the therapeutic or pharmaceutical aspects and in one class only (particular formulations or strengths can be given separate codes, e.g. clonidine in C02A as antihypertensive agent, N02C as anti-migraine product and S01E as ophthalmic product). EphMRA classifies products, mainly according to their indications and use. Therefore, it is possible to find the same compound in several classes, depending on the product, e.g., NAPROXEN tablets can be classified in M1A (antirheumatic), N2B (analgesic) and G2C if indicated for gynaecological conditions only. The purposes of classification are also different: The main purpose of the WHO classification is for international drug utilisation research and for adverse drug reaction monitoring. This classification is recommended by the WHO for use in international drug utilisation research. The EphMRA/Intellus Worldwide classification has a primary objective to satisfy the marketing needs of the pharmaceutical companies. Therefore, a direct comparison is sometimes difficult due to the different nature and purpose of the two systems. The aim of harmonisation is to reach a “full” agreement of all mono substances in a given class as listed in the WHO ATC Index, mainly at third level: whenever this is not possible, or harmonisation of third level is too difficult or makes no sense (e.g. -
Annex I List of the Names, Pharmaceutical Forms
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND 1 Member State Marketing Authorisation Invented name Strength Pharmaceutical Form Route of administration Holder United Kingdom Novartis Pharmaceuticals UK Ltd Prexige 100 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom United Kingdom Novartis Pharmaceuticals UK Ltd Prexige 200 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom United Kingdom Novartis Pharmaceuticals UK Ltd Prexige 400 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom United Kingdom Novartis Pharmaceuticals UK Ltd Lumiracoxib 100 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom United Kingdom Novartis Pharmaceuticals UK Ltd Lumiracoxib 200 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom 2 Member State Marketing Authorisation Invented name Strength Pharmaceutical Form Route of administration Holder United Kingdom Novartis Pharmaceuticals UK Ltd Lumiracoxib 400 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom United Kingdom Novartis Pharmaceuticals UK Ltd Frexocel 100 mg Film-coated tablet Oral Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom United Kingdom Novartis Pharmaceuticals