EA011568B1 - Способы и фармацевтические композиции для достоверного достижения приемлемых уровней тестостерона в сыворотке - Google Patents

Способы и фармацевтические композиции для достоверного достижения приемлемых уровней тестостерона в сыворотке Download PDF

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Publication number
EA011568B1
EA011568B1 EA200501819A EA200501819A EA011568B1 EA 011568 B1 EA011568 B1 EA 011568B1 EA 200501819 A EA200501819 A EA 200501819A EA 200501819 A EA200501819 A EA 200501819A EA 011568 B1 EA011568 B1 EA 011568B1
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EA
Eurasian Patent Office
Prior art keywords
testosterone
dose
castor oil
carrier
injection
Prior art date
Application number
EA200501819A
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English (en)
Russian (ru)
Other versions
EA200501819A1 (ru
Inventor
Дорис Хюблер
Забине Фрикке
Ян-Петер Ингверзен
Вильхельм Кунц
Original Assignee
Шеринг Акциенгезельшафт
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32748728&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA011568(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Шеринг Акциенгезельшафт filed Critical Шеринг Акциенгезельшафт
Publication of EA200501819A1 publication Critical patent/EA200501819A1/ru
Publication of EA011568B1 publication Critical patent/EA011568B1/ru

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/16—Masculine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Rheumatology (AREA)
  • Psychiatry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
EA200501819A 2003-03-14 2004-03-15 Способы и фармацевтические композиции для достоверного достижения приемлемых уровней тестостерона в сыворотке EA011568B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200300399 2003-03-14
PCT/IB2004/000716 WO2004080383A2 (en) 2003-03-14 2004-03-15 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels

Publications (2)

Publication Number Publication Date
EA200501819A1 EA200501819A1 (ru) 2006-06-30
EA011568B1 true EA011568B1 (ru) 2009-04-28

Family

ID=32748728

Family Applications (1)

Application Number Title Priority Date Filing Date
EA200501819A EA011568B1 (ru) 2003-03-14 2004-03-15 Способы и фармацевтические композиции для достоверного достижения приемлемых уровней тестостерона в сыворотке

Country Status (39)

Country Link
US (2) US7718640B2 (OSRAM)
EP (2) EP1457208B9 (OSRAM)
JP (1) JP4680891B2 (OSRAM)
KR (2) KR20080096717A (OSRAM)
CN (2) CN101884639A (OSRAM)
AR (1) AR043603A1 (OSRAM)
AT (1) ATE336251T1 (OSRAM)
AU (1) AU2004218893B2 (OSRAM)
BR (2) BR122017008910A8 (OSRAM)
CA (1) CA2518910C (OSRAM)
CL (1) CL2004000527A1 (OSRAM)
CO (1) CO5700724A2 (OSRAM)
CR (1) CR7999A (OSRAM)
CY (1) CY1105794T1 (OSRAM)
DE (1) DE602004001893T2 (OSRAM)
DK (1) DK1457208T3 (OSRAM)
EA (1) EA011568B1 (OSRAM)
EC (1) ECSP056095A (OSRAM)
ES (1) ES2271772T3 (OSRAM)
HR (1) HRP20050781B1 (OSRAM)
IL (1) IL170473A (OSRAM)
IS (1) IS2565B (OSRAM)
JO (1) JO2505B1 (OSRAM)
ME (2) MEP14508A (OSRAM)
MX (1) MXPA04002395A (OSRAM)
NO (1) NO335179B1 (OSRAM)
NZ (1) NZ542321A (OSRAM)
PE (1) PE20041065A1 (OSRAM)
PL (1) PL1457208T3 (OSRAM)
PT (1) PT1457208E (OSRAM)
RS (1) RS51537B (OSRAM)
RU (2) RU2354381C2 (OSRAM)
SA (1) SA04250040B1 (OSRAM)
SI (1) SI1457208T1 (OSRAM)
TW (1) TWI345976B (OSRAM)
UA (1) UA82510C2 (OSRAM)
UY (1) UY28231A1 (OSRAM)
WO (1) WO2004080383A2 (OSRAM)
ZA (2) ZA200508313B (OSRAM)

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US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
GB0807605D0 (en) 2008-04-28 2008-06-04 Diurnal Ltd Lipid composition
AU2014200332B2 (en) * 2008-04-28 2016-10-06 Diurnal Limited Lipid composition
WO2010094623A1 (en) 2009-02-18 2010-08-26 Bayer Schering Pharma Aktiengesellschaft Formulation comprising drospirenone for subcutaneous or intramuscular administration
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US20180153904A1 (en) 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US9358241B2 (en) 2010-11-30 2016-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions
US20130178454A1 (en) * 2011-11-17 2013-07-11 Shalender Bhasin Combination of testosterone and ornithine decarboxylase (odc) inhibitors
EP2833944A4 (en) 2012-04-06 2016-05-25 Antares Pharma Inc ADMINISTRATION OF TESTOSTERONE COMPOSITIONS BY NEEDLE-SUPPORTED NOZZLE INJECTION
AR091006A1 (es) * 2012-05-09 2014-12-30 Univ Western Health Sciences Formulaciones de testosterona proliposomal
US20140171918A1 (en) * 2012-12-14 2014-06-19 Bioject, Inc. Use of a novel subcutaneous needle-free technique to deliver testosterone in hypogonadal men
PT2953667T (pt) * 2013-02-11 2020-01-28 Antares Pharma Inc Dispositivo de injeção a jato auxiliado por agulha tendo força de gatilho reduzida
TW201521731A (zh) * 2013-03-15 2015-06-16 利波辛股份有限公司 用於口服之脂平衡的長鏈睪固酮酯
EP3033138A4 (en) * 2013-08-12 2017-03-29 Nanomedical Systems Inc. Device and method for sustained release of low water solubility therapeutic agent in solubilizer
EA201692083A1 (ru) 2014-04-16 2017-03-31 Вейкс-Фарма Гмбх Фармацевтическая композиция для ветеринарии и ее применение
US9498485B2 (en) 2014-08-28 2016-11-22 Lipocine Inc. Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
US20170246187A1 (en) 2014-08-28 2017-08-31 Lipocine Inc. (17-ß)-3-OXOANDROST-4-EN-17-YL TRIDECANOATE COMPOSITIONS AND METHODS OF THEIR PREPARATION AND USE
US20160361322A1 (en) 2015-06-15 2016-12-15 Lipocine Inc. Composition and method for oral delivery of androgen prodrugs
CN105056115A (zh) * 2015-08-05 2015-11-18 成都市飞龙水处理技术研究所 一种治疗化脓性睾丸炎的内服药物及其制备方法
US20180147215A1 (en) 2016-11-28 2018-05-31 Lipocine Inc. Oral testosterone undecanoate therapy
US11311554B2 (en) 2018-04-04 2022-04-26 Slayback Pharma Llc Pharmaceutical compositions of testosterone
US12150945B2 (en) 2018-07-20 2024-11-26 Lipocine Inc. Liver disease
KR102051808B1 (ko) * 2018-07-23 2019-12-04 주식회사 종근당 테스토스테론 운데카노에이트를 포함하는 안정한 약제학적 조성물
WO2020118437A1 (en) * 2018-12-14 2020-06-18 Acerus Biopharma Inc. Active ester derivatives of testosterone, compositions and uses thereof
US11564933B2 (en) 2019-04-12 2023-01-31 Tolmar, Inc. Methods of treating testosterone deficiency
EP4038147A4 (en) * 2019-10-03 2024-02-07 Caren Pharmaceuticals, Inc. COMBINATORIAL HORMONAL THERAPIES AND FORMULATIONS
CA3184810A1 (en) * 2020-06-11 2021-12-16 Ash Stevens, Llc Monomeric and oligomeric compound embodiments as contraceptives and therapies and methods of making and using the same
US12257257B2 (en) * 2023-07-27 2025-03-25 Lipocine, Inc. Testosterone dodecanoate compositions and methods
KR20250176964A (ko) * 2024-06-13 2025-12-22 주식회사 종근당 타다라필 또는 이의 약학적으로 허용가능한 염을 포함하는 주사용 조성물

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DE2548413A1 (de) * 1975-10-27 1977-04-28 Schering Ag Depotpraeparate in oeliger ungesaettigter loesung zur intramuskulaeren injektion
US4212863A (en) * 1977-10-29 1980-07-15 Akzo N.V. Highly concentrated pharmaceutical formulations of steroids and processes for their preparation
WO1995012383A1 (en) * 1993-10-30 1995-05-11 Zhejiang Medical University An injectable solution of testosterone undecanoate
WO1997040823A1 (en) * 1996-04-26 1997-11-06 R.P. Scherer Limited Oral pharmaceutical compositions containing sex hormones
WO1998036770A1 (en) * 1997-02-24 1998-08-27 Cortendo Ab Preparations for the treatment of metabolic syndrome containing human growth hormone in combination with a cortisol synthesis inhibitor
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RU2216546C2 (ru) 1998-06-19 2003-11-20 Акцо Нобель Н.В. СОЕДИНЕНИЕ (7α,17β)-7-МЕТИЛ-17-[(1-ОКСОУНДЕЦИЛ)ОКСИ]ЭСТР-4-ЕН-3-ОН, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, НАБОР ДЛЯ МУЖСКОЙ КОНТРАЦЕПЦИИ
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DE2548413A1 (de) * 1975-10-27 1977-04-28 Schering Ag Depotpraeparate in oeliger ungesaettigter loesung zur intramuskulaeren injektion
US4212863A (en) * 1977-10-29 1980-07-15 Akzo N.V. Highly concentrated pharmaceutical formulations of steroids and processes for their preparation
WO1995012383A1 (en) * 1993-10-30 1995-05-11 Zhejiang Medical University An injectable solution of testosterone undecanoate
WO1997040823A1 (en) * 1996-04-26 1997-11-06 R.P. Scherer Limited Oral pharmaceutical compositions containing sex hormones
WO1998036770A1 (en) * 1997-02-24 1998-08-27 Cortendo Ab Preparations for the treatment of metabolic syndrome containing human growth hormone in combination with a cortisol synthesis inhibitor
WO2000059512A1 (en) * 1999-04-01 2000-10-12 Akzo Nobel N.V. Formulation comprising testosteron undecanoate and castor oil

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DATABASE WPI, Section Ch, Week 199524, Derwent Publications Ltd., London, GB; Class B01, AN 1995-185577, XP002264337 & WO 95/12383 A (UNIV ZHEJIANG MEDICAL), 11 May 1995 (1995-05-11), cited in the application, abstract *

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EA200501819A1 (ru) 2006-06-30
US20090156564A1 (en) 2009-06-18
RU2007118196A (ru) 2008-11-27
ME00149B (me) 2010-06-10
AU2004218893B2 (en) 2008-10-09
TWI345976B (en) 2011-08-01
SI1457208T1 (sl) 2007-02-28
AU2004218893A1 (en) 2004-09-23
HRP20050781B1 (hr) 2015-04-10
ZA200508313B (en) 2007-04-25
EP1457208B1 (en) 2006-08-16
PE20041065A1 (es) 2005-02-24
JO2505B1 (en) 2009-10-05
WO2004080383B1 (en) 2005-05-06
UA82510C2 (uk) 2008-04-25
RS51537B (sr) 2011-06-30
NO20054711D0 (no) 2005-10-13
CN1761469A (zh) 2006-04-19
ATE336251T1 (de) 2006-09-15
US8338395B2 (en) 2012-12-25
KR20080096717A (ko) 2008-10-31
UY28231A1 (es) 2004-11-08
NZ542321A (en) 2008-05-30
AR043603A1 (es) 2005-08-03
HK1069325A1 (en) 2005-05-20
US20050032762A1 (en) 2005-02-10
US7718640B2 (en) 2010-05-18
IS2565B (is) 2009-12-15
PL1457208T3 (pl) 2007-01-31
RU2354381C2 (ru) 2009-05-10
TW200511997A (en) 2005-04-01
EP1457208B9 (en) 2006-10-25
CA2518910A1 (en) 2004-09-23
DK1457208T3 (da) 2006-12-11
BRPI0400214A8 (pt) 2023-05-09
MEP14508A (en) 2010-06-10
PT1457208E (pt) 2007-01-31
BRPI0400214A (pt) 2005-02-09
BR122017008910A8 (pt) 2023-05-09
KR100882378B1 (ko) 2009-02-05
WO2004080383A2 (en) 2004-09-23
IS8069A (is) 2005-10-12
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