BRPI0922804A8 - formas de dosagem sólidas de bendamustina - Google Patents

formas de dosagem sólidas de bendamustina

Info

Publication number
BRPI0922804A8
BRPI0922804A8 BRPI0922804A BRPI0922804A BRPI0922804A8 BR PI0922804 A8 BRPI0922804 A8 BR PI0922804A8 BR PI0922804 A BRPI0922804 A BR PI0922804A BR PI0922804 A BRPI0922804 A BR PI0922804A BR PI0922804 A8 BRPI0922804 A8 BR PI0922804A8
Authority
BR
Brazil
Prior art keywords
bendamustine
dosage forms
solid dosage
solid
forms
Prior art date
Application number
BRPI0922804A
Other languages
English (en)
Inventor
Colledge Jeffrey
Olthoff Margaretha
Alfred Profitlich Thomas
Ouatas Taoufik
Patzak Ulrich
Original Assignee
Astellas Deutschland Gmbh
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.)
Filing date
Publication date
Application filed by Astellas Deutschland Gmbh filed Critical Astellas Deutschland Gmbh
Publication of BRPI0922804A2 publication Critical patent/BRPI0922804A2/pt
Publication of BRPI0922804A8 publication Critical patent/BRPI0922804A8/pt
Publication of BRPI0922804B1 publication Critical patent/BRPI0922804B1/pt
Publication of BRPI0922804B8 publication Critical patent/BRPI0922804B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/243Platinum; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
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    • 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
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    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
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    • AHUMAN NECESSITIES
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    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
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    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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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
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    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
BRPI0922804A 2008-12-03 2009-12-03 composição farmacêutica em uma forma de dosagem sólida compreendendo bendamustina e um excipiente farmaceuticamente aceitável BRPI0922804B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08020996.8 2008-12-03
EP08020996 2008-12-03
PCT/EP2009/008639 WO2010063476A2 (en) 2008-12-03 2009-12-03 Solid dosage forms of bendamustine

Publications (4)

Publication Number Publication Date
BRPI0922804A2 BRPI0922804A2 (pt) 2015-12-22
BRPI0922804A8 true BRPI0922804A8 (pt) 2017-12-26
BRPI0922804B1 BRPI0922804B1 (pt) 2020-11-17
BRPI0922804B8 BRPI0922804B8 (pt) 2021-05-25

Family

ID=40588072

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0922804A BRPI0922804B8 (pt) 2008-12-03 2009-12-03 composição farmacêutica em uma forma de dosagem sólida compreendendo bendamustina e um excipiente farmaceuticamente aceitável

Country Status (26)

Country Link
US (4) US20120003309A1 (pt)
EP (1) EP2367538B1 (pt)
JP (3) JP5658679B2 (pt)
KR (1) KR101710935B1 (pt)
CN (2) CN107080742B (pt)
AU (1) AU2009321728B2 (pt)
BR (1) BRPI0922804B8 (pt)
CA (1) CA2745509A1 (pt)
CO (1) CO6400185A2 (pt)
CY (1) CY1119839T1 (pt)
DK (1) DK2367538T3 (pt)
EA (1) EA028179B1 (pt)
ES (1) ES2645008T3 (pt)
HR (1) HRP20171421T1 (pt)
HU (1) HUE036481T2 (pt)
IL (1) IL213269A (pt)
LT (1) LT2367538T (pt)
MX (1) MX2011005633A (pt)
NZ (1) NZ592971A (pt)
PL (1) PL2367538T3 (pt)
PT (1) PT2367538T (pt)
RS (1) RS56408B1 (pt)
SI (1) SI2367538T1 (pt)
UA (2) UA107186C2 (pt)
WO (1) WO2010063476A2 (pt)
ZA (1) ZA201103790B (pt)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA107186C2 (xx) * 2008-12-03 2014-12-10 Тверді форми дозування бендамустину
MX2012013872A (es) 2010-06-02 2013-04-03 Astellas Deutschland Gmbh Formas de dosificacion oral de bendamustina.
JO3659B1 (ar) * 2010-06-02 2020-08-27 Astellas Deutschland Gmbh أشكال جرعات بينداموستين عن طريق الفم وإستخداماته العلاجية
CN102375044B (zh) * 2010-08-18 2015-04-08 重庆华邦胜凯制药有限公司 一种盐酸苯达莫司汀中间体z6有关物质的分析方法
EP2641592A1 (en) 2012-03-23 2013-09-25 Salmon Pharma GmbH Pharmaceutical formulation comprising bendamustine
JP2016153374A (ja) * 2013-06-25 2016-08-25 シンバイオ製薬株式会社 炎症性疾患を治療又は予防するための医薬組成物
CN105491886B (zh) 2013-08-27 2019-01-29 V·沃道里斯 苯达莫司汀医药组合物
CN105566226B (zh) * 2014-05-06 2019-06-21 南京先声东元制药有限公司 盐酸苯达莫司汀二聚体的制备方法与应用
JP6608193B2 (ja) * 2014-06-27 2019-11-20 花王株式会社 固形状組成物
WO2016005995A2 (en) * 2014-07-10 2016-01-14 Leiutis Pharmaceuticals Pvt. Ltd. Glycol free stable liquid compositions of bendamustine
JP5897196B1 (ja) * 2015-10-05 2016-03-30 大同化成工業株式会社 糖又は糖アルコール、膨潤型結合剤、崩壊剤及び高吸収性賦形剤を含む複合化造粒物及びその製造方法
CN111201019A (zh) * 2017-10-05 2020-05-26 图贝药物有限公司 口服苯达莫司汀制剂
CN110437261A (zh) * 2018-05-02 2019-11-12 南京诺瑞特医药科技有限公司 苯达莫司汀杂质g的合成方法
CN113768038A (zh) * 2021-09-14 2021-12-10 江苏省协同医药生物工程有限责任公司 一种精准定量实验动物功能性饲料及制备方法与设备
CN117257913B (zh) * 2023-11-23 2024-01-26 江西中医药大学附属医院 一种温肺化纤颗粒剂及其制备方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY191349A (en) * 2004-08-27 2022-06-17 Bayer Pharmaceuticals Corp New pharmaceutical compositions for the treatment of hyper-proliferative disorders
EP1814544A4 (en) * 2004-11-05 2009-12-02 Cephalon Inc CANCER TREATMENTS
US8436190B2 (en) * 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
AR072777A1 (es) * 2008-03-26 2010-09-22 Cephalon Inc Formas solidas de clorhidrato de bendamustina
UA107186C2 (xx) * 2008-12-03 2014-12-10 Тверді форми дозування бендамустину

Also Published As

Publication number Publication date
SI2367538T1 (sl) 2017-11-30
US11160793B2 (en) 2021-11-02
US20170100376A1 (en) 2017-04-13
US20120003309A1 (en) 2012-01-05
UA107186C2 (xx) 2014-12-10
DK2367538T3 (en) 2017-10-02
CY1119839T1 (el) 2018-06-27
EP2367538B1 (en) 2017-08-02
KR101710935B1 (ko) 2017-02-28
AU2009321728A1 (en) 2011-06-30
JP2015061864A (ja) 2015-04-02
EA201190012A1 (ru) 2012-02-28
US20160106716A1 (en) 2016-04-21
CN102292073B (zh) 2018-07-10
LT2367538T (lt) 2017-12-27
BRPI0922804A2 (pt) 2015-12-22
CN107080742B (zh) 2020-08-18
ZA201103790B (en) 2012-08-29
BRPI0922804B1 (pt) 2020-11-17
AU2009321728B2 (en) 2016-07-07
BRPI0922804B8 (pt) 2021-05-25
CN107080742A (zh) 2017-08-22
JP5658679B2 (ja) 2015-01-28
HRP20171421T1 (hr) 2017-11-03
CN102292073A (zh) 2011-12-21
US20140004190A1 (en) 2014-01-02
JP6396980B2 (ja) 2018-09-26
EP2367538A2 (en) 2011-09-28
RS56408B1 (sr) 2018-01-31
MX2011005633A (es) 2011-09-27
IL213269A0 (en) 2011-07-31
JP2012510483A (ja) 2012-05-10
CO6400185A2 (es) 2012-03-15
PT2367538T (pt) 2017-11-14
UA116334C2 (uk) 2018-03-12
EA028179B1 (ru) 2017-10-31
ES2645008T3 (es) 2017-12-01
JP2017057225A (ja) 2017-03-23
IL213269A (en) 2017-04-30
PL2367538T3 (pl) 2017-12-29
WO2010063476A3 (en) 2010-08-05
HUE036481T2 (hu) 2018-07-30
KR20110102392A (ko) 2011-09-16
WO2010063476A2 (en) 2010-06-10
NZ592971A (en) 2013-08-30
CA2745509A1 (en) 2010-06-10

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