Essays on Entry and Market Profitability in the UK Pharmaceuticals

Total Page:16

File Type:pdf, Size:1020Kb

Essays on Entry and Market Profitability in the UK Pharmaceuticals UNIVERSITY OF EAST ANGLIA DOCTORAL THESIS Essays on entry and market profitability in the UK pharmaceuticals Author: Supervisors: Weijie YAN Dr. Farasat BOKHARI Dr. Franco MARIUZZO A thesis submitted in fulfillment of the requirements for the degree of Doctor of Philosophy in the School of Economics January, 2019 iii Declaration of Authorship I, Weijie YAN, declare that this thesis titled, “Essays on entry and market profitability in the UK pharmaceuticals” and the work presented in it is my own. I confirm that: • This work was done wholly or mainly while in candidature for a research de- gree at this University. • Where any part of this thesis has previously been submitted for a degree or any other qualification at this University or any other institution, this has been clearly stated. • Where I have consulted the published work of others, this is always clearly attributed. • Where I have quoted from the work of others, the source is always given. With the exception of such quotations, this thesis is entirely my own work. • I have acknowledged all main sources of help. • Where the thesis is based on work done by myself jointly with others, I have made clear exactly what was done by others and what I have contributed my- self. Signed: Date: iv ©This copy of the thesis has been supplied on condition that anyone who consults it is understood to recognise that its copyright rests with the author and that use of any information derived there from must be in accordance with current UK Copyright Law. In addition, any quotation or extract must include full attribution. v Abstract This thesis applies economic methods developed in industrial organization to assess entry barriers and profitability of the pharmaceutical market in the UK. The the- sis has two parts. The first part investigates whether incumbent firms strategically proliferate product varieties to delay and deter entry of competitors, and whether such strategy is effective to be a barrier. Three sets of regressions are employed: a non-monotonicity test between number of products and market size, as proposed by Ellison and Ellison (2011); a hazard rate model of entry probability, with focus on whether entry can be influenced by product varieties; and a regression of incum- bent’s market share post entry to test whether their share is positively correlated with product varieties built prior to entry. The results suggest that product prolifer- ation can be a barrier to entry in the UK, however, evidence on incumbents’ strategic incentive is inconclusive. The second part of the thesis focuses on antibiotic market. With the use of an- tibiotics, bacteria start to develop resistance, which has became a global crisis in healthcare. Despite the need for new entries because old molecules are losing effec- tiveness, research firms are leaving this market. We use nested logit and random coefficients logit model to estimate the price elasticity of demand between drugs in order to assess the profitability of the market and to evaluate policy interventions of shifting consumption away from molecules that cause higher resistance. We find that price-cost margin of this market is 35.2% on average but varies by molecules and drug types (branded/generics). We also find that some interventions can be effective to shift demand but with prices to pay. vii Acknowledgements I would like to sincerely thank my supervisors Dr. Farasat Bokhari and Dr. Franco Mariuzzo for their excellent and grateful advises throughout my entire student life as a PhD candidate. The thesis can not complete without their efforts. I would like to thank Professor Stephen Davies, Professor Bruce Lyons and Dr. Subhasish Modak Chowdhury, who taught industrial organization courses in my master years and developed my interests in this area. I would also like to thank Professor Peter Moffatt, who permitted my transfer from other economic modules to Industrial Economics at the beginning of my master, probably he already forgot it, but that was the start of my study in this field. I would like to thank my parents Professor Yongqiang Yan, BM, and Mrs. Rong Ma for their understanding and support. Last, a special thank is given to Mr. Ming- pei Li. ix Contents Declaration of Authorship iii Abstractv Acknowledgements vii 1 Introduction1 2 Product proliferation as entry deterrence7 2.1 Introduction..................................7 2.2 Literature review............................... 11 2.2.1 General approaches in IO...................... 11 2.2.2 Entry deterrence in pharmaceuticals................ 14 2.3 Legal protection in the EU and UK..................... 18 2.4 Model of entry and strategic entry-deterrence............... 20 2.5 Data....................................... 23 2.5.1 Market, originator and entrant................... 24 2.5.2 Market at risk and entry events................... 25 2.6 Conclusions.................................. 29 3 Empirical tests on entry deterrence 31 3.1 Introduction.................................. 31 3.2 Summary statistics.............................. 32 3.3 Empirical testing on entry-deterrence incentive.............. 35 3.3.1 Parametric approach......................... 36 3.3.2 Non-parametric approach...................... 39 3.4 Entry probability............................... 41 3.5 Share of incumbent.............................. 47 3.6 Robustness check............................... 50 3.7 Conclusions.................................. 50 4 Demand of antibiotics in the UK 53 4.1 Introduction.................................. 53 4.2 Literature review............................... 56 4.2.1 Optimal use of drugs with externalities.............. 56 4.2.2 Policy interventions to promote proper use of antibiotics.... 57 4.2.3 Empirical studies on antibiotic use and GP’s incentives..... 59 x 4.2.4 Over- and mis-use of antibiotics.................. 60 4.3 Antibiotic market and data.......................... 60 4.4 Structural modelling of demand...................... 67 4.5 Conclusions.................................. 73 5 Demand of antibiotics: empirical results 75 5.1 Introduction.................................. 75 5.2 Estimation and identification........................ 76 5.3 Estimation results............................... 79 5.4 Profitability of antibiotics market...................... 83 5.5 Price elasticity of demand.......................... 89 5.6 Demand shifting and welfare change.................... 92 5.7 Tax evaluation................................. 96 5.8 Conclusions.................................. 98 6 Concluding remarks 101 A Appendix for chapter 1 and 2 103 B Appendix for chapter 3 and 4 107 Bibliography 111 xi List of Figures 2.1 Trend of product proliferation by originators before and after entry by the first competitor. ................................. 10 2.2 Trend of product proliferation by originators since launch. .......... 10 2.3 Strategic investment and entry model ..................... 20 2.4 An illustration of non-monotonicity between number of products by incum- bent and market size .............................. 23 2.5 Difference in quarters between real product launch date in IMS and MA date in EMEA for matched originators. ....................... 25 2.6 Difference in entry years between the originator and the first competitor. .. 26 2.7 Number of molecules launched, number of molecules experienced entry and the average effective monopoly years over time between 1986 and 2015. ... 28 3.1 Number of products by incumbent along market size. ............. 36 3.2 Predicted extra number of products against market size. ........... 38 3.3 Survival distribution of being monopoly by market size. ........... 43 3.4 Predicted entry probability (left) and marginal effects (right) against number of products by market size group. ....................... 46 4.1 Antibiotic consumption by molecule group and UK population ....... 62 4.2 Tree structure for nested logit model ...................... 69 5.1 Histogram of the distribution of taste on price ................. 82 5.2 Histogram of the distribution of taste on spectrum .............. 82 5.3 Estimated marginal cost by branded/generics ................. 88 5.4 Estimated marginal cost by spectrum range .................. 88 5.5 Estimated product level own-price elasticities and weighted average of cross- price elasticities by molecule spectrum ..................... 91 5.6 Estimated product level weighted average of cross-price elasticities by spec- trum group ................................... 91 5.7 Estimated product level own-price elasticities and weighted average of cross- price elasticities by molecule age ........................ 92 5.8 Estimated new market equilibrium price for broad- and narrow-spectrum molecules .................................... 94 5.9 Estimated sales volume for broad- and narrow-spectrum molecules ..... 94 xiii List of Tables 2.1 Molecules at risk and entry events by ATC classes............ 26 3.1 Summary statistics.............................. 33 3.2 Regression results of entry-deterrence incentive. Dependent variable: Drugs f ..................................... 38 3.3 Non-parametric testing of monotonicity.................. 41 3.4 Effect of product proliferation on entry probability. C-loglog regres- sions. Dependent variable: log (− log(1 − lkt)) .............. 45 3.5 Change of incumbent market share post-entry.............. 48 3.6 Effect of product proliferation prior to entry on originators’ market share post entry................................ 49 4.1 Market information by molecule group.................
Recommended publications
  • Medical Product Quality Report – COVID-19 Vaccine Issues
    Medical Product Quality Report – COVID-19 vaccine issues Issue 5. Data included to 31 May 2021 16 June 2021 Countries linked to incidents of substandard, falsified or diverted COVID-19 vaccines on the Medicine Quality Monitoring Globe. The document has been produced by the Medicine Quality Research Group, Centre of Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford. Table of Contents Summary .................................................................................................................... 3 1. Introduction ......................................................................................................... 5 2. Reports of SF COVID-19 vaccine incidents in the lay press ............................... 7 2.1 Methodology.................................................................................................. 7 2.2 Incidents since the beginning of the pandemic.............................................. 8 2.3 New incidents included since the last SF COVID-19 vaccine report ........... 19 2.4 Hacking of COVID-19 vaccine data ............................................................. 21 3. Reports by international organisations .............................................................. 23 4. Reports from the scientific literature .................................................................. 31 5. Regulatory authorities ....................................................................................... 36 6. Miscellaneous ..................................................................................................
    [Show full text]
  • Summary of Product Characteristics
    SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT FSME-IMMUN 0.5 ml Suspension for injection in a pre-filled syringe Tick-Borne Encephalitis Vaccine (whole Virus, inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Tick-Borne Encephalitis Virus1,2 (strain Neudörfl) 2.4 micrograms 1adsorbed on aluminium hydroxide, hydrated (0.35 milligrams Al3+) 2produced in chick embryo fibroblast cells (CEF cells) Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in a pre-filled syringe. After shaking the vaccine is an off-white, opalescent suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications FSME-IMMUN 0.5 ml is indicated for the active (prophylactic) immunization of persons of 16 years of age and older against tick-borne encephalitis (TBE). FSME-IMMUN 0.5 ml is to be given on the basis of official recommendations regarding the need for, and timing of, vaccination against TBE. 4.2 Posology and method of administration Posology Primary vaccination schedule The primary vaccination schedule is the same for all persons from the age of 16 onwards and consists of three doses of FSME-IMMUN 0.5 ml. The first and second dose should be given at a 1 to 3 month interval. If there is a need to achieve an immune response rapidly, the second dose may be given two weeks after the first dose. After the first two doses sufficient protection for the ongoing tick season is to be expected (see section 5.1). The third dose should be given 5 to 12 months after the second vaccination.
    [Show full text]
  • Medical Product Quality Report – COVID‐19 Issues Issue 2
    Medical Product Quality Report – COVID‐19 Issues Issue 2. July 2020 The document has been produced by the Medicine Quality Research Group, Centre of Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford This report was prepared by Kerlijn Van Assche, Céline Caillet and Paul Newton of the Medicine Quality Research Group, that is part of the MORU Tropical Health Network and the Infectious Diseases Data Observatory (IDDO), Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, UK. The Globe system was developed by Clark Freifeld (HealthMap, Boston Children’s Hospital, NorthEastern University) and Andrew Payne (IDDO), Alberto Olliaro (IDDO) and Gareth Blower (ex‐ IDDO) with curation of the English reports by Kem Boutsamay, Konnie Bellingham and Vayouly Vidhamaly, based in the Lao‐Oxford‐Mahosot Hospital‐Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR. This document is open access but we would be grateful if you could cite it as: Medicine Quality Research Group, University of Oxford. Medical Product Quality Report – COVID‐19 Issues. Issue 2, July 2020. The work is kindly supported by the Bill&Melinda Gates Foundation, the University of Oxford and the Wellcome Trust. August 2020 2 Contents 1 Summary of findings ........................................................................................................................ 4 2 Introduction ....................................................................................................................................
    [Show full text]
  • Vaccine Xxx (2018) Xxx–Xxx
    Vaccine xxx (2018) xxx–xxx Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine Spontaneous reports of vaccination errors in the European regulatory database EudraVigilance: A descriptive study ⇑ Christina E. Hoeve a,b, , Anja van Haren a, Miriam C.J.M. Sturkenboom c, Sabine M.J.M. Straus a,b a Medicines Evaluation Board, Utrecht, the Netherlands b Erasmus University Medical Center, Rotterdam, the Netherlands c University Medical Center, Utrecht, the Netherlands article info abstract Article history: Background: Among all post-marketing medication error reports submitted to EudraVigilance, vaccines Received 4 August 2018 are the most frequently reported medicinal products. This study aims to describe the characteristics of Received in revised form 30 October 2018 vaccination errors submitted to Eudravigilance between 2001 and 2016. Accepted 1 November 2018 Methods: EudraVigilance is a spontaneous reporting database for adverse events maintained by the Available online xxxx European Medicines Agency. We extracted Individual Case Safety Reports (ICSRs) submitted to EudraVigilance between 1 January 2001 and 31 December 2016. Reports were included for analysis if Keywords: a vaccine was reported as interacting or suspect drug and at least one medication error term was listed Spontaneous reporting as an adverse reaction. ICSRs were stratified by age and gender, by year of reporting, region of origin, Medication errors Vaccination errors reporter profession, seriousness of outcome, ATC, and type of error. EudraVigilance Results: In total, 7097 ICSRs were included in the study. We observed a yearly increase in the reporting of Pharmacovigilance vaccination errors, with the proportion to all vaccine ICSRs increasing from 0.4% to 4.0% between 2001 and 2016.
    [Show full text]
  • Summary of Product Characteristics 1. Name Of
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PNEUMOCOCCAL POLYSACCHARIDE VACCINE IP Solution for injection 0.5-mL single dose vials and prefilled syringes BRAND NAME: PNEUMOVAX® 23 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: Each 0.5 ml Pre-filled Syringe contains: Pneumococcal serotypes ----- 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, l0A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F-- 25 meg each. Inactive Ingredients: Phenol Sodium chloride Water for injections 3. PHARMACEUTICAL FORM Solution for injection in a vial and prefilled syringe PNEUMOVAX® 23 is a sterile liquid vaccine for intramuscular or subcutaneous injection. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications PNEUMOVAX® 23 is indicated for active immunization against disease caused by the pneumococcal serotypes included in the vaccine. Guidance for Industry Drugs Standard Control Organization Page 71 4.2 Posology and method of administration Do not inject intravenously or intradermally. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PNEUMOVAX® 23 is a clear, colorless solution. Administer a single 0.5-mL dose of PNEUMOVAX® 23 subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh), with appropriate precautions to avoid intravascular administration. It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another. Single-Dose Vial Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics and detergents. Prefilled Syringe The prefilled syringe is for single use only.
    [Show full text]
  • Original Article No Signal of Interactions Between Influenza Vaccines and Drugs Used for Chronic Diseases
    Original Article No signal of interactions between influenza vaccines and drugs used for chronic diseases: a case-by-case analysis of the vaccine adverse event reporting system and vigibase Carla Carnovale1*, Emanuel Raschi2*, Luca Leonardi2, Ugo Moretti3, Fabrizio De Ponti2, Marta Gentili1, Marco Pozzi4, Emilio Clementi4,5, Elisabetta Poluzzi2§ and Sonia Radice1§ 1 Unit of Clinical Pharmacology Department of Biomedical and Clinical Sciences L. Sacco, “Luigi Sacco” University Hospital, Università di Milano, 20157 Milan, Italy. 2 Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy. 3 Dept. of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Verona, Italy. 4 Scientific Institute, IRCCS E. Medea, Bosisio Parini LC, Italy. 5 Clinical Pharmacology Unit, Department Biomedical and Clinical Sciences, CNR Institute of Neuroscience, L. Sacco University Hospital, Università di Milano, Milan, Italy. *Carla Carnovale and Emanuel Raschi contributed equally to this work §Sonia Radice and Elisabetta Poluzzi jointly directed this work. *Corresponding author: Emilio Clementi, Department of Biomedical and Clinical Sciences, Università di Milano Via GB Grassi, 74 - 20157 Milan, Tel: +39.02.50319643. Fax: +39.02.50319682 e-mail: [email protected] 1 ABSTRACT Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Research design and methods: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e., hemorrhages, overdosage and rhabdomyolysis, respectively).
    [Show full text]
  • Downloaded from UKBB Data Portal
    medRxiv preprint doi: https://doi.org/10.1101/2020.12.05.20244426; this version posted December 7, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Exploring drugs and vaccines associated with altered risks and severity of COVID-19: a UK Biobank cohort study of all ATC level-4 drug categories Yong XIANG1, Kenneth C.Y. Wong1, Hon-Cheong SO1-7* 1School of Biomedical Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong 2CUHK Shenzhen Research Institute, Shenzhen, China 3KIZ-CUHK Joint Laboratory of Bioresources and Molecular Research of Common Diseases, Kunming Institute of Zoology and The Chinese University of Hong Kong, China 4Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong 5Margaret K.L. Cheung Research Centre for Management of Parkinsonism, The Chinese University of Hong Kong, Shatin, Hong Kong 6Brain and Mind Institute, The Chinese University of Hong Kong, Shatin, Hong Kong 7Hong Kong Branch of the Chinese Academy of Sciences Center for Excellence in Animal Evolution and Genetics, The Chinese University of Hong Kong, Hong Kong SAR, China *Correspondence to: Hon-Cheong So, Lo Kwee-Seong Integrated Biomedical Sciences Building, The Chinese University of Hong Kong, Shatin, Hong Kong. Tel: +852 3943 9255; E-mail: [email protected] Abstract Background: COVID-19 is a major public health concern, yet its risk factors are not well-understood and effective therapies are lacking.
    [Show full text]
  • Pneumovax 23 Data Sheet
    DATA SHEET 1. PNEUMOVAX® 23 Pneumococcal vaccine polyvalent, MSD, 25 microgram/serotype/0.5 mL Single Dose Vial/Pre-filled Syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5mL single dose vials/pre-filled syringe contains 25 mcg of each of the following pneumococcal polysaccharide serotypes: 1 2 3 4 5 6B** 7F 8 9N 9V** 10A 11A 12F 14** 15B 17F 18C 19A** 19F** 20 22F 23F** 33F. ** These serotypes most frequently cause medicine-resistant pneumococcal infections For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Single dose vials/pre-filled syringes with a sterile clear colourless solution for intramuscular or subcutaneous administration. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteraemia has been demonstrated in controlled trials in South Africa, France and in case-controlled studies. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. If it is known that a person has not received any pneumococcal vaccine or if earlier pneumococcal vaccination status is unknown, then persons in the categories listed below should be administered pneumococcal vaccine, however, if a person has received a primary dose of pneumococcal vaccine, before administering an additional dose of vaccine, please refer to the Revaccination
    [Show full text]
  • Projekt Zur Erfassung Und Bewertung Von Medikationsfehlern Abschlussbericht
    Arzneimittelkommission der deutschen Ärzteschaft Fachausschuss der Bundesärztekammer Projekt zur Erfassung und Bewertung von Medikationsfehlern Abschlussbericht Teil 1: Sachbericht Berlin, 29.06.2018 Korrespondenzadresse: Arzneimittelkommission der deutschen Ärzteschaft Herbert-Lewin-Platz 1 10623 Berlin www.akdae.de Projekt zur Erfassung und Bewertung von Medikationsfehlern FKZ 2514ATS006 Titel und Verantwortliche Projekt: Zentrale Erfassung und Bewertung von Medikationsfehlern Förderkennzeichen: 2514ATS006 Leitung: Dr. med. Katrin Bräutigam, Geschäftsführerin Projektmitarbeitende: Dr. med. Ursula Köberle, Referentin; Lea Prause, Dokumentation Kontaktdaten: Arzneimittelkommission der deutschen Ärzteschaft Herbert-Lewin-Platz 1 10623 Berlin Tel.: 030 400456500 E-Mail: [email protected] Laufzeit: 01.01.2015 – 31.12.2017 Datum der Erstellung des Abschlussberichts: 29.06.2018 Seite 2 von 75 Projekt zur Erfassung und Bewertung von Medikationsfehlern FKZ 2514ATS006 Inhaltsverzeichnis Titel und Verantwortliche ....................................................................................................................... 2 Inhaltsverzeichnis .................................................................................................................................... 3 Abbildungsverzeichnis ............................................................................................................................. 4 Tabellenverzeichnis ................................................................................................................................
    [Show full text]
  • Giornale Italiano Di Farmacoeconomia E Farmacoutilizzazione FOCUS SU UTILIZZO, RISCHIO-BENEFICIO E COSTO-EFFICACIA DEI FARMACI E SULLE POLITICHE SANITARIE
    Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione FOCUS SU UTILIZZO, RISCHIO-BENEFICIO E COSTO-EFFICACIA DEI FARMACI E SULLE POLITICHE SANITARIE Rivista ufficiale di: Servizio di Epidemiologia e Farmacologia Preventiva (SEFAP) e Società Italiana di Terapia Clinica e Sperimentale (SITeCS) Pubblicazione trimestrale Volume 11 • Numero 1 • Marzo 2019 RASSEGNA Eventi avversi muscolo-scheletrici associati alla terapia con statine ARTICOLI ORIGINALI Assenza di interazioni tra vaccini antinfluenzali e farmaci usati per il trattamento di patologie croniche: analisi case-by-case provenienti dalle banche dati VAERS e VigiBase Analisi delle ADR da anticoagulanti orali in una divisione di medicina generale: modalità di presentazione, prevenibilità e necessità del monitoraggio clinico SELEZIONE DELLA LETTERATURA ANGOLO DEL MASTER IN FARMACOVIGILANZA Periodicità Trimestrale - Poste Italiane SpA - Spedizione in abbonamento Postale SpA - Spedizione in abbonamento Italiane - Poste Trimestrale Periodicità bianca Periodico trimestrale Reg. Trib. N. 506 del 15.09.2008 Giornale Italiano ISSN 2279-9168 di Farmacoeconomia e Farmacoutilizzazione FOCUS SU UTILIZZO, RISCHIO-BENEFICIO E COSTO-EFFICACIA Edizioni Internazionali srl DEI FARMACI E SULLE POLITICHE SANITARIE Divisione EDIMES Edizioni Medico-Scientifiche - Pavia Via Riviera, 39 - 27100 Pavia Rivista ufficiale di: Tel. 0382/526253 r.a. Servizio di Epidemiologia e Farmacologia Preventiva (SEFAP) e Fax 0382/423120 Società Italiana di Terapia Clinica e Sperimentale (SITeCS) E-mail: [email protected]
    [Show full text]
  • (ADULT) / 720 (JUNIOR) Inactivated
    For the use only of Registered Medical Practitioners or a Hospital or a Laboratory HAVRIX 1440 (ADULT) / 720 (JUNIOR) Inactivated Hepatitis A Vaccine (Adsorbed) IP 1. NAME OF THE MEDICINAL PRODUCT Inactivated Hepatitis A Vaccine (Adsorbed) IP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION HAVRIX 1440: Each dose (1.0 ml) contains: Hepatitis A virus antigen (HAV)[HM 175 strain , propagated in MRC5 human diploid cells] …………. 1440 ELISA units Aluminium (as adjuvant) ……….. 0.5 mg [as hydrated Aluminium Oxide IP] HAVRIX 720: Each dose (0.5 ml) contains: Hepatitis A virus antigen (HAV)[HM 175 strain, propagated in MRC5 human diploid cells ] ………… 720 ELISA units Aluminium (as adjuvant) ………… 0.25 mg [as hydrated Aluminium Oxide IP] . 3. PHARMACEUTICAL FORM Suspension for injection 4. CLINICAL PARTICULARS 4.1. Therapeutic indications For active immunisation against infections caused by hepatitis A virus (HAV) for Children and Adolescents (from 1 year up to and including 18 years of age) and adults (from age 19 years and onwards). The booster dose may be given at any time between 6 months and 5 years, but preferably between 6 and 12 months after the primary dose. 4.2. Posology and method of administration Posology • Primary vaccination - Adults from age 19 years and onwards A single dose of HAVRIX 1440 Adult (1.0 ml suspension) is used for primary immunisation. 1 - Children and adolescents from 1 year up to and including 18 years of age A single dose of HAVRIX 720 Junior (0.5 ml suspension) is used for primary immunisation. • Booster vaccination After primary vaccination with either HAVRIX 1440 Adult or HAVRIX 720 Junior, a booster dose is recommended in order to ensure long term protection.
    [Show full text]
  • Page 1 of 4 1 NAME of the MEDICINAL PRODUCT Imovax DT, Suspension for Injection in Prefilled Syringe Adsorbed Diphtheria And
    1 NAME OF THE MEDICINAL PRODUCT Imovax DT, suspension for injection in prefilled syringe Adsorbed diphtheria and tetanus vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diphtheria toxoid ................................................................................................................................. ≥ 2 I.U. Tetanus toxoid .................................................................................................................................. ≥ 20 I.U. Adsorbed on hydrated aluminium hydroxide ................................................................................ 0.6 mg Al3+ For one 0.5-ml dose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in prefilled syringe 4 CLINICAL PARTICULARS 4.1 Therapeutic indications This vaccine is indicated for adults over 18 years of age in the following cases: • Routine booster vaccinations against diphtheria and tetanus. The diphtheria toxoid content is reduced to one tenth of the normal dose to minimise the risks of a severe hypersensitivity reaction. • Primary vaccination. • Post-exposure prophylaxis following a tetanus-prone wound, if a booster diphtheria injection is required. This adsorbed diphtheria and tetanus vaccine (Imovax DT) may be administered as a booster vaccination in children over 10 years of age in whom poliomyelitis is prevented by separate administration of poliomyelitis vaccine. 4.2 Posology and method of administration • For routine booster injections, a single dose of 0.5 ml should be administered
    [Show full text]