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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 Cross Reference 0 Superseded Docs 0 (if applicable) Action Required 0 Timing / Deadlines By 00 January 1900 (if applicable) Contact Details for [email protected] further information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. -
Coagulation Factor IX (Recombinant) - Drugbank
12/7/2017 Coagulation Factor IX (Recombinant) - DrugBank Coagulation Factor IX (Recombinant) Targets (7) Biointeractions (4) IDENTIFICATION Name Coagulation Factor IX (Recombinant) Accession Number DB00100 (BTD00038, BIOD00038) Type Biotech Groups Approved Biologic Classification Protein Based Therapies Blood factors Description Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B). Protein structure Protein chemical formula C2041H3136N558O641S25 Protein average weight 46548.2 Da https://www.drugbank.ca/drugs/DB00100 1/13 12/7/2017 Coagulation Factor IX (Recombinant) - DrugBank 46548.2 Da Sequences >DB00100 sequence YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGG SCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAEN QKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTR VVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEE -
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 -
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
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
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. -
A Guide for People Living with Von Willebrand Disorder CONTENTS
A guide for people living with von Willebrand disorder CONTENTS What is von Willebrand disorder (VWD)?................................... 3 Symptoms............................................................................................... 5 Types of VWD...................................................................................... 6 How do you get VWD?...................................................................... 7 VWD and blood clotting.................................................................... 11 Diagnosis................................................................................................. 13 Treatment............................................................................................... 15 Taking care of yourself or your child.............................................. 19 (Education, information, first aid/medical emergencies, medication to avoid) Living well with VWD......................................................................... 26 (Sport, travel, school, telling others, work) Special issues for women and girls.................................................. 33 Connecting with others..................................................................... 36 Can I live a normal life with von Willebrand disorder?............. 37 More information................................................................................. 38 2 WHAT IS VON WILLEBRAND DISORDER (VWD)? Von Willebrand disorder (VWD) is an inherited bleeding disorder. People with VWD have a problem with a protein -
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. -
ER Guide to Bleeding Disorders
Bleeding disorders ER guide to bleeding disorders 1 Table of contents 4 General Guidelines 4–5 national Hemophilia Foundation guidelines 5–10 Treatment options 10 HemopHilia a Name:__________________________________________________________________________________________________ 10–11 national Hemophilia Foundation guidelines Address:________________________________________________________________________________________________ 12 dosage chart Phone:__________________________________________________________________________________________________ 14–15 Treatment products 16 HemopHilia B In case of emergency, contact: ______________________________________________________________________________ 16 national Hemophilia Foundation guidelines Relation to patient:________________________________________________________________________________________ 17 dosage chart 18 Treatment products 19 HemopHilia a or B with inHiBiTors Diagnosis: Hemophilia A: Mild Moderate Severe 20 national Hemophilia Foundation guidelines Inhibitors Inhibitors Bethesda units (if known) ____________________________________ 21 Treatment products Hemophilia B: Mild Moderate Severe 22–23 Von willeBrand disease Inhibitors Inhibitors Bethesda units (if known) ____________________________________ 23–24 national Hemophilia Foundation guidelines von Willebrand disease: Type 1 Type 2 Type 3 Platelet type 25 Treatment products 27 Bibliography Preferred product:_________________________________________________________________________________________ Dose for life-threatening -
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 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 .............................................................................................. -
Australian PI
AUSTRALIAN PRODUCT INFORMATION OBIZUR® (susoctocog alfa) 1 NAME OF THE MEDICINE Susoctocog alfa (bhk). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each OBIZUR vial contains nominally 500 units (U) of susoctocog alfa, which is a B domain deleted recombinant derived antihaemophilic factor VIII (rpFVIII), porcine sequence. After reconstitution, OBIZUR contains nominally 500 U/mL susoctocog alfa. Each vial of OBIZUR is labelled with the actual rpFVIII activity expressed in units determined by a one-stage clotting assay, using a reference rpFVIII material calibrated against the World Health Organization (WHO) 8th International Standard for human factor VIII concentrates. The specific activity of OBIZUR is in the range of 11000 - 18000 Units per milligram of protein. The potency values of OBIZUR determined by the chromogenic assay vary and are approximately 20-50 % lower than those of the one-stage clotting assay. Susoctocog alfa is expressed in a genetically engineered baby hamster kidney (BHK) cell line and secreted into the cell culture medium, and the protein is purified using a series of chromatography and filtration steps. The production process includes two dedicated viral clearance steps - a solvent/detergent treatment step for viral inactivation and a nanofiltration step through a series of two 15-nm filters for removal of viruses. No additives of human or animal origin are used in the formulation of OBIZUR. Excipient(s) with known effect Each vial of OBIZUR contains maximally 4.4 mg (198 mM) sodium per mL of reconstituted solution (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.