DOCSLIB.ORG

U.O. Acquisti Centralizzati SSR - CRAV 2017.001.16 FARMACI 2020 2 U.O

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

1 U.O. Acquisti Centralizzati SSR - CRAV 2017.001.16 FARMACI 2020 2 U.O. Acquisti Centralizzati SSR - CRAV 2017.001.16 FARMACI 2020 Note Rif. ATC Principio attivo Specialità Dosaggio Forma farmaceutica Via di somministrazione Unità di Aggiudicazione Indicazioni 1.A A01AB09 MICONAZOLO LORAMYC 50mg COMPRESSE MUCOADESIVE GENGIVALE COMPRESSA DIFLUCORTOLONE VALERATO/JOSAMICINA SOLUZIONE PER MUCOSA 2.A A01AC CORTIFLUORAL 12 mg OROFARINGEA FLACONE PROPIONATO ORALE 3.A A01AD02 BENZIDAMINA CLORIDRATO TANTUM VERDE 0.0402 mg SPRAY MUCOSA ORALE OROFARINGEA FLACONE 3.B A01AD02 BENZIDAMINA CLORIDRATO TANTUM VERDE 40.2 mg SPRAY MUCOSA ORALE OROFARINGEA FLACONE 4.A A02AD01 MAGNESIO IDROSSIDO/ALGELDRATO MAALOX 400 mg COMPRESSE MASTICABILI ORALE COMPRESSA 5.A A02AD01 MAGNESIO IDROSSIDO/ALGELDRATO MAALOX 6500 mg SOSPENSIONE ORALE ORALE FLACONE 6.A A02BB01 MISOPROSTOLO CYTOTEC 0.2mg COMPRESSE ORALE COMPRESSA 7.A A02BX13 SODIO ALGINATO/POTASSIO BICARBONATO GAVISCON ADVANCE 1g+0.2g SOSPENSIONE ORALE ORALE BUSTA 8.A A02BX13 SODIO ALGINATO/SODIO BICARBONATO GAVISCON 0.5g+0.267g SOSPENSIONE ORALE ORALE BUSTA 9.A A02BX13 SODIO ALGINATO/SODIO BICARBONATO GAVISCON 0.25g+0.1335g COMPRESSE MASTICABILI ORALE COMPRESSA 10.A A02BX13 SODIO ALGINATO/SODIO BICARBONATO GAVISCON 10 g SOSPENSIONE ORALE ORALE FLACONE CAPSULE RIGIDE RILASCIO 11.A A03AA04 MEBEVERINA CLORIDRATO DUSPATAL 200 mg ORALE CAPSULA PROLUNGATO GRANULATO PER 12.A A03AA05 TRIMEBUTINA DEBRIDAT 1200.175mg (0.787%) ORALE DILUITO FLACONE SOSPENSIONE ORALE 13.A A03AA05 TRIMEBUTINA MALEATO DEBRIDAT 50mg SOLUZIONE INIETTABILE ENDOVENOSA FIALA 14.A A03AA06 ROCIVERINA RILATEN 10mg COMPRESSE RIVESTITE ORALE COMPRESSA 15.A A03AA06 ROCIVERINA RILATEN 20mg SOLUZIONE INIETTABILE ENDOVENOSA FIALA 16.A A03AX12 FLOROGLUCINOLO SPASMEX 40mg SOLUZIONE INIETTABILE ENDOVENOSA FIALA 17.A A03AX12 FLOROGLUCINOLO/MEGLUCINOLO SPASMEX 80mg+80mg COMPRESSE ORALE COMPRESSA 18.A A03AX12 FLOROGLUCINOLO/MEGLUCINOLO SPASMEX 150 mg SUPPOSTE RETTALE SUPPOSTA 19.A A03BB01 SCOPOLAMINA BUTILBROMURO BUSCOPAN 10 mg SUPPOSTE RETTALE SUPPOSTA 20.A A03BB05 CIMETROPIO BROMURO ALGINOR 300 mg GOCCE ORALI SOLUZIONE ORALE FLACONE 21.A A03CB OCTATROPINA METILBROMURO/DIAZEPAM VALPINAX 2.5 mg COMPRESSE RIVESTITE ORALE COMPRESSA 22.A A03CB OCTATROPINA METILBROMURO/DIAZEPAM VALPINAX 75 mg GOCCE ORALI SOLUZIONE ORALE FLACONE METOCLOPRAMIDE MONOCLORIDRATO 23.A A03FA01 PLASIL 10 mg COMPRESSE ORALE COMPRESSA MONOIDRATO METOCLOPRAMIDE MONOCLORIDRATO 24.A A03FA01 PLASIL 120mg SCIROPPO ORALE FLACONE MONOIDRATO 25.A A03FA03 DOMPERIDONE PERIDON 30 mg SUPPOSTE RETTALE SUPPOSTA 26.A A03FA05 ALIZAPRIDE CLORIDRATO LIMICAN 50mg COMPRESSE ORALE COMPRESSA 27.A A03FA05 ALIZAPRIDE CLORIDRATO LIMICAN 50mg SOLUZIONE INIETTABILE ENDOVENOSA DILUITO FIALA 3 U.O. Acquisti Centralizzati SSR - CRAV 2017.001.16 FARMACI 2020 Note Rif. ATC Principio attivo Specialità Dosaggio Forma farmaceutica Via di somministrazione Unità di Aggiudicazione Indicazioni 28.A A03FA06 CLEBOPRIDE MALATO ACIDO MOTILEX 0.5 mg COMPRESSE ORALE COMPRESSA 29.A A03FA06 CLEBOPRIDE MALATO ACIDO MOTILEX (10%) SCIROPPO ORALE FLACONE 30.A A04AA01 ONDANSETRONE ZOFRAN 16mg SUPPOSTE RETTALE SUPPOSTA 31.A A04AA01 ONDANSETRONE CLORIDRATO ZOFRAN 40mg SCIROPPO ORALE FLACONE 32.A A04AA01 ONDANSETRONE CLORIDRATO DIIDRATO ZOFRAN 40mg SOLUZIONE INIETTABILE ENDOVENOSA DILUITO FIALA 33.A A04AA02 GRANISETRONE SANCUSO 3.1mg/d CEROTTI TRANSDERMICI TRANSDERMICA BUSTA 34.A A04AA55 NETUPITANT/PALONOSETRON CLORIDRATO AKYNZEO 300mg+0,5mg CAPSULE RIGIDE ORALE CAPSULA 35.A A04AD TIETILPERAZINA DIMALEATO TORECAN 6.5 mg SUPPOSTE RETTALE SUPPOSTA POLVERE PER SOSPENSIONE 36.A A04AD12 APREPITANT EMEND 125mg ORALE DILUITO BUSTA ORALE POLVERE PER SOLUZIONE 37.A A04AD12 FOSAPREPITANT DIMEGLUMINA IVEMEND 130.5 mg ENDOVENOSA DILUITO FLACONE PER INFUSIONE GRANULATO PER 38.A A05AA02 ACIDO URSODESOSSICOLICO URSILON 150 mg ORALE DILUITO BUSTA SOSPENSIONE ORALE ACIDO URSODESOSSICOLICO ESTERE 39.A A05AA02 URSOBIL 6200mg SCIROPPO ORALE FLACONE SOLFORICO SALE SODICO 40.A A05AA03 ACIDO COLICO ORPHACOL 50mg CAPSULE RIGIDE ORALE CAPSULA 41.A A05AA04 ACIDO OBETICOLICO OCALIVA 10mg COMPRESSE RIVESTITE ORALE COMPRESSA 41.B A05AA04 ACIDO OBETICOLICO OCALIVA 5mg COMPRESSE RIVESTITE ORALE COMPRESSA 42.A A05BA LEVOARGININA CLORIDRATO BIOARGININA 20 g SOLUZIONE PER INFUSIONE ENDOVENOSA FLACONE 43.A A06AB02 BISACODIL DULCOLAX 10 mg SUPPOSTE RETTALE SUPPOSTA POLVERE E SOLVENTE PER 44.A A06AB06 SENNA FOGLIA XPREP 150mg ORALE FLACONE SOLUZIONE ORALE 45.A A06AB06 SENNA FOGLIA (GLUCOSIDI PURI) PURSENNID 12 mg COMPRESSE RIVESTITE ORALE COMPRESSA GRANULATO PER SOLUZIONE 46.A A06AD11 LATTULOSIO EPALFEN 6G ORALE DILUITO g ORALE GRANULATO PER SOLUZIONE 47.A A06AD11 LATTULOSIO EPALFEN EPS 6G ORALE DILUITO g Encefalopatia portosistemica (EPS). Cirrosi epatica. ORALE Prevenzione e trattamento dell’encefalopatia porto–sistemica POLVERE PER SOLUZIONE 48.A A06AD12 LATTITOLO MONOIDRATO PORTOLAC 10g ORALE DILUITO BUSTA subclinica, acuta, cronica: profilassi del precoma e coma epatico. ORALE Cirrosi epatica. POLVERE PER SOLUZIONE 48.B A06AD12 LATTITOLO MONOIDRATO PORTOLAC 5 g ORALE DILUITO BUSTA ORALE 49.A A06AD12 LATTITOLO MONOIDRATO PORTOLAC 133.34 g SCIROPPO ORALE FLACONE POLVERE PER SOLUZIONE 50.A A06AD12 LATTITOLO MONOIDRATO PORTOLAC 200 g ORALE DILUITO g ORALE Prevenzione e trattamento dell’encefalopatia porto–sistemica POLVERE PER SOLUZIONE 51.A A06AD12 LATTITOLO MONOIDRATO PORTOLAC EPS 200g ORALE DILUITO BARATTOLO subclinica, acuta, cronica: profilassi del precoma e coma epatico. ORALE Cirrosi epatica. Prevenzione e trattamento dell’encefalopatia porto–sistemica POLVERE PER SOLUZIONE 52.A A06AD12 LATTITOLO MONOIDRATO PORTOLAC EPS 10g ORALE DILUITO BUSTA subclinica, acuta, cronica: profilassi del precoma e coma epatico. ORALE Cirrosi epatica. 4 U.O. Acquisti Centralizzati SSR - CRAV 2017.001.16 FARMACI 2020 Note Rif. ATC Principio attivo Specialità Dosaggio Forma farmaceutica Via di somministrazione Unità di Aggiudicazione Indicazioni 53.A A06AD12 LATTITOLO MONOIDRATO PORTOLAC EPS 333.35g SCIROPPO ORALE FLACONE MACROGOL 3350/SODIO BICARBONATO/SODIO CONCENTRATO PER 54.A A06AD65 MOVICOL 13.7008g/25ml ORALE FLACONE CLORURO/POTASSIO CLORURO SOLUZIONE ORALE MACROGOL 3350/SODIO BICARBONATO/SODIO 55.A A06AD65 MOVICOL SOLUZIONE 25ml (13.7046 g) SOLUZIONE ORALE ORALE BUSTA CLORURO/POTASSIO CLORURO MACROGOL 3350/SODIO SOLFATO POLVERE PER SOLUZIONE 56.A A06AD65 ANIDRO/SODIO BICARBONATO/SODIO KLEANPREP 68.5775g ORALE BUSTA ORALE CLORURO/POTASSIO CLORURO MACROGOL 3350/SODIO SOLFATO/SODIO POLVERE PER SOLUZIONE 57.A A06AD65 CLORURO/POTASSIO CLORURO/ACIDO MOVIPREP 111.206g+10.6g ORALE BUSTA ORALE ASCORBICO/SODIO ASCORBATO MACROGOL 4000/SODIO SOLFATO POLVERE PER SOLUZIONE 58.A A06AD65 ANIDRO/SODIO BICARBONATO/SODIO ISOCOLAN 0.371 g ORALE DILUITO BUSTA ORALE CLORURO/POTASSIO CLORURO MACROGOL 4000/SODIO SOLFATO POLVERE PER SOLUZIONE 59.A A06AD65 ANIDRO/SODIO BICARBONATO/SODIO ISOCOLAN 17.4-34.8g ORALE DILUITO g ORALE CLORURO/POTASSIO CLORURO 60.A A06AG LATTULOSIO LATTULAC EPS 200 g SOLUZIONE RETTALE RETTALE SACCA 61.A A06AG04 GLICEROLO/MALVA GLICEROLAX 2.25-3g MICROCLISMA RETTALE CLISMA 61.B A06AG04 GLICEROLO/MALVA GLICEROLAX 6.75-6.9g MICROCLISMA RETTALE CLISMA 62.A A06AH01 METILNALTREXONE BROMURO RELISTOR 12mg SOLUZIONE INIETTABILE SOTTOCUTANEA FLACONE 63.A A06AH03 NALOXEGOL OSSALATO MOVENTIG 25mg COMPRESSE RIVESTITE ORALE COMPRESSA 64.A A06AH05 NALDEMEDINA TOSILATO RIZMOIC 200mcg COMPRESSE RIVESTITE ORALE COMPRESSA 65.A A06AX04 LINACLOTIDE CONSTELLA 290mcg CAPSULE RIGIDE ORALE CAPSULA 66.A A06AX05 PRUCALOPRIDE SUCCINATO RESOLOR 1mg COMPRESSE RIVESTITE ORALE COMPRESSA 66.B A06AX05 PRUCALOPRIDE SUCCINATO RESOLOR 2mg COMPRESSE RIVESTITE ORALE COMPRESSA 67.A A07AA02 NISTATINA MYCOSTATIN 10000000UI SOSPENSIONE ORALE OROFARINGEA FLACONE 68.A A07AA11 RIFAXIMINA TIXTELLER 550mg COMPRESSE RIVESTITE ORALE COMPRESSA 69.A A07AA12 FIDAXOMICINA DIFICLIR 200mg COMPRESSE RIVESTITE ORALE COMPRESSA 70.A A07DA03 LOPERAMIDE CLORIDRATO DIARSTOP 1.5 mg CAPSULE RIGIDE ORALE CAPSULA COMPRESSE RILASCIO 71.A A07EA06 BUDESONIDE CORTIMENT 9 mg ORALE COMPRESSA PROLUNGATO COMPRESSE 72.A A07EA07 BECLOMETASONE DIPROPIONATO CLIPPER 50 mcg GASTRORESISTENTI RILASCIO ORALE COMPRESSA MODIFICATO 73.A A07EA07 BECLOMETASONE DIPROPIONATO TOPSTER 420mcg SCHIUMA RETTALE RETTALE BOMBOLETTA 74.A A07EA07 BECLOMETASONE DIPROPIONATO TOPSTER 30 mcg SUPPOSTE RETTALE SUPPOSTA 75.A A07EB01 ACIDO CROMOGLICICO SALE DISODICO NALCROM 250mg GRANULATO ORALE DILUITO BUSTA COMPRESSE 76.A A07EC01 SULFASALAZINA SALAZOPYRIN EN 500mg ORALE COMPRESSA GASTRORESISTENTI 5 U.O. Acquisti Centralizzati SSR - CRAV 2017.001.16 FARMACI 2020 Note Rif. ATC Principio attivo Specialità Dosaggio Forma farmaceutica Via di somministrazione Unità di Aggiudicazione Indicazioni COMPRESSE 77.A A07EC02 MESALAZINA MESAVANCOL 1200 mg GASTRORESISTENTI RILASCIO ORALE COMPRESSA PROLUNGATO POLVERE PER SOSPENSIONE 78.A A07FA02 SACCAROMICETI BOULARDII CODEX 250mg ORALE DILUITO BUSTA ORALE 79.A A07FA02 SACCAROMICETI BOULARDII CODEX 250 mg CAPSULE RIGIDE ORALE CAPSULA CAPSULE RIGIDE RILASCIO 80.A A09AA02 PANCRELIPASI CREON 150 mg ORALE CAPSULA MODIFICATO CAPSULE RIGIDE RILASCIO 80.B A09AA02 PANCRELIPASI CREON 300 mg ORALE CAPSULA MODIFICATO GRANULATO RILASCIO 81.A A09AA02 PANCRELIPASI CREON 5000U 12024mg ORALE DILUITO FLACONE MODIFICATO 82.A A10AB01 INSULINA UMANA DA DNA RICOMBINANTE INSUMAN 300UI SOLUZIONE INIETTABILE ENDOVENOSA CARTUCCIA 83.A A10AB01 INSULINA UMANA DA DNA RICOMBINANTE INSUMAN 1000U (0.00001%) SOLUZIONE INIETTABILE SOTTOCUTANEA FLACONE 84.A A10AB01 INSULINA
Recommended publications
  • TACHOSIL (Fibrin Sealant Patch)

    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
  • List of Patented Medicines 2018

    List of Patented Medicines 2018

    Patented Medicine Annual Report List 02 Apr 2019 Prices Review Board Protected A DIN Brand Chemical Name ATC Dosage Comments Status ABBVIE 02436027 HOLKIRA PAK 12.5/75/50/250 ombitasvir/paritaprevir/ritonavir/dasabuvir J05AX Oral Solid /Tablet Within Guidelines 02258595 HUMIRA - 40 MG/SYRINGE adalimumab L04AA Parenteral /Solution Within Guidelines 02312301 KALETRA 100/25 MG/TABLET lopinavir/ritonavir J05AE Oral Solid /Tablet Within Guidelines 02285533 KALETRA 200/50 MG/TABLET lopinavir/ritonavir J05AE Oral Solid /Tablet Within Guidelines 02243644 KALETRA 80/20 MG/MILLILITER lopinavir/ritonavir J05AE Oral Liquid /Solution Does Not Trigger 00884502 LUPRON DEPOT - 3.75 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 00836273 LUPRON DEPOT - 7.5 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02239834 LUPRON DEPOT - 11.25 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02230248 LUPRON DEPOT - 22.5 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02239833 LUPRON DEPOT - 30 MG/VIAL leuprolide acetate L02AE Parenteral /Modified release injections Within Guidelines 02467550 MAVIRET 100/40 MG/TABLET glecaprevir/pibrentasvir J05AP Oral Solid /Tablet Subj. Investigation 02229145 NORVIR - 80 MG/MILLILITER ritonavir J05AE Oral Liquid /Solution Within Guidelines 02357593 NORVIR - 100 MG/TABLET ritonavir J05AE Oral Solid /Tablet Within Guidelines 02481332 ORILISSA - 150 MG/TABLET elagolix
  • Monitoring International Trends Posted May 2016

    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.
  • Human and Recombinat Coagulation Factor VIII

    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.
  • PASS) Information

    PASS) Information

    Reference Number: RD-SOP-1214 Supplement Version: 14 Post Authorization Safety Study (PASS) Information HA-SAFE: Observational study evaluating long-term safety Acronym/Title of real-world treatment with damoctocog alfa pegol in previously treated patients with hemophilia A Protocol version and date v 1.0, 13 JAN 2020 IMPACT study number 20904 Study type / Study phase Observational, post-approval PASS Joint PASS: YES NO EU PAS register number Study not yet registered Active substance ATC code: B02BD02/Hematological/Damoctocog alfa pegol Medicinal product Jivi EU/1/18/1324/001 Jivi 250 IU; Product reference EU/1/18/1324/002 Jivi 500 IU; EU/1/18/1324/003 Jivi 1000 IU; EU/1/18/1324/004 Jivi 2000 IU; EU/1/18/1324/005 Jivi 3000 IU Procedure number EMEA/H/C/004054 Study Initiator and Funder Bayer Consumer Care AG, Basel, Switzerland Research question and objectives The aim of this study is to characterize in a real-world setting the long-term safety of damoctocog alfa pegol drug usage. The primary objective of this study is to assess the long- term safety of prophylaxis with damoctocog alfa pegol in patients with hemophilia A in the real-world setting through the collection and analysis of adverse events (AEs) of special interest including those potentially indicative of PEG accumulation (hypersensitivity reactions, loss of drug effect, renal impairment, neurocognitive disorders, and inhibitor development), AEs, serious adverse events (SAEs), and adverse reactions (ARs). The secondary objective is to monitor the clinical effects of long-term exposure of prophylaxis damoctocog alfa pegol in 20904; HA-SAFE; v 1.0, 13 JAN 2020 Page 1 of 48 Reference Number: RD-SOP-1214 Supplement Version: 14 patients with hemophilia A, including assessments of kidney and liver function parameters, neurological function and patients’ PEG plasma levels.
  • CHMP/565731/2018 Rev.1 Inspections, Human Medicines Pharmacovigilance and Committees Division

    CHMP/565731/2018 Rev.1 Inspections, Human Medicines Pharmacovigilance and Committees Division

    21 August 2018 EMA/CHMP/565731/2018 Rev.1 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP) Agenda of CHMP written procedure* 20-23 August 2018 Chair: Tomas Salmonson – Vice-Chair: Harald Enzmann * Written Procedure - comments on the draft documents should be forwarded to the Product Manager (PM) as identified in the CHMP agenda. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda 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). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
  • Minutes of PRAC Meeting on 09-12 July 2018

    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.
  • PRAC Draft Agenda of Meeting 4 -7 March 2013

    PRAC Draft Agenda of Meeting 4 -7 March 2013

    4 March 2013 EMA/PRAC/141813/2013 Pharmacovigilance Risk Assessment Committee (PRAC) Pharmacovigilance Risk Assessment Committee (PRAC) Agenda of the meeting on 4-7 March 2013 Explanatory notes The Notes give a brief explanation of relevant agenda items and should be read in conjunction with the agenda. EU Referral procedures for safety reasons: Urgent EU procedures and Other EU referral procedures (Items 2 and 3 of the PRAC agenda) A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). For further detailed information on safety related referrals please see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid =WC0b01ac05800240d0 Signals assessment and prioritisation (Item 4 of the PRAC agenda) A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks. The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient.
  • The Effect of Chitosan Dextran Gel As a Haemostatic and Anti-Adhesion

    The Effect of Chitosan Dextran Gel As a Haemostatic and Anti-Adhesion

    THE EFFECT OF CHITOSAN DEXTRAN GEL AS A HAEMOSTATIC AND ANTI ADHESION AGENT IN THE CENTRAL NERVOUS SYSTEM AND EVALUATION OF HAEMOSTATIC MECHANISM OF SKELETAL MUSCLE TISSUE Thesis submitted in March 2015 for The degree of Doctor of Philosophy In the University of Adelaide By Sukanya Rajiv, M.B.B.S, M.S The work described in this thesis was performed within The Department of Surgery Otolaryngology, Head and Neck Surgery, The University of Adelaide 1 Table of Contents TITLE PAGE________________________________________ 1 ABSTRACT________________________________________ 5 INTRODUCTION____________________________________________ 5 METHODS_________________________________________________ 5 RESULTS__________________________________________________ 7 CONCLUSION___________________________________________ 7 DECLARATION________________________________________ 9 PREFACE_____________________________________________ 10 ACKNOWLEDGEMENTS_______________________________ 11 CHAPTER 1 AIMS_____________________________________ 13 CHAPTER 2 INTRODUCTION_______________________________ 15 CHAPTER 3 NORMAL HAEMOSTASIS______________________ 21 BLOOD VESSEL/ ENDOTHELIAL CELL___________________________ 22 PLATELETS___________________________________________________ 25 COAGULATION CASCADE______________________________________ 27 INHIBITORS OF COAGULATION_________________________________ 28 FIBRINOLYTIC SYSTEM________________________________________ 29 COAGULATION SCREEN TESTS_________________________________ 30 CHAPTER 4 HEMOSTATIC TECHNIQUES IN CENTRAL NERVOUS SYSTEM___________________________________
  • Final Program N

    Final Program N

    XXII Congress The International Society on Thrombosis and Haemostasis B July 11-16 2009 O 55th Annual Meeting S of the Scientific and Standardization Committee of the ISTH T O Final Program N Boston - July 11-16 2009 XXII Congress of the International Society on Thrombosis and Haemostasis 2009 Table ISTH of Contents Venue and Contacts 2 Wednesday 209 Welcome Messages 3 – Plenary Lectures 210 Committees 7 – State of the Art Lectures 210 Congress Awards and Grants 15 – Abstract Symposia Lectures 212 Other Meetings 19 – Oral Communications 219 – Posters 239 ISTH Information 20 Program Overview 21 Thursday 305 SSC Meetings and – Plenary Lectures 306 Educational Sessions 43 – State of the Art Lectures 306 – Abstract Symposia Lectures 309 Scientific Program 89 – Oral Communications 316 Monday 90 – Posters 331 – Plenary Lectures 90 Nursing Program 383 – State of the Art Lectures 90 Special Symposia 389 – Abstract Symposia Lectures 92 Satellite Symposia 401 – Oral Communications 100 – Posters 118 Technical Symposia Sessions 411 Exhibition and Sponsors 415 Tuesday 185 – Plenary Lectures 186 Exhibitor and Sponsor Profiles 423 – State of the Art Lectures 186 Congress Information 445 – Abstract Symposia Lectures 188 Map of BCEC 446 – Oral Communications 196 Hotel and Transportation Information 447 ISTH 2009 Congress Information 452 Boston Information 458 Social Events 463 Excursions 465 Authors’ Index 477 1 Venue & Contacts Venue Boston Convention & Exhibition Center 415 Summer Street - Boston, Massachusetts 02210 - USA Phone: +1 617 954 2800 - Fax: +1 617 954 3326 The BCEC is only about 10 minutes by taxi from Boston Logan International Airport. The 2009 Exhibition is located in Hall A and B of the Exhibit Level of the BCEC, along with posters and catering.
  • Justification

    Justification

    Justification to the Resolution of the Federal Joint Committee (G-BA) on an Amendment of the Pharmaceuticals Directive (AM ‑ RL): Annex XII – Resolutions on the Benefit Assessment of Medicinal Products with New Active Ingredients in Accordance with Section 35a SGB V Damoctocog alfa pegol From 20 June 2019 Contents 1. Legal basis ................................................................................................................ 2 2. Key points of the resolution ..................................................................................... 2 2.1 Additional benefit of the medicinal product in relation to the appropriate comparator therapy ..................................................................................................... 3 2.1.1 Approved therapeutic indication of damoctocog alfa pegol (Jivi®) in accordance with the summary of product characteristics ............................................ 3 2.1.2 Appropriate comparator therapy ................................................................... 3 2.1.3 Extent and probability of the additional benefit .............................................. 5 2.1.4 Summary of the assessment ........................................................................ 6 2.2 Number of patients or demarcation of patient groups eligible for treatment ...... 6 2.3 Requirements for a quality-assured application ................................................ 7 2.4 Treatment costs ..............................................................................................
  • Management of Bleeding and Coagulopathy Following Major Trauma

    Management of Bleeding and Coagulopathy Following Major Trauma

    Spahn et al. Critical Care 2013, 17:R76 http://ccforum.com/content/17/2/R76 RESEARCH Open Access Management of bleeding and coagulopathy following major trauma: an updated European guideline Donat R Spahn1, Bertil Bouillon2, Vladimir Cerny3,4, Timothy J Coats5, Jacques Duranteau6, Enrique Fernández-Mondéjar7, Daniela Filipescu8, Beverley J Hunt9, Radko Komadina10, Giuseppe Nardi11, Edmund Neugebauer12, Yves Ozier13, Louis Riddez14, Arthur Schultz15, Jean-Louis Vincent16 and Rolf Rossaint17* Abstract Introduction: Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient. When these recommendations are implemented patient outcomes may be improved. Methods: The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document represents an updated version of the guideline published by the group in 2007 and updated in 2010. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature. Results: Key changes encompassed in this version of the guideline include new recommendations on the appropriate use of vasopressors and inotropic agents, and reflect an awareness of the growing number of patients in the population at large treated with antiplatelet agents and/or oral anticoagulants. The current guideline also includes recommendations and a discussion of thromboprophylactic strategies for all patients following traumatic injury. The most significant addition is a new section that discusses the need for every institution to develop, implement and adhere to an evidence-based clinical protocol to manage traumatically injured patients.