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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (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
DK0490/96 1996-04-24
DK0490/1996 1996-04-24
DK49096 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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Family Applications (1)

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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 (2)
EP (2) EP1629832A1 (2)
JP (2) JP4176834B2 (2)
KR (1) KR20000010630A (2)
CN (1) CN1130223C (2)
AT (1) ATE309819T1 (2)
AU (1) AU733592B2 (2)
BR (1) BR9708858A (2)
CA (1) CA2252535C (2)
CZ (1) CZ298292B6 (2)
DE (1) DE69734653T2 (2)
DK (1) DK0904099T3 (2)
ES (1) ES2253774T3 (2)
HU (1) HU229868B1 (2)
IL (2) IL126463A0 (2)
NO (1) NO323360B1 (2)
PL (1) PL188222B1 (2)
RU (1) RU2236250C2 (2)
UA (1) UA66758C2 (2)
WO (1) WO1997039768A1 (2)

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IL126999A (en) 1996-07-24 2002-03-10 Warner Lambert Co Pharmaceutical preparations containing isobutylgaba and its history for use in the treatment of pain
CA2309955A1 (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
TWI283182B (en) 2000-08-07 2007-07-01 Nektar Therapeutics Inhalable spray dried 4-helix bundle protein powders having minimized aggregation
JP4949828B2 (ja) * 2003-03-18 2012-06-13 アレス トレーディング ソシエテ アノニム 溶液中での成長ホルモンの安定化
JP4909071B2 (ja) 2003-03-24 2012-04-04 プルーローメッド, インコーポレイテッド 逆感熱性ポリマーを使用する一時的な塞栓形成
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
US8338374B2 (en) * 2003-12-23 2012-12-25 Pharmacia Corporation Stable growth hormone liquid formulation
US7662393B2 (en) * 2004-04-07 2010-02-16 Ares Trading S.A. Liquid growth hormone formulation and method of use
US7816320B2 (en) * 2004-12-22 2010-10-19 Ambrx, Inc. Formulations of human growth hormone comprising a non-naturally encoded amino acid at position 35
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
CN101356269A (zh) * 2004-12-22 2009-01-28 Ambrx公司 表达和纯化重组人类生长激素的方法
CN101268098A (zh) 2005-08-30 2008-09-17 诺沃-诺迪斯克保健股份有限公司 聚乙二醇化生长激素的液体制剂
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
EP2049148B1 (en) * 2006-07-06 2016-09-28 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
BRPI0713963A2 (pt) 2006-07-07 2012-11-27 Novo Nordisk Healthcare Ag conjugados de proteìna e métodos para sua preparação
AU2007333959A1 (en) * 2006-12-18 2008-06-26 Altus Pharmaceuticals Inc. Human growth hormone formulations
JP5980689B2 (ja) 2010-01-22 2016-08-31 ノヴォ・ノルディスク・ヘルス・ケア・アーゲー 安定な成長ホルモン化合物
CN118767117A (zh) 2010-01-22 2024-10-15 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
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
MX339605B (es) * 2010-09-21 2016-06-02 Ferring Bv Proceso mejorado para produccion de la hormona de crecimiento humano recombinante.
US9216219B2 (en) 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
JP6280546B2 (ja) 2012-06-26 2018-02-14 デル マー ファーマシューティカルズ ジアンヒドロガラクチトール、ジアセチルジアンヒドロガラクチトール、ジブロモズルシトール、又はこれらの類似体若しくは誘導体を用いた、遺伝子多型又はahi1の調節不全若しくは変異を有する患者におけるチロシンキナーゼインヒビター抵抗性悪性腫瘍を処置するための方法
US11045523B2 (en) 2013-04-05 2021-06-29 Novo Nordisk Healthcare Ag Formulation of growth hormone albumin-binder conjugate
EP2983674A4 (en) 2013-04-08 2017-05-10 Dennis M. Brown Therapeutic benefit of suboptimally administered chemical compounds
CN105764501A (zh) 2013-07-26 2016-07-13 现代化制药公司 改善比生群治疗效益的组合物
TW201605468A (zh) * 2013-09-27 2016-02-16 韓美藥品股份有限公司 長效人類生長激素接合物之製劑
US9119832B2 (en) 2014-02-05 2015-09-01 The Regents Of The University Of California Methods of treating mild brain injury
WO2017075535A1 (en) 2015-10-28 2017-05-04 Oxeia Biopharmaceuticals, Inc. Methods of treating neurodegenerative conditions
MD3436461T2 (ro) 2016-03-28 2024-05-31 Incyte Corp Compuși pirolotriazină ca inhibitori TAM
KR102655498B1 (ko) 2017-09-07 2024-04-11 제이씨알 파마 가부시키가이샤 수성 의약 조성물
SI3687996T1 (sl) 2017-09-27 2022-04-29 Incyte Corporation Soli pirolotriazinskih derivatov, ki so uporabne kot zaviralci TAM
MD3813800T2 (ro) 2018-06-29 2025-10-31 Incyte Corp Formulări de inhibitor al AXL/MER
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Also Published As

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

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