PL393608A1 - Kryształy E bezwodnego aripiprazolu i sposób ich wytwarzania oraz kompozycja farmaceutyczna je zawierająca, farmaceutyczny stały preparat doustny i sposób jego wytwarzania oraz sposób wytwarzania granulek - Google Patents

Kryształy E bezwodnego aripiprazolu i sposób ich wytwarzania oraz kompozycja farmaceutyczna je zawierająca, farmaceutyczny stały preparat doustny i sposób jego wytwarzania oraz sposób wytwarzania granulek

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Publication number
PL393608A1
PL393608A1 PL393608A PL39360802A PL393608A1 PL 393608 A1 PL393608 A1 PL 393608A1 PL 393608 A PL393608 A PL 393608A PL 39360802 A PL39360802 A PL 39360802A PL 393608 A1 PL393608 A1 PL 393608A1
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Poland
Prior art keywords
preparation
crystals
solid oral
pharmaceutical
pharmaceutical composition
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PL393608A
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English (en)
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PL219564B1 (pl
Inventor
Takuji Bando
Satoshi Aoki
Junichi Kawasaki
Makoto Ishigami
Youichi Tanigichi
Tsuyoshi Yabuuchi
Kiyoshi Fujimoto
Yoshihiro Nishioka
Noriyuki Kobayashi
Tsutomu Fujimura
Masanori Takahashi
Kaoru Abe
Tomonori Nakagawa
Koichi Shinhama
Naoto Utsumi
Michiaki Tominaga
Yoshihiro Oi
Shohei Yamada
Kenij Tomikawa
Original Assignee
Otsuka Pharmaceutical Co, Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36049773&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL393608(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from CA 2379005 external-priority patent/CA2379005A1/en
Application filed by Otsuka Pharmaceutical Co, Ltd. filed Critical Otsuka Pharmaceutical Co, Ltd.
Publication of PL393608A1 publication Critical patent/PL393608A1/pl
Publication of PL219564B1 publication Critical patent/PL219564B1/pl

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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/20—Oxygen atoms
    • C07D215/22—Oxygen atoms attached in position 2 or 4
    • C07D215/227—Oxygen atoms attached in position 2 or 4 only one oxygen atom which is attached in position 2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/20—Oxygen atoms
    • C07D215/22—Oxygen atoms attached in position 2 or 4
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P15/10—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
    • A61P25/00—Drugs for disorders of the nervous 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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    • 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
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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    • C07B2200/13—Crystalline forms, e.g. polymorphs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Epidemiology (AREA)
  • Addiction (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Reproductive Health (AREA)
  • Pain & Pain Management (AREA)
  • Endocrinology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Otolaryngology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Gynecology & Obstetrics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

Przedmiotem wynalazku są kryształy E bezwodnego aripiprazolu i sposób ich wytwarzania, kompozycja farmaceutyczna oraz farmaceutyczny stały preparat doustny zawierający kryształy E bezwodnego aripiprazolu, sposób wytwarzania takiego farmaceutycznego stałego preparatu doustnego oraz sposób wytwarzania granulek. Opracowana niskohigroskopijna postać aripiprazolu nie przekształca się w hydrat i nie traci swojej początkowej rozpuszczalności nawet wtedy, gdy preparat leczniczy zawierający kryształy bezwodnego aripiprazolu przechowuje się w ciągu dłuższego okresu czasu.
PL393608A 2001-09-25 2002-09-25 Kryształy E bezwodnego aripiprazolu, sposób ich wytwarzania, kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny zawierające kryształy E bezwodnego aripiprazolu PL219564B1 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2001290645 2001-09-25
JP2001348276 2001-11-14
CA 2379005 CA2379005A1 (en) 2001-09-25 2002-03-27 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof

Publications (2)

Publication Number Publication Date
PL393608A1 true PL393608A1 (pl) 2011-03-14
PL219564B1 PL219564B1 (pl) 2015-05-29

Family

ID=36049773

Family Applications (7)

Application Number Title Priority Date Filing Date
PL393607A PL393607A1 (pl) 2001-09-25 2002-09-25 Sposób wytwarzania granulek farmaceutycznego stałego preparat doustnego i sposób wytwarzania farmaceutycznego stałego preparatu doustnego oraz farmaceutyczny stały preparat doustny
PL393603A PL221536B1 (pl) 2001-09-25 2002-09-25 Kryształy C bezwodnego aripiprazolu i sposób ich wytwarzania oraz zawierające je kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny
PL417178A PL230869B1 (pl) 2001-09-25 2002-09-25 Hydrat A aripiprazolu i sposób jego wytwarzania
PL393608A PL219564B1 (pl) 2001-09-25 2002-09-25 Kryształy E bezwodnego aripiprazolu, sposób ich wytwarzania, kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny zawierające kryształy E bezwodnego aripiprazolu
PL393601A PL219565B1 (pl) 2001-09-25 2002-09-25 Kryształy D bezwodnego aripiprazolu, sposób ich wytwarzania, kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny zawierające kryształy D bezwodnego aripiprazolu
PL393596A PL393596A1 (pl) 2001-09-25 2002-09-25 Kryształy G bezwodnego aripiprazolu i sposób ich wytwarzania oraz kompozycja farmaceutyczna je zawierająca, farmaceutyczny stały preparat doustny i sposób jego wytwarzania oraz sposób wytwarzania granulek
PL393598A PL221521B1 (pl) 2001-09-25 2002-09-25 Kryształy F bezwodnego aripiprazolu i sposób ich wytwarzania oraz zawierające je kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny

Family Applications Before (3)

Application Number Title Priority Date Filing Date
PL393607A PL393607A1 (pl) 2001-09-25 2002-09-25 Sposób wytwarzania granulek farmaceutycznego stałego preparat doustnego i sposób wytwarzania farmaceutycznego stałego preparatu doustnego oraz farmaceutyczny stały preparat doustny
PL393603A PL221536B1 (pl) 2001-09-25 2002-09-25 Kryształy C bezwodnego aripiprazolu i sposób ich wytwarzania oraz zawierające je kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny
PL417178A PL230869B1 (pl) 2001-09-25 2002-09-25 Hydrat A aripiprazolu i sposób jego wytwarzania

Family Applications After (3)

Application Number Title Priority Date Filing Date
PL393601A PL219565B1 (pl) 2001-09-25 2002-09-25 Kryształy D bezwodnego aripiprazolu, sposób ich wytwarzania, kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny zawierające kryształy D bezwodnego aripiprazolu
PL393596A PL393596A1 (pl) 2001-09-25 2002-09-25 Kryształy G bezwodnego aripiprazolu i sposób ich wytwarzania oraz kompozycja farmaceutyczna je zawierająca, farmaceutyczny stały preparat doustny i sposób jego wytwarzania oraz sposób wytwarzania granulek
PL393598A PL221521B1 (pl) 2001-09-25 2002-09-25 Kryształy F bezwodnego aripiprazolu i sposób ich wytwarzania oraz zawierające je kompozycja farmaceutyczna i farmaceutyczny stały preparat doustny

Country Status (21)

Country Link
EP (1) EP3081216A1 (pl)
KR (2) KR100530731B1 (pl)
CN (12) CN103751118A (pl)
AR (3) AR073111A2 (pl)
CA (1) CA2713466C (pl)
CL (1) CL2010000405A1 (pl)
CY (4) CY1110212T1 (pl)
DK (1) DK1925308T3 (pl)
ES (1) ES2596354T3 (pl)
HK (5) HK1203059A1 (pl)
IL (3) IL204707A (pl)
LT (1) LT1925308T (pl)
MY (1) MY138669A (pl)
NO (1) NO337844B1 (pl)
PE (1) PE20030445A1 (pl)
PH (1) PH12014500782A1 (pl)
PL (7) PL393607A1 (pl)
PT (1) PT1925308T (pl)
RU (1) RU2279429C2 (pl)
SI (1) SI1927357T1 (pl)
TW (2) TWI318572B (pl)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE411797T2 (de) * 2003-10-23 2008-11-15 Otsuka Pharma Co Ltd Sterile injizierbare aripiprazol-formulierung mit kontrollierter freisetzung und verfahren
JOP20200109A1 (ar) * 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن
KR102128883B1 (ko) * 2019-10-02 2020-07-01 (주)삼화바이오팜 고순도 아리피프라졸의 신규 결정형 및 이의 제조방법

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54130587A (en) * 1978-03-30 1979-10-09 Otsuka Pharmaceut Co Ltd Carbostyryl derivative
JP2608788B2 (ja) 1988-10-31 1997-05-14 大塚製薬 株式会社 精神分裂病治療剤
US5006528A (en) * 1988-10-31 1991-04-09 Otsuka Pharmaceutical Co., Ltd. Carbostyril derivatives
JP3638447B2 (ja) * 1998-09-10 2005-04-13 積水ハウス株式会社 笠木取付金具および笠木取付構造
GB9930061D0 (en) * 1999-12-20 2000-02-09 Glaxo Group Ltd Quinolone compounds for use in treating viral infections
NZ519981A (en) * 2000-01-20 2005-02-25 Eisai Co Ltd Nitrogenous cyclic compounds and pharmaceutical compositions containing the same
CA2311734C (en) * 2000-04-12 2011-03-08 Bristol-Myers Squibb Company Flash-melt oral dosage formulation
US20020076437A1 (en) * 2000-04-12 2002-06-20 Sanjeev Kothari Flashmelt oral dosage formulation
JP4197088B2 (ja) 2000-06-05 2008-12-17 電気化学工業株式会社 低密度かつ低ガス透過性六方晶窒化硼素焼結体及びその製造方法
JP2002193915A (ja) * 2000-12-28 2002-07-10 Otsuka Pharmaceut Co Ltd ベンゼンスルフォナート化合物

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NO337844B1 (no) 2016-06-27
CN104945321A (zh) 2015-09-30
CN103751119A (zh) 2014-04-30
TWI318572B (en) 2009-12-21
EP3081216A1 (en) 2016-10-19
CY1110212T1 (el) 2015-01-14
PL393596A1 (pl) 2011-04-26
IL204707A0 (en) 2010-11-30
HK1136960A1 (en) 2010-07-16
ES2596354T3 (es) 2017-01-09
TW200942238A (en) 2009-10-16
RU2279429C2 (ru) 2006-07-10
HK1092808A1 (en) 2007-02-16
CN103288727B (zh) 2016-04-27
HK1203060A1 (en) 2015-10-16
IL204707A (en) 2016-06-30
NO20141193L (no) 2003-01-17
HK1136959A1 (en) 2010-07-16
PL230869B1 (pl) 2018-12-31
AR073111A2 (es) 2010-10-13
CL2010000405A1 (es) 2010-10-15
PL393603A1 (pl) 2011-04-26
HK1136958A1 (en) 2010-07-16
CN105267151A (zh) 2016-01-27
CN103288727A (zh) 2013-09-11
CY1110208T1 (el) 2015-01-14
PL221521B1 (pl) 2016-04-29
HK1215397A1 (zh) 2016-08-26
CN103755632A (zh) 2014-04-30
HK1223043A1 (zh) 2017-07-21
CY1110244T1 (el) 2015-01-14
SI1927357T1 (sl) 2010-09-30
AR077635A2 (es) 2011-09-14
HK1129891A1 (en) 2009-12-11
PT1925308T (pt) 2016-10-24
KR100490222B1 (ko) 2005-05-18
CN104306374A (zh) 2015-01-28
PL393607A1 (pl) 2011-03-14
HK1196128A1 (zh) 2014-12-05
HK1203059A1 (en) 2015-10-16
RU2004126636A (ru) 2006-02-10
CN103751118A (zh) 2014-04-30
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