CN1130223C - 包含生长激素,氨基酸和非离子去污剂的药物配方 - Google Patents

包含生长激素,氨基酸和非离子去污剂的药物配方 Download PDF

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Publication number
CN1130223C
CN1130223C CN97194040A CN97194040A CN1130223C CN 1130223 C CN1130223 C CN 1130223C CN 97194040 A CN97194040 A CN 97194040A CN 97194040 A CN97194040 A CN 97194040A CN 1130223 C CN1130223 C CN 1130223C
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China
Prior art keywords
growth hormone
amino acid
histidine
amount
formulation
Prior art date
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Expired - Lifetime
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CN97194040A
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English (en)
Chinese (zh)
Other versions
CN1216472A (zh
Inventor
S·比约恩
H·H·索伦森
P·朗巴勒
S·M·拉尔森
K·爱比霍
B·L·汉森
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Novo Nordisk Health Care AG
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Novo Nordisk AS
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Publication of CN1216472A publication Critical patent/CN1216472A/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/02Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/10Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Immunology (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Neurology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CN97194040A 1996-04-24 1997-04-24 包含生长激素,氨基酸和非离子去污剂的药物配方 Expired - Lifetime CN1130223C (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DK49096 1996-04-24
DK0490/96 1996-04-24
DK0490/1996 1996-04-24

Publications (2)

Publication Number Publication Date
CN1216472A CN1216472A (zh) 1999-05-12
CN1130223C true CN1130223C (zh) 2003-12-10

Family

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Application Number Title Priority Date Filing Date
CN97194040A Expired - Lifetime CN1130223C (zh) 1996-04-24 1997-04-24 包含生长激素,氨基酸和非离子去污剂的药物配方

Country Status (20)

Country Link
US (1) US20020077461A1 (OSRAM)
EP (2) EP0904099B1 (OSRAM)
JP (2) JP4176834B2 (OSRAM)
KR (1) KR20000010630A (OSRAM)
CN (1) CN1130223C (OSRAM)
AT (1) ATE309819T1 (OSRAM)
AU (1) AU733592B2 (OSRAM)
BR (1) BR9708858A (OSRAM)
CA (1) CA2252535C (OSRAM)
CZ (1) CZ298292B6 (OSRAM)
DE (1) DE69734653T2 (OSRAM)
DK (1) DK0904099T3 (OSRAM)
ES (1) ES2253774T3 (OSRAM)
HU (1) HU229868B1 (OSRAM)
IL (2) IL126463A0 (OSRAM)
NO (1) NO323360B1 (OSRAM)
PL (1) PL188222B1 (OSRAM)
RU (1) RU2236250C2 (OSRAM)
UA (1) UA66758C2 (OSRAM)
WO (1) WO1997039768A1 (OSRAM)

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US5981485A (en) 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
NZ332762A (en) 1996-07-24 2000-09-29 Warner Lambert Co Isobutylgaba and its derivatives for the treatment of pain
WO1999024071A1 (en) * 1997-11-12 1999-05-20 Alza Corporation Method for decreasing self-association of polypeptides
GB9803448D0 (en) * 1998-02-18 1998-04-15 Pharma Mar Sa Pharmaceutical formulation
JP4711520B2 (ja) * 2000-03-21 2011-06-29 日本ケミカルリサーチ株式会社 生理活性ペプチド含有粉末
AU8111301A (en) 2000-08-07 2002-02-18 Inhale Therapeutic Syst Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation
EP1603588A2 (en) * 2003-03-18 2005-12-14 Ares Trading S.A. Stabilisation of growth hormones in solution
CN106215226A (zh) 2003-03-24 2016-12-14 健赞公司 利用逆向热敏聚合物的暂时栓塞
DE10333317A1 (de) 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
WO2005046438A2 (en) * 2003-11-06 2005-05-26 Pluromed, Inc. Internal clamp for surgical procedures
BRPI0418115A (pt) * 2003-12-23 2007-04-17 Pharmacia Corp formulação lìquida estável de hormÈnio de crescimento
KR101120879B1 (ko) * 2004-04-07 2012-02-27 아레스 트레이딩 에스.아. 액체 성장 호르몬 제제
CA2594561C (en) * 2004-12-22 2014-12-23 Ambrx, Inc. Formulations of human growth hormone comprising a non-naturally encoded amino acid
JP2008525473A (ja) * 2004-12-22 2008-07-17 アンブレツクス・インコーポレイテツド 修飾されたヒト成長ホルモン
ZA200704928B (en) * 2004-12-22 2009-04-29 Ambrx Inc Formulations of human growth hormone comprising a non-naturally encoded amino acid
JP2009506096A (ja) 2005-08-30 2009-02-12 ノボ ノルディスク ヘルス ケア アーゲー ペグ化成長ホルモンの液状調製物
WO2007033427A1 (en) * 2005-09-23 2007-03-29 Metabolic Pharmaceuticals Limited Stabilisation of peptides with basic amino acids
CN1939534B (zh) * 2005-09-27 2010-12-01 长春金赛药业股份有限公司 含有人生长激素或人粒细胞巨噬细胞刺激因子的用于治疗损伤和溃疡的外用制剂
CN101505789A (zh) 2006-07-06 2009-08-12 株式会社大熊 稳定的人生长激素液体制剂
CN101495155A (zh) 2006-07-07 2009-07-29 诺沃-诺迪斯克保健股份有限公司 新的蛋白结合物及其制备方法
AU2007333959A1 (en) * 2006-12-18 2008-06-26 Altus Pharmaceuticals Inc. Human growth hormone formulations
CN103002918B (zh) 2010-01-22 2016-05-04 诺沃—诺迪斯克保健股份有限公司 体内功效延长的生长激素
RU2012134974A (ru) 2010-01-22 2014-02-27 Ново Нордиск Хелс Кеа Аг Стабилизированное соединение гормона роста
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
RU2592671C2 (ru) * 2010-09-21 2016-07-27 Ферринг Б.В. Улучшенный способ получения рекомбинантного человеческого гормона роста
US9216219B2 (en) 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
EP2872161B1 (en) 2012-06-26 2020-12-16 Del Mar Pharmaceuticals Dianhydrogalactitol for use in treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations
CN105120887A (zh) 2013-04-05 2015-12-02 诺和诺德保健股份有限公司 生长激素化合物制剂
AU2014251038A1 (en) 2013-04-08 2015-11-26 Dennis M. Brown Therapeutic benefit of suboptimally administered chemical compounds
US9993460B2 (en) 2013-07-26 2018-06-12 Race Oncology Ltd. Compositions to improve the therapeutic benefit of bisantrene and analogs and derivatives thereof
MX2016003705A (es) * 2013-09-27 2016-05-16 Hanmi Pharm Ind Co Ltd Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada.
US9119832B2 (en) 2014-02-05 2015-09-01 The Regents Of The University Of California Methods of treating mild brain injury
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HUE064656T2 (hu) 2016-03-28 2024-04-28 Incyte Corp Pirrolotriazin vegyületek mint TAM inhibitorok
WO2019049967A1 (ja) 2017-09-07 2019-03-14 Jcrファーマ株式会社 水性医薬組成物
SMT202200011T1 (it) 2017-09-27 2022-03-21 Incyte Corp Sali di derivati di pirrolotriazina utili come inibitori di tam
KR102839002B1 (ko) 2018-06-29 2025-07-29 인사이트 코포레이션 Axl/mer 억제제의 제형
PH12022552347A1 (en) 2020-03-06 2024-01-29 Incyte Corp Combination therapy comprising axl/mer and pd-1/pd-l1 inhibitors
CN115634284B (zh) * 2022-10-31 2025-02-11 景泽生物医药(合肥)股份有限公司 一种促性腺激素冻干制剂及其制备方法

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US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
RO111990B1 (ro) * 1991-12-20 1997-04-30 Novo Nordisk As Preparate farmaceutice, continand un hormon de crestere sau un derivat al acestuia, si procedeu de preparare
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Also Published As

Publication number Publication date
EP0904099B1 (en) 2005-11-16
AU733592B2 (en) 2001-05-17
PL329386A1 (en) 1999-03-29
NO984951L (no) 1998-10-23
EP1629832A1 (en) 2006-03-01
ATE309819T1 (de) 2005-12-15
CZ298292B6 (cs) 2007-08-15
CA2252535C (en) 2009-06-23
KR20000010630A (ko) 2000-02-25
UA66758C2 (en) 2004-06-15
JP2008231124A (ja) 2008-10-02
WO1997039768A1 (en) 1997-10-30
HUP9902476A3 (en) 2000-12-28
JP2000508665A (ja) 2000-07-11
RU2236250C2 (ru) 2004-09-20
CN1216472A (zh) 1999-05-12
US20020077461A1 (en) 2002-06-20
CZ320798A3 (cs) 1999-03-17
IL126463A (en) 2007-06-17
DK0904099T3 (da) 2006-03-06
EP0904099A1 (en) 1999-03-31
HUP9902476A2 (hu) 2000-11-28
CA2252535A1 (en) 1997-10-30
PL188222B1 (pl) 2004-12-31
NO984951D0 (no) 1998-10-23
IL126463A0 (en) 1999-08-17
ES2253774T3 (es) 2006-06-01
BR9708858A (pt) 1999-08-03
AU2634397A (en) 1997-11-12
DE69734653D1 (de) 2005-12-22
DE69734653T2 (de) 2006-08-10
NO323360B1 (no) 2007-04-10
HU229868B1 (en) 2014-10-28
JP4176834B2 (ja) 2008-11-05

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