Quality of medicines in Portugal: a retrospective review of medicine recalls ( ) Ana Teresa Reis Bruna Berardo Rui Loureiro
|
|
- Rudolph McBride
- 5 years ago
- Views:
Transcription
1 Quality of medicines in Portugal: a retrospective review of medicine recalls ( ) Ana Teresa Reis Bruna Berardo Rui Loureiro
2 Introduction Human medicines Cosmetics Veterinary medicines Medical devices Herbal and homeopathic medicines Other health products
3 Introduction Human medicines Cosmetics Veterinary medicines Medical devices Herbal and homeopathic medicines Other health products
4 Introduction INFARMED Alerts Quality Alerts Safety Alerts Medicinal Products Other Health Products Human Medicine Recall Alerts
5 Materials/Methods o INFARMED website Quality Alerts o Excel database File number Issuing date Drug name and Dosage Generic Comercially available MA Status MAH No. batches affected Expiry Date Shelf Life Time on the Market Pharmaceutical Dosage Form Quality Defect Issuing Agency Voluntary/Mandatory recall Notes
6 Materials/Methods o Item Time on the Market Expiry Date Shelf Life = Production Date Alert Issuing Date Production Date = Time on the market 0-6 months 7-12 months months months months months > 36 months
7 Materials/Methods o Item Pharmaceutical Dosage Form Oral Solids Tablets Capsules Lozenges Powders and/or granules for oral suspension/oral solution Liquids and Semi-solids Injectables Creams Ointments Gels Cutaneous solutions Transdermal systems Eye drops, eye ointments Powders for inhalation Pressurized inhalation solutions Oral suspensions and solutions Syrups Oral gels Oral drops Mouth solutions Solutions for gargling Ovules Vaginal ointments Rectal suppositories Rectal ointments
8 Total Alerts Issued ( ) n = Total Alerts other Health Products Total Medicine Alerts Medicine Recall Alerts Other Medicine Alerts Total Alerts other Health Products Total Medicine Alerts Medicine Recall Alerts Other Medicine Alerts
9 Frequency Total Medicine Quality Alerts / Total Medicine Recalls YEAR MEDICINES QUALITY ALERTS MEDICINE RECALLS
10 Frequency Total Medicine Quality Alerts ( ) YEAR
11 Frequency Total Medicine Quality Alerts ( ) YEAR
12 Frequency Total Medicine Quality Alerts / Total Medicine Recalls YEAR MEDICINES QUALITY ALERTS MEDICINE RECALLS
13 Alerts Issued 1115 quality alerts were issued between 2005 and 2015 Production No. Medicine Quality Alerts issued Regulatory agencies awareness Pharmaceutical Industries awareness
14 No. of Recalls per Marketing Authorisation Holder MAH No. Recalls Sandoz 15 Generis 13 B. Braun Labesfal GlaxoSmithKline Janssen 12 Baxter 10 Sanofi Teva Pharma 9 Laboratórios Basi Mylan Ratiopharm Roche Schering Plough Farma 8 MAH Grünenthal Jaba Pfizer Novartis Wynn Actavis Alter Bristol-Myers Hospira Octapharma Pierre Fabre ToLife UCB Pharma No. Recalls MAH Bayer Laboratórios Azevedos Pentafarma Ranbaxy Portugal Alexion Europe SAS Almirall Angelini Bluefish Farmacoquímica Baldacci Ferring Portuguesa Gilead Sciences Laboratório Medinfar Lundbeck Portugal Mallinckrodt Medical BV Tecnimede No. Recalls 4 3
15 No. Alerts issued Alerts Issued Infarmed 6 UK 6 Spain 6 France 5 Germany 4 EMA 4 Italy 4 Denmark 9 Other
16 No. of defects Quality Defect Origin Pharmaceutical Form Primary Packaging Secondary Packaging Packaging Regulatory Affairs Other N/A
17 Affected Medicinal Products by Pharmaceutical Form 36% 45% Oral Solids Liquids and Semi-solids Injectables 19%
18 Recall Causes / Type o Product recall causes: 1. Pharmaceutical Dosage Form 2. Packaging problems o Pharmaceutical Dosage Form 36 % Injectables 45 % Oral Solids Pharmaceutical Industry concern with product s quality 87% (338) Voluntary recalls Efficient detection of quality issues
19 Number of Batches 29 1 batch 2 batches 3 batches 4 batches All product batches
20 Time on the Market months 7% > 36 months 7% 0-6 months 17% months 8% months 18% 7-12 months 21% months 22%
21 AUTHORS Ana Teresa Reis Bruna Berardo Rui Loureiro o QUESTIONS?
22 THANK YOU!
EUROPEAN COMMISSION DIRECTORATE-GENERAL III INDUSTRY Industrial affairs III: Consumer goods industries Pharmaceuticals and Cosmetics
EUROPEAN COMMISSION DIRECTORATE-GENERAL III INDUSTRY Industrial affairs III: Consumer goods industries Pharmaceuticals and Cosmetics Community Basic Format for Manufacturing Authorisation Explanatory Notes
More informationPrincipals and dosage forms of pharmaceutics
Principals and dosage forms of pharmaceutics Part II. Semisolid dosage forms: ointments, creams, gels, pastes, suppositories, pessaries 2017 Dr. Farkas, Gyula Pharmaceutical Propedeutics Institute of Pharmaceutical
More informationList of nationally authorised medicinal products
5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline Procedure no.: PSUSA/00000477/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/00000017/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More information300 3PORTUGUESE 65M GLOBAL WHO WE ARE WE OFFER PORTUGUESE
WHO WE ARE PORTUGUESE WE OFFER Licensing out Contract Manufacturing Packaging Services EU Batch Release R&D Services Marketing & Distribution Medinfar is a fully integrated Pharmaceutical Company with
More informationGUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V) OCTOBER 2003
EUROPN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, implementation and legislation for consumer goods Pharmaceuticals : regulary framework and market authorisations Brussels, F2/AW D(2002)
More informationEUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, March 2018 SANTE-2017-11668 Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment
More informationLegal Supplement Part B Vol. 57, No. 6 18th January, NOTIFICATION NOTICE OF APPROVAL IN RESPECT OF NEW DRUGS
Legal Supplement Part B Vol. 57, No. 6 18th January, 2018 11 LEGAL NOTICE NO. 5 REPUBLIC OF TRINIDAD AND TOBAGO FOOD AND DRUGS ACT, CHAP. 30:01 NOTIFICATION NOTICE OF APPROVAL IN RESPECT OF NEW DRUGS ISSUED
More informationAssessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form
38 East and Central African Journal of Pharmaceutical Sciences Vol. 15 (2012) 38-46 Assessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form N.N.
More informationTHE CORPORATE REPUTATION OF PHARMA 2015 THE PERSPECTIVE OF 139 PATIENT GROUPS with an interest in DIABETES
THE CORPORATE REPUTATION OF PHARMA 2015 THE PERSPECTIVE OF 139 PATIENT GROUPS with an interest in DIABETES PUBLISHED AUGUST 2016 There is growing distrust of pharma in light of several recent and dramatic
More information<1151> Pharmaceutical Dosage Forms and <1152> Animal Drugs for Use in Animal Feeds
Pharmaceutical Dosage Forms and Animal Drugs for Use in Animal Feeds Will Brown Veterinary Drugs Stakeholder Forum February 19-20, 2014 Development of a Compendial Taxonomy and Glossary for
More informationSystemic and inhaled fluoroquinolones: risk of aortic aneurysm and dissection
Direct Healthcare Professional Communication 23 rd October 2018 Systemic and inhaled fluoroquinolones: risk of aortic aneurysm and dissection Dear Healthcare Professional, The Marketing Authorisation Holders
More informationPlease note that this draft Annex I will be updated to amend information on concerned products/mahs
22 March 2018 EMA/197481/2018 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, applicants, marketing authorisation holders in the member states for for omega-3
More informationMedication Administration. By: Carolyn McCune RN, BSN, MSN, CRNP
Medication Administration By: Carolyn McCune RN, BSN, MSN, CRNP Percutaneous Administration Medications application to the skin or mucus membranes Ointments, creams, powders, lotions, solutions into the
More informationDecentralised Procedure. Public Assessment Report. Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack
Decentralised Procedure Public Assessment Report Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack Memantin-ratiopharm Starterpackung 5 mg /10 mg /15 mg /20 mg Filmtabletten ;10 mg/20 mg Filmtabletten
More informationMEDICINES FOR SMOKING CESSATION: GLOBAL MARKETS. PHM154A September Anand Gijare Project Analyst ISBN:
MEDICINES FOR SMOKING CESSATION: GLOBAL MARKETS PHM154A September 2013 Anand Gijare Project Analyst ISBN: 1-56965-544-8 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 866-285-7215, 781-489-7301
More informationPHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION
PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION 1 PHARMACEUTICS Pharmaceutics is the science of dosage form design. The general area of study concerned with the formulation, manufacture, stability, and
More informationAward of Contracts without Competition December 2013
SERIVCES 2850 Open Text Opentext Web CMS Software Support 125,000.00 Business Services Organisation 2259 Lynas Cooked Pork (Lynas) 63,063.00 2703 Limavady Office Products 169,477.00 2817 Merck no 3 Nutritional
More informationFor External Use Only. Should neither be swallowed. Nor injected
For External Use Only Should neither be swallowed Nor injected Preparations which are applied to the skin. (Topical preparations) Preparations which are applied to the mucus membranes. Local effect Systemic
More informationMarketing authorisations granted in September 2012
PL 00037/0648 03/09/2012 ABBOTT LABORATORIES LIMITED LEVELANZ 250 MG FILM-COATED TABLETS LEVETIRACETAM 250 MILLIGRAMMES POM PL 00037/0649 03/09/2012 ABBOTT LABORATORIES LIMITED LEVELANZ 500 MG FILM-COATED
More informationINFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:
LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,
More informationMember State Marketing Authorisation Holder Invented Name Strength Pharmaceutical Route of administration
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1 Member State Marketing
More informationPalliative Coverage Drug Benefit Supplement
Palliative Coverage Drug Benefit Supplement Effective April 1, 2017 Inquiries should be directed to: Pharmacy Services Alberta Blue Cross 10009 108 Street NW Edmonton AB T5J 3C5 Telephone Number: (780)
More informationEUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, Draft Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment and information
More informationSuspected Defective Product Report
Defective Product Report Form European Medicines Agency Inspections Suspected Defective Product Report London, 9 February 2007 Doc. Ref. EMEA/INS/GMP/75464/2007 1. Origin of Report Shaded areas to be completed
More informationDECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Office of Consumer Protection and Food Safety Mauerstraße 39-42 10117 Berlin (Germany) DECENTRALISED PROCEDURE PUBLICLY AVAILABLE
More informationWITH APPLICATIONS TO : ; : GENERAL AND SPECIALTY AREAS
f Fourth Edition WITH APPLICATIONS TO : ; : GENERAL AND SPECIALTY AREAS Joyce LeFever Kee, RN, MS Associate Professor Emerita College of Health and Nursing Sciences University of Delaware Newark, Delaware
More information(Adopted by the Committee of Ministers on 19 January 2011 at the 1103rd meeting of the Ministers Deputies)
Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (Adopted by the Committee of Ministers on 19 January
More informationUS pharmaceutical market: trends, issues, forecast. Doug Long Vice President Industry Relations IMS Health
US pharmaceutical market: trends, issues, forecast Doug Long Vice President Industry Relations IMS Health 2006 Strategic management review The World Pharmaceutical Market All reproduction rights, quotations,
More informationOVERVIEW OF COMMENTS RECEIVED ON COMMUNITY HERBAL MONOGRAPH ON HAMAMELIS VIRGINIANA L., FOLIUM (EMEA/HMPC/114586/2008)
European Medicines Agency Evaluation of Medicines for Human Use London, 12 November 2009 Doc. Ref.: EMA/HMPC/280729/2009 OVERVIEW OF COMMENTS RECEIVED ON COMMUNITY HERBAL MONOGRAPH ON HAMAMELIS VIRGINIANA
More informationUpdate on the revision of the new package leaflet (PL) template. An agency of the European Union
Update on the revision of the new package leaflet (PL) template An agency of the European Union Contents Regulatory background New QRD package leaflet template -Origin - Contents and structure 2 Regulatory
More informationCooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far
Cooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far Ana Boban, MPharm. Agency for Medicinal Product and Medical Devices of Croatia Dubrovnik, 06.05.2013.
More informationINFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:
LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,
More informationIntroduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D
Introduction to 1 Pharmacokinetics University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 2 Learning objectives Understand compartment models and how they effects
More informationPackage leaflet: Information for the User Clarityn 10 mg tablets Loratadine
Package leaflet: Information for the User Clarityn 10 mg tablets Loratadine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always
More informationWhat's Important to Consider When Developing a Complex Generic Drug? September 5, 2018
What's Important to Consider When Developing a Complex Generic Drug? September 5, 2018 Session Description FDA has provided drug manufacturers tools to assist the development of complex generic drugs to
More informationhttps://www.indiamart.com/medisoftpharma/
+91-8048558363 Medi Soft Pharma https://www.indiamart.com/medisoftpharma/ Medi Soft Pharma is a leading Trader and Supplier of Soft Gelatin Capsules, Pharmaceutical Tablets, Pharmaceutical Capsules, Cream
More informationFrequently asked questions
13 February 2017 EMA/527628/2011 Rev. 1 Directorate This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question
More informationRoutes of drug administration
Routes of drug administration Definition:- A route of administration in pharmacy is the path by which a drug is taken into the body. Classification:- The various routes of administrations are classified
More information67 Years of Leadership in Pharmacy. A Journey of Continuous Improvement
67 Years of Leadership in Pharmacy A Journey of Continuous Improvement September 2012 GALENIKA A.D. IS The only Serbian state-owned pharmaceutical company Manufacturer of generic drugs its manufacturing
More information905 UNIFORMITY OF DOSAGE UNITS
Change to read: 905 UNIFORMITY OF DOSAGE UNITS [ NOTE In this chapter, unit and dosage unit are synonymous. ] To ensure the consistency of dosage units, each unit in a batch should have a drug substance
More informationList of nationally authorised medicinal products
11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/00000494/201506 30 Churchill
More informationFree Trial Future Generics Database
API Atazanavir Structure O 2 C N H O H N OH N NH O N H N CO2 Brand REYATAZ (BMS : World) Indication Antiviral Originator Ciba-Geigy (Novartis) Developer / Licensee BMS Comments Atazanavir is an azapeptide
More informationCompletion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation
Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation Workshop on Paediatric Formulations For Assessors in National Regulatory Agencies
More informationPRAC recommendations on signals
5 November 2013 EMA/PRAC/625262/2013 Pharmacovigilance Risk Assessment Committee Adopted at the PRAC meeting of 7-10 October 2013 This document provides an overview of the recommendations adopted by the
More informationPublic Assessment Report. Scientific discussion. Desloratadine Lek 5 mg film-coated tablets. (Desloratadine) DK/H/2041/001/DC.
Public Assessment Report Scientific discussion Desloratadine Lek 5 mg film-coated tablets (Desloratadine) DK/H/2041/001/DC 29 February 2016 This module reflects the scientific discussion for the approval
More informationDisclosure. Objectives. Objectives. Introduction. Introduction. Non-Sterile Compounding/Calculations
49th Annual Meeting Non-Sterile Compounding/ Sunil Jambhekar, B. Pharm., M.S., Ph.D Professor, Pharmaceutical Sciences LECOM Bradenton, School of Pharmacy Bradenton, FL 34211 Disclosure I do not have a
More informationLIQUID PREPARATIONS FOR ORAL USE. Final text for addition to The International Pharmacopoeia (November 2007)
November 2007 LIQUID PREPARATIONS FOR ORAL USE Final text for addition to The International Pharmacopoeia (November 2007) This monograph was adopted at the Forty-second WHO Expert Committee on Specifications
More informationOpinion 8 January 2014
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 8 January 2014 WYSTAMM 1 mg/ml, oral solution 120 ml vial with syringe for oral administration (CIP: 34009 222 560
More informationChanging practice to support service delivery
Nurse and Midwife Medicinal Product Prescribing Toolkit Authorised Medicinal Products, Off-label Prescription and Exempt Medicinal Products Toolkit Changing practice to support service delivery Introduction
More informationPRAC recommendations on signals
3 October 2013 EMA/PRAC/550442/2013 Pharmacovigilance Risk Assessment Committee Adopted at the PRAC meeting of 2-5 September 2013 This document provides an overview of the recommendations adopted by the
More informationANNEX I LIST OF THE NAMES OF THE MEDICINAL PRODUCTS, MARKETING AUTHORISATION HOLDERS, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION,
ANNEX I LIST OF THE NAMES OF THE MEDICINAL PRODUCTS, MARKETING AUTHORISATION HOLDERS, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATE 1 SERTINDOLE
More informationEuropean Medicines Agency decision
EMA/662557/2012 European Medicines Agency decision P/0254/2012 of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for riociguat, (EMEA- 000718-PIP01-09-M02)
More informationA Layperson s Guide to Pediatric Formulation Development
A Layperson s Guide to Pediatric Formulation Development Karen C. Thompson PhD Senior Principal Scientist Preclinical Development Merck Research Laboratory West Point, Pennsylvania Martin J. Gartland PhD
More informationInternational Pharmaceutical Aerosol Consortium on Regulation and Science
International Pharmaceutical Aerosol Consortium on Regulation and Science 1500 K Street NW Washington DC 20005 Telephone +1 202 230 5607 Fax +1 202 842 8465 Email info@ipacrs.org Web www.ipacrs.org Submitted
More informationArtemether 20mg/lumefantrine 120mg WHOPAR part 5 12/2011 Dispersible tablets (Novartis Pharma AG), MA069 LABELLING. Page 1 of 6
LABELLING Page 1 of 6 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON OF UNIT PACK 1. NAME OF THE MEDICINAL PRODUCT Coartem Dispersible Artemether/Lumefantrine 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artemether
More informationUnited Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE
United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Thyforon
More informationEU PSUR Work Sharing Summary Assessment Report AFLAMIN (aceclofenac) HU/H/PSUR/0030/002 HU
P-RMS EU PSUR Work Sharing Summary Assessment Report AFLAMIN (aceclofenac) HU/H/PSUR/0030/002 HU Invented name of the medicinal product(s) INN (or common name) of the active substance(s) MAHs whose PSURs
More informationREGULATORY UPDATES: APPROVAL, DENIALS AND AGREEMENTS REGULATORY UPDATES: APPROVAL, (CONTINUED)... 38
CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED
More informationAllergan s Blephamide (sulfacetamide/prednisolone ophthalmic ointment) 10%/0.2%, 3.5Gm tube
Allergan s Blephamide (sulfacetamide/prednisolone ophthalmic ointment) 10%/0.2%, 3.5Gm tube On Aug. 24, 2015, Allergan recalled three lots (86258 expires September 2017, 87189 December 2017 and 87514 February
More informationT Pharmaceutics-I (Dispensing Pharmacy)
T.1.1.1. Pharmaceutics-I (Dispensing Pharmacy) Dosage Forms 1. Define Dosage Forms. Give classification. 2. Define: Creams, Pastes, Gargles, Elixirs, 3. Give Classification of dosage form. Prescription
More informationAntifungal Drugs Market by Drug Type [Echinocandins {Caspofungin, Micafungin, Anidulafungin and Others}, Azoles {Imidazoles, Voricanazole, Thiazoles
Antifungal Drugs Market by Drug Type [Echinocandins {Caspofungin, Micafungin, Anidulafungin and Others}, Azoles {Imidazoles, Voricanazole, Thiazoles and Others}, Polyenes {Amphotericin B, Candicidin, Hamycin,
More informationMedication errors. Impact of medication error guidance and regulation on drug-device combination products. June 2017 Dan Wozinski
Medication errors Impact of medication error guidance and regulation on drug-device combination products June 2017 Dan Wozinski Agenda Understand the management of medication errors within global requirements
More informationDraft Guideline on Pharmaceutical Development of Medicines for Paediatric Use. C. Nopitsch-Mai London 1
Draft Guideline on Pharmaceutical Development of Medicines for Paediatric Use C. Nopitsch-Mai 08-11-2011 London 1 Content - Background - Pharmaceutical Problems - Scope - Characterisation of the Active
More informationPublic Assessment Report. Scientific discussion. Elisox 50 microgram/actuation, nasal spray, suspension. (mometasone furoate) NL/H/2672/001/DC
Public Assessment Report Scientific discussion Elisox 50 microgram/actuation, nasal spray, suspension (mometasone furoate) NL/H/2672/001/DC Date: 24 September 2014 This module reflects the scientific discussion
More informationEurope Ginseng Market Report 2016
Published on Market Research Reports Inc. (https://www.marketresearchreports.com) Home > Europe Ginseng Market Report 2016 Europe Ginseng Market Report 2016 Publication ID: QYR12167206 Publication December
More informationEXCIPIENTS FOR PHARMACEUTICALS
EXCIPIENTS FOR PHARMACEUTICALS SCOPE OF APPLICATION IOI Oleo GmbH PHARMA Contents Regulatory background for the IOI Oleo site in Witten: Regulatory background for the IOI Oleo site in Witten... 3 Injectables
More informationBRITISH PHARMACOPOEIA COMMISSION EXPERT ADVISORY GROUP: MEDICINAL CHEMICALS 3 SUMMARY MINUTES
BRITISH PHARMACOPOEIA COMMISSION EXPERT ADVISORY GROUP: MEDICINAL CHEMICALS 3 SUMMARY MINUTES A meeting of Expert Advisory Group (EAG): Medicinal Chemicals 3 (MC3) was held at 151 Buckingham Palace Road,
More informationAmoxicillin 40 mg Clavulanic acid 10 mg. Clavulanic acid 10 mg. Clavulanic acid 10 mg. Clavulanic acid 10 mg
Annex I List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of applicant/marketing authorisation holder in the member states 1/10 Member State EU/EEA
More informationBlanka Hirschlerová. EDQM CEP conference Prague, Czech Republic
1 Experience with CEPs from a European regulatory authority perspective Blanka Hirschlerová EDQM CEP conference Prague, Czech Republic 2012 STATE INSTITUTE FOR DRUG CONTROL Agenda 2 Agenda Introduction
More informationIMDG CODE Poison Treatment Chest
2018 IMDG CODE Poison Treatment Chest This document contains the complete list of medicines and medical supplies for the vessels poison treatment chest and is based on the IMDG code international maritime
More informationCommission. Product. Notification. Decision. Issued 2 / affected 3 amended on. 18/08/2017 SmPC and PL. 24/05/2017 SmPC, Annex II, Labelling
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
More informationThomas Karlsson & Esa Österberg National Research and Development Centre for Welfare and Health Alcohol and Drug Research Group P.O.
European Comparative Alcohol Study Europe and Alcohol Policy Thomas Karlsson & Esa Österberg National Research and Development Centre for Welfare and Health Alcohol and Drug Research Group P.O.BO 220 FIN-00531
More informationCONTRACT UPDATE July 20, 2012
CONTRACT UP July 20, 2012 ADDS AMPHETAMINE SALT MIX ER CAPSULE 10MG 100 002-3059-11 $422.45 ACTAVIS ADDS AMPHETAMINE SALT MIX ER CAPSULE 20MG 100 002-3060-11 $422.45 ACTAVIS ADDS AMPHETAMINE SALT MIX ER
More informationCOPD and Asthma Devices Market by Inhalers Type (Drug powder, Metered Dose, Soft Mist), Nebulizers (Compressor, Ultrasonic, Mesh) - Global
COPD and Asthma Devices Market by Inhalers Type (Drug powder, Metered Dose, Soft Mist), Nebulizers (Compressor, Ultrasonic, Mesh) - Global Opportunity Analysis and Industry Forecasts, 2015-2022 COPD and
More informationSummary Public Assessment Report. Generics. Etoricoxib Aurobindo. 30 mg, 60 mg, 90 mg, 120 mg Film-coated tablet (Etoricoxib) PT/H/1603/ /DC
Summary Public Assessment Report Generics 30 mg, 60 mg, 90 mg, 120 mg Film-coated tablet (Etoricoxib) Date: 08-03-2017 Summary PAR Generics 1/10 Summary Public Assessment Report Generics 30 mg, 60 mg,
More informationIMDG CODE Poison Treatment Chest
2017 IMDG CODE Poison Treatment Chest This document contains the complete list of medicines and medical supplies for the vessels poison treatment chest and is based on the IMDG code international maritime
More informationList of nationally authorised medicinal products
29 November 2018 EMA/880324/2018 Human Medicines Evaluation Division Active substance: enalapril Procedure no.: PSUSA/00001211/201803 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationInformation for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs CADUET (amlodipine besylate/atorvastatin calcium) tablets This list does not imply that the products on this chart are interchangeable or have
More informationAnnex I. Article 107i of Directive 2001/83/EC. Procedure number: EMEA/H/A-107i/ March 2013 EMA/147828/2013 Patient Health Protection
07 March 2013 EMA/147828/2013 Patient Health Protection Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisation holders in the member states
More informationAllopathic Medicines and Types
Campaign for Awareness on Responsible Use of Medicines Allopathic Medicines and Types What are MEDICINES? ü Medicines are any substances that are meant to change the way your body deals with an illness
More informationMEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA
MEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA Document No.: MCA/NSG/17/11/01 Date of Adoption: 20 th January 2017 Date of Issue: 25 th July 2017
More informationLessons learned on the review of the labelling of pandemic vaccines
Lessons learned on the review of the labelling of pandemic vaccines Presented on 29-30 April 2015 by Thomas Girard Regulatory Affairs Officer Regulatory Affairs Office An agency of the European Union Problems
More informationEUROPEAN AEROSOL PRODUCTION
Introduction EUROPEAN AEROSOL PRODUCTION 2017 EU European production Market share Production by segment Worldwide production / FEA, 2018. 1 INTRODUCTION More than 5.7 billion over 16 billion units globally
More informationSummary Public Assessment Report. Generics. Amiodarona Aurobindo. 200 mg, Tablets. (Amiodarone hydrochloride) PT/H/1444/001/DC
Summary Public Assessment Report Generics 200 mg, Tablets (Amiodarone hydrochloride) Summary PAR Generics 1/9 Summary Public Assessment Report Generics 200 mg, Tablets Amiodarone hydrochloride 200 mg,
More informationCHAPTER FOUR: UPDATE ON THE AIDS PANDEMIC TABLE 2 MILESTONES IN THE HISTORY OF HIV/AIDS TABLE 2 (CONTINUED) REGIONAL OVERVIEW...
CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THE STUDY... 1 SCOPE OF REPORT... 1 MARKET ANALYSES AND FORECASTS... 2 INTENDED AUDIENCE... 2 INFORMATION SOURCES... 2 ANALYST
More informationCHAPTER ONE: EXECUTIVE SUMMARY
CHAPTER ONE: EXECUTIVE SUMMARY Introduction Scope and Methodology Total Size and Growth of the Market Issues and Trends Affecting Market Leading Competitors CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS
More informationInformation for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs LIPITOR (atorvastatin calcium) tablets This list does not imply that the products on this chart are interchangeable or have the same efficacy or
More informationCHAPTER ONE: EXECUTIVE SUMMARY
CHAPTER ONE: EXECUTIVE SUMMARY Introduction Scope and Methodology Size and Growth of the Market Issues and trends Leading Competitors CHAPTER TWO: INTRODUCTION AND OVERVIEW Definition of Pain Magnitude
More informationList of nationally authorised medicinal products
30 November 2017 EMA/817351/2017 Human Medicines Evaluation Division Active substance: Lidocaine / prilocaine (not centrally authorised product) Procedure no.: PSUSA/00001867/201703 30 Churchill Place
More informationJohn Ansell President, John Ansell Consultancy Thame, UK
Rutgers University Monday 29 September 2014 Co Eli Lilly Bristol-Myers Squibb Novo Nordisk Pfizer GlaxoSmithKline Takeda Sanofi Novartis AstraZeneca Roche Otsuka Johnson & Johnson Otsuka Abbott Teva 1
More informationPUBLIC ASSESSMENT REPORT Scientific Discussion
Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion Tramadol hydrochloride + paracetamol 37.5 mg-325 mg Grünenthal film coated tablets Bonoc
More informationINTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE
RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended for a restricted
More informationLondon, 24 January 2000 EMEA/1952/00
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 24 January 2000 EMEA/1952/00 EMEA PUBLIC STATEMENT ON ABACAVIR (Ziagen) IMPORTANT SAFETY INFORMATION
More informationUNIT I EVOLUTION OF THE PHARMACY
Contents UNIT I EVOLUTION OF THE PHARMACY........................ 1 Chapter 1 Pharmacy History................................................. 3 Egyptian History 4 Greek Influence 4 British Apothecaries
More informationMEDICINES SHORTAGES PGEU GPUE. John Chave - Secretary general. Pharmaceutical Group of European Union Groupement Pharmaceutique de l Union Européenne
MEDICINES SHORTAGES John Chave - Secretary general Members: Professional Bodies & Pharmacists Associations 2013: 32 Countries Austria Belgium Bulgaria Bosnia Herzegovina Cyprus Czech Rep Denmark Estonia
More informationANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
European Medicines Agency Veterinary Medicines and Inspections ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION
More informationRecommended comparator products: Medicines for HIV/AIDS and related diseases
Recommended comparator products: Medicines for HIV/AIDS and related diseases Comparator products should be purchased from a well regulated market with stringent regulatory authority 1. Invited medicinal
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF VETERINARY MEDICINAL PRODUCT HESKA PERIOceutic Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose contains: 2.1 Active substance Doxycycline
More information