DOCSLIB.ORG

1908-Liste-Comm.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
1908-Liste-Comm.Pdf Liste des médicaments commercialisés valable au 1er août 2019 Cette liste se base sur des données qui sont de la compétence de la Direction de la Santé, Division de la Pharmacie et des Médicaments, du Ministère de la sécurité sociale et de la Caisse nationale de santé. mode de délivrance P: médicament non soumis à prescription médicale mode de délivrance R ou RR: médicament soumis à prescription médicale mode de délivrance S: médicament soumis à prescription médicale spéciale (stupéfiants) conditions de prescription restreinte H: usage strictement hospitalier conditions de prescription restreinte D: délivrance à partir de l'hôpital vers l'ambulatoire conditions de prescription restreinte C: prescription réservée à certains médecins spécialistes OD: médicament orphelin RPM: plan de gestion du risque obligatoire PCC: Prise en charge conditionnelle de la CNS Numéro Dénomination abrégée mode de conditions de OD RMP PCC Prix ex-us. Prix d'achat pharm. Prix public Taux national délivrance prescription A01AA01 sodium fluoride 0045694 FLUOR SMB GTTES 5,5 MG / 1 ML 1*1 GTTES 30 ML P 0 0 1,78 2,05 3,06 80 0131307 ZYMAFLUOR CPR. 0,25 MG 1*250 CPR. P 0 0 2,32 2,77 4,62 80 0131324 ZYMAFLUOR CPR. 1 MG 1*250 CPR. P 0 0 3,61 4,30 6,95 80 A01AA30 combinations 0444332 ELMEX GEL 1,25 PC 1*1 GEL 38 G R 0 0 4,15 4,98 14,05 0 0141883 FLUOCARIL BIFLUORE 250 GOÛT ANIS PATE DENTIFRICE 1*1 P 0 0 3,11 3,58 5,33 0 TUBE 125 ML 0136124 FLUOCARIL BIFLUORE 250 GOÛT ANIS PATE DENTIFRICE 1*1 P 0 0 2,26 2,61 3,88 0 TUBE 75 ML A01AB03 chlorhexidine 0248151 CORSODYL GEL DENTAIRE 1*1 TUBE 50 G P 0 0 3,20 3,68 5,49 0 0207727 CORSODYL SOL. BAIN BOUCHE 10 MG / 5 ML 1*1 SOL. 200 ML P 0 0 3,25 3,74 5,58 40 0207731 CORSODYL SOL.PULV.BUCC. 10 MG / 5 ML 1*1 SPRAY 60 ML P 0 0 4,19 4,82 7,19 0 A01AB09 miconazole 0027634 DAKTARIN GEL ORAL 20 MG / 1 G 1*1 GEL 40 G R 0 0 2,65 3,05 7,71 80 A01AB11 various 0022204 CIONAL SOL.BUCC.GTTES 1*1 SOL. 30 ML P 0 0 0,00 2,89 4,47 0 0140788 COLLUDOL SOL.PULV.BUCC. 2 MG / 1 ML 1*1 AER. 30 ML P 0 0 4,70 5,42 8,09 0 0264303 ELUDRIL PRO SOL. BAIN BOUCHE 1*1 FL. PET 200 ML P 0 0 3,96 4,65 7,54 0 0636748 ELUDRIL PRO SOL. BAIN BOUCHE 1*1 FL. PET 500 ML P 0 0 6,82 8,00 12,97 0 0038834 ELUDRIL SOL.PULV.BUCC. 1*1 FL. PRESSURISÉ 55 ML P 0 0 1,91 2,20 3,40 0 A01AB12 hexetidine 0053603 HEXTRIL SOL. BAIN BOUCHE 5 MG / 5 ML 1*1 FLACON 200 ML P 0 0 3,30 3,80 5,67 40 0368339 HEXTRIL SOL. BAIN BOUCHE 5 MG / 5 ML 1*1 FLACON 400 ML P 0 0 5,92 6,82 10,18 0 A01AD11 various 0438853 DENTINOX GEL N GEL 1*1 GEL 10 G P 0 0 2,75 3,21 4,15 0 0049483 GLANDOSAN SPRAY 1*1 SPRAY 50 ML P 0 0 4,82 5,71 9,23 0 0258869 PANSORAL GEL BUCC. 1*1 TUBE 15 G P 0 0 0,00 3,64 5,63 0 0095942 PYRALVEX SOL.BUCC. 1*1 FLACON 10 ML P 0 0 3,50 4,03 6,02 0 0180329 TEEJEL GEL BUCC. 1*1 TUBE 30 G P 0 0 4,74 5,45 8,14 0 0436103 XOGEL ADULTE GEL 1*1 GEL 50 G R P 0 0 70,00 72,18 82,01 0 0436117 XOGEL ENFANT GEL 1*1 GEL 50 G R 0 0 70,00 72,18 82,01 0 A02AB10 combinations Page 1 of 221 Numéro Dénomination abrégée mode de conditions de OD RMP PCC Prix ex-us. Prix d'achat pharm. Prix public Taux national délivrance prescription 0655811 MAALOX ANTACID CITRON SP.BUV. 230 MG / 4,3 ML + 400 MG P 0 0 5,41 6,23 9,29 40 / 4,3 ML 1*20 SACH. 0655838 MAALOX ANTACID SANS SUCRE CITRON CPR. CROQUER 200 P 0 0 3,45 3,97 5,92 40 MG + 400 MG 1*40 CPR.SS BLIST. A02AC01 calcium carbonate 0415733 ZIRKULIN MAGEN PASTILLEN CPR. SUCER 500 MG 1*10 CPR. P 0 0 1,00 1,15 1,78 0 0415747 ZIRKULIN MAGEN PASTILLEN CPR. SUCER 500 MG 1*40 CPR. P 0 0 2,17 2,50 3,87 0 0415751 ZIRKULIN MAGEN PASTILLEN CPR. SUCER 500 MG 1*90 CPR. P 0 0 4,13 4,75 7,35 0 A02AD Combinations and complexes of aluminium, calcium and magnesium compounds 0399612 MOXYDAR SUSP. 1*30 SACH. 20 ML P 0 0 2,57 2,87 3,42 0 A02AD01 ordinary salt combinations 0643421 MAALOX ANTACID- 200MG/400MG CPR. CROQUER 1*100 P 0 0 5,98 6,88 10,27 40 CPR.SS BLIST. 0643434 MAALOX ANTACID- 200MG/400MG CPR. CROQUER 1*40 P 0 0 3,00 3,45 5,15 40 CPR.SS BLIST. 0790765 MAALOX ANTACID- 230MG/400MG SP.BUV. 230 MG / 10 ML + P 0 0 5,19 5,97 8,92 40 400 MG / 10 ML 1*1 FLACON 250 ML 0643448 MAALOX ANTACID- 230MG/400MG SP.BUV. 230 MG / 10 ML + P 0 0 4,93 5,67 8,48 40 400 MG / 10 ML 1*1 FLACON 355 ML 0176245 MAGLID CPR. CROQUER 200 MG + 200 MG 1*48 CPR.A SUCER P 0 0 2,93 3,38 5,05 40 0399593 MOXYDAR CPR.DISP. 1*30 CPR.SS BLIST. P 0 0 2,57 2,87 3,42 0 0848431 NEUTRICID SP.BUV.SACH. 1*18 SACHETS 20 ML P 0 0 4,41 5,20 6,46 0 A02AD02 magaldrate 0255299 GASTRICALM CPR. CROQUER 1*50 CPR.SS BLIST. P 0 0 5,04 5,81 8,66 40 0628021 RIOPAN SP.BUV. 800 MG / 10 ML 1*1 BOUTEILLE 250 ML P 0 0 5,06 5,83 8,69 40 0100197 RIOPAN SP.BUV. 800 MG / 10 ML 1*20 SACH. 10 ML P 0 0 5,06 5,83 8,70 40 0511791 RIOPAN SP.BUV. 800 MG / 10 ML 1*50 SACH. 10 ML P 0 0 10,12 11,65 17,39 40 A02AD04 hydrotalcite 0253862 TALIDAT CPR. 500 MG 1*100 CPR.A MACHER P 0 0 8,91 10,51 16,02 40 0253845 TALIDAT CPR. 500 MG 1*20 CPR.A MACHER P 0 0 2,26 2,70 4,50 40 0253859 TALIDAT CPR. 500 MG 1*50 CPR.A MACHER P 0 0 4,96 5,88 9,51 40 A02AF Antacids with antiflatulents 0252977 KESTOMATINE CPR. CROQUER 1*16 CPR.SS BLIST. P 0 0 2,94 3,38 5,06 0 A02AH Antacids with sodium bicarbonate 0048150 GASTROPAX PDRE 1*1 PDRE 100 G P 0 0 4,90 5,75 8,94 0 A02AX Antacids, other combinations 0529491 RENNIE MINT SANS SUCRE CPR. CROQUER 680 MG + 80 MG P 0 0 7,00 8,06 12,02 0 1*120 CPR. 0529457 RENNIE MINT SANS SUCRE CPR. CROQUER 680 MG + 80 MG P 0 0 2,24 2,58 3,85 0 1*24 CPR. 0311272 RENNIE MINT SANS SUCRE CPR. CROQUER 680 MG + 80 MG P 0 0 4,37 5,03 7,51 0 1*60 CPR. 0156595 SYNGEL SP.BUCC. 1*1 SUSP. 300 ML P 0 0 8,20 9,44 14,09 40 A02BA02 ranitidine 0541353 ACIDINE CPR.EFF. 75 MG 1*20 CPR.(TUBE) P 0 0 4,76 5,48 8,18 80 0218555 RANITIC-150 CPR.ENR. 150 MG 1*100 CPR.SS BLIST. R 0 0 7,01 7,93 17,18 80 0218538 RANITIC-150 CPR.ENR. 150 MG 1*20 CPR.SS BLIST. R 0 0 0,99 1,72 10,59 80 0218541 RANITIC-150 CPR.ENR. 150 MG 1*50 CPR.SS BLIST. R 0 0 3,47 4,28 13,31 80 0218524 RANITIC-300 CPR.ENR. 300 MG 1*100 CPR.SS BLIST. R 0 0 14,69 15,85 25,59 80 0218507 RANITIC-300 CPR.ENR. 300 MG 1*20 CPR.SS BLIST. R 0 0 2,86 3,65 12,64 80 0218511 RANITIC-300 CPR.ENR. 300 MG 1*50 CPR.SS BLIST. R 0 0 7,30 8,23 17,50 80 0543926 RANITIDINE EG-150 CPR.EFF. 150 MG 1*112 CPR.(TUBE) R 0 0 6,15 7,07 12,06 80 Page 2 of 221 Numéro Dénomination abrégée mode de conditions de OD RMP PCC Prix ex-us. Prix d'achat pharm. Prix public Taux national délivrance prescription 0543909 RANITIDINE EG-150 CPR.EFF. 150 MG 1*56 CPR.(TUBE) R 0 0 7,71 9,10 14,04 0 0446628 RANITIDINE EG-150 CPR.ENR. 150 MG 1*112 CPR.SS BLIST. R 0 0 4,44 5,23 9,96 80 0286314 RANITIDINE EG-150 CPR.ENR. 150 MG 1*56 CPR.SS BLIST.U.D. R 0 0 3,45 4,07 8,71 80 0544047 RANITIDINE EG-300 CPR.EFF. 300 MG 1*28 CPR.(TUBE) R 0 0 2,86 3,37 7,97 80 0544064 RANITIDINE EG-300 CPR.EFF.
Load more

Recommended publications
  • Specifications of Approved Drug Compound Library
    Annexure-I : Specifications of Approved drug compound library The compounds should be structurally diverse, medicinally active, and cell permeable Compounds should have rich documentation with structure, Target, Activity and IC50 should be known Compounds which are supplied should have been validated by NMR and HPLC to ensure high purity Each compound should be supplied as 10mM solution in DMSO and at least 100µl of each compound should be supplied. Compounds should be supplied in screw capped vial arranged as 96 well plate format.
    [Show full text]
  • Clinical Commissioning Policy: Susoctocog Alfa for Treating Bleeding Episodes in People with Acquired Haemophilia a (All Ages)
    Clinical Commissioning Policy: Susoctocog alfa for treating bleeding episodes in people with acquired haemophilia A (all ages) NHS England Reference: 170061P 1 NHS England INFORMATION READER BOX Directorate Medical Operations and Information Specialised Commissioning Nursing Trans. & Corp. Ops. Commissioning Strategy Finance Publications Gateway Reference: 07603 Document Purpose Policy Clinical commissioning policy: Susoctocog alfa for treating bleeding Document Name episodes in people with acquired haemophilia A (all ages) Author Specialised Commissioning Team Publication Date 29 June 2018 Target Audience CCG Clinical Leaders, Care Trust CEs, Foundation Trust CEs , Medical Directors, Directors of PH, Directors of Nursing, NHS England Regional Directors, NHS England Directors of Commissioning Operations, Directors of Finance, NHS Trust CEs Additional Circulation #VALUE! List Description Routinely Commissioned - NHS England will routinely commission this specialised treatment in accordance with the criteria described in this policy. Cross Reference 0 Superseded Docs 0 (if applicable) Action Required 0 Timing / Deadlines By 00 January 1900 (if applicable) Contact Details for [email protected] further information 0 0 0 0 0 0 Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. 2 Standard Operating Procedure: Clinical Commissioning Policy: Susoctocog alfa for treating bleeding episodes in people with acquired haemophilia A (all ages) First published: June 2018 Prepared by the National Institute for Health and Care Excellence (NICE) Commissioning Support Programme Published by NHS England, in electronic format only.
    [Show full text]
  • TACHOSIL (Fibrin Sealant Patch)
    Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMORANDUM To: Craig Zinderman, MD, MPH Acting Director, Division of Epidemiology (DE) Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER) Through: Meghna Alimchandani, MD Associate Director for Medical Policy, OBE, CBER From: Faith Barash, MD, MPH Medical Officer, Pharmacovigilance Branch Office of Biostatistics and Epidemiology (OBE) Center for Biologics Evaluation and Research (CBER) Subject: Safety and Utilization Review for the Pediatric Advisory Committee Applicant: Takeda Pharma A/S Product: TACHOSIL (Fibrin Sealant Patch) STN: 125351/279 Indication: TACHOSIL is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Meeting Date: Pediatric Advisory Committee Meeting, September 2019 1 Contents 1 INTRODUCTION ................................................................................................................................ 3 1.1 Objective ...................................................................................................................................... 3 1.2 Product Description .................................................................................................................... 3 1.3 Regulatory
    [Show full text]
  • Scientific Program Saturday, 17. July 2021 Factor VIII, Factor IX and Rare
    Scientific programThe XXIX Congress of the International Society on Thrombosis and Haemostasis July 17-21, 2021 Philadelphia, U.S. Saturday, 17. July 2021 SSC Session 08:00 - 10:00 R1 Factor VIII, Factor IX and Rare Coagulation Disorders Introduction 08:00 - 08:02 Speaker: Johnny Mahlangu, ZA Non-Factor Replacement Therapies 08:02 - 08:02 Moderators: Johnny Mahlangu, South Africa, Tarek Owaidah, Saudi Arabia In Patients on Non-Factor Therapies, Exposure to Clotting 08:02 - 08:14 Factor Replacement Should Be Early (Debate) Speaker: Manuel Carcao, CA In Patients on Non-Factor Therapies, Exposure to Clotting 08:14 - 08:26 Factor Replacement Should Be Early (Debate) Speaker: Jayanthi Alamelu, GB Non-Factor Replacement Therapy Versus Factor Replacement 08:26 - 08:38 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Bhavya Doshi, US Non-Factor Replacement Therapy Versus Factor Replacement 08:38 - 08:50 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Gili Kenet, IL Beyond Annualized Bleed Rates What Should Be the Alternative 08:50 - 09:02 Endpoints for Non-Replacement Therapies Speaker: Alok Srivastava, IN Q&A Session 09:02 - 09:06 Gene Therapy 09:06 - 09:06 Moderators: Valder Arruda, United States, Savita Rangarajan, United Kingdom Anti Adeno-Associated Virus Antibodies Antibodies: What Are 09:06 - 09:18 the Standardization Issues? Speaker: David Lillicrap, CA Rationale for Adeno-associated Virus (AAV) Mediated Gene 09:24 - 09:30 Therapy in Patients With Anti Adeno-associated Virus Antibodies Speaker: David Cooper, NL What Should We Be Following-up Post Gene Therapy? 09:30 - 09:42 Speaker: Barbara A.
    [Show full text]
  • Bebulin VH Corifact Factor VII Concentrate
    P RODUCTS TO TREAT RARE FACTOR DEFICIENCIES Product Plasma source Fractionation Viral inactivation Vial size Storage Availability USA: volunteer, Vapour heat @ 60°C for 10 hr at Available through Special Bebulin VH remunerated Ion exchange 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Shire donors distributed in all provinces. Comments Factor IX complex containing factors II, VII, IX and X, heparin added. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Purification steps: 1) Precipitation/adsorption 250 IUs USA: volunteer, (4 mL of diluent) 2) Ion exchange chromatography Corifact remunerated Multiple Licensed by Health Canada. 1,250 IUs 2‐8°C Manufactured by plasmapheresis precipitation 3) Heat‐treatment (+60°C for 10 (20 mL of diluent) Distributed in all provinces. CSL Behring donors hours in an aqueous solution) 4) Virus filtration over two 20 nm Mix2Vial filters in series Comments Indicated for routine prophylaxis and peri‐operative management of surgical bleeding in patients with congenital factor XIII deficiency. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor VII USA: volunteer, Aluminium Vapour heat @ 60°C for 10 hr at Available through Special remunerated concentrate hydroxide 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Distributed in all provinces. Shire donors Comments Used to treat factor VII deficiency. 1 Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor XI USA: volunteer, Affinity heparin Available through Special concentrate remunerated sepharose Dry heat @ 80°C, 72 hr 1,000 IUs 2‐8°C Access Programme.
    [Show full text]
  • Tyrothricin ÂŒ an Underrated Agent for the Treatment of Bacterial Skin
    REVIEW Engelhard Arzneimittel GmbH & Co KG, Niederdorfelden, Germany Tyrothricin – An underrated agent for the treatment of bacterial skin infections and superficial wounds? C. LANG , C. STAIGER Received February 22, 2015, accepted March 23, 2016 Dr. Christopher Lang, Engelhard Arzneimittel GmbH & Co. KG, Herzbergstr. 3, 61138 Niederdorfelden, Germany [email protected] Pharmazie 71:299–305 (2016) doi: 10.1691/ph.2016.6038 The antimicrobial agent tyrothricin is a representative of the group of antimicrobial peptides (AMP). It is produced by Bacillus brevis and consists of tyrocidines and gramicidins. The compound mixture shows activity against bacteria, fungi and some viruses. A very interesting feature of AMPs is the fact, that even in vitro it is almost impossible to induce resistances. Therefore, this class of molecules is discussed as one group that could serve as next generation antibiotics and overcome the increasing problem of bacterial resistances. In daily practice, the application of tyrothricin containing formulations is relatively limited: It is used in sore throat medications and in agents for the healing of infected superficial and small-area wounds. However, due to the broad spectrum anti- microbial activity and the low risk of resistance development it is worth to consider further fields of application. 1. Introduction 2. Structure, production, properties A decade after Alexander Fleming published his findings on Tyrothricin is a mixture of polypeptides, consisting of 50 % - 70 % the antibiotic effect of penicillin in 1929 (Fleming 1929), René tyrocidines and 25 % to 50 % gramicidins (Ph.Eur. 8th edition Dubos discovered tyrothricin, a polypeptide mixture obtained 2014). The group of tyrocidines are basic, cyclic peptides, whereas from Bacillus brevis, which was isolated from soil.
    [Show full text]
  • The Systemic Activity and Phytotoxic Effects of Fungicides Effective Against Certain Cotton Pathogens
    Louisiana State University LSU Digital Commons LSU Historical Dissertations and Theses Graduate School 1970 The ysS temic Activity and Phytotoxic Effects of Fungicides Effective Against Certain Cotton Pathogens. Robert Gene Davis Louisiana State University and Agricultural & Mechanical College Follow this and additional works at: https://digitalcommons.lsu.edu/gradschool_disstheses Recommended Citation Davis, Robert Gene, "The ysS temic Activity and Phytotoxic Effects of Fungicides Effective Against Certain Cotton Pathogens." (1970). LSU Historical Dissertations and Theses. 1776. https://digitalcommons.lsu.edu/gradschool_disstheses/1776 This Dissertation is brought to you for free and open access by the Graduate School at LSU Digital Commons. It has been accepted for inclusion in LSU Historical Dissertations and Theses by an authorized administrator of LSU Digital Commons. For more information, please contact [email protected]. 71-3408 DAVIS, Robert Gene, 1932- THE SYSTEMIC ACTIVITY AND PHYTOTOXIC EFFECTS' OF FUNGICIDES EFFECTIVE AGAINST CERTAIN COTTON PATHOGENS. The Louisiana State University and Agricultural and Mechanical College, Ph.D., 1970 Agriculture, plant pathology University Microfilms, Inc., Ann Arbor, Michigan DISSERTATION HAS BEEN MICROFILMED EXACTLY AS RECEIVED THE SYSTEMIC ACTIVITY AND FHYTOTOXIC EFFECTS OF FUNGICIDES EFFECTIVE AGAINST CERTAIN COTTON PATHOGENS A Dissertation Submitted to the Graduate Faculty of the Louisiana State University and Agricultural and Mechanical College in partial fulfillment of the requirements for the degree of Doctor of Philosophy in The Department of Botany and Plant Pathology by Robert Gene Davis B.S., Mississippi State University, 1953 M.S., Mississippi State University, 1968 May, 1970 ACKNOWLEDGEMENT The contributions to this study by others is recognized and appre­ ciated. Dr. J. A.
    [Show full text]
  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
    [Show full text]
  • Monitoring International Trends Posted May 2016
    Monitoring International Trends posted May 2016 The NBA monitors international developments that may influence the management of blood and blood products in Australia. Our focus is on: Potential new product developments and applications; Global regulatory and blood practice trends; Events that may have an impact on global supply, demand and pricing, such as changes in company structure, capacity, organisation and ownership; and Other emerging risks that could potentially put financial or other pressures on the Australian sector. A selection of recent matters of interest appears below. Highlights include: BioMarin Pharmaceutical released preliminary data on its investigational gene therapy treatment for haemophilia A. (Section 1) Data on Bluebird bio’s gene therapy in severe sickle cell disease and transfusion- dependent β-thalassemia was discussed at the American Society of Gene & Cell Therapy Annual Meeting. (Section 1) Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension to the marketing authorisation for Baxalta’s subcutaneous immunoglobulin, HyQvia. (Section 2) NovoNordisk submitted to the US Food and Drug Administration (FDA) a Biologics License Application for its long-acting factor IX. (Section 2) The European Commission approved Swedish Orphan Biovitrum and Biogen’s recombinant factor IX Fc Fusion protein therapy. (Section 2) The FDA granted seven years of marketing exclusivity for CSL Behring's Coagulation Factor IX (Recombinant), Albumin Fusion Protein, with an extended dosing interval]. (Section 2) In Australia, the Therapeutic Goods Administration (TGA) approved a monoclonal antibody that reverses the anticoagulant effect of dabigatran in patients who require emergency surgery or have life-threatening bleeding.
    [Show full text]
  • Human and Recombinat Coagulation Factor VIII
    08 July 2016 EMA/PRAC/471535/2016 PRAC List of questions To be addressed by the marketing authorisation holder(s) for human and recombinant coagulation factor VIII containing medicinal products Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/1448 Advate EMEA/H/C/0520/A31/0078 Elocta EMEA/H/C/3964/A31/0006 Helixate Nexgen EMEA/H/C/0276/A31/0178 Iblias EMEA/H/C/4147/A31/0002 Kogenate EMEA/H/C/0275/A31/0185 Kovaltry EMEA/H/C/3825/A31/0004 Novoeight EMEA/H/C/2719/A31/0014 Nuwiq EMEA/H/C/2813/A31/0015 Obizur EMEA/H/C/2792/A31/0003 Refacto AF EMEA/H/C/0232/A31/0134 Voncento EMEA/H/C/2493/A31/0022 Active substances: human coagulation factor VIII; efmoroctocog alfa; moroctocog alfa; octocog alfa; simoctocog alfa; susoctocog alfa; turoctocog alfa 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 1. Background Today’s standard treatment of congenital haemophilia (and acquired haemophilia A) is based on prophylactic or on-demand replacement therapy with coagulation factor VIII (FVIII), either with plasma derived or with recombinant FVIII products. Principally both substance classes may be used for prophylactic treatment as well as for therapeutic treatment in case of spontaneous bleedings. Inhibitor development in haemophilia A patients receiving FVIII products mostly occurs in previously untreated or minimally treated patients (PUPs), who are still within the first 50 days of exposure to the treatment.
    [Show full text]
  • (OTC) Antibiotics in the European Union and Norway, 2012
    Perspective Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012 L Both 1 , R Botgros 2 , M Cavaleri 2 1. Public Health England (PHE), London, United Kingdom 2. Anti-infectives and Vaccines Office, European Medicines Agency (EMA), London, United Kingdom Correspondence: Marco Cavaleri ([email protected]) Citation style for this article: Both L, Botgros R, Cavaleri M. Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012. Euro Surveill. 2015;20(34):pii=30002. DOI: http://dx.doi.org/10.2807/1560-7917.ES.2015.20.34.30002 Article submitted on 16 September 2014 / accepted on 09 February 2015 / published on 27 August 2015 Antimicrobial resistance is recognised as a growing throughout the EU; however, there are still consider- problem that seriously threatens public health and able differences in Europe due to the different health- requires prompt action. Concerns have therefore been care structures and policies (including the extent of raised about the potential harmful effects of making pharmacist supervision for OTC medicines), reimburse- antibiotics available without prescription. Because of ment policies, and cultural differences of each Member the very serious concerns regarding further spread of State. Therefore, the availability of OTC medicines var- resistance, the over-the-counter (OTC) availability of ies in the EU and products sold as POM in certain coun- antibiotics was analysed here. Topical and systemic tries can be obtained as OTC medicines in others. OTC antibiotics and their indications were determined across 26 European Union (EU) countries and Norway As risk minimisation is an important criterion for some by means of a European survey.
    [Show full text]
  • Minutes of PRAC Meeting on 09-12 July 2018
    6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018.
    [Show full text]