Patient s awareness and education with respect to the safe and appropriate use of medicines with special attention to OTC medicines Regulatory view
|
|
- Dorothy Murphy
- 6 years ago
- Views:
Transcription
1 s awareness and education with respect to the safe and appropriate use of medicines with special attention to OTC medicines Regulatory view EDQM Expert workshop: OTC medicines: The role of good classification practices promoting medication safety and accessibility in Europe Zagreb November 2014 Presented by: Zaide Frias Head of Human Medicines Research & Development Support Division (ad interim) An agency of the European Union
2 Network of European patients / consumers organisations 36 eligible organisations by Q2/ Building the foundation of the interaction between EMA and patients 2006 Framework of interaction with patient and consumer organisations Real life experience of patients is now routinely embedded in regulatory output Clinical practice is becoming an important element of the regulatory process 1
3 involvement in EMA activities involvement in SAGs Public Consultation Orphan Designation representation in COMP = 2 2 Scientific Advice protocol Assistance Involvement Paediatric Investigation Plan Evaluation CHMP representation in PDCO = 3 representation in PRAC = 1 representation in CAT = 2 MA and Product Information involvement in review Market and patient access PA
4 involvement in EMA activities 551 interactions with patients in 2013 s systematically review package leaflets and EPAR summaries 3
5 Risk/Benefit of Non-prescription Additional benefits: rapid access, reduced absences efficient use of doctor s time healthcare budgets Well known safety profile 4
6 Risk/Benefit of Non-prescription A different perspective R/B known in Rx setting only Masking underlying conditions Self-assessment Understanding CI/warnings/ Role of pharmacist Perception that is safer Incorrect use 5
7 EMA - Centrally authorised switches orlistat Suma- triptan Esomeprazol Pantoprazol IBU/ DiPH sildena fil alli Nexium control Controloc Control 6
8 Nexium Control 20 mg (OTC) Short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Section 4.2: treatment: up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor Nexium 10mg granules, 20mg, 40mg tablets, 40 mg iv (Rx) Gastroesophageal Reflux Disease (GERD); Treatment of erosive reflux esophagitis; Prolonged treatment after i.v. induced; Prevention of rebleeding of peptic ulcers Treatment of Zollinger Ellison Syndrome Pack sizes: up to 140 tablets Pack sizes 7, 14 tablets 7
9 alli 60mg (OTC) Weight loss in adults who are overweight (body mass index, BMI, 28 kg/m 2 ) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. CIs: under 18s, pregnant / breastfeeding, concomitant medication Take special care with alli: diabetes, renal impairment Interactions : ciclosporine, oral anticoagulants, oral contraceptives, Levothyroxine, fat soluble vitamins, amiodarone, etc. Xenical 120mg (Rx) Indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors. 8
10 Pantozol Control 20mg (OTC) 1) Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. Section 4.2: The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Pack sizes: 7,14 Pantozol 20 mg (Rx) 1) For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). 2) For long-term management and prevention of relapse in reflux oesophagitis. 3) Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4). Pack sizes:14,15, 28, 30, 56, 60, 98,
11 Challenges ahead Identify when regulators should get views from individual versus patient community Develop means to identify and manage differences of view between patients and between patients and other stakeholders Ensure that patients and healthcare professionals views come from independent sources Research how to collect and use the wealth of information available from patients and healthcare professionals in post-marketing phase 10
AESGP views. Johannes Koch, Head of European Policy and International Affairs German Medicines Manufacturers' Association BAH. Who is AESGP?
The international Generic Drug Regulators Programme (IGDRP): an initiative to further strengthen collaboration, promote regulatory convergence and improve worksharing at a worldwide level EDQM premises
More informationOVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LOSEC AND ASSOCIATED NAMES (SEE ANNEX I)
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA 21 SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE
More informationRpts. GENERAL General Schedule (Code GE)
Pantoprazole 20mg Name, Restriction, Manner of administration and form Pantoprazole 20mg enteric tablet, 30 (8399C) Gastro-oesophageal reflux disease Name, Restriction, Manner of administration and form
More informationThe European Medicines Agency (EMA)
The European Medicines Agency (EMA) Nathalie Bere and Maria Mavris Public Engagement Department EMA Training Day 21 November, 2017 An agency of the European Union What is the European Medicines Agency
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 informationThe European Medicines Agency (EMA)
The European Medicines Agency (EMA) Nathalie Bere Patient Relations Public Engagement Department EMA Training Day 29 November, 2016 An agency of the European Union What is the European Medicines Agency
More informationDrug Class Monograph
Drug Class Monograph Class: Proton Pump Inhibitors Drugs: Aciphex Sprinkle (rabeprazole), Dexilant (dexlansoprazole), Lansoprazole, Nexium (esomeprazole capsule, esomeprazole granules), Omeprazole, Pantoprazole,
More informationRpts. GENERAL General Schedule (Code GE) Program Prescriber type: Dental Medical Practitioners Nurse practitioners Optometrists Midwives
Esomeprazole 20mg Name, Restriction, Manner of esomeprazole 20 mg enteric tablet, 30 (8886Q) (029W) Gastric ulcer Peptic ulcer Treatment Phase: Initial treatment The therapy must be for initial treatment
More informationSummary of the risk management plan (RMP) for Synjardy (empagliflozin / metformin)
EMA/217413/2015 Summary of the risk management plan (RMP) for Synjardy (empagliflozin / metformin) This is a summary of the risk management plan (RMP) for Synjardy, which details the measures to be taken
More informationZantac for stomach ulcers
P ford residence southampton, ny Zantac for stomach ulcers Information on the drug ranitidine (Zantac) used in and duodenal ulcers, heartburn, esophagitis, and Zollinger Ellison Syndrome. Side. But with
More informationPatient Group Direction for the Supply of Orlistat (Xenical) from Designated Community Pharmacies
Patient Group Direction for the Supply of Orlistat (Xenical) from Designated Community Pharmacies Written by: Sheila Brown, Prescribing Adviser Date: September 2006 Reviewed by: Date: Ratified by: East
More informationProton Pump Inhibitors
Market DC Proton Pump Inhibitors Override(s) Prior Authorization Quantity Limit** Approval Duration Preferred PPI: No Prior Authorization required Preferred PPI quantity override: Lifetime Non-Preferred
More informationPATIENT GROUP DIRECTION FOR THE SUPPLY OF ORLISTAT BY COMMUNITY PHARMACISTS
PATIENT GROUP DIRECTION FOR THE SUPPLY OF ORLISTAT BY COMMUNITY PHARMACISTS November 2009 Orlistat PGD Page 1 of 7 Rationale Patient Group Direction For Supply Of Orlistat By Community Pharmacists To enable
More informationDifference between omeprazole and omeprazole delayed release
Cari untuk: Cari Cari Difference between omeprazole and omeprazole delayed release 7-2-2018 Easy to read patient leaflet for Omeprazole Delayed-Release Capsules. Includes indications, proper use, special
More informationSummary of the risk management plan (RMP) for Zykadia (ceritinib)
EMA/154751/2015 Summary of the risk management plan (RMP) for Zykadia (ceritinib) This is a summary of the risk management plan (RMP) for Zykadia, which details the measures to be taken in order to ensure
More informationProton Pump Inhibitors. Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.01 Subject: Proton Pump Inhibitors Page: 1 of 6 Last Review Date: June 24, 2015 Proton Pump Inhibitors
More informationEU RISK MANAGEMENT PLAN (EU RMP)
EU RISK MANAGEMENT PLAN (EU RMP) Active substance(s) (INN or common name): Esomeprazole Pharmaco-therapeutic group (ATC Code): A02B C05 Name of Marketing Authorisation Holder or Applicant: Strength and
More informationDeveloping Evidence-Based Best Practices for the Prescribing and Use of Proton Pump Inhibitors in Canada
Developing Evidence-Based Best Practices for the Prescribing and Use of Proton Pump Inhibitors in Canada Presented by: Sumeet R. Singh, COMPUS April 4, 2006 Background COMPUS Objective: To identify and
More informationProton Pump Inhibitors Drug Class Prior Authorization Protocol
Proton Pump Inhibitors Drug Class Prior Authorization Protocol Line of Business: Medi-Cal P&T Approval Date: November 15, 2017 Effective Date: January 1, 2018 This policy has been developed through review
More informationSummary of the risk management plan (RMP) for Olysio (simeprevir)
EMA/191406/2014 Summary of the risk management plan (RMP) for Olysio (simeprevir) This is a summary of the risk management plan (RMP) for Olysio, which details the measures to be taken in order to ensure
More informationOmeprazole 10mg. Name, Restriction, Manner of administration and form OMEPRAZOLE omeprazole 10 mg enteric tablet, 30 (8332M) Max. Qty.
Omeprazole 10mg Name, Restriction, Manner of administration and form omeprazole 10 mg enteric tablet, 30 (8332M) Gastro-oesophageal reflux disease Name, Restriction, Manner of administration and form omeprazole
More informationProton Pump Inhibitors (PPIs) (Sherwood Employer Group)
Proton Pump Inhibitors (PPIs) (Sherwood Employer Group) BCBSKS will review Prior Authorization requests Prior Authorization Form: https://www.bcbsks.com/customerservice/forms/pdf/priorauth-6058ks-st-ippi.pdf
More informationPATIENT INFORMATION LEAFLET PEPLOC RANGE
Scheduling Status: S4 Proprietary name, Strength and Pharmaceutical Form: Peploc 20 mg tablets Peploc 40 mg tablets Read all of this leaflet carefully before using PEPLOC 20 mg or 40 mg Keep this leaflet.
More informationNexium 24HR. Tools and information for you and your pharmacy team NOW OTC FOR FREQUENT HEARTBURN. Consumer Healthcare Pfizer Inc.
NOW OTC FOR FREQUENT HEARTBURN w e N Nexium 24HR P H A R M A S S I S T K I T Tools and information for you and your pharmacy team 2014 Pfizer Inc. NXM041468 05/14 Q: What is the indication for Nexium 24HR
More informationAll Indiana Medicaid Prescribers and Pharmacy Providers
P R O V I D E R B U L L E T I N BT200148 NOVEMBER 28, 2001 To: All Indiana Medicaid Prescribers and Pharmacy Providers Subject: Note: The information in this bulletin regarding prior authorization payment
More informationPharmacy Coverage Guidelines are subject to change as new information becomes available.
PROTON PUMP INHIBITORS, NON-PREFERRED FORMS: ACIPHEX (rabeprazole sodium EC) oral tablet ACIPHEX SPRINKLE (rabeprazole sodium DR) oral capsule ESOMEPRAZOLE STRONTIUM (esomeprazole strontium DR) oral capsule
More informationSummary of the risk management plan (RMP) for Vokanamet (canagliflozin / metformin)
EMA/137565/2014 Summary of the risk management plan (RMP) for Vokanamet (canagliflozin / metformin) This is a summary of the risk management plan (RMP) for Vokanamet, which details the measures to be taken
More informationCOMPUS OPTIMAL THERAPY REPORT. Supporting Informed Decisions. À l appui des décisions éclairées
OPTIMAL THERAPY REPORT COMPUS Volume 1, Issue 5 March 2007 Current Practice Analysis Report for the Prescribing and Use of Proton Pump Inhibitors (PPIs) Supporting Informed Decisions À l appui des décisions
More informationH o w d o e a c t. y o u r a c i
H o w d o e a c t p a n t o p r a b r e a k d y o u r a c i Pantoprazole Sodium is the sodium salt form of a substituted benzimidazole with proton pump inhibitor activity. Pantoprazole is a lipophilic,
More informationProton Pump Inhibitors. Description. Section: Prescription Drugs Effective Date: July 1, 2014
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.09.01 Subject: Proton Pump Inhibitors Page: 1 of 7 Last Review Date: June 12, 2014 Proton Pump Inhibitors
More informationMEDICATION GUIDE Lansoprazole Delayed-Release Capsules, USP
MEDICATION GUIDE Lansoprazole Delayed-Release Capsules, USP Read this Medication Guide before you start taking lansoprazole delayed-release capsules and each time you get a refill. There may be new information.
More informationWorkshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation
Dr. Anja Holm Chair of CVMP, EMA Danish Medicines Agency Copenhagen, DK - Denmark anh@dkma.dk Overview of existing structures relevant for Veterinary Products Regional Structures: Europe European Medicine
More informationRegulatory update on guidelines relevant to paediatric formulations
Regulatory update on guidelines relevant to paediatric formulations Workshop on Paediatric Formulations II London, 8 November 2011 Presented by: Piotr Kozarewicz Scientific Administrator Quality of Medicines
More informationPRESCRIBING SUPPORT TEAM AUDIT: PROTON PUMP INHIBITOR PRESCRIBING REVIEW
PRESCRIBING SUPPORT TEAM AUDIT: PROTON PUMP INHIBITOR PRESCRIBING REVIEW DATE OF AUTHORISATION: AUTHORISING GP: PRESCRIBING SUPPORT TECHNICIAN: SUMMARY Dyspepsia refers to a broad range of symptoms related
More informationSummary of the risk management plan (RMP) for Duloxetine Lilly (duloxetine)
EMA/674705/2014 Summary of the risk management plan (RMP) for Duloxetine Lilly (duloxetine) This is a summary of the risk management plan (RMP) for Duloxetine Lilly which details the measures to be taken
More informationSummary of the risk management plan (RMP) for Raxone (idebenone)
EMA/467186/2015 Summary of the risk management plan (RMP) for Raxone (idebenone) This is a summary of the risk management plan (RMP) for Raxone, which details the measures to be taken in order to ensure
More informationHerbal summaries for the public
Herbal summaries for the public Involvement of PCOs in preparation of herbal summaries Federica Castellani Medical Information Sector, European Medicines Agency An agency of the European Union Overview
More informationPPIs: Good or Bad? 1. Basics of PPIs. Gastric Acid Basics. Outline. Gastric Acid Basics. Proton Pump Inhibitors (PPI)
Outline Quick basics on Proton Pump Inhibitors (PPIs) PPIs: Good or Bad? What are potential risks of PPI therapy? How to approach your patients American Gastroenterology Association (AGA) recommendations
More informationSummary of the risk management plan (RMP) for Oncaspar (pegaspargase)
EMA/829065/2015 Summary of the risk management plan (RMP) for Oncaspar (pegaspargase) This is a summary of the risk management plan (RMP) for Oncaspar, which details the measures to be taken in order to
More informationSummary of the risk management plan (RMP) for Genvoya (elvitegravir/ cobicistat/ emtricitabine / tenofovir alafenamide)
EMA/661227/2015 Summary of the risk management plan (RMP) for Genvoya (elvitegravir/ cobicistat/ emtricitabine / tenofovir alafenamide) This is a summary of the risk management plan (RMP) for Genvoya,
More informationlong term use Nexium Nexium
NEXIUM 40 mg Tablets - Summary of Product Characteristics (SPC) by AstraZeneca Pharmaceuticals (Ireland) DAC. Nexium 20mg, 40mg Tablets - Patient Information Leaflet (PIL) by AstraZeneca UK Limited. Information
More informationSummary of the risk management plan (RMP) for Ebymect (dapagliflozin / metformin)
EMA/672415/2015 Summary of the risk management plan (RMP) for Ebymect (dapagliflozin / metformin) This is a summary of the risk management plan (RMP) for Ebymect, which details the measures to be taken
More informationResearch Topics. ENCePP Plenary Survey (April 2011) An agency of the European Union
Research Topics ENCePP Plenary Survey (April 2011) An agency of the European Union Q: Can you suggest any research topics that you would like to see included in public funding programmes? More than 40
More informationWORK PLAN FOR THE EFFICACY WORKING PARTY (EWP) CHAIRPERSON: Barbara van Zwieten-Boot
European Medicines Agency London, 17 December 2009 EMA/CHMP/EWP/248088/2009 Rev. 1 WORK PLAN FOR THE EFFICACY WORKING PARTY (EWP) 2010 CHAIRPERSON: Barbara van Zwieten-Boot 1. MEETINGS SCHEDULED FOR 2010
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER. EASOFEN MAX STRENGTH 400mg FILM-COATED TABLETS. Ibuprofen
PACKAGE LEAFLET: INFORMATION FOR THE USER EASOFEN MAX STRENGTH 400mg FILM-COATED TABLETS Ibuprofen Read all of this leaflet carefully before you start taking Easofen Max Strength Tablets because it contains
More informationMEDICATION GUIDE. Rabeprazole Sodium Delayed-Release Tablets Rx Only
MEDICATION GUIDE Rabeprazole Sodium Delayed-Release Tablets Rx Only Read the Medication Guide that comes with rabeprazole sodium delayed-release tablets before you start taking it and each time you get
More informationMEDICATION GUIDE. PREVACID can have other serious side effects. See What are the possible side effects of PREVACID?
Page 33 of 39 MEDICATION GUIDE PREVACID (prev-a-sid) (lansoprazole) Delayed-Release Capsules and PREVACID SoluTab (prev-a-sid sol-u-tab) (lansoprazole) Delayed-Release Orally Disintegrating Tablets Read
More informationREAD THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. rabeprazole sodium tablets
READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Pr RABEPRAZOLE EC rabeprazole sodium tablets Read this carefully before you start taking RABEPRAZOLE EC and each time
More informationNEXIUM INTRAVENOUS esomeprazole sodium
NEXIUM INTRAVENOUS esomeprazole sodium Consumer Medicine Information What is in this leaflet This leaflet answers some of the common questions people ask about NEXIUM Intravenous (IV). It does not contain
More informationANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES 1 Member State EU/EEA Austria Denmark Finland France Germany
More informationHow is the introduction of a new medicine regulated in the UK?
Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone (idebenone) and the Early Access to Medicines Scheme in the UK (EAMS 46555/0001) A medicine called Raxone, which
More informationThe Paediatric Committee (PDCO)
www.eurordis.org The Paediatric Committee (PDCO) Fernando de Andres-Trelles (UCM, PDCO, AEMPS) Barcelona, June 2013 1 Some of the slides based on EMA sources, gratefully acknowledged* but opinions are
More informationInformation provided to Duchenne muscular dystrophy patient organisations regarding Raxone
Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone (idebenone) and the Early Access to Medicines Scheme in the UK (EAMS 46555/0001) April 26 th 2018 Raxone tablets
More informationSummary of the risk management plan (RMP) for Wakix (pitolisant)
EMA/794885/2015 Summary of the risk management plan (RMP) for Wakix (pitolisant) This is a summary of the risk management plan (RMP) for Wakix, which details the measures to be taken in order to ensure
More informationSummary of the risk management plan (RMP) for Scenesse (afamelanotide)
EMA/692496/2014 Summary of the risk management plan (RMP) for Scenesse (afamelanotide) This is a summary of the risk management plan (RMP) for Scenesse, which details the measures to be taken in order
More informationMEDICATION GUIDE Lansoprazole (lan-so-pruh-zole) Delayed-release Capsules, USP
MEDICATION GUIDE Lansoprazole (lan-so-pruh-zole) Delayed-release Capsules, USP Read this Medication Guide before you start taking lansoprazole delayed-release capsules and each time you get a refill. There
More informationSummary of the risk management plan (RMP) for Rezolsta (darunavir / cobicistat)
EMA/608280/2014 Summary of the risk management plan (RMP) for Rezolsta (darunavir / cobicistat) This is a summary of the risk management plan (RMP) for Rezolsta, which details the measures to be taken
More informationSummary of the risk management plan (RMP) for Kyprolis (carfilzomib)
EMA/639793/2015 Summary of the risk management plan (RMP) for Kyprolis (carfilzomib) This is a summary of the risk management plan (RMP) for Kyprolis, which details the measures to be taken in order to
More informationSummary of the risk management plan (RMP) for Clopidogrel/Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid)
EMA/411850/2014 London, 28 July 2014 Summary of the risk management plan (RMP) for (clopidogrel / acetylsalicylic acid) This is a summary of the risk management plan (RMP) for, which details the measures
More informationSummary of the risk management plan (RMP) for Vizamyl (flutemetamol 18 F)
EMA/404996/2014 Summary of the risk management plan (RMP) for Vizamyl (flutemetamol 18 F) This is a summary of the risk management plan (RMP) for Vizamyl, which details the measures to be taken in order
More informationSummary of the risk management plan (RMP) for Lenvima (lenvatinib)
EMA/227224/2015 Summary of the risk management plan (RMP) for Lenvima (lenvatinib) This is a summary of the risk management plan (RMP) for Lenvima, which details the measures to be taken in order to ensure
More informationCommission. Product. Notification. Decision. Issued 2 / affected 3 amended on
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 information1. The proposed strength, quantity, dosage form, dose and route of administration of the medicine including indication
Investigation 10mg 1. The proposed strength, quantity, dosage form, dose and route of administration of the medicine including indication Blister packs of 14 Solid dose form for oral administration. It
More informationIdentifying the Future Needs for Big Data in Medicines Regulation
Identifying the Future Needs for Big Data in Medicines Regulation Hans Hillege Member of the Committee for Medicinal Products for Human Use (CHMP) for The Netherlands 1 Disclaimer The views and opinions
More informationPaediatric Investigation Plans for treatment of osteoporosis
Paediatric Investigation Plans for treatment of osteoporosis Presentation to EMA expert meeting 2 June 2014 Presented by: Richard Veselý Scientific officer An agency of the European Union The European
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 informationMedicinal product no longer authorised
EMA/764409/2015 Summary of the risk management plan (RMP) for Ionsys (fentanyl) This is a summary of the risk management plan (RMP) for Ionsys, which details the measures to be taken in order to ensure
More informationSubmission for. Reclassification. Xenical. (Orlistat capsules 120mg) Pharmacist Only Medicine. for. Weight Control in Adults.
Submission for Reclassification of Xenical (Orlistat capsules 120mg) To Pharmacist Only Medicine for Weight Control in Adults December 2003 Prepared for: Prepared by: Medicines Classification Committee
More informationThis leaflet answers some of the common questions people ask about Pharmacor Omeprazole.
PHARMACOR OMEPRAZOLE CAPSULES Omeprazole Consumer Medicine Information What is in this leaflet This leaflet answers some of the common questions people ask about Pharmacor Omeprazole. It does not contain
More informationPLENADREN EU-RMP VERSION 3.2. Elements for a Public Summary. Overview of Disease Epidemiology
PLENADREN EU-RMP VERSION 3.2 VI.2 VI.2.1 Elements for a Public Summary Overview of Disease Epidemiology PLENADREN contains hydrocortisone and is used to treat adrenal insufficiency (AI) in adults. AI occurs
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.CPA.209 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy for important
More informationTable Of Content. European Organisation for Rare Diseases... 2 Summary... 3 Coordinator, Leader contact and partners... 6 Outputs...
Table Of Content European Organisation for Rare Diseases... 2 Summary... 3 Coordinator, Leader contact and partners... 6 Outputs... 7 D04 - Electronic Newsletter (EN)... 7 D01 - Activity Report EURORDIS
More informationFor practical information about using Revlimid, patients should read the package leaflet or contact their doctor or pharmacist.
EMA/113870/2017 EMEA/H/C/000717 EPAR summary for the public lenalidomide This is a summary of the European public assessment report (EPAR) for. It explains how the Agency assessed the medicine to recommend
More informationCommission. Product. Notification 1. Decision. Information issued on. Issued 2 / affected 3 amended on. 12/12/2018 Annex II and PL.
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification 1 Decision Information issued on Issued 2 / affected
More informationGuidance for Pharmacists on the Safe Supply of Non-Prescription Levonorgestrel 1500mcg for Emergency Hormonal Contraception
Guidance for Pharmacists on the Safe Supply of Non-Prescription Levonorgestrel 1500mcg for Emergency Hormonal Contraception Pharmaceutical Society of Ireland Version 4 December 2016 Updates made following
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT alli 60 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 60 mg orlistat. For a full
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 5 January 2011
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 5 January 2011 Review of the dossier of the proprietary drugs included on the list of reimbursable medicines for a
More informationSummary of the risk management plan (RMP) for Duavive (conjugated oestrogens / bazedoxifene)
EMA/679870/2014 Summary of the risk management plan (RMP) for Duavive (conjugated oestrogens / bazedoxifene) This is a summary of the risk management plan (RMP) for Duavive, which details the measures
More informationPART VI Summary of the RMP
PART VI Summary of the RMP Summary of Risk Management Plan for ORKAMBI This is a summary of the risk management plan (RMP) for ORKAMBI. The RMP details important risks of ORKAMBI, how these risks can be
More informationA C A D E M I C D E TA I L I N G C H O O S I N G W I S E LY C O N F E R E N C E O C T 2 1, PA M M C L E A N - V E Y S E Y B S C P H A R M D R
PPI DEPRESCRIBING Canadian Deprescribing Network (CaDeN) goals are to: Reduce harm by raising awareness and cutting risky prescriptions for seniors by 50% by 2020. Promote health by ensuring access to
More informationSummary of the risk management plan (RMP) for Viekirax (ombitasvir / paritaprevir / ritonavir)
EMA/775985/2014 Summary of the risk management plan (RMP) for Viekirax (ombitasvir / paritaprevir / ritonavir) This is a summary of the risk management plan (RMP) for Viekirax, which details the measures
More informationSummary of the risk management plan (RMP) for Neofordex (dexamethasone)
EMA/934/2016 Summary of the risk management plan (RMP) for Neofordex (dexamethasone) This is a summary of the risk management plan (RMP) for Neofordex, which details the measures to be taken in order to
More informationREAD THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. lansoprazole delayed-release capsule (Manufacturer s standard)
READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Pr PREVACID lansoprazole delayed-release capsule (Manufacturer s standard) Read this carefully before you start taking
More informationGASTROINTESTINAL AND ANTIEMETIC DRUGS. Submitted by: Shaema M. Ali
GASTROINTESTINAL AND ANTIEMETIC DRUGS Submitted by: Shaema M. Ali GASTROINTESTINAL AND ANTIEMETIC DRUGS by: Shaema M. Ali There are four common medical conditions involving the GI system 1) peptic ulcers
More informationControloc 40 mg is used for:
Name Controloc 40 mg gastro-resistant tablets Pantoprazole Before you start taking this medicine Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need
More informationPantoprazole (as sodium sesquihydrate) enteric coated tablets
SOZOL Consumer Medicine Information Pantoprazole (as sodium sesquihydrate) enteric coated tablets What is in this leaflet? This leaflet answers some common questions about SOZOL. It does not contain all
More informationSummary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin)
EMA/247834/2014 Summary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin) Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised
More informationSummary of the risk management plan (RMP) for Fexeric (ferric citrate coordination complex)
EMA/576868/2015 Summary of the risk management plan (RMP) for Fexeric (ferric citrate coordination complex) This is a summary of the risk management plan (RMP) for Fexeric, which details the measures to
More informationCOMPUS OPTIMAL THERAPY REPORT. Supporting Informed Decisions. À l appui des décisions éclairées
OPTIMAL THERAPY REPORT COMPUS Volume 1, Issue 6 March 2007 Gap Analysis Report for the Prescribing and Use of Proton Pump Inhibitors (PPIs) Supporting Informed Decisions À l appui des décisions éclairées
More informationVI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology VI.2.2 Summary of treatment benefits
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nausea and vomiting are common ailments had by many individuals. Nausea is defined as the unpleasant, painless sensation that
More informationSummary of the risk management plan (RMP) for Sirturo (bedaquiline)
EMA/16634/2014 Summary of the risk management plan (RMP) for Sirturo (bedaquiline) This is a summary of the risk management plan (RMP) for Sirturo, which details the measures to be taken in order to ensure
More informationSummary of the risk management plan (RMP) for Moventig (naloxegol)
EMA/611606/2014 Summary of the risk management plan (RMP) for Moventig (naloxegol) This is a summary of the risk management plan (RMP) for Moventig, which details the measures to be taken in order to ensure
More informationSummary of product characteristics (SmPC)
Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the European Union Table of contents 1.What is the summary of product characteristics (SmPC)? 2.Where SmPC information
More informationAstraZeneca and Daiichi Sankyo Launch Proton Pump Inhibitor Nexium 10 mg and 20 mg Granules for Suspension, Sachet, in Japan
AstraZeneca K.K. Daiichi Sankyo Co., Ltd. AstraZeneca and Daiichi Sankyo Launch Proton Pump Inhibitor Nexium 10 mg and 20 mg Granules for Suspension, Sachet, in Japan Osaka and Tokyo, Japan, April 18,
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER. ULCERBREX 10 mg mg gastro-resistant tablets Rabeprazole sodium
PACKAGE LEAFLET: INFORMATION FOR THE USER ULCERBREX 10 mg mg gastro-resistant tablets Rabeprazole sodium Read all of this leaflet carefully before you start taking this medicine because it contains important
More informationElements for a Public Summary. Overview of disease epidemiology. Cardiovascular Events
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Cardiovascular Events Each year cardiovascular disease (CVD) causes 3.9 million deaths in Europe and over 1.8 million deaths in
More informationElements for a Public Summary Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Acute pain usually responds to medication and should settle in less than three months. Inadequate pain relief may lead to other
More informationSummary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin)
EMA/285074/2015 Summary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin) This is a summary of the risk management plan (RMP) for Pregabalin Mylan, which details the measures to be taken
More informationSummary of the risk management plan (RMP) for Ketoconazole HRA (ketoconazole)
EMA/609213/2014 Summary of the risk management plan (RMP) for Ketoconazole HRA (ketoconazole) This is a summary of the risk management plan (RMP) for Ketoconazole HRA, which details the measures to be
More information