Section B Changed Classes/Guidelines Final
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Supplement Ii to the Japanese Pharmacopoeia Fifteenth Edition
SUPPLEMENT II TO THE JAPANESE PHARMACOPOEIA FIFTEENTH EDITION Official From October 1, 2009 English Version THE MINISTRY OF HEALTH, LABOUR AND WELFARE Notice: This English Version of the Japanese Pharmacopoeia is published for the conven- ience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. The Ministry of Health, Labour and Welfare Ministerial Notification No. 425 Pursuant to Paragraph 1, Article 41 of the Pharmaceutical Affairs Law (Law No. 145, 1960), we hereby revise a part of the Japanese Pharmacopoeia (Ministerial Notification No. 285, 2006) as follows*, and the revised Japanese Pharmacopoeia shall come into ef- fect on October 1, 2009. However, in the case of drugs which are listed in the Japanese Pharmacopoeia (hereinafter referred to as “previous Pharmacopoeia”) [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as “new Pharmacopoeia”)] and drugs which have been approved as of October 1, 2009 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as those ex- empted from marketing approval pursuant to Paragraph 1, Article 14 of the Pharmaceu- tical Affairs Law (hereinafter referred to as “drugs exempted from approval”)], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on March 31, 2011. -
What Are the Acute Treatments for Migraine and How Are They Used?
2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”. -
Horsemen's Information 2016和文TGP 1 薬物修正後 E
[Conditions] 1 Date December 29 (Tue), 2020 2020 Oi Racetrack, Race 10 2 Location TCK, Oi Racetrack 3 Race The 66th Running of Tokyo Daishoten (GI) 4 Eligibility Thoroughbreds, 3 years old & up 5 Full Gate 16 horses 6 Foreign Runners Selected by the selection committee from among the pre-entered horses. 7 Distance 2,000m, 1 1/4 mile (Right-handed, dirt course) 8 Weight 3 years old: 121.5 lbs,4 years old & up: 125.5 lbs, Female: 4.4 lbs less For 3 year-old-horses from the southern hemisphere, reduce 4.4 lbs from the above weight. 9 Purse Unit: 1,000 JPY Prize Purse & Bonus money Running Record 1st place 6th place allowances prize *1 prize *2 1st place 2nd place 3rd place 4th place 5th place or lower Owner 80,000 28,000 16,000 8,000 4,000 300 300 50 1,600 Trainer 880 70 60 50 40 30 30 80 Jockey 120 110 100 80 70 60 30 80 Groom 80 70 60 50 40 30 30 80 Rider 30 30 80 *1 Paid for the runner who broke the previous record and also set the best record during the race. *2 Prize equivalent to the amount listed in the table above is presented. *3 1 USD= 105.88 JPY (As of August,2020) 10 Handling of Late Scratch No allowance is paid in the case of a late scratch (including cancelation of race due to standstill in a starting gate) approved by TCK, Stewards, and Starter. However, if the chairman of the race meeting operation committee deems that the horse is involved in an accident not caused by the horse, the owner is given an running allowance. -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
Synthesis of 4-Hydroperoxy Derivatives of Ifosfamide and Trofosfamide by Direct Ozonation and Preliminary Antitumor Evaluation in V/Vo
[CANCER RESEARCH, 36, 2278-2281, July 1976] Synthesis of 4-Hydroperoxy Derivatives of Ifosfamide and Trofosfamide by Direct Ozonation and Preliminary Antitumor Evaluation in V/vo Hans-J. Hohorst, Gernot Peter, and Robert F. Struck Gustav-Embden-Zentrum der Biologischen Chemie, Abteilung KIr Zellchemie der J. W. Goethe-Universit~t, 6000 Frankfurt am Main, West Germany [H-J. H., G. P.], and Kettering-Meyer Laboratory, Southern Research Institute, Birmingham, Alabama 35205 [R. F. S.] SUMMARY reported routes (15, 17 to 19, 20), as well as to improve the yields. Two of us (11) have recently described such a syn- A one-step synthesis of 4-hydroperoxyifosfamide and 4- thesis of 4-hydroperoxycyclophosphamide, and application hydroperoxytrofosfamide is described. The method in- of this method to ifosfamide and trofosfamide and evalua- volves direct ozonation of ifosfamide and trofosfamide and tion of the products against leukemia L1210 in vivo are the offers improved yields in comparison with Fenton oxidation subjects of this report. The method is advantageous be- and greater convenience in comparison with ozonation of cause of its simplicity, its use of available starting materials, the appropriate 3-butenyl phosphorodiamidate. Evaluation the ease of isolation of products, and respectable yields. of the 4-hydroperoxy derivatives of cyclophosphamide, ifos- famide, and trofosfamide against leukemia L1210 in vivo suggests a superior effect for the ifosfamide derivative. MATERIALS AND METHODS Starting Materials. Cyclophosphamide, ifosfamide, and INTRODUCTION trofosfamide were obtained from Dr. Robert R. Engle, Drug Development Branch, National Cancer Institute, Silver Cyclophosphamide and its congeners ifosfamide and tro- Spring, Md., and from Asta Werke, 4800 Bielefeld, West fosfamide (1, 3) (Chart 1) are effective antitumor agents in Germany. -
Combination Effects of Radiotherapy / Drug Treatments for Cancer Recommendation by the German Commission on Radiological Protection with Scientific Background
Strahlenschutzkommission Geschäftsstelle der Strahlenschutzkommission Postfach 12 06 29 D-53048 Bonn http://www.ssk.de + Combination Effects of Radiotherapy / Drug Treatments for Cancer Recommendation by the German Commission on Radiological Protection with scientific Background Adopted at the 264th session of the SSK on 21 October 2013 Combination Effects of Radiotherapy / Drug Treatments for Cancer 2 The German original of this English translation was published in 2013 by the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety under the title: Kombinationswirkungen Strahlentherapie/medikamentöse Tumortherapie Empfehlung der Strahlenschutzkommission mit wissenschaftlicher Begründung This translation is for informational purposes only, and is not a substitute for the official statement. The original version of the statement, published on www.ssk.de, is the only definitive and official version. Combination Effects of Radiotherapy / Drug Treatments for Cancer 3 Contents Preface ....................................................................................................................... 8 Recommendation ...................................................................................................... 9 Scientific background of the recommendation .................................................... 11 1 Introduction ..................................................................................................... 11 2 Drug licensing and pharmacovigilance ....................................................... -
Protocol of Clinical Study
Protocol of clinical study Title Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents Inclusion Criteria: Disease Characteristics • Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma • Refractory or relapsed disease • Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid Patients characteristics • Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40% • Life expectancy ≥ 8 weeks Hematological: • Absolute leukocyte count ≥ 2.0 x 10^9 /l • Hemoglobin ≥ 10g/dl • Platelet count ≥ 70 x 10^9/l Renal: • Creatinine no greater than 1.5 times UNL • No overt renal disease Hepatic: • Bilirubin less than 2.5 times UNL • AST and ALT less than 5 times UNL • No overt hepatic disease • Pulmonary: • No overt pulmonary disease • Cardiovascular: • No overt cardiovascular disease Other: • Not pregnant or nursing • Negative pregnancy test • Fertile patients must use effective contraception Orphanet Database. Clinical trial 2009. http://www.orpha.net/data/eth/DE/ID60629Eng.pdf • No uncontrolled infection Prior concurrent therapy • More than 2 weeks since prior systemic chemotherapy • More than 4 weeks since prior radiotherapy • No other concurrent anticancer or experimental drugs Examinations required • Examination of lumbar CSF • Cranial and spinal MRI within 14 days prior to start of treatment Intervention 1: P-HIT-REZ 2005: Active Comparator Carboplatine, Etoposide, Thiotepa, Trofosfamide intravenous chemotherapy 2: P-HIT-REZ 2005: Active Comparator Temozolomide, Etoposide, Thiotepa oral chemotherapy 3: E-HIT-REZ 2005: Experimental Temozolomide, Etoposide, Trofosfamide Phase II Intravent. Etoposide: Experimental Etoposide Phase II Number of expected inclusions 200 patients Study start February 2006 Estimated Study Completion January 2016 Study phase Phase II Phase III Study Design National, multicentre, treatment, randomized, crossover assignment, active control efficacy study Orphanet Database. -
(12) United States Patent (10) Patent No.: US 8,580,267 B2 Pedretti Et Al
US008580267B2 (12) United States Patent (10) Patent No.: US 8,580,267 B2 Pedretti et al. (45) Date of Patent: Nov. 12, 2013 (54) IMMUNOCYTOKINES FORTUMOUR (56) References Cited THERAPY WITH CHEMOTHERAPEUTIC AGENTS FOREIGN PATENT DOCUMENTS (75) Inventors: Marta Pedretti, Zurich (CH): Dario WO O2/O59264 8, 2002 WO O3,O93478 11, 2003 Neri, Buchs (CH) WO 2004/OO2528 1, 2004 WO 2006/026020 3, 2006 (73) Assignee: Philogen S.p.A., Siena (IT) WO 2006/050834 5, 2006 WO 2007/128563 11, 2007 (*) Notice: Subject to any disclaimer, the term of this OTHER PUBLICATIONS patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. Paul, William, Fundamental Immunology, 3rd Edition, Raven Press, New York, 1993, pp. 292-295.* (21) Appl. No.: 13/139,655 Vajdos et al., Comprehensive functional maps of the antigen-binding site of an anti-ErbB2 antibody obtained with shotgun scanning 1-1. mutagenesis. J. Mol. Biol. 320:415-428, 2002.* (22) PCT Filed: Dec. 14, 2009 Bartolomei, M., et al. “Combined treatment of glioblastomapatients with locoregional pre-targeted 90Y-biotin radioimmunotherapy and (86). PCT No.: PCT/EP2009/008920 temozolomide.” QJNuclMed Mol Imaging. Sep. 2004:48(3):220-8. S371 (c)(1) Marlind, J., et al. "Antibody-mediated delivery of interleukin-2 to the (2), (4) Date. Jun. 14, 2011 Stroma of breast cancer strongly enhances the potency of chemo s 9 therapy” Clin Cancer Res. Oct. 15, 2008;14(20):6515-24. Brack, S.S., et al. “Tumor-targeting properties of novel antibodies (87) PCT Pub. No.: WO2010/078916 specific to the large isoform oftenascin-C.” Clin Cancer Res. -
NIH Public Access Author Manuscript CA Cancer J Clin
NIH Public Access Author Manuscript CA Cancer J Clin. Author manuscript; available in PMC 2012 July 1. NIH-PA Author ManuscriptPublished NIH-PA Author Manuscript in final edited NIH-PA Author Manuscript form as: CA Cancer J Clin. 2011 ; 61(4): 250±281. doi:10.3322/caac.20114. PHOTODYNAMIC THERAPY OF CANCER: AN UPDATE Patrizia Agostinis1, Kristian Berg2, Keith A. Cengel3, Thomas H. Foster4, Albert W. Girotti5, Sandra O. Gollnick6, Stephen M. Hahn3, Michael R. Hamblin7,8,9, Asta Juzeniene2, David Kessel10, Mladen Korbelik11, Johan Moan2,12, Pawel Mroz7,8, Dominika Nowis13, Jacques Piette14, Brian C. Wilson15, and Jakub Golab13,16,* 1Department of Molecular Cell Biology, Cell Death Research & Therapy Laboratory, Catholic University of Leuven, B-3000 Leuven, Belgium, [email protected] 2Department of Radiation Biology, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Montebello, N-0310 Oslo, Norway, [email protected]; [email protected] 3Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA 19004, USA, [email protected]; [email protected] 4Department of Imaging Sciences, University of Rochester, Rochester, NY 14642, USA, [email protected] 5Department of Biochemistry, Medical College of Wisconsin, Milwaukee, WI, 53226-3548, USA, [email protected] 6Department of Cell Stress Biology, Roswell Park Cancer Institute, Elm and Carlton Sts, Buffalo, NY, 14263, USA, [email protected] 7Wellman Center for Photomedicine, -
(12) United States Patent (10) Patent No.: US 9,005,660 B2 Tygesen Et Al
USOO9005660B2 (12) United States Patent (10) Patent No.: US 9,005,660 B2 Tygesen et al. (45) Date of Patent: Apr. 14, 2015 (54) IMMEDIATE RELEASE COMPOSITION 4,873,080 A 10, 1989 Bricklet al. RESISTANT TO ABUSEBY INTAKE OF 4,892,742 A 1, 1990 Shah 4,898,733. A 2f1990 DePrince et al. ALCOHOL 5,019,396 A 5/1991 Ayer et al. 5,068,112 A 11/1991 Samejima et al. (75) Inventors: Peter Holm Tygesen, Smoerum (DK); 5,082,655 A 1/1992 Snipes et al. Jan Martin Oevergaard, Frederikssund 5,102,668 A 4, 1992 Eichel et al. 5,213,808 A 5/1993 Bar Shalom et al. (DK); Joakim Oestman, Lomma (SE) 5,266,331 A 11/1993 Oshlack et al. 5,281,420 A 1/1994 Kelmet al. (73) Assignee: Egalet Ltd., London (GB) 5,352.455 A 10, 1994 Robertson 5,411,745 A 5/1995 Oshlack et al. (*) Notice: Subject to any disclaimer, the term of this 5,419,917 A 5/1995 Chen et al. patent is extended or adjusted under 35 5,422,123 A 6/1995 Conte et al. U.S.C. 154(b) by 473 days. 5,460,826 A 10, 1995 Merrill et al. 5,478,577 A 12/1995 Sackler et al. 5,508,042 A 4/1996 OShlack et al. (21) Appl. No.: 12/701.248 5,520,931 A 5/1996 Persson et al. 5,529,787 A 6/1996 Merrill et al. (22) Filed: Feb. 5, 2010 5,549,912 A 8, 1996 OShlack et al. -
Ep 2569287 B1
(19) TZZ _T (11) EP 2 569 287 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: C07D 413/04 (2006.01) C07D 239/46 (2006.01) 09.07.2014 Bulletin 2014/28 (86) International application number: (21) Application number: 11731562.2 PCT/US2011/036245 (22) Date of filing: 12.05.2011 (87) International publication number: WO 2011/143425 (17.11.2011 Gazette 2011/46) (54) COMPOUNDS USEFUL AS INHIBITORS OF ATR KINASE VERBINDUNGEN ALS HEMMER DER ATR-KINASE COMPOSÉS UTILISABLES EN TANT QU’INHIBITEURS DE LA KINASE ATR (84) Designated Contracting States: • VIRANI, Aniza, Nizarali AL AT BE BG CH CY CZ DE DK EE ES FI FR GB Abingdon GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO Oxfordshire OX144RY (GB) PL PT RO RS SE SI SK SM TR • REAPER, Philip, Michael Abingdon (30) Priority: 12.05.2010 US 333869 P Oxfordshire OX144RY (GB) (43) Date of publication of application: (74) Representative: Coles, Andrea Birgit et al 20.03.2013 Bulletin 2013/12 Kilburn & Strode LLP 20 Red Lion Street (73) Proprietor: Vertex Pharmaceuticals Inc. London WC1R 4PJ (GB) Boston, MA 02210 (US) (56) References cited: (72) Inventors: WO-A1-2010/054398 WO-A1-2010/071837 • CHARRIER, Jean-Damien Abingdon • C. A. HALL-JACKSON: "ATR is a caffeine- Oxfordshire OX144RY (GB) sensitive, DNA-activated protein kinase with a • DURRANT, Steven, John substrate specificity distinct from DNA-PK", Abingdon ONCOGENE, vol. 18, 1999, pages 6707-6713, Oxfordshire OX144RY (GB) XP002665425, cited in the application • KNEGTEL, Ronald, Marcellus Alphonsus Abingdon Oxfordshire OX144RY (GB) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
Modifications to the Harmonized Tariff Schedule of the United States To
U.S. International Trade Commission COMMISSIONERS Shara L. Aranoff, Chairman Daniel R. Pearson, Vice Chairman Deanna Tanner Okun Charlotte R. Lane Irving A. Williamson Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement the Dominican Republic- Central America-United States Free Trade Agreement With Respect to Costa Rica Publication 4038 December 2008 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 18, 2008, set forth in the Appendix hereto, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement the Dominican Republic- Central America-United States Free Trade Agreement, as approved in the Dominican Republic-Central America- United States Free Trade Agreement Implementation Act, with respect to Costa Rica. (This page is intentionally blank) Annex I Effective with respect to goods that are entered, or withdrawn from warehouse for consumption, on or after January 1, 2009, the Harmonized Tariff Schedule of the United States (HTS) is modified as provided herein, with bracketed matter included to assist in the understanding of proclaimed modifications. The following supersedes matter now in the HTS. (1). General note 4 is modified as follows: (a). by deleting from subdivision (a) the following country from the enumeration of independent beneficiary developing countries: Costa Rica (b).